Seeking Biotech Alpha JANUARY 2020 Insight

Tybost (cobicistat)

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 On 30 January 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Tybost. The marketing authorisation holder for this medicinal product is Gilead Sciences Ireland UC. 


 

European advisory group backs expanded label for Gilead's Tybost

Jan. 31, 2020 8:55 AM ET|About: Gilead Sciences, Inc. (GILD)|By: , SA News Editor  

 https://seekingalpha.com/news/3536860-european-advisory-group-backs-expanded-label-for-gileads-tybost 


 https://www.gilead.com/-/media/files/pdfs/medicines/hiv/tybost/tybost_pi.pdf 


 https://seekingalpha.com/symbol/GILD 



31 January 2020 EMA/CHMP/55713/2020 Committee for Medicinal Products for Human Use (CHMP) Summary of opinion1 (post authorisation) Tybost cobicistat

leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications

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CytoDyn Announces Stunning Results from Clinical Trials Evaluating mTNBC and MBC with Leronlimab and will Request an Emergency Type C Meeting with FDA to Enroll 50 Awaiting Patients with a Serious Solid Tumor Cancer Condition

Fri January 31, 2020 6:00 AM|GlobeNewswire|About: CYDYGlobeNewswire

VANCOUVER, Washington, Jan. 31, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)


 https://www.cytodyn.com/ 


 https://www.cytodyn.com/pipeline/cancer 


 https://seekingalpha.com/symbol/CYDY 



Leronlimab and Cancer

MabThera (rituximab)

 On 30 January 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product MabThera. The marketing authorisation holder for this medicinal product is Roche Registration GmbH. 


 

European advisory group backs expanded use of Roche's MabThera

Jan. 31, 2020 8:11 AM ET|About: Roche Holding AG (RHHBY)|By: , SA News Editor  

 https://seekingalpha.com/news/3536828-european-advisory-group-backs-expanded-use-of-roches-mabthera 


 https://seekingalpha.com/symbol/RHHBY 




30 January 2020 EMA/CHMP/55667/2020 Committee for Medicinal Products for Human Use (CHMP) Summary of opinion1 (post authorisation) MabThera rituximab

Rezolsta (darunavir/cobicistat)

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 On 30 January 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Rezolsta. The marketing authorisation holder for this medicinal product is Janssen-Cilag International NV. 


 

European advisory group backs expanded use of J&J's Rezolsta

Jan. 31, 2020 8:41 AM ET|About: Johnson & Johnson (JNJ)|By: , SA News Editor  

 https://seekingalpha.com/news/3536851-european-advisory-group-backs-expanded-use-of-j-and-js-rezolsta 


 https://seekingalpha.com/symbol/JNJ 


 https://www.medicines.org.uk/emc/product/3466/smpc 



30 January 2020 EMA/CHMP/36079/2020 Committee for Medicinal Products for Human Use (CHMP) Summary of opinion1 (post authorisation) Rezolsta darunavir / cobicistat

Suliqua (insulin glargine/lixisenatide)

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 On 30 January 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Suliqua. The marketing authorisation holder for this medicinal product is sanofi-aventis groupe. 


 

European advisory group backs updated labeling for Sanofi's Suliqua

Jan. 31, 2020 8:48 AM ET|About: Sanofi (SNY)|By: , SA News Editor  

 https://seekingalpha.com/news/3536853-european-advisory-group-backs-updated-labeling-for-sanofis-suliqua 


 https://seekingalpha.com/symbol/SNY 



30 January 2020 EMA/CHMP/41157/2020 Committee for Medicinal Products for Human Use (CHMP) Summary of opinion1 (post authorisation) Suliqua insulin glargine / lixisenatide

tucatinib, in combination with trastuzumab and capecitabine

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EMA Validates Seattle Genetics’ Marketing Authorization Application for Tucatinib for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

Fri January 31, 2020 8:00 AM|Business Wire|About: SGEN

- Application Supported by Results of Pivotal HER2CLIMB Trial -

- First Investigational Therapy in a Pivotal Trial to Include Patients with Metastatic HER2-Positive Breast Cancer with Active Brain Metastases -

- EU Marketing Authorization Application (MAA) Follows Recent Submission of Tucatinib New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) -

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN)

 

A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer

 https://clinicaltrials.gov/ct2/show/NCT03975647?term=tucatinib&draw=3 


 https://www.seattlegenetics.com/ 


 https://www.businesswire.com/news/home/20200131005084/en/ 

 

TUCATINIB

 https://www.seattlegenetics.com/pipeline/tucatinib 

Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer

Seeking Biotech Alpha JANUARY 2020 Insight

Staquis is crisaborole, a non-corticosteroid dermatological agent for dermatitis, (ATC code: D11AH)

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 On 30 January 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Staquis, intended for the treatment of atopic dermatitis. The applicant for this medicinal product is Pfizer Europe MA EEIG. 

 

European advisory group backs Pfizer's crisaborole for atopic dermatitis

Jan. 31, 2020 7:37 AM ET|About: Pfizer Inc. (PFE)|By: , SA News Editor  

 https://seekingalpha.com/news/3536796-european-advisory-group-backs-pfizers-crisaborole-for-atopic-dermatitis 


 https://seekingalpha.com/symbol/PFE 


 https://www.pfizer.com/ 

30 January 2020 EMA/CHMP/35206/2020 Committee for Medicinal Products for Human Use (CHMP) Summary of opinion1 (initial authorisation) Staquis crisaborole

Rybelsus is semaglutide, a glucagon-like peptide 1 (GLP-1) receptor agonist (ATC code: A10BJ06)

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 On 30 January 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Rybelsus, intended for the treatment of type 2 diabetes. The applicant for this medicinal product is Novo Nordisk A/S. 


 

European advisory group backs Novo's semaglutide for T2D

Jan. 31, 2020 7:32 AM ET|About: Novo Nordisk A/S (NVO)|By: , SA News Editor  

 https://seekingalpha.com/news/3536782-european-advisory-group-backs-novos-semaglutide-for-t2d 


 https://seekingalpha.com/symbol/NVO 


 https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-rybelsus_en.pdf 

Rybelsus® (semaglutide) tablets 7 mg or 14 mg is a prescription medicine for adults with type 2 diabetes that along with diet and exercise may improve blood sugar (glucose). Rybelsus® is not recommended as the first choice of medicine for treating diabetes It is not known if Rybelsus® can be used in people who have had pancreatitis Rybelsus® is not for use in people with type 1 diabetes and people with diabetic ketoacidosis It is not known if Rybelsus® is safe and effective for use in children under 18 years of age

MAVIRET® (glecaprevir/pibrentasvir)

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AbbVie Receives Positive CHMP Opinion for MAVIRET® (glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks in Genotype 3, Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis

Fri January 31, 2020 7:15 AM|PR Newswire|About: ABBV

- Final European Commission decision expected in 2020

PR Newswire

NORTH CHICAGO, Ill., Jan. 31, 2020 /PRNewswire/ -- AbbVie (ABBV)


 https://www.abbvie.com/ 


 https://www.prnewswire.com/news-releases/abbvie-receives-positive-chmp-opinion-for-maviret-glecaprevirpibrentasvir-to-shorten-treatment-duration-to-eight-weeks-in-genotype-3-treatment-naive-patients-with-chronic-hepatitis-c-and-compensated-cirrhosis-300996801.html 


 https://news.abbvie.com/news/press-releases/abbvie-receives-positive-chmp-opinion-for-maviret-glecaprevirpibrentasvir-to-shorten-treatment-duration-to-eight-weeks-in-genotype-3-treatment-nave-patients-with-chronic-hepatitis-c-and-compensated-cirrhosis.htm 


 https://seekingalpha.com/symbol/ABBV 



MAVYRET is a prescription medicine used to treat adults and children 12 years of age and older or weighing at least 99 pounds (45 kilograms) with chronic (lasting a long time) hepatitis C virus (hep C): Genotypes (GT) 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis. Or GT 1 infection and have been previously treated with a regimen that contained a hep C NS5A inhibitor or an NS3/4A protease inhibitor, but not both.

VENCLYXTO® (venetoclax) in combination with obinutuzumab

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AbbVie Receives Positive CHMP Opinion for VENCLYXTO® as a Chemotherapy-Free Combination Regimen for Patients with Previously Untreated Chronic Lymphocytic Leukemia

Fri January 31, 2020 6:55 AM|PR Newswire|About: ABBV

- Represents third positive CHMP opinion for VENCLYXTO; further supports the growing utility of the therapy across multiple lines of CLL

- Positive opinion based on data from Phase 3 CLL14 trial, which showed that patients who completed one year of treatment with VENCLYXTO plus obinutuzumab had prolonged progression-free survival and higher rates of minimal residual disease negativity compared to patients receiving a standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil [1]


Newswire

NORTH CHICAGO, Ill., Jan. 31, 2020 /PRNewswire/ -- AbbVie (ABBV)


 https://www.abbvie.com/our-science/therapeutic-focus-areas/oncology.html 


 https://www.abbvie.com/ 


 https://news.abbvie.com/news/press-releases/abbvie-receives-positive-chmp-opinion-for-venclyxto-as-chemotherapy-free-combination-regimen-for-patients-with-previously-untreated-chronic-lymphocytic-leukemia.htm 


 https://www.prnewswire.com/news-releases/abbvie-receives-positive-chmp-opinion-for-venclyxto-as-a-chemotherapy-free-combination-regimen-for-patients-with-previously-untreated-chronic-lymphocytic-leukemia-300996798.html 


 https://seekingalpha.com/symbol/ABBV 




VENCLEXTA is a prescription medicine used: to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who: are 75 years of age or older, or have other medical conditions that prevent the use of standard chemotherapy. VENCLEXTA was approved based on response rates. Continued approval for this use may depend on the results of an ongoing study to find out how VENCLEXTA works over a longer period of time. It is not known if VENCLEXTA is safe and effective in children.

Liumjev™ - fast-acting formulation of insulin lispro

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CHMP Recommends Approval of Lilly's New Fast-Acting Mealtime Insulin to Improve Glycemic Control in Adults with Diabetes

Fri January 31, 2020 6:15 AM|PR Newswire|About: LLY 


 https://www.humalog.com/index.aspx 


 https://www.lillyinsulinlispro.com/ 


 https://www.lillydiabetes.com/ 


 https://www.lilly.com/ 


 https://investor.lilly.com/news-releases/news-release-details/chmp-recommends-approval-lillys-new-fast-acting-mealtime-insulin 


 https://www.prnewswire.com/news-releases/chmp-recommends-approval-of-lillys-new-fast-acting-mealtime-insulin-to-improve-glycemic-control-in-adults-with-diabetes-300996785.html 



CHMP Recommends Approval of Lilly’s New Fast-Acting Mealtime Insulin to Improve Glycemic Control in Adults with Diabetes

Ruxience is rituximab, a monoclonal antibody (ATC code: L01XC02)

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 On 30 January 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ruxience, intended for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and Pemphigus vulgaris (PV). The applicant for this medicinal product is Pfizer Europe MA EEIG. 


 

European advisory group backs Pfizer's Rituxan biosimilar

Jan. 31, 2020 7:47 AM ET|About: Pfizer Inc. (PFE)|By: , SA News Editor 

 https://seekingalpha.com/news/3536804-european-advisory-group-backs-pfizers-rituxan-biosimilar 


 https://seekingalpha.com/symbol/PFE 

30 January 2020 EMA/CHMP/28049/2020 Committee for Medicinal Products for Human Use (CHMP) Summary of opinion1 (initial authorisation) Ruxience rituximab

Seeking Biotech Alpha JANUARY 2020 Insight

OLUMIANT® (baricitinib) 2-mg

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Lilly and Incyte Announce Positive Top-Line Results from the North American (BREEZE-AD5) Phase 3 Study of Oral Selective JAK Inhibitor Baricitinib in Patients with Moderate to Severe Atopic Dermatitis

Thu January 30, 2020 6:15 AM|PR Newswire|About: INCY, LLY

- Safety profile was consistent with the known safety findings of baricitinib in atopic dermatitis

- Results from this study conducted in North America continue to support a U.S. submission

PR Newswire

INDIANAPOLIS, Jan. 30, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY)


 http://pi.lilly.com/us/olumiant-uspi.pdf 


 https://www.lilly.com/ 

 https://investor.lilly.com/news-releases/news-release-details/lilly-and-incyte-announce-positive-top-line-results-north 


 https://www.incyte.com/ 


 https://www.prnewswire.com/news-releases/lilly-and-incyte-announce-positive-top-line-results-from-the-north-american-breeze-ad5-phase-3-study-of-oral-selective-jak-inhibitor-baricitinib-in-patients-with-moderate-to-severe-atopic-dermatitis-300995759.html 


 https://seekingalpha.com/symbol/INCY 


 https://seekingalpha.com/symbol/LLY 




Olumiant is a Janus kinase (JAK) inhibitor. JAK inhibitors help disrupt how cells respond to some cytokines. Cytokines are proteins that allow cells to communicate with each other, and excess cytokines may cause inflammation. In RA, joint inflammation may cause pain, swelling, and tenderness. It is not known which disrupted cytokines are most related to the therapeutic effects of Olumiant.

darolutamide + ADT

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Bayer's darolutamide extends survival in late-state prostate cancer study

Jan. 30, 2020 7:16 AM ET|About: Bayer Aktiengesellschaft (BAYRY)|By: , SA News Editor  


  Nubeqa 

 

Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Nonmetastatic Castration-resistant Prostate Cancer (ARAMIS)

 https://clinicaltrials.gov/ct2/show/NCT02200614?titles=aramis&lead=bayer&phase=2&draw=2&rank=1 


 https://media.bayer.com/baynews/baynews.nsf/id/en-doccheck-disclaimer?OpenDocument&dcp=Darolutamide-androgen-deprivation-therapy-significantly-increased-overall-survival-non-metastatic&pi=2020-0026&ccm= 


 https://seekingalpha.com/symbol/BAYRY 

NUBEQA is indicated for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC).

