Moorestown, New Jersey, United States
Seeking Biotech Alpha JANUARY 2020 Insight
Tybost (cobicistat)
leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications
leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications
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: Douglas W. House, SA News Editor
https://www.gilead.com/-/media/files/pdfs/medicines/hiv/tybost/tybost_pi.pdf
https://seekingalpha.com/symbol/GILD
leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications
leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications
leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications
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/pipeline/cancer
https://seekingalpha.com/symbol/CYDY
MabThera (rituximab)
leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications
Rezolsta (darunavir/cobicistat)
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: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3536828-european-advisory-group-backs-expanded-use-of-roches-mabthera
https://seekingalpha.com/symbol/RHHBY
Rezolsta (darunavir/cobicistat)
tucatinib, in combination with trastuzumab and capecitabine
Rezolsta (darunavir/cobicistat)
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: Douglas W. House, SA News Editor
https://seekingalpha.com/symbol/JNJ
https://www.medicines.org.uk/emc/product/3466/smpc
Suliqua (insulin glargine/lixisenatide)
tucatinib, in combination with trastuzumab and capecitabine
tucatinib, in combination with trastuzumab and capecitabine
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: Douglas W. House, SA News Editor
https://seekingalpha.com/symbol/SNY
tucatinib, in combination with trastuzumab and capecitabine
tucatinib, in combination with trastuzumab and capecitabine
tucatinib, in combination with trastuzumab and capecitabine
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
Seeking Biotech Alpha JANUARY 2020 Insight
Staquis is crisaborole, a non-corticosteroid dermatological agent for dermatitis, (ATC code: D11AH)
Staquis is crisaborole, a non-corticosteroid dermatological agent for dermatitis, (ATC code: D11AH)
Staquis is crisaborole, a non-corticosteroid dermatological agent for dermatitis, (ATC code: D11AH)
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: Douglas W. House, SA News Editor
https://seekingalpha.com/symbol/PFE
Rybelsus is semaglutide, a glucagon-like peptide 1 (GLP-1) receptor agonist (ATC code: A10BJ06)
Staquis is crisaborole, a non-corticosteroid dermatological agent for dermatitis, (ATC code: D11AH)
Staquis is crisaborole, a non-corticosteroid dermatological agent for dermatitis, (ATC code: D11AH)
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: Douglas W. House, 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
MAVIRET® (glecaprevir/pibrentasvir)
Staquis is crisaborole, a non-corticosteroid dermatological agent for dermatitis, (ATC code: D11AH)
VENCLYXTO® (venetoclax) in combination with obinutuzumab
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://seekingalpha.com/symbol/ABBV
VENCLYXTO® (venetoclax) in combination with obinutuzumab
Ruxience is rituximab, a monoclonal antibody (ATC code: L01XC02)
VENCLYXTO® (venetoclax) in combination with obinutuzumab
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://seekingalpha.com/symbol/ABBV
Liumjev™ - fast-acting formulation of insulin lispro
Ruxience is rituximab, a monoclonal antibody (ATC code: L01XC02)
Ruxience is rituximab, a monoclonal antibody (ATC code: L01XC02)
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/
Ruxience is rituximab, a monoclonal antibody (ATC code: L01XC02)
Ruxience is rituximab, a monoclonal antibody (ATC code: L01XC02)
Ruxience is rituximab, a monoclonal antibody (ATC code: L01XC02)
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: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3536804-european-advisory-group-backs-pfizers-rituxan-biosimilar
Seeking Biotech Alpha JANUARY 2020 Insight
OLUMIANT® (baricitinib) 2-mg
Olipudase alfa, an investigational recombinant human acid sphingomyelinase
OLUMIANT® (baricitinib) 2-mg
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://seekingalpha.com/symbol/INCY
https://seekingalpha.com/symbol/LLY
