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seeking biotech alpha 寻求生物技术阿尔法 4/7/2020 the heart of biotech™

seeking biotech alpha 寻求生物技术阿尔法 4/7/2020 the heart of biotech™

seeking biotech alpha 寻求生物技术阿尔法 4/7/2020 the heart of biotech™ seeking biotech alpha 寻求生物技术阿尔法 4/7/2020 the heart of biotech™

Seeking Biotech Alpha February/MARCH 2020 Insight

EPIDIOLEX®/EPIDYOLEX® (cannabidiol) oral solution

Enanta Pharmaceuticals Announces Efforts to Discover a Treatment for the Novel Coronavirus- COVID-19

Enanta Pharmaceuticals Announces Efforts to Discover a Treatment for the Novel Coronavirus- COVID-19

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GW Pharmaceuticals submits Type II Variation Application to the European Medicines Agency (EMA) to expand the use of EPIDYOLEX®, (cannabidiol) oral solution, for the treatment of seizures associated with Tuberous Sclerosis Complex (TSC)

Fri March 13, 2020 7:00 AM|GlobeNewswire|About: GWPH

LONDON, March 13, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (GWPRF) (Nasdaq: GWPH)


 https://www.gwpharm.com/ 


 https://ghr.nlm.nih.gov/condition/tuberous-sclerosis-complex 


 https://seekingalpha.com/symbol/GWPH 


 http://ir.gwpharm.com/news-releases/news-release-details/gw-pharmaceuticals-submits-type-ii-variation-application 



Enanta Pharmaceuticals Announces Efforts to Discover a Treatment for the Novel Coronavirus- COVID-19

Enanta Pharmaceuticals Announces Efforts to Discover a Treatment for the Novel Coronavirus- COVID-19

Enanta Pharmaceuticals Announces Efforts to Discover a Treatment for the Novel Coronavirus- COVID-19

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Enanta Pharmaceuticals Announces Efforts to Discover a Treatment for the Novel Coronavirus Disease COVID-19

Fri March 13, 2020 7:00 AM|Business Wire|About: ENTA

Company Leverages Proven Antiviral and Respiratory Expertise to Evaluate Existing Compounds and New Approaches for Treating the Novel Coronavirus Disease COVID-19

WATERTOWN, Mass.--(BUSINESS WIRE)-- Enanta Pharmaceuticals, Inc. (ENTA)


 https://www.enanta.com/home/default.aspx 


 https://www.enanta.com/investors/news-releases/press-release/2020/Enanta-Pharmaceuticals-Announces-Efforts-to-Discover-a-Treatment-for-the-Novel-Coronavirus-Disease-COVID-19/default.aspx 


 https://seekingalpha.com/symbol/ENTA 

FDA Issues Emergency Use to Thermo Fisher Scientific for Diagnostic Test Used to Detect COVID-19

Enanta Pharmaceuticals Announces Efforts to Discover a Treatment for the Novel Coronavirus- COVID-19

FDA Issues Emergency Use to Thermo Fisher Scientific for Diagnostic Test Used to Detect COVID-19

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KEVZARA® (sarilumab) INJECTION

Roche begins shipments of first 400,000 COVID-19 tests to laboratories across US

FDA Issues Emergency Use to Thermo Fisher Scientific for Diagnostic Test Used to Detect COVID-19

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Regeneron and Sanofi Begin Global Kevzara® (sarilumab) Clinical Trial Program in Patients with Severe COVID-19

Mon March 16, 2020 8:09 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y. and CAMBRIDGE, Mass., March 16, 2020 /PRNewswire/ --

U.S. Phase 2/3 trial initiated and will begin enrolling patients immediately

Regeneron is leading U.S. trials, Sanofi will lead upcoming ex-U.S. trials

Regeneron Pharmaceuticals, Inc. (REGN) (NASDAQ: REGN) and Sanofi today announced they have started a clinical program evaluating Kevzara® (sarilumab) in patients hospitalized with severe COVID-19 infection.