Olipudase alfa, an investigational recombinant human acid sphingomyelinase

 

Sanofi : Positive topline results demonstrated by olipudase alfa, first and only investigational therapy in late-stage development for acid sphingomyelinase deficiency

Thu January 30, 2020 1:00 AM|GlobeNewswire|About: SNY

Positive topline results demonstrated by olipudase alfa, first and only investigational therapy in late-stage development for acid sphingomyelinase deficiency

                 · Acid sphingomyelinase deficiency (ASMD) is a rare, progressive and potentially life-threatening disease for which no treatments are approved

PARIS – January 30, 2020 – 


 

i www.clinicaltrials.gov; ClinicalTrials.gov Identifier: NCT02004691

ii www.clinicaltrials.gov; ClinicalTrials.gov Identifier: NCT02292654


 https://www.sanofi.com/en/media-room/press-releases/2020/2020-01-30-07-00-00 


 https://seekingalpha.com/symbol/SNY 



Positive topline results demonstrated by olipudase alfa, first and only investigational therapy in late-stage development for acid sphingomyelinase deficiency

Tendyne™ Transcatheter Mitral Valve Implantation (TMVI) system

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Abbott's Tendyne™ Device Receives World's First CE Mark for Transcatheter Mitral Valve Implantation

Thu January 30, 2020 9:00 AM|PR Newswire|About: ABT

- Tendyne valve provides relief from heart failure symptoms and quality-of-life improvement in high-surgical-risk patients

- Together with MitraClip™, Tendyne expands Abbott's market-leading portfolio of innovative minimally invasive mitral valve solutions

PR Newswire

ABBOTT PARK, Ill., Jan. 30, 2020 /PRNewswire/ -- Abbott (ABT)


 MITRACLIP CLIP DELIVERY SYSTEMS
INDICATION FOR USE 

 https://www.structuralheartsolutions.com/us/structural-heart-products-solutions/mitral-valve-mitraclip/overview/#isi 


 https://www.abbott.com/ 


 https://www.prnewswire.com/news-releases/abbotts-tendyne-device-receives-worlds-first-ce-mark-for-transcatheter-mitral-valve-implantation-300995780.html 


 https://seekingalpha.com/symbol/ABT 



Heart valve invented in Roseville allows new kind of heart treatment Abbott Laboratories

Cobalt™ & Crome™ implantable cardioverter-defibrillators (ICD) & cardiac resynchronization therapy-

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Medtronic Receives CE Mark for Cobalt™ and Crome™ Portfolio of BlueSync™-Enabled Implantable Defibrillators, Cardiac Resynchronization Therapy-Defibrillators

Thu January 30, 2020 9:30 AM|GlobeNewswire|About: MDT

Next Generation Technology Includes Features that Automatically Adjust to Patient Needs, and Offers Physicians Heart Failure Diagnostic Insights

DUBLIN, Jan. 30, 2020 (GLOBE NEWSWIRE) --  Medtronic plc (MDT)


 https://www.medtronic.com/us-en/index.html 


 https://www.medtronic.com/us-en/healthcare-professionals/reimbursement/cardiac-rhythm-heart-failure/resources-device-type/implantable-cardioverter-defibrillators.html 


 https://seekingalpha.com/symbol/MDT 



RESOURCES FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) CARDIAC RHYTHM AND HEART FAILURE

KRAS inhibitor BI 1701963, a FORMA-discovered, BI-licensed protein-protein interaction

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FORMA Reports Achievement of Early-stage Clinical Development Milestones for Assets Licensed Exclusively to Boehringer Ingelheim and Bristol-Myers Squibb

Thu January 30, 2020 7:05 AM|Business Wire|About: BMY

Boehringer Ingelheim initiates Phase 1 clinical trial for SOS1:KRAS inhibitor BI 1701963, a FORMA-discovered, BI-licensed protein-protein interaction program for patients with advanced, KRAS-mutated solid tumors

Bristol-Myers Squibb (BMY) initiates Phase 1B clinical trial in patients with advanced or unresectable solid tumors for FORMA-discovered, Celgene-licensed pan BET inhibitor CC-95775

WATERTOWN, Mass.--(BUSINESS WIRE)-- FORMA Therapeutics, Inc., a clinical stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the achievement of clinical development milestones for two of its exclusively-licensed, clinical-stage products to Boehringer Ingelheim (BI) and Bristol-Myers Squibb Company (BMS) (NYSE:BMY).

BI initiated a Phase 1 clinical trial for BI 1701963, a SOS1:KRAS inhibitor


 https://www.boehringer-ingelheim.com/human-pharma/innovation-disease-focus/beginning-end-kras-cancers 


 https://www.businesswire.com/news/home/20200130005064/en/ 


 https://www.formatherapeutics.com/pipeline/ 


 https://seekingalpha.com/symbol/BMY 

Boehringer Ingelheim Advances First Pan-KRAS Inhibitor BI 1701963 into Clinical Testing Results were presented from the company’s pan-KRAS program including BI 1701963, which is being investigated alone and in combination with MEK inhibition in an ongoing Phase I clinical study in cancer patients Around 15% off all cancers can potentially be blocked by this compound, targeting all major oncogenic KRAS mutations Dual KRAS pathway blockade combining pan-KRAS and MEK inhibition has potential to further enhance efficacy SOS the pacemaker Ingelheim, Germany, 29 October 2019 –

Seeking Biotech Alpha JANUARY 2020 Insight

Selpercatinib (LOXO-292)

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Lilly Receives FDA Priority Review for the Selpercatinib New Drug Application

Wed January 29, 2020 6:45 AM|PR Newswire|About: LLY

INDIANAPOLIS, Jan. 29, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY)


 https://www.lillyoncology.com/ 


 https://www.lilly.com/ 


 https://www.prnewswire.com/news-releases/lilly-receives-fda-priority-review-for-the-selpercatinib-new-drug-application-300995006.html 


 https://seekingalpha.com/symbol/LLY 

Lilly Receives FDA Priority Review for the Selpercatinib New Drug Application PR Newswire PR NewswireJanuary 29, 2020

CABOMETYX® (cabozantinib)

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Exelixis Announces Partner Takeda Files New Drug Application in Japan for CABOMETYX® (cabozantinib) for Advanced Hepatocellular Carcinoma

Wed January 29, 2020 2:01 AM|Business Wire|About: EXEL

– Submission based on two clinical trials in patients with advanced hepatocellular carcinoma who had received prior systemic therapy –

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (EXEL) (NASDAQ: EXEL) today announced that Takeda Pharmaceutical Company Limited (Takeda (TKPHF))


 https://cabometyx.com/downloads/CABOMETYXUSPI.pdf 


 https://www.exelixis.com/ 


 https://www.businesswire.com/news/home/20200128005841/en/ 


 https://seekingalpha.com/symbol/TKPHF 


 https://seekingalpha.com/symbol/EXEL 


 https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-partner-takeda-files-new-drug-application 

CABOMETYX is a prescription medicine used to treat people with: Advanced kidney cancer (renal cell carcinoma) Liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib.

CYNK-001, an allogeneic

 

Sorrento and Celularity to Initiate Emergency Allogeneic Natural Killer (NK) Cell Therapy Development for Coronavirus Infection

Wed January 29, 2020 7:00 AM|GlobeNewswire|About: SRNE

SAN DIEGO and WARREN, N.J., Jan. 29, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (SRNE) 


 https://sorrentotherapeutics.com/ 


 https://www.celularity.com/ 


 https://seekingalpha.com/symbol/SRNE 

our pipeline cell therapy pipeline

Johnson & Johnson Launches Multi-Pronged Response to Coronavirus Global Public Health Threat

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 https://www.janssen.com/  

Johnson & Johnson Launches Multi-Pronged Response to Coronavirus Global Public Health Threat

Wed January 29, 2020 8:48 AM|PR Newswire|About: JNJ 


 J&J enters coronavirus fray with planned vaccine

Jan. 29, 2020 9:11 AM ET|About: Johnson & Johnson (JNJ)|By: , SA News Edito 

 https://seekingalpha.com/news/3535736-j-and-j-enters-coronavirus-fray-planned-vaccine 


 The vaccine program will leverage Janssen's AdVac® and PER.C6® technologies 


 (JNJ)   has also donated 300 boxes of HIV med Prezcobix (darunavir/cobicistat) to the Shanghai Public Health Clinical Center and Zhongnan Hospital of Wuhan University for use in research to support efforts in finding a solution against 2019-nCoV. An additional 50 boxes have been provided to the Chinese Center for Disease Control and Prevention for laboratory-based investigations (drug-screening for antiviral properties against 2019-nCoV). 


 https://www.janssen.com/ 


 https://www.prnewswire.com/news-releases/johnson--johnson-launches-multi-pronged-response-to-coronavirus-global-public-health-threat-300995266.html 

 

What You Need to Know About the Latest on the Coronavirus—and a Potential Preventive Vaccine

The coronavirus has made headlines as it has spread from China to other parts of the world. To help stop the global outbreak in its tracks, Johnson & Johnson is already hard at work on a potential preventive vaccine.By Johnson & JohnsonJanuary 28, 2020 

 https://www.jnj.com/latest-news/what-you-need-to-know-about-coronavirus-and-a-potential-johnson-johnson-vaccine 

PREZCOBIX® is a prescription HIV-1 (Human Immunodeficiency Virus 1) medicine always used with other antiretroviral medicines to treat HIV-1 infection in adults. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). PREZCOBIX® contains prescription medicines PREZISTA® (darunavir) and TYBOST® (cobicistat). PREZCOBIX® does not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses. PREZCOBIX® should be taken once daily with food.

obeticholic acid (OCA) for treatment of cirrhosis due to nonalcoholic steatohepatitiitis (NASH)

 

Intercept Completes Enrollment of Phase 3 REVERSE Study Evaluating Obeticholic Acid for the Treatment of Compensated Cirrhosis due to NASH

Wed January 29, 2020 8:00 AM|GlobeNewswire|About: ICPT

NEW YORK, Jan. 29, 2020 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (ICPT)


 https://www.interceptpharma.com/ 


 https://seekingalpha.com/symbol/ICPT 



Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (REVERSE)

technology designed to individually or in combination, stimulate and enhance the immune system

 

Technology platforms

Our four current technologies are designed to stimulate and enhance the immune system.


Technology  

Vir Biotech up 21% on coronavirus buying frenzy

Jan. 27, 2020 10:19 AM ET|About: Vir Biotechnology, Inc. (VIR)|By: , SA News Editor  platforms

Our four current technologies are designed to stimulate and enhance the immune system.


 (VIR)   has four technology platforms that it is leveraging to develop treatments for infectious diseases, including influenza and tuberculosis. 


 https://seekingalpha.com/symbol/VIR 


 https://www.vir.bio/ 


Vir Biotechnology (VIR) Presents At 38th Annual J.P. Morgan Healthcare Conference - Slideshow Jan. 15, 2020 3:23 PM ET | About: Vir Biotechnology, Inc. (VIR)

Seeking Biotech Alpha JANUARY 2020 Insight

KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy

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European Medicines Agency Validates Kite’s Marketing Application for Company’s Second CAR T Cell Therapy

Tue January 28, 2020 4:15 PM|Business Wire|About: GILD

-- Investigational KTE-X19 To Be First Chimeric Antigen Receptor (CAR) T Cell Therapy for Mantle Cell Lymphoma in Europe if Approved --

-- Filing for Kite’s Second CAR T Therapy Marks Potential Expansion of Company’s Cell Therapy Portfolio --

SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD)


 https://www.kitepharma.com/ 


 https://www.gilead.com/ 


 https://www.businesswire.com/news/home/20200128005723/en/ 


 https://seekingalpha.com/symbol/GILD 


Pipeline Gilead’s research and development program identifies and evaluates investigational compounds that show potential to advance the treatment of life-threatening diseases in areas of unmet medical need.

ZIRABEV™ (bevacizumab-bvzr), RUXIENCE™ (rituximab-pvvr) and TRAZIMERA™ (trastuzumab-qyyp)

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PFIZER BRINGS THREE NEW BIOSIMILARS TO U.S. PATIENTS AT SUBSTANTIAL DISCOUNTS

January 23, 2020

Pfizer will become the first company to bring three oncology monoclonal antibody (mAb) biosimilar treatments to the U.S. market

Pfizer announced that it is introducing three new biosimilars, ZIRABEV™ (bevacizumab-bvzr), RUXIENCE™ (rituximab-pvvr) and TRAZIMERA™ (trastuzumab-qyyp) in the United States (U.S.). The medicines are expected to launch at the lowest Wholesale Acquisition Cost (WAC) among bevacizumab, rituximab or trastuzumab products currently on the market, becoming available at a substantially discounted price to the originator product.


 https://www.pfizer.com/ 


 

1 Avastin® is a registered trademark of Genentech, Inc.

2 Rituxan® is a registered trademark of Genentech, Inc. and Biogen, Inc.

3 Herceptin® is a registered trademark of Genentech, Inc.


 https://clinicaltrials.gov/ct2/show/NCT02031991?term=reflections%2Bbevacizumab 


 https://clinicaltrials.gov/ct2/show/NCT01989676?term=NCT01989676 


 https://clinicaltrials.gov/ct2/show/NCT02187744?term=NCT02187744 


 https://seekingalpha.com/symbol/PFE 

Pfizer launches three biosimilars priced for market penetration Jan. 28, 2020 11:29 AM ET|About: Pfizer Inc. (PFE)|By: Douglas W. House, SA News Editor

XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension)

 

Bausch Health and Clearside Biomedical Announce Publication of PIVOTAL Phase 3 Data ON XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension) in Ophthalmology

Tue January 28, 2020 7:00 AM|PR Newswire|About: BHC, CLSD

LAVAL, Quebec and ALPHARETTA, Ga., Jan. 28, 2020 /PRNewswire/ -- Bausch Health Companies Inc. (BHC) ("Bausch Health") and Bausch + Lomb, its leading global eye health business, and Clearside Biomedical (CLSD), Inc. (Nasdaq: CLSD)


 http://www.clearsidebio.com/ 


 https://www.bausch.com/ 


 https://www.prnewswire.com/news-releases/bausch-health-and-clearside-biomedical-announce-publication-of-pivotal-phase-3-data-on-xiperetm-triamcinolone-acetonide-suprachoroidal-injectable-suspension-in-ophthalmology-300994122.html 


 https://seekingalpha.com/symbol/BHC 

 https://seekingalpha.com/symbol/CLSD 

Bausch Health and Clearside Biomedical Announce Publication of PIVOTAL Phase 3 Data ON XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) in Ophthalmology 01/28/20 PDF Version LAVAL, Quebec and ALPHARETTA, Ga., Jan. 28, 2020 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") and Bausch + Lomb, its leading global eye health business, and Clearside Biomedical, Inc. (Nasdaq: CLSD),

AJOVY® (fremanezumab-vfrm) Injection Autoinjector

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Teva Announces FDA Approval of AJOVY® (fremanezumab-vfrm) Injection Autoinjector

Tue January 28, 2020 4:05 PM|Business Wire|About: TEVA

PARSIPPANY, N.J.--(BUSINESS WIRE)-- Teva Pharmaceuticals USA, Inc. an affiliate of Teva Pharmaceutical Industries Ltd. (TEVVF) (NYSE and TASE: TEVA)


 https://www.tevapharm.com/ 


 https://www.businesswire.com/news/home/20200128005810/en/ 


 https://seekingalpha.com/symbol/TEVA 

AJOVY is a prescription medicine used for the preventive treatment of migraine in adults.

AKCEA-ANGPTL3-LRx

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Akcea and Ionis report positive topline phase 2 study results of AKCEA-ANGPTL3-LRx

Tue January 28, 2020 4:05 PM|GlobeNewswire|About: AKCA, IONS

Favorable safety and tolerability were observed

Primary and multiple secondary endpoints were met with significant reduction in triglyceride levels, additional lipid parameters and ANGPTL3

BOSTON and CARLSBAD, Calif., Jan. 28, 2020 (GLOBE NEWSWIRE) -- Akcea Therapeutics, Inc. (AKCA), a majority-owned affiliate of Ionis Pharmaceuticals, Inc. (IONS), and Ionis Pharmaceuticals, Inc.,


 https://akceatx.com/ 


 https://www.ionispharma.com/ 


 https://akceatx.com/our-programs/pipeline/ 


 https://seekingalpha.com/symbol/IONS 

 https://seekingalpha.com/symbol/AKCA 

AKCEA-ANGPTL3-LRx for the treatment of rare hyperlipidemias We are developing AKCEA-ANGPTL3-LRx to treat multiple lipid disorders, or rare hyperlipidemias. In preclinical studies, an analog of AKCEA-ANGPTL3-LRx inhibited the production of the angiopoietin like 3, or ANGPTL3, protein in the liver, inhibiting liver fat accumulation and lowering blood levels of LDL C and very low density lipoprotein cholesterol, or VLDL C.

novel coronavirus (2019-nCoV)

 

China coronavirus: death toll hits 132 as number of cases surpasses that of Sars

  • There are 840 newly confirmed cases in Hubei province, where the outbreak began, Chinese health authorities say
  • Most patients who have died were older than 60 and had pre-existing conditions, according to local authorities

Cissy Zhou andWilliam Zheng

Published: 7:08am, 29 Jan, 2020


 https://www.caixinglobal.com/ 


 Jan 29, 2020 06:25 AMSOCIETY & CULTURE

Hong Kong Sharply Cuts Transport Links With Mainland in Virus Fight

By Wen Simin, Zhao Zuoyan and Denise Jia 

 https://www.caixinglobal.com/2020-01-29/hong-kong-sharply-cuts-transport-links-with-mainland-in-virus-fight-101509187.html 


 China coronavirus: Washington asks Beijing for permission to send health team to battle outbreak

  • Health and Human Services Secretary Alex Azar says he hopes ‘the Chinese government will take us up’ on the offer
  • Centres for Disease Control and Prevention director says agency seeks data concerning the transmission of the disease

Robert Delaney

Published: 2:04am, 29 Jan, 2020

 https://www.scmp.com/news/china/article/3047967/china-coronavirus-washington-asks-beijing-permission-send-health-team 


 Wuhan Virus  

Source: China's NHC, state media, other authorities

SCMP

 https://multimedia.scmp.com/widgets/china/wuhanvirus/# 

 

Frequently Asked Influenza (Flu) Questions: 2019-2020 Season

Español 

 https://www.cdc.gov/flu/season/faq-flu-season-2019-2020.htm 

Jan 28, 2020 10:26 PM Wuhan Virus Latest: Transportation Curbs Proliferate as China Fights to Limit Spread of Coronavirus By Lin Jinbing, Dave Yin, Han Wei, Flynn Murphy and Matthew Walsh

Seeking Biotech Alpha JANUARY 2020 Insight

Dupixent® (dupilumab)

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FDA Accepts for Priority Review Dupixent® (dupilumab) for Children Aged 6 to 11 Years with Moderate-to-Severe Atopic Dermatitis

Tue January 28, 2020 12:59 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y. and PARIS, Jan. 28, 2020 /PRNewswire/ --

If approved, Dupixent would be the first biologic medicine available in the U.S. for these children

Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi 


 https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf 


 https://www.regeneron.com/ 


 https://investor.regeneron.com/news-releases/news-release-details/fda-accepts-priority-review-dupixentr-dupilumab-children-aged-6 

 https://www.prnewswire.com/news-releases/fda-accepts-for-priority-review-dupixent-dupilumab-for-children-aged-6-to-11-years-with-moderate-to-severe-atopic-dermatitis-300994046.html 


 https://seekingalpha.com/symbol/REGN 


DUPIXENT is a prescription medicine used: to treat people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 12 years of age. with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. DUPIXENT is not used to treat sudden breathing problems. It is not known if DUPIXENT is safe and effective in children with asthma under 12 years of age. with other medicines to treat chronic rhinosinusitis with nasal polyposis in adults whose disease is not controlled.