darolutamide + ADT
Olipudase alfa, an investigational recombinant human acid sphingomyelinase
OLUMIANT® (baricitinib) 2-mg
Bayer's darolutamide extends survival in late-state prostate cancer study
Jan. 30, 2020 7:16 AM ET|About: Bayer Aktiengesellschaft (BAYRY)|By: Douglas W. House, SA News Editor
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
Olipudase alfa, an investigational recombinant human acid sphingomyelinase
Olipudase alfa, an investigational recombinant human acid sphingomyelinase
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
Tendyne™ Transcatheter Mitral Valve Implantation (TMVI) system
Cobalt™ & Crome™ implantable cardioverter-defibrillators (ICD) & cardiac resynchronization therapy-
Olipudase alfa, an investigational recombinant human acid sphingomyelinase
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://seekingalpha.com/symbol/ABT
Cobalt™ & Crome™ implantable cardioverter-defibrillators (ICD) & cardiac resynchronization therapy-
Cobalt™ & Crome™ implantable cardioverter-defibrillators (ICD) & cardiac resynchronization therapy-
Cobalt™ & Crome™ implantable cardioverter-defibrillators (ICD) & cardiac resynchronization therapy-
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://seekingalpha.com/symbol/MDT
KRAS inhibitor BI 1701963, a FORMA-discovered, BI-licensed protein-protein interaction
Cobalt™ & Crome™ implantable cardioverter-defibrillators (ICD) & cardiac resynchronization therapy-
Cobalt™ & Crome™ implantable cardioverter-defibrillators (ICD) & cardiac resynchronization therapy-
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.businesswire.com/news/home/20200130005064/en/
https://www.formatherapeutics.com/pipeline/
Seeking Biotech Alpha JANUARY 2020 Insight
Selpercatinib (LOXO-292)
CABOMETYX® (cabozantinib)
CABOMETYX® (cabozantinib)
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/
CABOMETYX® (cabozantinib)
CABOMETYX® (cabozantinib)
CABOMETYX® (cabozantinib)
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.businesswire.com/news/home/20200128005841/en/
https://seekingalpha.com/symbol/TKPHF
https://seekingalpha.com/symbol/EXEL
CYNK-001, an allogeneic
CABOMETYX® (cabozantinib)
Johnson & Johnson Launches Multi-Pronged Response to Coronavirus Global Public Health Threat
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/
Johnson & Johnson Launches Multi-Pronged Response to Coronavirus Global Public Health Threat
obeticholic acid (OCA) for treatment of cirrhosis due to nonalcoholic steatohepatitiitis (NASH)
Johnson & Johnson Launches Multi-Pronged Response to Coronavirus Global Public Health Threat
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: Douglas W. House, 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).
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
obeticholic acid (OCA) for treatment of cirrhosis due to nonalcoholic steatohepatitiitis (NASH)
obeticholic acid (OCA) for treatment of cirrhosis due to nonalcoholic steatohepatitiitis (NASH)
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
technology designed to individually or in combination, stimulate and enhance the immune system
obeticholic acid (OCA) for treatment of cirrhosis due to nonalcoholic steatohepatitiitis (NASH)
obeticholic acid (OCA) for treatment of cirrhosis due to nonalcoholic steatohepatitiitis (NASH)
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: Douglas W. House, 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
Seeking Biotech Alpha JANUARY 2020 Insight
KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy
ZIRABEV™ (bevacizumab-bvzr), RUXIENCE™ (rituximab-pvvr) and TRAZIMERA™ (trastuzumab-qyyp)
ZIRABEV™ (bevacizumab-bvzr), RUXIENCE™ (rituximab-pvvr) and TRAZIMERA™ (trastuzumab-qyyp)
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.businesswire.com/news/home/20200128005723/en/
https://seekingalpha.com/symbol/GILD
ZIRABEV™ (bevacizumab-bvzr), RUXIENCE™ (rituximab-pvvr) and TRAZIMERA™ (trastuzumab-qyyp)
ZIRABEV™ (bevacizumab-bvzr), RUXIENCE™ (rituximab-pvvr) and TRAZIMERA™ (trastuzumab-qyyp)
ZIRABEV™ (bevacizumab-bvzr), RUXIENCE™ (rituximab-pvvr) and TRAZIMERA™ (trastuzumab-qyyp)
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.