Trijardy™ XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets)

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  Trijardy combines three medicines - Jardiance (empagliflozin), Tradjenta (linagliptin) and metformin hydrochloride extended release - in one pill, which will be a once-a-day medication. 


US FDA approves only triple-combination tablet with Jardiance® for adults with type 2 diabetes

Mon January 27, 2020 5:34 PM|PR Newswire|About: LLYPR Newswire

RIDGEFIELD, Conn., and INDIANAPOLIS, Jan. 27, 2020 /PRNewswire/


 https://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Trijardy%20XR/Trijardy%20XR.pdf?DMW_FORMAT=pdf 


 https://www.boehringer-ingelheim.us/our-responsibility/our-responsibility 


 https://www.lillydiabetes.com/ 


 https://www.prnewswire.com/news-releases/us-fda-approves-only-triple-combination-tablet-with-jardiance-for-adults-with-type-2-diabetes-300993928.html 


 https://www.lilly.com/ 


 

TRADJENTA is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

TRADJENTA is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

If you have had inflammation of the pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take TRADJENTA.

 https://www.tradjenta.com/ 


 JARDIANCE is the first type 2 diabetes pill proven to go beyond lowering A1C to reduce the risk of cardiovascular (CV) death for adults who have type 2 diabetes and known heart disease. 

 https://www.jardiance.com/ 

U.S. FDA Accepts New Drug Application for Triple Combination Tablet for Adults with Type 2 Diabetes Ridgefield, Conn. and Indianapolis, June 4, 2019 – The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the investigational fixed-dose combination tablet of empagliflozin, linagliptin and metformin extended release (XR) for the treatment of adults with type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.

ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder

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Alkermes Announces U.S. Food and Drug Administration Acceptance of ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder

Tue January 28, 2020 7:00 AM|PR Newswire|About: ALKS

DUBLIN, Jan. 28, 2020 /PRNewswire/ -- Alkermes plc (ALKS) (Nasdaq: ALKS)


 http://www.alkermes.com/ 


 https://www.prnewswire.com/news-releases/alkermes-announces-us-food-and-drug-administration-acceptance-of-alks-3831-new-drug-application-for-treatment-of-schizophrenia-and-bipolar-i-disorder-300994014.html 


 https://seekingalpha.com/symbol/ALKS 

Alkermes Announces U.S. Food and Drug Administration Acceptance of ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder DUBLIN, Jan. 28, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS)

Bria-IMT™ in combination with pembrolizumab KEYTRUDA®

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BriaCell’s Clinical Data Accepted to be Presented at the Annual Symposium of Society of Surgical Oncology 2020 in Boston

Tue January 28, 2020 6:30 AM|GlobeNewswire|About: MRK

Safety and early efficacy data to be presented from clinical trial of Bria-IMT™ in combination with immune checkpoint inhibitors in advanced breast cancer:
• Bria-IMT™ in combination with pembrolizumab (KEYTRUDA®; by Merck & Co., Inc. (MRK));
• Bria-IMT™ in combination with INCMGA00012 (by Incyte Corporation).

BERKELEY, Calif., and VANCOUVER, British Columbia, Jan. 28, 2020 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (BCTXF) ("BriaCell" or the "Company") (TSX-V:BCT) (OTCQB:BCTXD)


 https://briacell.com/novel-technology/scientific-publications/ 


  ClinicalTrials.gov as NCT03328026. 


 https://briacell.com/ 


 http://www.cancerinsight.com/ 


 https://seekingalpha.com/symbol/BCTXF 


BriaCell’s Clinical Data Accepted to be Presented at the Annual Symposium of Society of Surgical Oncology 2020 in Boston POSTED ON JANUARY 28, 2020 BY FARRAH DEAN Safety and early efficacy data to be presented from clinical trial of Bria-IMT™ in combination with immune checkpoint inhibitors in advanced breast cancer: • Bria-IMT™ in combination with pembrolizumab (KEYTRUDA®; by Merck & Co., Inc.); • Bria-IMT™ in combination with INCMGA00012 (by Incyte Corporation). BERKELEY, Calif., and VANCOUVER, British Columbia, January 28, 2020 — BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSX-V:BCT) (OTCQB:BCTXD)

Vascepa® (Icosapent Ethyl)

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HLS Therapeutics Provides Investor Update on the Canadian Launch of Vascepa® (Icosapent Ethyl)

Tue January 28, 2020 6:30 AM|Canada Newswire|About: AMRN, HLTRF

  • Vascepa to be available on or about February 18, 2020, supported by a national Cardiovascular salesforce
  • Vascepa becomes the first and only Health Canada-approved medication for reducing cardiovascular risk beyond cholesterol-lowering therapy in the studied high-risk patients approved for treatment
  • Vascepa is supported by data from the REDUCE-IT® trial, an international 8,179 patient outcomes study that showed a 25% placebo-controlled risk reduction in the first occurrence of major adverse cardiovascular events
  • Cardiovascular disease is the number one killer globally1 and HLS is taking steps to make Vascepa accessible and affordable to the Canadian population

TORONTO, Jan. 28, 2020 /CNW/ - HLS Therapeutics Inc. (HLTRF) ("HLS" or the "Company") (TSX:HLS),


 http://www.hlstherapeutics.com/ 


 https://www.vascepa.com/ 

 

Vascepa to launch in Canada next month

Jan. 28, 2020 6:55 AM ET|About: HLS Therapeutics Inc. (HLTRF)|By: , SA News Editor 

 https://seekingalpha.com/news/3535025-vascepa-to-launch-in-canada-next-month 


 https://seekingalpha.com/symbol/HLTRF 


 https://seekingalpha.com/symbol/AMRN 

VASCEPA® is now approved, along with certain medicines (statins), to reduce the risk of heart attack, stroke and certain types of heart issues requiring hospitalization in adults with heart (cardiovascular) disease, or diabetes and 2 or more additional risk factors for heart disease. READ PRESS RELEASE READ FDA APPROVAL

ruxolitinib cream

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Incyte Announces that the TRuE-AD2 Pivotal Trial of Ruxolitinib Cream Met its Primary Endpoint in Patients with Atopic Dermatitis

Tue January 28, 2020 7:30 AM|Business Wire|About: INCY

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (INCY)


 https://clinicaltrials.gov/ct2/show/NCT03745651 


 https://clinicaltrials.gov/ct2/show/NCT03745638 


 https://www.incyte.com/ 


 https://www.businesswire.com/news/home/20200128005173/en/ 


 https://investor.incyte.com/news-releases/news-release-details/incyte-announces-true-ad2-pivotal-trial-ruxolitinib-cream-met 


 https://seekingalpha.com/symbol/INCY 

Incyte's Big Dermatitis Week: Ruxolitinib and Baricitinib Hit Primary Endpoints Published: Jan 28, 2020 By Mark Terry

Seeking Biotech Alpha JANUARY 2020 Insight

DIFICID® (fidaxomicin)

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FDA Approves Merck’s DIFICID® (fidaxomicin) to Treat Clostridioides difficile in Children Aged Six Months and Older

Mon January 27, 2020 6:45 AM|Business Wire|About: MRK

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK)


 https://www.businesswire.com/news/home/20200127005296/en/ 


 https://www.merck.com/index.html 


 https://www.merckconnect.com/dificid/coverage/ 


 https://www.mrknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-dificid-fidaxomicin-treat-clostridioides 

DIFICID is a macrolide antibacterial drug indicated in adults (≥18 years of age) for treatment of Clostridium difficile-associated diarrhea (CDAD). To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile.

BRILINTA (ticagrelor) 90 mg

 

BRILINTA Met Primary Endpoint in the Phase III THALES Trial in Stroke

Mon January 27, 2020 7:00 AM|Business Wire|About: AZN

BRILINTA reduced the risk of the composite of stroke and death after an acute ischemic stroke or transient ischemic attack

WILMINGTON, Del.--(BUSINESS WIRE)-


 https://www.azpicentral.com/brilinta/brilinta.pdf#page=1 


 https://www.businesswire.com/news/home/20200127005174/en/ 


 https://www.astrazeneca-us.com/ 


 https://www.astrazeneca-us.com/content/az-us/media/press-releases/2020/brilinta-met-primary-endpoint-in-the-phase-iii-thales-trial-in-stroke-01272020.html 


 https://www.brilinta.com/#isihead 


 

AstraZeneca's Brilinta reduced risk of stroke & death in late-stage study

Jan. 27, 2020 7:28 AM ET|About: AstraZeneca PLC (AZN)|By: , SA News Editor  

 https://seekingalpha.com/news/3534593-astrazenecas-brilinta-reduced-risk-of-stroke-death-in-late-stage-study 

BRILINTA is used to lower your chance of having another heart attack or dying from a heart attack or stroke, but BRILINTA (and similar drugs) can cause bleeding that can be serious and sometimes lead to death. Instances of serious bleeding, such as internal bleeding, may require blood transfusions or surgery. While you take BRILINTA, you may bruise and bleed more easily and be more likely to have nosebleeds. Bleeding will also take longer than usual to stop.

JAK Inhibitor Baricitinib in Combination with Topical Corticosteroids

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Lilly and Incyte Announce Top-Line Results from Phase 3 Study (BREEZE-AD4) of Oral Selective JAK Inhibitor Baricitinib in Combination with Topical Corticosteroids in Patients with Moderate to Severe Atopic Dermatitis Not Controlled with Cyclosporine

Mon January 27, 2020 6:45 AM|PR Newswire|About: INCY, LLY

- Safety profile was consistent with the known safety findings of baricitinib in atopic dermatitis (AD)

- Study was conducted outside of the U.S. and is the first and only report of a JAK inhibitor in patients who failed, were intolerant, or contraindicated to cyclosporine

PR Newswire

INDIANAPOLIS, Jan. 24, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY) and Incyte (INCY) 


 http://pi.lilly.com/us/olumiant-uspi.pdf 


 https://www.lilly.com/ 


 https://www.incyte.com/ 


 https://www.prnewswire.com/news-releases/lilly-and-incyte-announce-top-line-results-from-phase-3-study-breeze-ad4-of-oral-selective-jak-inhibitor-baricitinib-in-combination-with-topical-corticosteroids-in-patients-with-moderate-to-severe-atopic-dermatitis-not-controlle-300993285.html 



Lilly and Incyte Announce Top-Line Results from Phase 3 Study (BREEZE-AD4) of Oral Selective JAK Inhibitor Baricitinib in Combination with Topical Corticosteroids in Patients with Moderate to Severe Atopic Dermatitis Not Controlled with Cyclosporine 27 January, 2020

Tecentriq® (atezolizumab) & Avastin® (bevacizumab)

image174

 

Genentech Submits Supplemental Biologics License Application to the FDA for Tecentriq in Combination With Avastin for the Most Common Form of Liver Cancer

Mon January 27, 2020 1:00 AM|Business Wire|About: RHHBY

– Application is being reviewed under FDA's Real-Time Oncology Review pilot program –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)


 https://www.gene.com/topics/cancer-immunotherapy 


 https://www.gene.com/ 


 https://www.businesswire.com/news/home/20200126005034/en/ 


 https://www.gene.com/media/press-releases/14835/2020-01-26/genentech-submits-supplemental-biologics 


 https://www.avastin.com/ 


 https://www.tecentriq.com/ 


TECENTRIQ is a prescription medicine used to treat adults with: A type of bladder and urinary tract cancer called urothelial carcinoma. - A type of lung cancer called non-small cell lung cancer (NSCLC). - A type of breast cancer called triple-negative breast cancer (TNBC).

STELARA® (ustekinumab)

image175

 

Health Canada Approves New Indication for STELARA®* (ustekinumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

Mon January 27, 2020 7:31 AM|Canada Newswire

In the Phase 3 pivotal trial, nearly 44 per cent of patients receiving STELARA® subcutaneous (SC) injections every 8 weeks were in clinical remission at one year

TORONTO, Jan. 27, 2020 /CNW/ - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has approved STELARA® (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC)


 https://www.nejm.org/doi/10.1056/NEJMoa1900750 


 https://www.janssen.com/canada/ 


 https://www.jnj.com/ 



STELARA® is a prescription medicine used to treat adults 18 years and older with moderately to severely active Crohn’s disease. STELARA® is a prescription medicine used to treat adults 18 years and older with moderately to severely active ulcerative colitis. STELARA® is a prescription medicine used to treat adults and children 12 years and older with moderate or severe psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). STELARA® is a prescription medicine used to treat adults 18 years and older with active psoriatic arthritis. STELARA® can be used alone or with the medicine methotrexate.