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
XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension)
ZIRABEV™ (bevacizumab-bvzr), RUXIENCE™ (rituximab-pvvr) and TRAZIMERA™ (trastuzumab-qyyp)
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)
AJOVY® (fremanezumab-vfrm) Injection Autoinjector
AJOVY® (fremanezumab-vfrm) Injection Autoinjector
XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension)
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.businesswire.com/news/home/20200128005810/en/
AKCEA-ANGPTL3-LRx
AJOVY® (fremanezumab-vfrm) Injection Autoinjector
novel coronavirus (2019-nCoV)
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/our-programs/pipeline/
novel coronavirus (2019-nCoV)
AJOVY® (fremanezumab-vfrm) Injection Autoinjector
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
Published: 7:08am, 29 Jan, 2020
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
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
Published: 2:04am, 29 Jan, 2020
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
Seeking Biotech Alpha JANUARY 2020 Insight
Dupixent® (dupilumab)
Trijardy™ XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets)
Trijardy™ XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets)
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://seekingalpha.com/symbol/REGN
Trijardy™ XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets)
Trijardy™ XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets)
Trijardy™ XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets)
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://www.boehringer-ingelheim.us/our-responsibility/our-responsibility
https://www.lillydiabetes.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.
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.
ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder
Trijardy™ XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets)
ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder
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)
Bria-IMT™ in combination with pembrolizumab KEYTRUDA®
Bria-IMT™ in combination with pembrolizumab KEYTRUDA®
ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder
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://seekingalpha.com/symbol/BCTXF
Vascepa® (Icosapent Ethyl)
Bria-IMT™ in combination with pembrolizumab KEYTRUDA®
Vascepa® (Icosapent Ethyl)
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/
Vascepa to launch in Canada next month
Jan. 28, 2020 6:55 AM ET|About: HLS Therapeutics Inc. (HLTRF)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3535025-vascepa-to-launch-in-canada-next-month
https://seekingalpha.com/symbol/HLTRF
ruxolitinib cream
Bria-IMT™ in combination with pembrolizumab KEYTRUDA®
Vascepa® (Icosapent Ethyl)
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.businesswire.com/news/home/20200128005173/en/
Seeking Biotech Alpha JANUARY 2020 Insight
DIFICID® (fidaxomicin)
JAK Inhibitor Baricitinib in Combination with Topical Corticosteroids
BRILINTA (ticagrelor) 90 mg
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/
BRILINTA (ticagrelor) 90 mg
JAK Inhibitor Baricitinib in Combination with Topical Corticosteroids
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.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: Douglas W. House, SA News Editor
JAK Inhibitor Baricitinib in Combination with Topical Corticosteroids
JAK Inhibitor Baricitinib in Combination with Topical Corticosteroids
JAK Inhibitor Baricitinib in Combination with Topical Corticosteroids
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
Tecentriq® (atezolizumab) & Avastin® (bevacizumab)
DESTINY-Gastric01 trial of DS-8201, a HER2 directed antibody drug conjugate (ADC)
JAK Inhibitor Baricitinib in Combination with Topical Corticosteroids
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.businesswire.com/news/home/20200126005034/en/
https://www.gene.com/media/press-releases/14835/2020-01-26/genentech-submits-supplemental-biologics
STELARA® (ustekinumab)
DESTINY-Gastric01 trial of DS-8201, a HER2 directed antibody drug conjugate (ADC)
DESTINY-Gastric01 trial of DS-8201, a HER2 directed antibody drug conjugate (ADC)
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/
DESTINY-Gastric01 trial of DS-8201, a HER2 directed antibody drug conjugate (ADC)
DESTINY-Gastric01 trial of DS-8201, a HER2 directed antibody drug conjugate (ADC)
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://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: Douglas W. House, SA News Editor
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
Seeking Biotech Alpha JANUARY 2020 Insight
DKN-01 plus KEYTRUDA® (pembrolizumab)
PulseSelect™ Pulsed Field Ablation (PFA) System
PulseSelect™ Pulsed Field Ablation (PFA) System
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)
Leap's DKN-01 shows positive effect in esophagogastric cancer
Jan. 23, 2020 7:48 AM ET|About: Leap Therapeutics, Inc. (LPTX)|By: Douglas W. House, SA News Editor
PulseSelect™ Pulsed Field Ablation (PFA) System
PulseSelect™ Pulsed Field Ablation (PFA) System
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: Douglas W. House, SA News Editor
novel coronavirus (2019-nCoV)
PulseSelect™ Pulsed Field Ablation (PFA) System
cabozantinib (CABOMETYX®) and nivolumab (Opdivo®) with or without ipilimumab (Yervoy®)
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
cabozantinib (CABOMETYX®) and nivolumab (Opdivo®) with or without ipilimumab (Yervoy®)
KALETRA® (lopinavir/ritonavir) Tablets and KALETRA® (lopinavir/ritonavir) Oral Solution
cabozantinib (CABOMETYX®) and nivolumab (Opdivo®) with or without ipilimumab (Yervoy®)
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://clinicaltrials.gov/ct2/show/NCT01658878?term=NCT01658878
https://www.businesswire.com/news/home/20200124005066/en/
KALETRA® (lopinavir/ritonavir) Tablets and KALETRA® (lopinavir/ritonavir) Oral Solution
KALETRA® (lopinavir/ritonavir) Tablets and KALETRA® (lopinavir/ritonavir) Oral Solution
KALETRA® (lopinavir/ritonavir) Tablets and KALETRA® (lopinavir/ritonavir) Oral Solution
China names HIV drugs as part of treatment plan for Wuhan virus
BLOOMBERG
- JAN 26, 2020ARTICLE HISTORY
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
AbbVie Drugs Named as Part of China Treatment Plan: Virus Update
5 million residents left Wuhan before lockdown, mayor reveals, as 1,000 new confirmed cases expected in city
https://www.abbvie.com/our-science/products.html
Scientists race to find out how Wuhan victims became ill
https://www.nytimes.com/2020/01/25/world/asia/china-coronavirus.html
Wuhan Coronavirus map (with updates)
https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6
Wuhan Virus
novel coronavirus (2019-nCoV)
KALETRA® (lopinavir/ritonavir) Tablets and KALETRA® (lopinavir/ritonavir) Oral Solution
KALETRA® (lopinavir/ritonavir) Tablets and KALETRA® (lopinavir/ritonavir) Oral Solution
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
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
Published: 7:35am, 25 Jan, 2020
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
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
Jan 25, 2020 12:46 AMSOCIETY & CULTURE
Months Needed to Develop Coronavirus Vaccine: Epidemiology Group
By Dave Yin
Seeking Biotech Alpha JANUARY 2020 Insight
Baqsimi™ (glucagon nasal powder 3 mg)
KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with Inlyta® (axitinib)
KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with Inlyta® (axitinib)
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
KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with Inlyta® (axitinib)
KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with Inlyta® (axitinib)
KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with Inlyta® (axitinib)
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/static/pdf/KEYTRUDA-PM_E.pdf
Generic Version of Viagra® (sildenafil citrate)
KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with Inlyta® (axitinib)
Generic Version of Viagra® (sildenafil citrate)
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/
Efficio™ Software
Moderna = CEPI Funding to Development of Messenger RNA (mRNA) Vaccine Against Novel Coronavirus
Generic Version of Viagra® (sildenafil citrate)
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
Moderna = CEPI Funding to Development of Messenger RNA (mRNA) Vaccine Against Novel Coronavirus