DESTINY-Gastric01 trial of DS-8201, a HER2 directed antibody drug conjugate (ADC)

 

Phase 2 DESTINY-Gastric01 Trial of DS-8201 Versus Chemotherapy Met Primary Endpoint

Mon January 27, 2020 2:00 AM|Business Wire|About: DSNKY

  • Trial met primary endpoint of objective response rate and key secondary endpoint of overall survival in patients with previously treated HER2 positive metastatic gastric cancer

TOKYO, MUNICH & BASKING RIDGE, N.J.--(BUSINESS WIRE)-- Daiichi Sankyo Company, Limited (DSKYF) (hereafter, Daiichi Sankyo (DSKYY)) and AstraZeneca 


 https://dsi.com/oncology 


 https://www.daiichisankyo.com/ 


 https://www.businesswire.com/news/home/20200126005029/en/ 


 

Daiichi/AstraZeneca ADC successful in mid-stage gastric cancer study

Jan. 27, 2020 11:29 AM ET|About: Daiichi Sankyo Company... (DSKYF)|By: , SA News Editor 

 https://seekingalpha.com/news/3534766-daiichi-astrazeneca-adc-successful-in-mid-stage-gastric-cancer-study 


 

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]

 https://clinicaltrials.gov/ct2/show/NCT03329690?term=destiny-gastric01&draw=2&rank=1 

Phase 2 DESTINY-Gastric01 Trial of DS-8201 Versus Chemotherapy Met Primary Endpoint January 27, 2020 Trial met primary endpoint of objective response rate and key secondary endpoint of overall survival in patients with previously treated HER2 positive metastatic gastric cancer Tokyo, Munich and Basking Ridge, NJ – (January 27, 2020) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca

Seeking Biotech Alpha JANUARY 2020 Insight

DKN-01 plus KEYTRUDA® (pembrolizumab)

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Leap Therapeutics Presents Updated Data at the ASCO 2020 Gastrointestinal Cancers Symposium (ASCO GI) Global Meeting

Thu January 23, 2020 7:00 AM|PR Newswire|About: LPTX

- Tumoral DKK1 levels will be used to prospectively identify patients in subsequent studies in new collaboration with BeiGene

- Radiomic imaging analysis has identified a potentially useful biomarker to non-invasively evaluate DKK1 expression

PR Newswire

CAMBRIDGE, Mass., Jan. 23, 2020 /PRNewswire/ -- Leap Therapeutics, Inc. (LPTX)


 https://www.prnewswire.com/news-releases/leap-therapeutics-presents-updated-data-at-the-asco-2020-gastrointestinal-cancers-symposium-asco-gi-global-meeting-300991794.html 


 https://www.leaptx.com/ 


 https://investors.leaptx.com/news-releases/news-release-details/leap-therapeutics-presents-updated-data-asco-2020 


 

Leap's DKN-01 shows positive effect in esophagogastric cancer

Jan. 23, 2020 7:48 AM ET|About: Leap Therapeutics, Inc. (LPTX)|By: , SA News Editor 

 https://seekingalpha.com/news/3533853-leaps-dknminus-01-shows-positive-effect-in-esophagogastric-cancer 

First-In-Class Antibodies

PulseSelect™ Pulsed Field Ablation (PFA) System

 

Medtronic Receives FDA Approval for Trial Evaluating New Energy Source with Pulsed Electric Fields to Treat Atrial Fibrillation

Thu January 23, 2020 10:00 AM|GlobeNewswire|About: MDT

Investigative Technology Designed to Interrupt Irregular Pathways in the Heart

DUBLIN, Jan. 23, 2020 (GLOBE NEWSWIRE) --  Medtronic plc (MDT)


 https://www.medtronic.com/us-en/index.html 


Emprint™ Ablation System with Thermosphere™ Technology

The Emprint™ ablation system maintains predictable spherical ablation zones throughout procedures.

 https://www.medtronic.com/covidien/en-us/products/ablation-systems/emprint-ablation-system.html 

 

FDA signs off on study of Medtronic PFA system for atrial fibrillation

Jan. 23, 2020 10:27 AM ET|About: Medtronic plc (MDT)|By: , SA News Editor  

 https://seekingalpha.com/news/3533983-fda-signs-off-on-study-of-medtronic-pfa-system-for-atrial-fibrillation 

ABLATION SYSTEMS CONTACT US

novel coronavirus (2019-nCoV)

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China coronavirus: first fatality reported outside Hubei province as man dies in Hebei near Beijing, while eight cities now on lockdown

  • The Hebei victim, aged 80, was visiting relatives in Wuhan before he was diagnosed; 76 people who had close contact with him have reportedly been quarantined
  • Travel bans have been imposed on eight cities in Hubei province: Wuhan, Huanggang, Ezhou, Chibi, Xiantao, Qianjiang, Zhijiang and Lichuan

Cissy Zhou andRobert Delaney in Washington

Published: 2:05am, 24 Jan, 2020


 

Patients with no history of Wuhan travel confirmed with viral infection

Source: Xinhua| 2020-01-23 21:53:15|Editor: huaxia 

 http://www.xinhuanet.com/english/2020-01/23/c_138729811.htm 


 

More cities in China's Hubei suspend public transport to curb virus spread

Source: Xinhua| 2020-01-23 21:26:12|Editor: huaxia 

 http://www.xinhuanet.com/english/2020-01/23/c_138729715.htm 

Jan 23, 2020 10:21 PM Wuhan Virus Latest: Transit Bans Spread to 7 Cities as New Year Events Are Cancelled By Matthew Walsh, Flynn Murphy and Han Wei

cabozantinib (CABOMETYX®) and nivolumab (Opdivo®) with or without ipilimumab (Yervoy®)

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Exelixis Announces Results for Combination of Cabozantinib and Nivolumab With or Without Ipilimumab in Advanced Hepatocellular Carcinoma

Fri January 24, 2020 7:30 AM|Business Wire|About: EXEL

– Data from the CheckMate 040 trial presented at the 2020 American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium –

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (EXEL)


 https://www.exelixis.com/ 


 https://clinicaltrials.gov/ct2/show/NCT01658878?term=NCT01658878 


 https://www.businesswire.com/news/home/20200124005066/en/ 


 https://www.cabometyx.com/ 


 https://seekingalpha.com/symbol/EXEL 

What is CABOMETYX? CABOMETYX is a prescription medicine used to treat people with: Advanced kidney cancer (renal cell carcinoma) Liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib.

KALETRA® (lopinavir/ritonavir) Tablets and KALETRA® (lopinavir/ritonavir) Oral Solution

 

China names HIV drugs as part of treatment plan for Wuhan virus

BLOOMBERG

BEIJING – China is using AbbVie Inc.’s HIV drugs as an ad-hoc treatment for pneumonia caused by the novel coronavirus while the global search for a cure continues.

 

World
China Names AbbVie’s HIV Drugs in Treatment Plan for New Virus

 https://www.bloomberg.com/news/articles/2020-01-26/china-names-abbvie-s-hiv-drugs-in-treatment-plan-for-new-virus 

 

AbbVie Drugs Named as Part of China Treatment Plan: Virus Update

 https://www.bloomberg.com/news/articles/2020-01-25/wuhan-gets-aid-as-singapore-malaysia-report-cases-virus-update 

 

5 million residents left Wuhan before lockdown, mayor reveals, as 1,000 new confirmed cases expected in city

 https://www.scmp.com/news/china/society/article/3047720/chinese-premier-li-keqiang-head-coronavirus-crisis-team-outbreak 


 https://www.abbvie.com/our-science/products.html 

 

Scientists race to find out how Wuhan victims became ill

 https://www.theguardian.com/science/2020/jan/25/scientists-race-to-find-out-how-wuhan-victims-became-ill-coronavirus 


 https://www.nytimes.com/2020/01/25/world/asia/china-coronavirus.html 

 

 https://www.caixinglobal.com/ 


Wuhan Coronavirus map (with updates)

 https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6 


 Wuhan Virus 

 https://multimedia.scmp.com/widgets/china/wuhanvirus/# 

What are KALETRA® (lopinavir/ritonavir) tablets and oral solution?2 KALETRA is a prescription medicine that is used with other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults and children 14 days of age and older. HIV is the virus that causes AIDS (acquired immune deficiency syndrome). It is not known if KALETRA is safe and effective in children under 14 days old.

novel coronavirus (2019-nCoV)

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China coronavirus: Wuhan residents describe ‘doomsday’ scenes as patients overwhelm hospitals

  • One woman said her husband had been feverish and coughing blood but was turned away by several hospitals that said they had no room
  • Desperate scenes come as death toll rises to 41 and more than 1,000 cases of infection confirmed nationwide

Mimi Lau

Published: 7:00am, 25 Jan, 2020


 

China coronavirus: Death toll rises to 41; more than 1,000 cases of infection confirmed in mainland

  • Deaths in Hubei province, the epidemic’s epicentre, rise by 15 as contagion spreads
  • Some 29 Chinese provinces have reported 1,112 cases of the deadly pneumonia-like virus

Cissy Zhou

Published: 7:35am, 25 Jan, 2020

 https://www.scmp.com/news/china/society/article/3047631/china-coronavirus-death-toll-rises-41-over-1000-cases-infection 

 Jan 24, 2020 06:43 PMSOCIETY & CULTURE

Wuhan Virus Latest: U.S. Confirms 2nd Case as 15 China Jurisdictions Declare ‘Level I’ Emergency

By Matthew Walsh, Flynn Murphy, Han Wei and Lin Jinbing 

 https://www.caixinglobal.com/2020-01-24/wuhan-virus-latest-china-reports-second-pneumonia-linked-death-101505300.html 


 

China reports 1,287 confirmed cases of new coronavirus pneumonia, 41 deaths

Source: Xinhua| 2020-01-25 09:14:13|Editor: Lu Hui 

 http://www.xinhuanet.com/english/2020-01/25/c_138732461.htm 


 https://www.caixinglobal.com/ 


 Jan 25, 2020 12:46 AMSOCIETY & CULTURE

Months Needed to Develop Coronavirus Vaccine: Epidemiology Group

By Dave Yin 

 https://www.caixinglobal.com/2020-01-25/months-needed-to-develop-coronavirus-vaccine-epidemiology-group-101508197.html 

Coronavirus response highlights flaws in the way China’s bureaucracy handles a crisis After a slow response to the situation, Beijing needs to act promptly and boost transparency as its credibility is once again on the line As President Xi Jinping has consolidated power and tightened controls, officials tend to cover up disasters and avoid taking decisions Wang Xiangwei Wang Xiangwei Published: 9:30am, 25 Jan, 2020

Seeking Biotech Alpha JANUARY 2020 Insight

Baqsimi™ (glucagon nasal powder 3 mg)

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Ready for Rescue – New Nasally Administered Glucagon for Severe Hypoglycemia Available in Canada

Thu January 23, 2020 8:00 AM|GlobeNewswire|About: LLYGlobeNewswire

TORONTO, Jan. 23, 2020 (GLOBE NEWSWIRE) -- Eli Lilly Canada


 https://www.lilly.ca/en/index.aspx 


 https://www.diabetes.ca/health-care-providers/clinical-practice-guidelines/chapter-14#panel-tab_FullText 


 https://www.baqsimi.ca/ 


 https://www.baqsimi.com/ 



Be prepared with BAQSIMI. The first and only dry nasal spray to treat low blood sugar emergencie

KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with Inlyta® (axitinib)

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Health Canada Approves KEYTRUDA® (pembrolizumab) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma (RCC)

Thu January 23, 2020 7:31 AM|Canada Newswire|About: MRK

Approval Based on Results of KEYNOTE-426, Where KEYTRUDA® in Combination with Axitinib Reduced the Risk of Death by Nearly Half Compared to Sunitinib

  • Renal cell carcinoma (RCC) is the most common form of kidney cancer, representing 80 per cent of all cases1
  • The five-year survival rate for advanced RCC is currently estimated to be 8 per cent2

KIRKLAND, QC, Jan. 23, 2020 /CNW/ - Merck (MRK)


 https://www.merck.ca/en/home/ 


 https://www.merck.ca/static/pdf/KEYTRUDA-PM_E.pdf 


 https://www.inlyta.com/ 


 https://www.keytruda.com/ 



KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen any time during treatment or even after your treatment has ended.

Generic Version of Viagra® (sildenafil citrate)

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Pfizer’s Greenstone and Digital Men’s Health Clinic Roman Collaborate to Offer Patients Remote Access to the Only FDA-Approved Authorized Generic Version of Viagra® (sildenafil citrate)

Thu January 23, 2020 6:45 AM|Business Wire|About: PFE

Agreement provides Roman members with erectile dysfunction treatment backed by Pfizer’s quality manufacturing standards and supply chain excellence

PEAPACK, N.J. & NEW YORK--(BUSINESS WIRE)-- Greenstone, Upjohn’s U.S.-based generics business and a wholly owned subsidiary of Pfizer Inc. (PFE)


 https://www.greenstonellc.com/products 


 https://www.greenstonegenerics.com/ 


 https://www.pfizer.com/ 


 https://www.businesswire.com/news/home/20200123005195/en/ 

PFIZER’S GREENSTONE AND DIGITAL MEN’S HEALTH CLINIC ROMAN COLLABORATE TO OFFER PATIENTS REMOTE ACCESS TO THE ONLY FDA-APPROVED AUTHORIZED GENERIC VERSION OF VIAGRA® (SILDENAFIL CITRATE) Agreement provides Roman members with erectile dysfunction treatment backed by Pfizer’s quality manufacturing standards and supply chain excellence Thursday, January 23, 2020 - 6:45am EST PEAPACK, N.J. & Greenstone, Upjohn’s U.S.-based generics business and a wholly owned subsidiary of Pfizer Inc.

Efficio™ Software

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Medtronic Launches Efficio™ Software to Help Clinicians Efficiently Manage Targeted Drug Delivery Therapy with SynchroMed™ II

Thu January 23, 2020 8:30 AM|GlobeNewswire|About: MDT

 Efficio Software Provides Enhanced, Secure Access to Patient Data and Delivers
Actionable Insights in a Secure Cloud Environment

DUBLIN, Jan. 23, 2020 (GLOBE NEWSWIRE) --  Medtronic plc (MDT)


 https://www.medtronic.com/us-en/c/efficio.html?cmpid=vanity_url_medtronic_com_Efficio_RTG_Pain_FY20 


 https://www.medtronic.com/us-en/index.html 


 http://newsroom.medtronic.com/news-releases/news-release-details/medtronic-launches-efficiotm-software-help-clinicians 

EFFICIO PUMP THERAPY MANAGEMENT

Moderna = CEPI Funding to Development of Messenger RNA (mRNA) Vaccine Against Novel Coronavirus

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Moderna Announces Funding Award from CEPI to Accelerate Development of Messenger RNA (mRNA) Vaccine Against Novel Coronavirus

Thu January 23, 2020 9:15 AM|Business Wire|About: AZN, MRK, MRNA

Collaboration includes the National Institutes of Health (NIH) and leverages flexibility of Moderna’s mRNA vaccine technology

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Moderna, Inc. (MRNA), (Nasdaq: MRNA)


 https://seekingalpha.com/symbol/MRNA 


 https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-additional-positive-phase-1-data 


 https://investors.modernatx.com/news-releases/news-release-details/moderna-receives-fda-fast-track-designation-zika-vaccine-mrna 


 https://www.modernatx.com/ 


 https://www.modernatx.com/pipeline/therapeutic-areas/infectious-diseases 

 

Moderna nabs funding to make vaccine against China coronavirus

Jan. 23, 2020 9:41 AM ET|About: Moderna, Inc. (MRNA)|By: , SA News Editor  

 https://seekingalpha.com/news/3533957-moderna-nabs-funding-to-make-vaccine-against-china-coronavirus 



Moderna Announces Funding Award from CEPI to Accelerate Development of Messenger RNA (mRNA) Vaccine Against Novel Coronavirus January 23, 2020 at 9:15 AM EST Collaboration includes the National Institutes of Health (NIH) and leverages flexibility of Moderna’s mRNA vaccine technology CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 23, 2020-- Moderna, Inc., (Nasdaq: MRNA)

novel coronavirus (2019-nCoV)

image185

 China / Society

Wuhan virus killing mostly the elderly, those with previous health problems

  • Almost half the fatalities were 80 years or older, all of them from Hubei province
  • Chinese authorities say children have been infected but are not highly susceptible to the virus

Keegan Elmer andLaurie Chen

Published: 8:30pm, 23 Jan, 2020


 

Wuhan Coronavirus Could Hit China’s Economy Harder Than SARS

The new consumer-led economy has many advantages—but it is also more vulnerable to a SARS-like epidemic

By Nathaniel TaplinUpdated Jan. 23, 2020 5:05 am ET

 https://www.wsj.com/articles/wuhan-coronavirus-could-hit-chinas-economy-harder-than-sars-11579773756?mod=pls_whats_news_us_business_f 


 

Respiratory virus in China less virulent than 2003 SARS

Jan. 23, 2020 6:59 AM ET|About: Moderna, Inc. (MRNA)|By: , SA News Editor  

 https://seekingalpha.com/news/3533816-respiratory-virus-in-china-less-virulent-2003-sars 

Jan 23, 2020 08:41 PM Wuhan Virus Latest: Wuhan Imposes Massive Quarantine, Shutting Down Public Transit By Matthew Walsh, Flynn Murphy and Han Wei

Seeking Biotech Alpha JANUARY 2020 Insight

Eli Lilly and Company Selects North Carolina for Major Pharmaceutical Plant

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Governor Cooper Announces over 460 Jobs in Durham as Eli Lilly and Company Selects North Carolina for Major Pharmaceutical Plant

Tue January 21, 2020 12:47 PM|PR Newswire|About: LLYPR Newswire

RALEIGH, N.C., Jan. 21, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY)


 https://www.nccommerce.com/grants-incentives/county-distress-rankings-tiers 


 https://www.lilly.com/ 


 https://www.prnewswire.com/news-releases/governor-cooper-announces-over-460-jobs-in-durham-as-eli-lilly-and-company-selects-north-carolina-for-major-pharmaceutical-plant-300990502.html 


 

Lilly to invest $470M in North Carolina site

Jan. 21, 2020 1:21 PM ET|About: Eli Lilly and Company (LLY)|By: , SA News Editor  

 https://seekingalpha.com/news/3533180-lilly-to-invest-470m-in-north-carolina-site 

Governor Cooper Announces over 460 Jobs in Durham as Eli Lilly and Company Selects North Carolina for Major Pharmaceutical Plant 01/21/2020 Download PDF Company will invest more than $470 million to build new manufacturing facility RALEIGH, N.C., Jan. 21, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY),

TEPEZZATM (teprotumumab-trbw)

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FDA Approves TEPEZZATM (teprotumumab-trbw) for the Treatment of Thyroid Eye Disease (TED)

Tue January 21, 2020 3:04 PM|Business Wire|About: HZNP

-- First and only FDA-approved medicine for TED, a serious, progressive, vision-threatening rare disease --

-- Clinical improvements were seen as early as six weeks, with continued improvement across the 24-week treatment period --

-- Approval comes ahead of the Prescription Drug User Fee Act (PDUFA) goal date of March 8, 2020 --

-- Horizon to host investor webcast Tuesday, January 21 at 5:00 p.m. ET --

DUBLIN--(BUSINESS WIRE)-- Horizon Therapeutics plc (Nasdaq: HZNP)


 https://www.nejm.org/doi/full/10.1056/NEJMoa1614949 


 https://ir.horizontherapeutics.com/ 


 https://www.horizontherapeutics.com/ 


 https://www.horizontherapeutics.com/our-pipeline/ 


 https://www.businesswire.com/news/home/20200121006017/en/ 


 https://seekingalpha.com/symbol/HZNP 

TEPEZZA is a prescription medicine used to treat Thyroid Eye Disease.