Moderna = CEPI Funding to Development of Messenger RNA (mRNA) Vaccine Against Novel Coronavirus
Moderna = CEPI Funding to Development of Messenger RNA (mRNA) Vaccine Against Novel Coronavirus
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://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: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3533957-moderna-nabs-funding-to-make-vaccine-against-china-coronavirus
novel coronavirus (2019-nCoV)
Moderna = CEPI Funding to Development of Messenger RNA (mRNA) Vaccine Against Novel Coronavirus
Moderna = CEPI Funding to Development of Messenger RNA (mRNA) Vaccine Against Novel Coronavirus
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
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
Respiratory virus in China less virulent than 2003 SARS
Jan. 23, 2020 6:59 AM ET|About: Moderna, Inc. (MRNA)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3533816-respiratory-virus-in-china-less-virulent-2003-sars
Seeking Biotech Alpha JANUARY 2020 Insight
Eli Lilly and Company Selects North Carolina for Major Pharmaceutical Plant
Eli Lilly and Company Selects North Carolina for Major Pharmaceutical Plant
Eli Lilly and Company Selects North Carolina for Major Pharmaceutical Plant
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
Lilly to invest $470M in North Carolina site
Jan. 21, 2020 1:21 PM ET|About: Eli Lilly and Company (LLY)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3533180-lilly-to-invest-470m-in-north-carolina-site
TEPEZZATM (teprotumumab-trbw)
Eli Lilly and Company Selects North Carolina for Major Pharmaceutical Plant
Eli Lilly and Company Selects North Carolina for Major Pharmaceutical Plant
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/
Medtronic Intellis™ Platform
Eli Lilly and Company Selects North Carolina for Major Pharmaceutical Plant
Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier
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.
Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier
Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier
Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier
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: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3533806-roches-risdiplam-successful-in-sma-study
AXS-05 (dextromethorphan/bupropion modulated delivery tablet)
Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier
Wuhan coronavirus has entered transmission stage among families and hospitals
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/axs-pipeline/overview/
Wuhan coronavirus has entered transmission stage among families and hospitals
Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier
Wuhan coronavirus has entered transmission stage among families and hospitals
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
Published: 6:17pm, 21 Jan, 2020
Seeking Biotech Alpha JANUARY 2020 Insight
Mayzent® (siponimod)
Polivy® (polatuzumab vedotin), in combination with bendamustine plus MabThera® (rituximab) (BR
Polivy® (polatuzumab vedotin), in combination with bendamustine plus MabThera® (rituximab) (BR
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: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3532960-novartis-mayzent-okd-in-europe-for-multiple-sclerosis
https://www.mayzent.com/index.jsp
Polivy® (polatuzumab vedotin), in combination with bendamustine plus MabThera® (rituximab) (BR
Polivy® (polatuzumab vedotin), in combination with bendamustine plus MabThera® (rituximab) (BR
Polivy® (polatuzumab vedotin), in combination with bendamustine plus MabThera® (rituximab) (BR
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
anti-PD-1 antibody tislelizumab in combination with two chemotherapy regimens
Polivy® (polatuzumab vedotin), in combination with bendamustine plus MabThera® (rituximab) (BR
anti-PD-1 antibody tislelizumab in combination with two chemotherapy regimens
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)
BeiGene's tislelizumab successful in late-stage lung cancer study
Jan. 21, 2020 7:31 AM ET|About: BeiGene, Ltd. (BGNE)|By: Douglas W. House, SA News Editor
belantamab mafodotin (GSK2857916)
Micra™ AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony
anti-PD-1 antibody tislelizumab in combination with two chemotherapy regimens
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)
Glaxo's balantamab mafodotin nabs accelerated review in U.S. for MM
Jan. 21, 2020 9:21 AM ET|About: GlaxoSmithKline plc (GSK)|By: Douglas W. House, SA News Editor
Optune® in Combination with Temozolomide
Micra™ AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony
Micra™ AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony
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.businesswire.com/news/home/20200121005576/en/
Micra™ AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony
Micra™ AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony
Micra™ AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony
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
Seeking Biotech Alpha JANUARY 2020 Insight
AXL Inhibitor Bemcentinib in Combination With Keytruda®
China says infections spreading as it reports third death from Wuhan virus
AXL Inhibitor Bemcentinib in Combination With Keytruda®
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)
BerGenBio's bemcentinib shows positive action in mid-stage lung cancer study
Jan. 15, 2020 11:57 AM ET|About: BerGenBio ASA (BRRGF)|By: Douglas W. House, SA News Editor
t:slim X2 Insulin Pump with Control-IQ Technology
China says infections spreading as it reports third death from Wuhan virus
AXL Inhibitor Bemcentinib in Combination With Keytruda®
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/
China says infections spreading as it reports third death from Wuhan virus
China says infections spreading as it reports third death from Wuhan virus
China says infections spreading as it reports third death from Wuhan virus
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
Published: 8:58am, 20 Jan, 2020
Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody
Human-to-human link to some cases of new China virus, Sars expert says
China says infections spreading as it reports third death from Wuhan virus
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: Yoel Minkoff, SA News Editor
LYNPARZA® (olaparib)
Human-to-human link to some cases of new China virus, Sars expert says
Human-to-human link to some cases of new China virus, Sars expert says
.
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: Douglas W. House, SA News Editor
https://www.businesswire.com/news/home/20200121005282/en/
Human-to-human link to some cases of new China virus, Sars expert says
Human-to-human link to some cases of new China virus, Sars expert says
Human-to-human link to some cases of new China virus, Sars expert says
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
Published: 9:40pm, 20 Jan, 2020
Seeking Biotech Alpha JANUARY 2020 Insight
LibtayoTM (cemiplimab)
Tafasitamab (MOR208, formerly Xmab®5574) is an investigational monoclonal antibody
APD418, a β3-adrenergic receptor (AdrR) antagonist and cardiac myotrope
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
APD418, a β3-adrenergic receptor (AdrR) antagonist and cardiac myotrope
Tafasitamab (MOR208, formerly Xmab®5574) is an investigational monoclonal antibody
APD418, a β3-adrenergic receptor (AdrR) antagonist and cardiac myotrope
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/pipeline/apd418/
Tafasitamab (MOR208, formerly Xmab®5574) is an investigational monoclonal antibody
Tafasitamab (MOR208, formerly Xmab®5574) is an investigational monoclonal antibody
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;
Ozempic® (semaglutide) injection 0.5 mg or 1 mg
Eli Lilly targets quarterly deals of $1 billion-$5 billion in 2020
Tafasitamab (MOR208, formerly Xmab®5574) is an investigational monoclonal antibody
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: Carl Surran, SA News Editor
https://seekingalpha.com/news/3532608-novo-nordisk-says-fda-approves-new-indication-for-ozempic
Eli Lilly targets quarterly deals of $1 billion-$5 billion in 2020
Eli Lilly targets quarterly deals of $1 billion-$5 billion in 2020
Eli Lilly targets quarterly deals of $1 billion-$5 billion in 2020
BUSINESS NEWSJANUARY 16, 2020 / 6:25 PM / UPDATED 13 HOURS AGO
Eli Lilly targets quarterly deals of $1 billion-$5 billion in 2020: CFO