Medtronic Intellis™ Platform

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DTM™ Spinal Cord Stimulation Using the Medtronic Intellis™ Platform Shows Superior Back Pain Relief Compared to Conventional SCS Therapy in an RCT

Tue January 21, 2020 6:07 PM|GlobeNewswire|About: MDT

At Three-Months, 80% of Patients Treated with DTM SCS Reported Back Pain Relief
of at Least 50%; 63% Reported Profound Back Pain Relief of 80% or Greater1

DUBLIN, Jan. 21, 2020 (GLOBE NEWSWIRE) --  Medtronic plc (MDT) 


 https://www.medtronic.com/us-en/index.html 


 The Intellis™ with AdaptiveStim™ implantable neurostimulator is powered by proprietary Overdrive™ battery technology. It is designed to overcome limitations with other SCS systems and is optimized for the increased energy demands of High Dose (HD) therapy. Medtronic exclusive features on the Intellis™ platform include wireless programming using the clinician tablet, wireless trialing system, and SureScan™ full-body MRI technologies. 

 https://www.medtronic.com/us-en/healthcare-professionals/products/neurological/spinal-cord-stimulation-systems/intellis-platform.html 

INTELLIS™ PLATFORM Spinal Cord Stimulation

Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier

image189

 

Roche’s Risdiplam meets primary endpoint in pivotal FIREFISH trial in infants with type 1 spinal muscular atrophy

  • Risdiplam demonstrated statistically significant and medically meaningful motor milestone improvement in infants with Type 1 SMA
  • No treatment related safety findings leading to withdrawal seen in any risdiplam trial to date
  • Data will be shared with health authorities globally

Basel, 23 January 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY)


 

Roche's risdiplam successful in SMA study

Jan. 23, 2020 6:42 AM ET|About: Roche Holding AG (RHHBY)|By: , SA News Editor  

 https://seekingalpha.com/news/3533806-roches-risdiplam-successful-in-sma-study 


 https://seekingalpha.com/pr/17756953-genentech-s-risdiplam-meets-primary-endpoint-in-pivotal-firefish-trial-in-infants-type-1 

REGULATORY NEWS - AMERICASJANUARY 23, 2020 / 1:21 AM / UPDATED 7 HOURS AGO Roche's risdiplam meets primary endpoint in trial of SMA drug in infants - ZURICH, Jan 23 (Reuters)

AXS-05 (dextromethorphan/bupropion modulated delivery tablet)

image190

 

Axsome Therapeutics Completes Patient Randomization in the STRIDE-1 Phase 3 Trial of AXS-05 in Treatment Resistant Depression

Wed January 22, 2020 7:00 AM|GlobeNewswire|About: AXSM

NEW YORK, Jan. 22, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (AXSM),


 https://axsome.com/ 


 https://axsome.com/axs-pipeline/overview/ 


 https://seekingalpha.com/symbol/AXSM 

AXS-05 is a novel, oral, investigational drug product under development for the treatment of central nervous system (CNS) disorders. AXS-05 utilizes Axsome’s technology of combining bupropion and dextromethorphan (DM). DM is an NMDA receptor antagonist, sigma-1 receptor agonist, and inhibitor of the serotonin and norepinephrine transporters. Bupropion serves to increase the bioavailability of DM and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. AXS-05 has been granted Fast Track designation by the FDA for both the treatment of agitation associated with Alzheimer’s Disease (AD) and Treatment Resistant Depression (TRD). AXS-05 is an investigational drug product not approved by the FDA.

Wuhan coronavirus has entered transmission stage among families and hospitals

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 Hong Kong / Health & Environment

Wuhan coronavirus has entered transmission stage among families and hospitals, taking it a step closer to full-blown community epidemic, Hong Kong expert warns

  • Professor Yuen Kwok-yung, a top infectious diseases expert, says transmission of new coronavirus has entered its ‘third wave’
  • Warning comes as Hong Kong University study suggests outbreak worse than officially reported, with virus already spreading to 20 mainland cities

Elizabeth Cheung

Published: 6:17pm, 21 Jan, 2020

Jan 21, 2020 07:48 PM Wuhan Virus Latest: First Case Confirmed in U.S. as Experts Warn of ‘Super-Spreader’ By Matthew Walsh, Flynn Murphy and Han Wei

Seeking Biotech Alpha JANUARY 2020 Insight

Mayzent® (siponimod)

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Novartis announces EU approval of Mayzent® (siponimod) for adult patients with secondary progressive multiple sclerosis (SPMS) with active disease

Jan 20, 2020

  • Mayzent® (siponimod) is the first and only oral treatment specifically indicated for patients with secondary progressive multiple sclerosis (SPMS) with active disease in Europe1
     
  • Mayzent addresses an unmet need for SPMS patients with active disease who, until now, did not have an oral treatment that has been shown to be effective in delaying progression in this patient population
     
  • Approval is based on the Phase III EXPAND trial, the largest randomized clinical study in a broad range of SPMS patients, showing Mayzent significantly reduced the risk of disease progression, including physical disability and cognitive decline2,3
  •  Basel, January 20, 2020 

 https://www.pharmaceutical-technology.com/news/eu-approval-novartis-mayzent/ 


 

Novartis' Mayzent OK'd in Europe for multiple sclerosis

Jan. 21, 2020 6:49 AM ET|About: Novartis AG (NVS)|By: , SA News Editor  

 https://seekingalpha.com/news/3532960-novartis-mayzent-okd-in-europe-for-multiple-sclerosis 


 https://www.mayzent.com/index.jsp 


What is MAYZENT® (siponimod) tablets? MAYZENT is a prescription medicine that is used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Polivy® (polatuzumab vedotin), in combination with bendamustine plus MabThera® (rituximab) (BR

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European Commission approves Roche’s Polivy for people with previously treated aggressive lymphoma

Basel, 21 January 2020

  • Novel combination regimen includes first-in-class antibody-drug conjugate that specifically targets CD79b
  • Targeted off-the-shelf treatment provides much-needed new option for people with relapsed or refractory diffuse large B-cell lymphoma
  • Polivy approval is based on a phase Ib/II study, the first and only study showing improved response rates and overall survival in patients with this aggressive lymphoma who are not candidates for a haematopoietic stem cell transplant, compared to a commonly used regimen

Roche (SIX: RO, ROG; OTCQX: RHHBY) 


 https://www.gene.com/patients/medicines/polivy 


 https://www.polivy.com/hcp.html 


 https://seekingalpha.com/news/3532955-roches-polivy-okd-in-europe-for-dlbcl 

POLIVY in combination with bendamustine and a rituximab product is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least 2 prior therapies. Accelerated approval was granted for this indication based on complete response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

anti-PD-1 antibody tislelizumab in combination with two chemotherapy regimens

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BeiGene Announces that the Phase 3 Clinical Trial of its Anti-PD-1 Antibody Tislelizumab in Patients with First-Line Squamous Non-Small Cell Lung Cancer Met the Primary Endpoint of Progression-Free Survival at Interim Analysis

Tue January 21, 2020 7:00 AM|GlobeNewswire|About: BGNE

BEIJING, China, and CAMBRIDGE, Mass., Jan. 21, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE) (NASDAQ: BGNE; HKEX: 06160)


 (NCT 03594747, known as BGB-A317-307) 


 https://www.beigene.com/ 


 

BeiGene's tislelizumab successful in late-stage lung cancer study

Jan. 21, 2020 7:31 AM ET|About: BeiGene, Ltd. (BGNE)|By: , SA News Editor 

 https://seekingalpha.com/news/3532989-beigenes-tislelizumab-successful-in-late-stage-lung-cancer-study 

Tislelizumab Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

belantamab mafodotin (GSK2857916)

 

US Food and Drug Administration (FDA) grants priority review of belantamab mafodotin for patients with relapsed or refractory multiple myeloma

Tue January 21, 2020 9:00 AM|PR Newswire|About: GSK

  • Biologics License Application based on results from the pivotal DREAMM-2 study of immunoconjugate targeting B-cell maturation antigen (BCMA) in heavily pre-treated patient population who was refractory to an immunomodulatory drug and a proteasome inhibitor, and refractory or intolerant to an anti-CD38 antibody
  • Belantamab mafodotin has potential to be the first anti-BCMA treatment available to patients

LONDON, Jan. 21, 2020 /PRNewswire/ -- GlaxoSmithKline plc (GSK)


 https://www.gsk.com/ 


 https://www.gsk.com/en-gb/media/press-releases/us-food-and-drug-administration-fda-grants-priority-review-of-belantamab-mafodotin-for-patients-with-relapsed-or-refractory-multiple-myeloma/ 


 https://www.prnewswire.com/news-releases/us-food-and-drug-administration-fda-grants-priority-review-of-belantamab-mafodotin-for-patients-with-relapsed-or-refractory-multiple-myeloma-300990248.html 

 

Glaxo's balantamab mafodotin nabs accelerated review in U.S. for MM

Jan. 21, 2020 9:21 AM ET|About: GlaxoSmithKline plc (GSK)|By: , SA News Editor 

 https://seekingalpha.com/news/3533065-glaxos-balantamab-mafodotin-nabs-accelerated-review-in-u-s-for-mm 

21 January 2020 US Food and Drug Administration (FDA) grants priority review of belantamab mafodotin for patients with relapsed or refractory multiple myeloma Biologics License Application based on results from the pivotal DREAMM-2 study of immunoconjugate targeting B-cell maturation antigen (BCMA) in heavily pre-treated patient population who was refractory to an immunomodulatory drug and a proteasome inhibitor, and refractory or intolerant to an anti-CD38 antibody Belantamab mafodotin has potential to be the first anti-BCMA treatment available to patients Issued: London, UK GlaxoSmithKline plc (LSE/NYSE: GSK)

Optune® in Combination with Temozolomide

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Novocure Announces National Reimbursement in Israel for Optune® in Combination with Temozolomide for the Treatment of Newly Diagnosed Glioblastoma

Tue January 21, 2020 7:40 AM|Business Wire|About: NVCR

ST. HELIER, Jersey--(BUSINESS WIRE)-- Novocure (NVCR)


 https://www.novocure.com/ 


 https://www.businesswire.com/news/home/20200121005576/en/ 


 https://seekingalpha.com/symbol/NVCR 

Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery, and completion of radiation therapy together with concomitant standard of care chemotherapy. For the treatment of recurrent GBM, Optune is indicated following histologically- or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted. The NovoTTF-100L System is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic, malignant mesothelioma (MPM) to be used concurrently with pemetrexed and platinum-based chemotherapy.

Micra™ AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony

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FDA Approves Medtronic Micra™ AV, the World’s Smallest Pacemaker Which Can Now Treat AV Block

Tue January 21, 2020 12:01 PM|GlobeNewswire|About: MDT

With FDA Approval, More Patients in the U.S. Are Now Candidates for a Leadless Pacing Option

 DUBLIN, Jan. 21, 2020 (GLOBE NEWSWIRE) --  Medtronic plc (MDT) 


 http://electrophysiology.onlinejacc.org/content/6/1/94 


 https://www.medtronic.com/us-en/index.html 


 https://www.medtronic.com/us-en/patients/treatments-therapies/pacemakers/our/micra.html 


 animation of the Micra AV in use 

 https://www.medtronic.com/content/dam/medtronic-com/us-en/newsroom/media-resources/video-gallery/business-unit/cardiac-rhythm-heart-failure-management/medtronic-micra-av-animation.mp4 

MICRA TRANSCATHETER PACING SYSTEM Bradycardia (Slow Heart Rate)

Seeking Biotech Alpha JANUARY 2020 Insight

AXL Inhibitor Bemcentinib in Combination With Keytruda®

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BerGenBio Meets Efficacy Endpoint For First Stage Of Phase II Trial With AXL Inhibitor Bemcentinib in Combination With Keytruda® in NSCLC Patients Progressing on Immune Checkpoint Inhibitors

Wed January 15, 2020 11:30 AM|PR Newswire

- Criteria were met for expansion of this cohort to a second stage

PR Newswire

BERGEN, Norway, Jan. 15, 2020 /PRNewswire/ -- BerGenBio ASA (BRRGF) (OSE: BGBIO) 


 (ClinicalTrials.gov Identifier: NCT03184571) 


 https://www.bergenbio.com/ 


 https://www.prnewswire.com/news-releases/bergenbio-meets-efficacy-endpoint-for-first-stage-of-phase-ii-trial-with-axl-inhibitor-bemcentinib-in-combination-with-keytruda-in-nsclc-patients-progressing-on-immune-checkpoint-inhibitors-300987587.html 


 

BerGenBio's bemcentinib shows positive action in mid-stage lung cancer study

Jan. 15, 2020 11:57 AM ET|About: BerGenBio ASA (BRRGF)|By: , SA News Editor  

 https://seekingalpha.com/news/3532096-bergenbios-bemcentinib-shows-positive-action-in-mid-stage-lung-cancer-study 

PIPELINE BerGenBio is focused on developing a pipeline of transformative drugs targeting AXL as a potential cornerstone of therapy for aggressive diseases, including immune-evasive, therapy resistant cancers.

t:slim X2 Insulin Pump with Control-IQ Technology

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Tandem Diabetes Care Announces Commercial Launch of the t:slim X2 Insulin Pump with Control-IQ Technology in the United States

Wed January 15, 2020 4:05 PM|Business Wire|About: TNDM

SAN DIEGO--(BUSINESS WIRE)-- Tandem Diabetes Care, Inc. (TNDM)


 https://www.tandemdiabetes.com/products/tandem-device-updater/control-iq 


 https://www.tandemdiabetes.com/products/t-simulator-demo-app 


 https://www.tandemdiabetes.com/ 


 https://www.tandemdiabetes.com/legal/important-safety-information 


 https://www.businesswire.com/news/home/20200115005808/en/ 


 https://seekingalpha.com/symbol/TNDM 

t:simulator app A free virtual pump demo and more available on your smart phone or tablet.

China says infections spreading as it reports third death from Wuhan virus

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China says infections spreading as it reports third death from Wuhan virus; WHO indicates human transmission likely

  • Authorities find 136 new infections in Wuhan, confirm first cases in other cities – one in Shenzhen and two in Beijing
  • World Health Organisation says there could be some limited human-to-human infection

SCMP Reporters

Published: 8:58am, 20 Jan, 2020



Jan 20, 2020 03:39 PM Wuhan Virus Latest: Death Toll Grows to Three as More Cities Report Cases By Matthew Walsh

Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody

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Imfinzi and tremelimumab granted Orphan Drug Designation in the US for liver cancer

PUBLISHED20 January 2020

20 January 2020 07:00 GMT

 

AstraZeneca liver cancer treatments win orphan FDA status

Jan. 20, 2020 6:03 AM ET|About: AstraZeneca PLC (AZN)|By: , SA News Editor  

AstraZeneca Treatments Win Orphan FDA Status in Liver Cancer By John Lauerman January 20, 2020, 2:22 AM EST Updated on January 20, 2020, 3:09 AM EST

LYNPARZA® (olaparib)

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. 

FDA Accepts Regulatory Submission of Supplemental New Drug Application for LYNPARZA® (olaparib) in HRR-Mutated Metastatic Castration-Resistant Prostate Cancer and Grants Priority Review

Tue January 21, 2020 6:55 AM|Business Wire|About: MRK

Submission Based on PROfound, the First Phase 3 Trial Evaluating a Targeted Treatment in Biomarker-Selected Prostate Cancer Patients

KENILWORTH, N.J.--(BUSINESS WIRE)-- AstraZeneca and Merck (MRK)


 https://www.azpicentral.com/lynparza_tb/lynparza_tb.pdf#page=1 

 

AstraZeneca's Lynparza nabs accelerated review in U.S. for prostate cancer

Jan. 21, 2020 6:39 AM ET|About: AstraZeneca PLC (AZN)|By: , SA News Editor  

 https://seekingalpha.com/news/3532956-astrazenecas-lynparza-nabs-accelerated-review-in-u-s-for-prostate-cancer 


 https://www.mrknewsroom.com/news-release/oncology/fda-accepts-regulatory-submission-supplemental-new-drug-application-lynparza-0 


 https://www.businesswire.com/news/home/20200121005282/en/ 



LYNPARZA is a prescription medicine used to treat adults who have: advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, as maintenance treatment, when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy advanced ovarian cancer with a certain type of abnormal inherited BRCA gene, and have received treatment with 3 or more prior types of chemotherapy medicines. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you

Human-to-human link to some cases of new China virus, Sars expert says

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Human-to-human link to some cases of new China virus, Sars expert says

  • Priority now must be to stop emergence of ‘super-spreader’, with one carrier already infecting more than a dozen medical personnel, specialist says
  • Authorities in Wuhan, the epicentre of the coronavirus outbreak, report a third death and more than 130 new cases over the weekend

Gigi Choy andAlice Yan

Published: 9:40pm, 20 Jan, 2020

Jan 20, 2020 03:39 PM Wuhan Virus Latest: New Coronavirus Can Spread Person-to-Person By Matthew Walsh, Flynn Murphy and Han Wei

Seeking Biotech Alpha JANUARY 2020 Insight

LibtayoTM (cemiplimab)

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Libtayo™ (cemiplimab) Receives Positive Recommendation from the pan-Canadian Oncology Drug Review Expert Review Committee for the Treatment of Metastatic Cutaneous Squamous Cell Carcinoma

Thu January 16, 2020 8:00 AM|Canada Newswire

  • Cutaneous squamous cell carcinoma (CSCC) is the second most common form of skin cancer accounting for approximately 20% of all skin cancer cases in Canada.1

OAKVILLE, ON, Jan. 16, 2020 /CNW Telbec/ - The Melanoma Network of Canada


 https://www.melanomanetwork.ca/ 


 http://products.sanofi.ca/en/libtayo.pdf 


LIBTAYO is a medicine that may treat a type of skin cancer by working with your immune system. LIBTAYO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. Indication LIBTAYO is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that: has spread –or– cannot be cured by surgery or radiation

APD418, a β3-adrenergic receptor (AdrR) antagonist and cardiac myotrope

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FDA Grants Fast Track Designation to Arena Pharmaceuticals' APD418 for Development in Decompensated Heart Failure Patients

Thu January 16, 2020 9:00 AM|PR Newswire|About: ARNAPR Newswire

SAN DIEGO, Jan. 16, 2020 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (ARNA) (Nasdaq: ARNA)


 https://www.arenapharm.com/# 


 http://invest.arenapharm.com/news-releases/news-release-details/fda-grants-fast-track-designation-arena-pharmaceuticals-apd418 


 https://www.arenapharm.com/pipeline/apd418/ 


 https://www.prnewswire.com/news-releases/fda-grants-fast-track-designation-to-arena-pharmaceuticals-apd418-for-development-in-decompensated-heart-failure-patients-300988176.html 


 https://seekingalpha.com/symbol/ARNA 

FDA Grants Fast Track Designation to Arena Pharmaceuticals' APD418 for Development in Decompensated Heart Failure Patients - APD418 currently in Phase 1 clinical investigation - data expected this year SAN DIEGO, Jan. 16, 2020 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA)

Tafasitamab (MOR208, formerly Xmab®5574) is an investigational monoclonal antibody

 

MorphoSys AG: Ad hoc: MorphoSys and Incyte Sign Global Collaboration and License Agreement, including U.S. Co-Commercialization and Ex-U.S. Commercialization Rights, for Tafasitamab

Mon January 13, 2020 2:25 AM|Accesswire|About: MOR

PLANEGG/MUNICH, GERMANY / ACCESSWIRE / January 13, 2020 / MorphoSys AG (MPSYF) (FSE: MOR;


 https://www.morphosys.com/ 


 https://www.incyte.com/ 


 https://www.accesswire.com/572835/MorphoSys-AG-Ad-hoc-MorphoSys-and-Incyte-Sign-Global-Collaboration-and-License-Agreement-including-US-Co-Commercialization-and-Ex-US-Commercialization-Rights-for-Tafasitamab 


 https://seekingalpha.com/symbol/MOR 

Tafasitamab (MOR208) You are here HOMEPIPELINEPROPRIETARY PORTFOLIOMOR208 (TAFASITAMAB) Tafasitamab (MOR208) is a humanized monoclonal antibody directed against CD19 in clinical development for the treatment of B cell malignancies.

Ozempic® (semaglutide) injection 0.5 mg or 1 mg

 

FDA approves Ozempic® for cardiovascular risk reduction in adults with type 2 diabetes and known heart disease, updates Rybelsus® label

PLAINSBORO, N.J., Jan. 16, 2020 /PRNewswire/ -- Novo Nordisk


 https://www.novonordisk-us.com/ 


 https://www.novo-pi.com/rybelsus.pdf 


 

Novo Nordisk says FDA approves new indication for Ozempic

Jan. 16, 2020 7:11 PM ET|About: Novo Nordisk A/S (NVO)|By: , SA News Editor  

 https://seekingalpha.com/news/3532608-novo-nordisk-says-fda-approves-new-indication-for-ozempic 

Ozempic® (semaglutide) injection 0.5 mg or 1 mg is an injectable prescription medicine for adults with type 2 diabetes that along with diet and exercise may improve blood sugar.

Eli Lilly targets quarterly deals of $1 billion-$5 billion in 2020

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 BUSINESS NEWSJANUARY 16, 2020 / 6:25 PM / UPDATED 13 HOURS AGO

Eli Lilly targets quarterly deals of $1 billion-$5 billion in 2020: CFO

Carl O'Donnell

3 MIN READ

SAN FRANCISCO (Reuters) - Eli Lilly and Co (LLY.N)


 https://seekingalpha.com/news/3532615-eli-lilly-targets-buying-spree-in-2020 


 https://seekingalpha.com/symbol/LLY 

MEDICINES IN DEVELOPMENT MOLECULE & POTENTIAL INDICATION DATA AS OF OCTOBER 21, 2019 Interested in Lilly clinical trials? Learn more at LillyTrialGuide.com

SkinMedica® Instant Bright Eye Cream

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SkinMedica® Launches New Instant Bright Eye Cream For Immediate, Visible Results

Fri January 17, 2020 7:30 AM|PR Newswire|About: AGNPR Newswire

DUBLIN, Jan. 17, 2020 /PRNewswire/ -- Allergan plc (AGN)


 https://www.prnewswire.com/news-releases/skinmedica-launches-new-instant-bright-eye-cream-for-immediate-visible-results-300988701.html 


 https://www.allergan.com/ 



Advancing the Science of Skin Rejuvenation At SkinMedica® we’ve dedicated years of research to formulate advanced skin care products to deliver optimal results for our patients and the physicians who care for them.

Seeking Biotech Alpha JANUARY 2020 Insight

LRRK2 inhibitor

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Denali Therapeutics Announces Broad Pipeline Progress Including Positive Results From Its LRRK2 Program for Parkinson’s Disease

Tue January 14, 2020 9:00 AM|GlobeNewswire|About: DNLI

  • LRRK2 inhibitor DNL201 Phase 1b demonstrated high levels of target and pathway engagement and improvement of lysosomal biomarkers in patients with Parkinson’s disease 
  • LRRK2 inhibitor DNL151 Phase 1 demonstrated high levels of target and pathway engagement and modulation of lysosomal biomarkers in healthy volunteers and continues in an expanded Phase 1b study in patients with Parkinson’s disease
  • IND submitted for DNL310 (ETV:IDS) for Hunter syndrome, Denali’s first clinical submission for a large molecule therapeutic enabled by its Transport Vehicle platform technology
  • CTA approved for DNL343, a small molecule activator of EIF2B for ALS and other neurodegenerative diseases
  • RIPK1 inhibitor DNL747 Phase 1b trials in Alzheimer’s and ALS fully enrolled and open label extension in ALS ongoing with data readouts on track for mid-2020

SOUTH SAN FRANCISCO, Calif., Jan. 14, 2020 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (DNLI) (NASDAQ: DNLI)


 https://clinicaltrials.gov/ct2/show/NCT04056689 


 https://denalitherapeutics.com/ 


 https://denalitherapeutics.com/partnering 



We develop a broad portfolio of drug candidates that have the potential to meaningfully improve the lives of patients by directly addressing the causes and risk factors of neurodegenerative diseases.

Opdivo (nivolumab) Plus Yervoy (ipilimumab)

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U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in First-Line Non-Small Cell Lung Cancer

Wed January 15, 2020 6:59 AM|Business Wire|About: BMY

Application based on results from Part 1 of Phase 3 CheckMate -227 study

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY)


 https://www.bms.com/ 


 https://packageinserts.bms.com/pi/pi_opdivo.pdf 


 https://packageinserts.bms.com/pi/pi_yervoy.pdf 


 https://www.businesswire.com/news/home/20200115005245/en/ 


 https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-accepts-priority-review-bris-1 


 https://www.opdivo.com/ 


 

Indications

YERVOY® (ipilimumab) is a prescription medicine used in adults and children 12 years of age and older to treat melanoma (a kind of skin cancer) that has spread (metastatic) or cannot be removed by surgery (unresectable)

 https://www.yervoy.com/ 

Important Facts About OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab) This is a summary of important information that you need to know about OPDIVO and OPDIVO + YERVOY. Your healthcare team can work with you to help answer any questions you may have about these medications. Keep this information in a safe place so you can refer to it before and during your treatment.

Rubraca® (rucaparib)

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Clovis Oncology’s Rubraca® (rucaparib) Granted FDA Priority Review for Advanced Prostate Cancer

Wed January 15, 2020 8:00 AM|Business Wire|About: CLVS

- Clovis seeks U.S. approval for rucaparib as monotherapy treatment for patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer

- FDA submission based on data from TRITON clinical program in advanced prostate cancer

- FDA has assigned PDUFA date of May 15, 2020

BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (CLVS) 


 https://www.clovisoncology.com/ 


 https://www.clovisoncology.com/pipeline/rucaparib/ 


 https://www.businesswire.com/news/home/20200115005158/en/ 


 

Rubraca® (rucaparib) tablets are a prescription medicine used for:

  • The maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer whose cancer has come back and who are in response (complete or partial response) to a platinum-based chemotherapy
  • The treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have certain “BRCA” gene mutations, either inherited (germline) or acquired (somatic), and who have been treated with 2 or more chemotherapy medicines for their cancer. Your healthcare provider will perform a test to make sure Rubraca is right for you

 https://www.rubraca.com/ 

Rucaparib Clinical Development Overview Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment of under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, and lung cancer

Dovato (dolutegravir 50 mg/lamivudine 300 mg)

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15 January 2020

Dovato (dolutegravir/lamivudine), the once-daily, single-pill, 2-drug regimen for the treatment of HIV-1 infection, granted marketing approval by Japan Ministry of Health, Labour and Welfare

Issued: Japan and UK

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited 


 https://www.medicines.org.uk/emc/product/10446 


 https://www.dovato.com/ 


 

ViiV Healthcare's Dovato OK'd in Japan

Jan. 15, 2020 6:49 AM ET|About: GlaxoSmithKline plc (GSK)|By: , SA News Editor  

 https://seekingalpha.com/news/3531913-viiv-healthcares-dovato-okd-in-japan 

DOVATO is a prescription medicine that is used without other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults who have not received antiretroviral medicines in the past, and without known resistance to the medicines dolutegravir or lamivudine. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS)

SPRAVATO®▼ (esketamine) nasal spray

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Janssen Seeks Expanded Use of SPRAVATO®▼ (Esketamine) Nasal Spray in Europe as a Treatment for Depressive Symptoms in Adults with Major Depressive Disorder Who Have Current Suicidal Ideation with Intent

In two pivotal Phase 3 trials, SPRAVATO®▼ combined with comprehensive standard of care achieved statistically significant rapid reduction of depressive symptoms in patients with major depressive disorder who have current suicidal ideation with intent compared to comprehensive standard of care alone

January 15, 2020 07:40 AM Eastern Standard Time

BEERSE, Belgium--(BUSINESS WIRE)--The Janssen Pharmaceutical Companies of Johnson & Johnson


 https://www.janssen.com/ 


 

J&J files application in Europe for expanded use of Spravato

Jan. 15, 2020 7:56 AM ET|About: Johnson & Johnson (JNJ)|By: , SA News Editor  

 https://seekingalpha.com/news/3531956-j-and-j-files-application-in-europe-for-expanded-use-of-spravato 


 https://www.ema.europa.eu/en/documents/product-information/spravato-epar-product-information_en.pdf 

Indication SPRAVATO™ (esketamine) CIII Nasal Spray is indicated, in conjunction with an oral antidepressant (AD), for the treatment of treatment-resistant depression (TRD) in adults. SPRAVATO™ is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO™ as an anesthetic agent have not been established.