3 MIN READ
SAN FRANCISCO (Reuters) - Eli Lilly and Co (LLY.N)
https://seekingalpha.com/news/3532615-eli-lilly-targets-buying-spree-in-2020
SkinMedica® Instant Bright Eye Cream
Eli Lilly targets quarterly deals of $1 billion-$5 billion in 2020
Eli Lilly targets quarterly deals of $1 billion-$5 billion in 2020
Seeking Biotech Alpha JANUARY 2020 Insight
LRRK2 inhibitor
Opdivo (nivolumab) Plus Yervoy (ipilimumab)
Opdivo (nivolumab) Plus Yervoy (ipilimumab)
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
Opdivo (nivolumab) Plus Yervoy (ipilimumab)
Opdivo (nivolumab) Plus Yervoy (ipilimumab)
Opdivo (nivolumab) Plus Yervoy (ipilimumab)
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://packageinserts.bms.com/pi/pi_opdivo.pdf
https://packageinserts.bms.com/pi/pi_yervoy.pdf
https://www.businesswire.com/news/home/20200115005245/en/
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)
Rubraca® (rucaparib)
Opdivo (nivolumab) Plus Yervoy (ipilimumab)
Dovato (dolutegravir 50 mg/lamivudine 300 mg)
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
Dovato (dolutegravir 50 mg/lamivudine 300 mg)
Stealth Autoguide™ Cranial Robotic Guidance Platform
Dovato (dolutegravir 50 mg/lamivudine 300 mg)
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
ViiV Healthcare's Dovato OK'd in Japan
Jan. 15, 2020 6:49 AM ET|About: GlaxoSmithKline plc (GSK)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3531913-viiv-healthcares-dovato-okd-in-japan
SPRAVATO®▼ (esketamine) nasal spray
Stealth Autoguide™ Cranial Robotic Guidance Platform
Stealth Autoguide™ Cranial Robotic Guidance Platform
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
J&J files application in Europe for expanded use of Spravato
Jan. 15, 2020 7:56 AM ET|About: Johnson & Johnson (JNJ)|By: Douglas W. House, SA News Editor
https://www.ema.europa.eu/en/documents/product-information/spravato-epar-product-information_en.pdf
Stealth Autoguide™ Cranial Robotic Guidance Platform
Stealth Autoguide™ Cranial Robotic Guidance Platform
Stealth Autoguide™ Cranial Robotic Guidance Platform
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
Seeking Biotech Alpha JANUARY 2020 Insight
VASCEPA® (icosapent ethyl)
Exonate & Janssen to Develop a New Eye Drop for Treatment of Retinal Vascular Diseases
Exonate & Janssen to Develop a New Eye Drop for Treatment of Retinal Vascular Diseases
Amarin Stock Is Surging as Rival Makers of Fish-Oil Heart Drugs Fall Short
By Josh Nathan-KazisJan. 13, 2020 11:07 am ET
Acasti Pharma's pain is Amarin's gain, up 12% premarket
Jan. 13, 2020 6:39 AM ET|About: Acasti Pharma Inc. (ACST)|By: Douglas W. House, SA News Editor
Exonate & Janssen to Develop a New Eye Drop for Treatment of Retinal Vascular Diseases
Exonate & Janssen to Develop a New Eye Drop for Treatment of Retinal Vascular Diseases
Exonate & Janssen to Develop a New Eye Drop for Treatment of Retinal Vascular Diseases
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,
J&J to collaborate with Exonate in eye diseases
Jan. 13, 2020 11:24 AM ET|About: Johnson & Johnson (JNJ)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3531385-j-and-j-to-collaborate-exonate-in-eye-diseases
genome editing and cell therapy technologies
Exonate & Janssen to Develop a New Eye Drop for Treatment of Retinal Vascular Diseases
Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen®
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://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: Douglas W. House, SA News Editor
Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen®
Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen®
Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen®
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://lillypad.lilly.com/entry.php?e=11640
ELZONRIS® (tagraxofusp)
Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen®
ELZONRIS® (tagraxofusp)
SKYRIZI™ (risankizumab)
Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen®
ELZONRIS® (tagraxofusp)
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://clinicaltrials.gov/ct2/show/NCT03478787
Seeking Biotech Alpha JANUARY 2020 Insight
antibody cytokine engrafted protein, referred to as IOV-3001