Stealth Autoguide™ Cranial Robotic Guidance Platform

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Phoenix Children’s Is the First-Ever Health System in the U.S to Use Medtronic Stealth Autoguide™ Cranial Robotic Guidance Platform for Neurosurgery

Thu January 16, 2020 7:00 AM|GlobeNewswire|About: MDT

Pediatric Health System First to Use Groundbreaking Cranial Robotic System in a Patient Surgery

DUBLIN and PHOENIX, Jan. 16, 2020 (GLOBE NEWSWIRE) 


 https://www.phoenixchildrens.org/ 


 https://www.medtronic.com/us-en/index.html 



STEALTH AUTOGUIDE™ Cranial Robotic Guidance Platform

Seeking Biotech Alpha JANUARY 2020 Insight

VASCEPA® (icosapent ethyl)

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Amarin Stock Is Surging as Rival Makers of Fish-Oil Heart Drugs Fall Short

By Josh Nathan-KazisJan. 13, 2020 11:07 am ET 


 https://www.acastipharma.com/en/investors/news-events/press-releases/detail/173/acasti-pharma-reports-topline-results-for-trilogy-1-phase-3?mod=article_inline 


 https://www.barrons.com/articles/amarin-stock-vascepa-fish-oil-heart-drug-wins-at-the-fda-51576503843?mod=article_inline 


 https://www.astrazeneca.com/media-centre/press-releases/2020/update-on-phase-iii-strength-trial-for-epanova-in-mixed-dyslipidaemia-13012020.html 


 https://amarincorp.com/ 


 https://www.evaluate.com/vantage/articles/news/trial-results/astra-and-acasti-throw-amarin-bulls-more-fodder 


 

Acasti Pharma's pain is Amarin's gain, up 12% premarket

Jan. 13, 2020 6:39 AM ET|About: Acasti Pharma Inc. (ACST)|By: , SA News Editor 

 https://seekingalpha.com/news/3531176-acasti-pharmas-pain-is-amarins-gain-up-12-premarket?v=1578921724 



VASCEPA® is now approved, along with certain medicines (statins), to reduce the risk of heart attack, stroke and certain types of heart issues requiring hospitalization in adults with heart (cardiovascular) disease, or diabetes and 2 or more additional risk factors for heart disease.

Exonate & Janssen to Develop a New Eye Drop for Treatment of Retinal Vascular Diseases

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Exonate Announces Collaboration With Janssen to Develop a New Eye Drop for the Treatment of Retinal Vascular Diseases Including Wet Age-related Macular degeneration (AMD) and Diabetic Macular Oedema (DMO)

Mon January 13, 2020 3:00 AM|PR NewswirePR Newswire

CAMBRIDGE, England, Jan. 13, 2020 /PRNewswire/ -- Exonate,


 https://www.exonate.com/ 


 https://www.prnewswire.com/news-releases/exonate-announces-collaboration-with-janssen-to-develop-a-new-eye-drop-for-the-treatment-of-retinal-vascular-diseases-including-wet-age-related-macular-degeneration-amd-and-diabetic-macular-oedema-dmo-300984951.html 


 

J&J to collaborate with Exonate in eye diseases

Jan. 13, 2020 11:24 AM ET|About: Johnson & Johnson (JNJ)|By: , SA News Editor  

 https://seekingalpha.com/news/3531385-j-and-j-to-collaborate-exonate-in-eye-diseases 


Exploiting the alternative splicing of vascular endothelial growth factor (VEGF) Exonate’s science targets mRNA altering it so that an isoform of VEGF (165b) is produced to cause inhibition of new blood vessel growth.

genome editing and cell therapy technologies

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Editas Medicine and Sandhill Therapeutics, Inc. Announce Collaboration to Develop Engineered Cell Medicines to Treat Cancer

Mon January 13, 2020 8:55 AM|GlobeNewswire|About: EDIT

CAMBRIDGE, Mass. and DALLAS, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (EDIT)


 https://www.editasmedicine.com/ 


 https://www.sandhilltx.com/ 


 https://seekingalpha.com/symbol/EDIT 


 

Editas teams up with Sandhill Therapeutics in cancer; shares up 2% premarket

Jan. 13, 2020 9:10 AM ET|About: Editas Medicine, Inc. (EDIT)|By: , SA News Editor  

 https://seekingalpha.com/news/3531295-editas-teams-up-sandhill-therapeutics-in-cancer-shares-up-2-premarket 

Sandhill’s proprietary BINATE technology is the only technology to specifically leverage a defined combination of multiple innate immune cell populations. The BINATE technology will be used clinically in both treatment of solid tumors and after hematologic stem cell transplantation for treatment and prevention of infections and relapse. Antigen targeted CAR-modified BINATE products will be used in solid tumors initially, followed by hematologic tumors.

Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen®

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Lilly expands insulin affordability options with lower-priced versions of Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen®

Tue January 14, 2020 6:45 AM|PR Newswire|About: LLYPR Newswire

INDIANAPOLIS, Jan. 14, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY)


 https://www.humalog.com/index.aspx 


 https://www.lillyinsulinlispro.com/ 


 https://www.lillydiabetes.com/ 


 https://www.lilly.com/ 


 https://lillypad.lilly.com/entry.php?e=11640 


 https://www.prnewswire.com/news-releases/lilly-expands-insulin-affordability-options-with-lower-priced-versions-of-humalog-mix7525-kwikpen-and-humalog-junior-kwikpen-300986041.html 

Lilly expands insulin affordability options with lower-priced versions of Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen® 01/14/2020

ELZONRIS® (tagraxofusp)

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Stemline Therapeutics Announces Preliminary 2019 Net Revenues for ELZONRIS® (tagraxofusp) and Highlights Commercial and Clinical Growth Drivers

Mon January 13, 2020 4:15 PM|GlobeNewswire|About: STML

NEW YORK, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (STML)


 https://stemline.com/ 


 https://bpdcninfo.com/ 



About ELZONRIS® (tagraxofusp-erzs) ELZONRIS is a prescription medicine used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients 2 years and older.

SKYRIZI™ (risankizumab)

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New Head-to-Head Phase 3 Data Show SKYRIZI™ (risankizumab) Superior to Cosentyx® (secukinumab) Across Primary and All Ranked Secondary Endpoints in Adults with Moderate to Severe Plaque Psoriasis at 52 Weeks

Tue January 14, 2020 8:45 AM|PR Newswire|About: ABBV

- Of patients treated with SKYRIZI, 87 percent achieved PASI 90 compared to 57 percent of Cosentyx-treated patients at 52 weeks (p<0.001)[1]

- No new safety signals were observed[1]

PR Newswire

NORTH CHICAGO, Ill., Jan. 14, 2020 /PRNewswire/ -- AbbVie (ABBV)


 More information on this trial can be found at www.clinicaltrials.gov (NCT03478787). 


 https://www.abbvie.com/ 


 https://clinicaltrials.gov/ct2/show/NCT03478787 


 https://www.prnewswire.com/news-releases/new-head-to-head-phase-3-data-show-skyrizi-risankizumab-superior-to-cosentyx-secukinumab-across-primary-and-all-ranked-secondary-endpoints-in-adults-with-moderate-to-severe-plaque-psoriasis-at-52-weeks-300986617.html 



USE for SKYRIZI™ (risankizumab-rzaa) SKYRIZI is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

Seeking Biotech Alpha JANUARY 2020 Insight

antibody cytokine engrafted protein, referred to as IOV-3001

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Iovance Biotherapeutics Obtains License to Develop and Commercialize a Novel IL-2 Analog

Sun January 12, 2020 4:30 PM|GlobeNewswire|About: IOVA

SAN CARLOS, Calif., Jan. 12, 2020 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (IOVA)


 https://www.iovance.com/ 


 https://seekingalpha.com/symbol/IOVA 


 

Iovance in-licenses engineered protein candidate from Novartis

Jan. 12, 2020 6:19 PM ET|About: Iovance Biotherapeutic... (IOVA)|By: , SA News Editor  

 https://seekingalpha.com/news/3531139-iovance-in-licenses-engineered-protein-candidate-from-novartis 


Clinical Pipeline

ZW25 in Combination with Ibrance® (palbociclib)

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Zymeworks Announces Agreement with Pfizer and Initiation of a New Phase 2 Trial Evaluating ZW25 in Combination with Ibrance® (palbociclib)

Sun January 12, 2020 10:00 AM|Business Wire|About: ZYME

  • Potential for a Novel Chemotherapy-Free Treatment Option for People with Advanced HER2-positive, HR-positive Breast Cancer

VANCOUVER, British Columbia--(BUSINESS WIRE)-- Zymeworks Inc. (ZYME)


 https://seekingalpha.com/symbol/ZYME 


 (clinicaltrials.gov: NCT04224272) 


 https://clinicaltrials.gov/ct2/show/NCT02892123?cond=zw25&rank=1 


 https://www.zymeworks.com/ 


 https://www.businesswire.com/news/home/20200112005029/en/ 


Our clinical and preclinical pipeline includes wholly-owned and partnered therapeutic candidates initially targeting cancers.

Tyvyt® (Sintilimab Injection) Combined with ALIMTA® (Pemetrexed)

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Tyvyt® (Sintilimab Injection) Combined with ALIMTA® (Pemetrexed) and Platinum Met Predefined Primary Endpoint in Phase 3 ORIENT-11 Study as First-Line Therapy in Nonsquamous NSCLC

Mon January 13, 2020 6:30 AM|PR Newswire|About: LLY

INDIANAPOLIS, Jan. 13, 2020 /PRNewswire/ -- Today, Eli Lilly and Company (LLY) jointly announced with Innovent Biologics


 http://innoventbio.com/#/ 


 https://www.prnewswire.com/news-releases/tyvyt-sintilimab-injection-combined-with-alimta-pemetrexed-and-platinum-met-predefined-primary-endpoint-in-phase-3-orient-11-study-as-first-line-therapy-in-nonsquamous-nsclc-300985366.html 


 https://clinicaltrials.gov/ct2/show/NCT03607539?term=NCT03607539&draw=2&rank=1 


 https://www.lillyoncology.com/ 


 

Lilly's Tyvyt + Alimta successful in lung cancer study

Jan. 13, 2020 7:06 AM ET|About: Eli Lilly and Company (LLY)|By: , SA News Editor  

 https://seekingalpha.com/news/3531196-lillys-tyvyt-alimta-successful-in-lung-cancer-study 

What Is ALIMTA® (pemetrexed for injection) Approved For? ALIMTA® (pemetrexed for injection) is approved by the FDA in combination with KEYTRUDA® (pembrolizumab) (an immunotherapy) and platinum chemotherapy (carboplatin or cisplatin, two other chemotherapy drugs) as the first treatment for nonsquamous non-small cell lung cancer (NSCLC) that has spread with no abnormal EGFR or ALK gene.* ALIMTA is approved by the FDA in combination with cisplatin (another chemotherapy drug) for the first (initial) treatment of advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC that has spread. ALIMTA is approved by the FDA as a single agent (used alone) for maintenance treatment of patients with advanced nonsquamous non-small cell lung cancer (NSCLC) after you have received 4 cycles of chemotherapy that contains platinum for first treatment and your cancer has not progressed. ALIMTA is approved by the FDA as a single agent (used alone) for the treatment of patients with recurrent, metastatic nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC, which has returned or spread after prior chemotherapy.

ARAZLO™ (tazarotene) Lotion

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Ortho Dermatologics Announces Publication Of Pivotal Phase 3 Data On ARAZLO™ (tazarotene) Lotion, 0.045% In The Journal Of Drugs In Dermatology (JDD)

Mon January 13, 2020 6:45 AM|PR Newswire|About: BHC

ARAZLO Lotion Demonstrated Statistically Significant Superiority Over Placebo with Favorable Efficacy, Safety and Tolerability Profile

Post Hoc Analysis of the Two Phase 3 Studies Also Published in JDD

BRIDGEWATER, N.J., Jan. 13, 2020 /PRNewswire/ -- Bausch Health Companies Inc. (BHC) and its dermatology business, Ortho Dermatologics


 https://ortho-dermatologics.com/ 


 https://www.bauschhealth.com/ 


 https://www.prnewswire.com/news-releases/ortho-dermatologics-announces-publication-of-pivotal-phase-3-data-on-arazlo-tazarotene-lotion-0-045-in-the-journal-of-drugs-in-dermatology-jdd-300985477.html 



Continually investing in our pipeline

PF-05251749 is a CNS-penetrant regulator of circadian rhythm

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Biogen to Acquire Novel Clinical Stage Asset with Application in Alzheimer’s Disease and Parkinson’s Disease from Pfizer Inc.

Mon January 13, 2020 7:30 AM|GlobeNewswire|About: BIIB, PFE

  • PF-05251749 is a CNS-penetrant regulator of circadian rhythm with potential to address behavioral and neurological symptoms across various psychiatric and neurological diseases
     
  • Biogen to pay Pfizer (PFE) $75 million upfront plus potential milestones of up to $635 million, and royalties
     
  • PF-05251749 complements the Company’s pipeline of potential disease-modifying therapies for Alzheimer’s and Parkinson’s diseases

CAMBRIDGE, Mass., Jan. 13, 2020 (GLOBE NEWSWIRE) -- Biogen Inc. (BIIB) today announced an agreement to acquire from Pfizer Inc. PF-05251749


 https://www.biogen.com/ 


 https://www.biogen.com/en_us/pipeline.html 




BIOGEN TO ACQUIRE NOVEL CLINICAL STAGE ASSET WITH APPLICATION IN ALZHEIMER’S DISEASE AND PARKINSON’S DISEASE FROM PFIZER INC. January 13, 2020 at 7:30 AM EST PF-05251749 is a CNS-penetrant regulator of circadian rhythm with potential to address behavioral and neurological symptoms across various psychiatric and neurological diseases Biogen to pay Pfizer $75 million upfront plus potential milestones of up to $635 million, and royalties PF-05251749 complements the Company’s pipeline of potential disease-modifying therapies for Alzheimer’s and Parkinson’s diseases CAMBRIDGE, Mass., Jan. 13, 2020 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced an agreement to acquire from Pfizer Inc. (NYSE: PFE) PF-05251749

SYLVANT® and QARZIBA®

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EUSA Pharma and BeiGene Announce Exclusive Development and Commercialization Agreement for SYLVANT® and QARZIBA®▼ in Greater China

Mon January 13, 2020 7:00 AM|GlobeNewswire|About: BGNE

- SYLVANT® and QARZIBA®▼ recently listed for fast-track approval in China –

- Expands EUSA’s global product offering; broadens BeiGene’s portfolio –

HEMEL HEMPSTEAD, England and CAMBRIDGE, Mass. and BEIJING, China, Jan. 13, 2020 (GLOBE NEWSWIRE) -- EUSA Pharma (EUSA) and BeiGene, Ltd. (BGNE)


 https://www.eusapharma.com/ 


 https://www.sylvant.com/index.html 


 https://www.beigene.com/science-and-product-portfolio/pipeline 


 https://www.beigene.com/science-and-product-portfolio/research-development 

SYLVANT® (siltuximab) is a prescription medicine used to treat people with multicentric Castleman’s disease (MCD) who do not have human immunodeficiency virus (HIV) and human herpesvirus-8 (HHV-8) infection.

Seeking Biotech Alpha JANUARY 2020 Insight

(mRNA-1647)

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Moderna Announces Additional Positive Phase 1 Data from Cytomegalovirus (CMV) Vaccine (mRNA-1647) and First Participant Dosed in Phase 2 Study

Thu January 9, 2020 4:01 PM|Business Wire|About: MRNA

New interim analysis after third and final vaccination shows continued boosting of neutralizing antibody titers in both seronegative participants (exceeding seropositive baseline levels 10-fold at 90 and 180 µg) and seropositive participants (exceeding baseline levels by 20- to 40-fold at 90 and 180 µg)

Phase 2 interim data at three months, expected in 2H 2020, intended to inform Phase 3 dose selection

Pivotal Phase 3 study manufacturing and planning already underway; study start expected in 2021

CMV is the most common infectious cause of birth defects in the U.S.; there is no approved vaccine to prevent CMV

Conference call to be held at 8:00 a.m. ET on Friday, January 10, 2020

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Moderna, Inc. (MRNA), (Nasdaq: MRNA) 


 https://www.modernatx.com/ 


 https://www.modernatx.com/pipeline 


 https://www.businesswire.com/news/home/20200109005801/en/ 


 https://seekingalpha.com/symbol/MRNA 


 https://investors.modernatx.com/news-releases/news-release-details/moderna-receives-fda-fast-track-designation-zika-vaccine-mrna 



Moderna Announces Additional Positive Phase 1 Data from Cytomegalovirus (CMV) Vaccine (mRNA-1647) and First Participant Dosed in Phase 2 Study

bempegaldesleukin Plus Opdivo (nivolumab)

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Nektar Therapeutics and Bristol-Myers Squibb Amend Strategic Collaboration Agreement for bempegaldesleukin Plus Opdivo (nivolumab)

Fri January 10, 2020 6:59 AM|Business Wire|About: BMY, NKTR

SAN FRANCISCO & NEW YORK--(BUSINESS WIRE)-- Nektar Therapeutics (NKTR) (Nasdaq:NKTR) and Bristol-Myers Squibb Company (BMY) (NYSE:BMY)


 https://www.businesswire.com/news/home/20200110005103/en/ 


 https://packageinserts.bms.com/pi/pi_opdivo.pdf 


 https://www.nektar.com/ 


 https://seekingalpha.com/symbol/NKTR?s=nktr 


 https://seekingalpha.com/symbol/BMY 



Bempegaldesleukin (NKTR-214)

Acquisition also includes QBREXZA, Dermira's medicated cloth for primary axillary hyperhidrosis

 

Lilly Announces Agreement to Acquire Dermira

Fri January 10, 2020 6:30 AM|PR Newswire|About: DERM, LLY

Acquisition also includes QBREXZA, Dermira's medicated cloth for primary axillary hyperhidrosis

PR Newswire

INDIANAPOLIS and MENLO PARK, Calif., Jan. 10, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY) and Dermira, Inc. (DERM)


 https://www.dermira.com/ 


 https://investor.lilly.com/news-releases/news-release-details/lilly-announces-agreement-acquire-dermira 


 https://www.prnewswire.com/news-releases/lilly-announces-agreement-to-acquire-dermira-300984850.html 


 

Eli Lilly to acquire Dermira for $1.1B

Jan. 10, 2020 6:44 AM ET|About: Eli Lilly and Company (LLY)|By: , SA News Editor 

 https://seekingalpha.com/news/3530903-eli-lilly-to-acquire-dermira-for-1_1b 

What is QBREXZA? QBREXZA is a prescription medication used on the skin to treat excessive underarm sweating (primary axillary hyperhidrosis) in people 9 years of age and older.

fostemsavir, an investigational, first-in-class attachment inhibitor

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10 January 2020

ViiV Healthcare submits regulatory application to the European Medicines Agency for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available

Issued: London, UK


 https://viivhealthcare.com/en-gb/media/press-releases/2019/july/viiv-healthcare-presents-positive-96-week-data-from-phase-iii-st/ 


 https://viivhealthcare.com/en-us/ 


 https://www.gsk.com/en-gb/products/ 


 

Viiv Healthcare files fostemsavir application in Europe

Jan. 10, 2020 9:00 AM ET|About: GlaxoSmithKline plc (GSK)|By: , SA News Editor 

 https://seekingalpha.com/news/3530955-viiv-healthcare-files-fostemsavir-application-in-europe 

ViiV Healthcare submits New Drug Application to the FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available London, 5 December 2019 – ViiV Healthcare,

First Death From New SARS-like Virus Reported in Central China’s Wuhan

 Hong Kong / Health & Environment

Wuhan pneumonia: Hong Kong set to develop new test for mystery virus after obtaining genetic sequence from mainland China

  • A team of experts will also fly over to the mainland city to be briefed on the situation and learn about control measures
  • News comes after China confirms first death from novel coronavirus strain

 Ng Kang-chung

Published: 8:35pm, 12 Jan, 2020


 

Wuhan pneumonia: new strain ‘bears close similarity to Sars’ as Hong Kong health minister assures public city is prepared

  • Secretary for Food and Health Sophia Chan says Hong Kong has plenty of beds and protective gear, but appeals to retailers not to jack up prices of masks

 Victor Ting

Published: 2:21pm, 11 Jan, 2020


 Caixin Global Limited. All Rights Reserved.  

No new cases reported since January 3; World Health Organization praises China’s response to outbreak of mysterious new virus

Jan 11, 2020 08:31 PMENVIRONMENT First Death From New SARS-like Virus Reported in Central China’s Wuhan By Isabelle Li

mRNA-6231 & mRNA-6981

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Moderna Builds on Clinical Validation of Systemic Delivery with Two Additional Development Candidates in New Autoimmune Therapeutic Area

Sun January 12, 2020 2:00 PM|Business Wire|About: AZN, MRK, MRNA

mRNA-6231 encodes a long-acting selective IL-2 to preferentially expand regulatory T cells that suppress immune activity in autoimmune diseases

mRNA-6981 encodes PD-L1 to treat autoimmune disease, initially to be developed in autoimmune hepatitis

Company to expand pipeline of innovative vaccines in the near term based on clinical success of infectious disease vaccine portfolio to date

CAMBRIDGE, Mass--(BUSINESS WIRE)-- Moderna, Inc. (MRNA)


 https://seekingalpha.com/symbol/MRNA 


 https://www.modernatx.com/pipeline 


 https://www.nasdaq.com/press-release/annual-changes-to-the-nasdaq-biotechnology-index-2019-12-13 


 https://www.modernatx.com/ 


 https://www.businesswire.com/news/home/20200112005052/en/ 

Pipeline

Seeking Biotech Alpha JANUARY 2020 Insight

KEYTRUDA® (pembrolizumab)

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FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer With Carcinoma In Situ With or Without Papillary Tumors Who Are Ineligible for or Have Elected Not to Undergo Cystectomy

Wed January 8, 2020 4:31 PM|Business Wire|About: MRK

KEYTRUDA Is the First Anti-PD-1 Therapy Approved for Certain Patients With High-Risk, Non-Muscle Invasive Bladder Cancer

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK)


 KEYNOTE-057 (NCT02625961) 

 https://clinicaltrials.gov/ct2/show/NCT02625961 


 https://www.merckaccessprogram-keytruda.com/hcc/ 


 https://www.mrknewsroom.com/news-release/oncology/fda-approves-mercks-keytruda-pembrolizumab-patients-bcg-unresponsive-high-risk 


 https://www.businesswire.com/news/home/20200108005864/en/ 


AN IMMUNOTHERAPY THAT MAY HELP FIGHT YOUR CANCER. IT’S TRU. KEYTRUDA. AN IMMUNOTHERAPY THAT MAY HELP FIGHT YOUR CANCER. IT’S TRU. KEYTRUDA

garetosmab (REGN2477)

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Regeneron Announces Encouraging Garetosmab Phase 2 Results in Patients with Ultra-Rare Debilitating Bone Disease

Thu January 9, 2020 7:00 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y., Jan. 9, 2020 /PRNewswire/ -- 

Approximately 25% decrease in total bone lesions (both new and existing) driven by nearly 90% reduction in formation of new lesions in patients with fibrodysplasia ossificans progressiva (FOP)

Regeneron plans to discuss regulatory submission with regulatory authorities; pediatric trial planning underway

Regeneron Pharmaceuticals, Inc. (REGN) (NASDAQ: REGN)


 https://www.regeneron.com/ 


 https://www.regeneron.com/pipeline 


 https://www.prnewswire.com/news-releases/regeneron-announces-encouraging-garetosmab-phase-2-results-in-patients-with-ultra-rare-debilitating-bone-disease-300984302.html 


 https://clinicaltrials.gov/ct2/show/NCT03188666 


 

Regeneron's garetosmab shows benefit in patients with rare bone growth disorder

Jan. 9, 2020 7:39 AM ET|About: Regeneron Pharmaceutic... (REGN)|By: , SA News Editor  

 https://seekingalpha.com/news/3530636-regenerons-garetosmab-shows-benefit-in-patients-rare-bone-growth-disorder 

January 9, 2020 at 7:00 AM EST Back REGENERON ANNOUNCES ENCOURAGING GARETOSMAB PHASE 2 RESULTS IN PATIENTS WITH ULTRA-RARE DEBILITATING BONE DISEASE TARRYTOWN, N.Y., Jan. 9, 2020 /PRNewswire/ --

Optune®

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Zai Lab and Novocure Announce First Patient Enrolled in a Phase 2 Pilot Trial of Tumor Treating Fields Together with Chemotherapy as First-Line Treatment of Gastric Cancer

Thu January 9, 2020 7:30 AM|Business Wire|About: NVCR, ZLAB

SHANGHAI & ST. HELIER, Jersey--(BUSINESS WIRE)-- Zai Lab Limited (ZLAB), a China and U.S.-based innovative commercial stage biopharmaceutical company, and Novocure (NVCR)


 https://www.novocure.com/ 


 https://www.businesswire.com/news/home/20200109005409/en/ 


 http://www.zailaboratory.com/index.aspx 


 http://www.zailaboratory.com/pipeline/list.aspx 


 https://www.optune.com/hcp 


Zai Lab has a broad and validated late-stage pipeline in oncology and infectious disease. We currently have 2 products commercialized and 3 drugs approved in the U.S. (marked with * below). Overall, our pipeline consists of over 15 drug candidates with over 20 ongoing or planned clinical trials.

Reblozyl® (luspatercept-aamt)

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New England Journal of Medicine Publishes Results of Pivotal Phase 3 Reblozyl® (luspatercept-aamt) MEDALIST Trial

Thu January 9, 2020 6:59 AM|Business Wire|About: BMY, XLRN

Data from MEDALIST showed significant clinical benefit of Reblozyl in treating anemia in adults with myelodysplastic syndromes

PRINCETON, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY) (NYSE:BMY) and Acceleron Pharma Inc. (XLRN)


 https://www.bms.com/patient-and-caregivers/our-medicines.html 


 https://www.reblozylpro.com/ 


 https://media.celgene.com/content/uploads/reblozyl-pi.pdf 


 http://acceleronpharma.com/ 


 

New England Journal of Medicine Publishes Results of Pivotal Phase 3 Reblozyl® (luspatercept-aamt) MEDALIST Trial

Data from MEDALIST showed significant clinical benefit of Reblozyl in treating anemia in adults with myelodysplastic syndromes

CATEGORY: 

CORPORATE/FINANCIAL NEWSTHURSDAY, JANUARY 9, 2020 6:59 AM EST 

 https://news.bms.com/press-release/corporatefinancial-news/new-england-journal-medicine-publishes-results-pivotal-phase-

 

Luspatercept-aamt

Novel erythroid maturation agent in development for treatment of serious and chronic anemias

Luspatercept-aamt is a first-in-class erythroid (red blood cell) maturation agent being developed to treat patients who have serious blood disorders associated with ineffective erythropoiesis.

Discovered by scientists at Acceleron, luspatercept-aamt is a recombinant fusion protein that binds several TGF-beta superfamily ligands, thereby diminishing Smad2/3 signaling.

 http://acceleronpharma.com/science-pipeline/luspatercept/ 

THE FIRST AND ONLY ERYTHROID MATURATION AGENT (EMA) for anemia in adults with β-thalassemia requiring regular RBC transfusions1 REBLOZYL is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

NV-HHV-101

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NanoViricides Successfully Completes Required Genetic Toxicology Testing of Lead Drug Candidate NV-HHV-101

Thu January 9, 2020 8:00 AM|Accesswire|About: NNVC

SHELTON, CT / ACCESSWIRE / January 9, 2020 / NanoViricides, Inc. (NNVC)


 http://www.nanoviricides.com/ 



NanoViricides Successfully Completes Required Genetic Toxicology Testing of Lead Drug Candidate NV-HHV-101 Thursday, January 9, 2020 8:00 AM SHELTON, CT / ACCESSWIRE / January 9, 2020 / NanoViricides, Inc. (NYSE American:NNVC)

Microbiome Metabolic Therapies (MMT™)

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Kaleido Biosciences Announces Collaboration with Janssen to Explore the Potential for Microbiome Metabolic Therapies (MMT™) to Prevent Childhood-Onset of Atopic, Immune and Metabolic Conditions by Promoting Healthy Function of the Gut Microbiome

Thu January 9, 2020 8:00 AM|GlobeNewswire|About: KLDO

LEXINGTON, Mass., Jan. 09, 2020 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc (KLDO). (Nasdaq: KLDO)


 https://kaleido.com/our-pipeline/ 


 

Kaleido Biosciences Announces Collaboration with Janssen to Explore the Potential for Microbiome Metabolic Therapies (MMT™) to Prevent Childhood-Onset of Atopic, Immune and Metabolic Conditions by Promoting Healthy Function of the Gut Microbiome

January 9, 2020 

 https://investors.kaleido.com/news-releases/news-release-details/kaleido-biosciences-announces-collaboration-janssen-explore 

Kaleido has a broad pipeline of Microbiome Metabolic Therapy candidates (MMTs) across a variety of diseases and conditions with significant unmet need, including programs that have advanced into human clinical studies.*

Seeking Biotech Alpha JANUARY 2020 Insight

Pemigatinib

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Incyte Announces the Validation by the European Medicines Agency of its Marketing Authorization Application for Pemigatinib in Patients with Cholangiocarcinoma

Tue January 7, 2020 6:00 AM|Business Wire|About: INCY

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (INCY)


 https://clinicaltrials.gov/ct2/show/NCT02924376 


 https://www.incyte.com/ 


 https://www.businesswire.com/news/home/20200107005093/en/ 



Incyte Announces the Validation by the European Medicines Agency of its Marketing Authorization Application for Pemigatinib in Patients with Cholangiocarcinoma 07 January, 2020 PDF Version WILMINGTON, Del.--(BUSINESS WIRE)--Jan. 7, 2020-- Incyte (Nasdaq:INCY)

RINVOQ® (upadacitinib)

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AbbVie Receives Health Canada Approval of RINVOQ® (upadacitinib), an Oral Medication for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis

Tue January 7, 2020 8:01 AM|Canada Newswire|About: ABBV

  • Approval supported by efficacy and safety data from the pivotal Phase 3 SELECT rheumatoid arthritis (RA) program, one of the largest registrational Phase 3 programs in RA with approximately 4,400 patients evaluated across five studies1-5
  • About one in every 100 adult Canadians, or approximately 300,000 people, are living with rheumatoid arthritis, the majority of whom don't achieve remission6,7

MONTREAL, Jan. 7, 2020 /CNW/ - AbbVie (ABBV


 http://www.abbvie.ca/ 


 https://abbviecare.ca/ 


 https://www.abbvie.com/ 



RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated.

pegcetacoplan (APL-2)

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Apellis Reports Positive Top-line Results from Phase 3 Head-to-Head Study of Pegcetacoplan (APL-2) Compared to Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

Tue January 7, 2020 7:00 AM|GlobeNewswire|About: APLS

  • Pegcetacoplan met the primary endpoint in the PEGASUS study, demonstrating superiority to eculizumab (p<0.0001) with an improvement in adjusted means of 3.8 g/dL of hemoglobin at week 16
  • Safety profile of pegcetacoplan was comparable to eculizumab in this study
  • Conference call scheduled today at 8:30 a.m. ET

WALTHAM, Mass., Jan. 07, 2020 (GLOBE NEWSWIRE) --  Apellis Pharmaceuticals (APLS), Inc. (Nasdaq: APLS)


 https://www.apellis.com/our-science/clinical-trials 


 https://apellis.com/our-science/our-pipeline/ 



PEGASUS Phase 3 Positive Top-Line Results Conference Call January 7, 2020

ADXS-504

image238

 

Advaxis Announces FDA Clearance of IND for ADXS-504 for Treatment of Prostate Cancer

Tue January 7, 2020 8:00 AM|GlobeNewswire|About: ADXSGlobeNewswire

PRINCETON, N.J., Jan. 07, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (ADXS)


 https://advaxis.com/ 


 https://advaxis.com/clinical-trials-3/ 


 https://seekingalpha.com/symbol/ADXS 


ADXS-HOT Program Targeting Hotpot Mutations and Tumor Associated Antigens

NV-HHV-101

image239

 

NanoViricides Has Initiated Genetic Toxicology Testing Required for an IND for Its Drug Candidate

Tue January 7, 2020 8:30 AM|Accesswire|About: NNVC

SHELTON, CT / ACCESSWIRE / January 7, 2020 / NanoViricides, Inc. (NNVC) (NYSE Amer.:NNVC)


 http://www.nanoviricides.com/ 


 https://seekingalpha.com/symbol/NNVC