Tyvyt® (Sintilimab Injection) Combined with ALIMTA® (Pemetrexed)
antibody cytokine engrafted protein, referred to as IOV-3001
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://seekingalpha.com/symbol/IOVA
Iovance in-licenses engineered protein candidate from Novartis
Jan. 12, 2020 6:19 PM ET|About: Iovance Biotherapeutic... (IOVA)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3531139-iovance-in-licenses-engineered-protein-candidate-from-novartis
ZW25 in Combination with Ibrance® (palbociclib)
Tyvyt® (Sintilimab Injection) Combined with ALIMTA® (Pemetrexed)
antibody cytokine engrafted protein, referred to as IOV-3001
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.businesswire.com/news/home/20200112005029/en/
Tyvyt® (Sintilimab Injection) Combined with ALIMTA® (Pemetrexed)
Tyvyt® (Sintilimab Injection) Combined with ALIMTA® (Pemetrexed)
Tyvyt® (Sintilimab Injection) Combined with ALIMTA® (Pemetrexed)
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
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: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3531196-lillys-tyvyt-alimta-successful-in-lung-cancer-study
ARAZLO™ (tazarotene) Lotion
PF-05251749 is a CNS-penetrant regulator of circadian rhythm
Tyvyt® (Sintilimab Injection) Combined with ALIMTA® (Pemetrexed)
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/
PF-05251749 is a CNS-penetrant regulator of circadian rhythm
PF-05251749 is a CNS-penetrant regulator of circadian rhythm
PF-05251749 is a CNS-penetrant regulator of circadian rhythm
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/en_us/pipeline.html
SYLVANT® and QARZIBA®
PF-05251749 is a CNS-penetrant regulator of circadian rhythm
PF-05251749 is a CNS-penetrant regulator of circadian rhythm
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.sylvant.com/index.html
https://www.beigene.com/science-and-product-portfolio/pipeline
https://www.beigene.com/science-and-product-portfolio/research-development
Seeking Biotech Alpha JANUARY 2020 Insight
(mRNA-1647)
Acquisition also includes QBREXZA, Dermira's medicated cloth for primary axillary hyperhidrosis
bempegaldesleukin Plus Opdivo (nivolumab)
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/pipeline
https://www.businesswire.com/news/home/20200109005801/en/
https://seekingalpha.com/symbol/MRNA
bempegaldesleukin Plus Opdivo (nivolumab)
Acquisition also includes QBREXZA, Dermira's medicated cloth for primary axillary hyperhidrosis
bempegaldesleukin Plus Opdivo (nivolumab)
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://seekingalpha.com/symbol/NKTR?s=nktr
https://seekingalpha.com/symbol/BMY
Acquisition also includes QBREXZA, Dermira's medicated cloth for primary axillary hyperhidrosis
Acquisition also includes QBREXZA, Dermira's medicated cloth for primary axillary hyperhidrosis
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.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: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3530903-eli-lilly-to-acquire-dermira-for-1_1b
fostemsavir, an investigational, first-in-class attachment inhibitor
First Death From New SARS-like Virus Reported in Central China’s Wuhan
Acquisition also includes QBREXZA, Dermira's medicated cloth for primary axillary hyperhidrosis
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-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: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3530955-viiv-healthcare-files-fostemsavir-application-in-europe
First Death From New SARS-like Virus Reported in Central China’s Wuhan
First Death From New SARS-like Virus Reported in Central China’s Wuhan
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
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
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
mRNA-6231 & mRNA-6981
First Death From New SARS-like Virus Reported in Central China’s Wuhan
First Death From New SARS-like Virus Reported in Central China’s Wuhan
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
Seeking Biotech Alpha JANUARY 2020 Insight
KEYTRUDA® (pembrolizumab)
KEYTRUDA® (pembrolizumab)
KEYTRUDA® (pembrolizumab)
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.businesswire.com/news/home/20200108005864/en/