 http://www.chinaxiv.org/abs/202003.00026 


 https://newsroom.regeneron.com/news-releases/news-release-details/regeneron-and-sanofi-announce-intent-restructure-antibody 


 http://products.sanofi.us/Kevzara/Kevzara.pdf 


 https://www.regeneron.com/ 


 https://www.prnewswire.com/news-releases/regeneron-and-sanofi-begin-global-kevzara-sarilumab-clinical-trial-program-in-patients-with-severe-covid-19-301024752.html 


 https://seekingalpha.com/symbol/REGN 


 https://seekingalpha.com/symbol/SNY 


 December 10, 2019 at 8:29 AM EST Back

REGENERON AND SANOFI ANNOUNCE INTENT TO RESTRUCTURE ANTIBODY COLLABORATION FOR KEVZARA® (SARILUMAB) AND PRALUENT® (ALIROCUMAB)

TARRYTOWN, N.Y. and PARIS, Dec. 10, 2019 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi 

 https://newsroom.regeneron.com/news-releases/news-release-details/regeneron-and-sanofi-announce-intent-restructure-antibody 

mRNA Vaccine (mRNA-1273) Against Novel Coronavirus

Roche begins shipments of first 400,000 COVID-19 tests to laboratories across US

Roche begins shipments of first 400,000 COVID-19 tests to laboratories across US

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Moderna Announces First Participant Dosed in NIH-led Phase 1 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus

Mon March 16, 2020 12:42 PM|Business Wire|About: MRNA

63 days from sequence selection to Phase 1 study dosing

mRNA-1273 is Moderna’s 10th infectious disease vaccine to begin a clinical trial

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


 

NIH Scientists Identify Atomic Structure of Novel Coronavirus Protein

NIAID Now | February 19, 2020


 https://www.modernatx.com/ 


 https://www.businesswire.com/news/home/20200316005666/en/ 



 https://www.niaid.nih.gov/news-events/atomic-structure-novel-coronavirus-protein 


 https://seekingalpha.com/symbol/MRNA 

Roche begins shipments of first 400,000 COVID-19 tests to laboratories across US

Roche begins shipments of first 400,000 COVID-19 tests to laboratories across US

Roche begins shipments of first 400,000 COVID-19 tests to laboratories across US

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Roche begins shipments of first 400,000 COVID-19 tests to laboratories across US to begin patient testing under FDA Emergency Use Authorization

Mon March 16, 2020 4:53 PM|PR Newswire|About: CHGCY, RHHBY

- First available commercial test kit for novel coronavirus will enable labs to expand and expedite testing to meet urgent medical needs

PR Newswire

INDIANAPOLIS, March 16, 2020 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY)


 https://diagnostics.roche.com/ 


 https://diagnostics.roche.com/global/en/products/params/cobas-sars-cov-2-test.html 


 https://www.roche.com/ 


 https://diagnostics.roche.com/us/en/home.html#selectProfile 


 https://www.prnewswire.com/news-releases/roche-begins-shipments-of-first-400-000-covid-19-tests-to-laboratories-across-us-to-begin-patient-testing-under-fda-emergency-use-authorization-301025096.html 


 https://seekingalpha.com/symbol/RHHBY 


 https://seekingalpha.com/symbol/CHGCY 



 

Seeking Biotech Alpha February/MARCH 2020 Insight

World Health Organization declares the coronavirus outbreak a global pandemic

World Health Organization declares the coronavirus outbreak a global pandemic

World Health Organization declares the coronavirus outbreak a global pandemic

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World Health Organization declares the coronavirus outbreak a global pandemic

PUBLISHED WED, MAR 11 202012:27 PM EDTUPDATED WED, MAR 11 20208:55 PM EDTDawn Kopecki@DAWN_KOPECKIBerkeley Lovelace Jr.@BERKELEYJRWilliam Feuer@WILLFOIANoah Higgins-Dunn@HIGGINSDUNN
 

VENCLYXTO® (venetoclax) in combination with obinutuzumab

World Health Organization declares the coronavirus outbreak a global pandemic

World Health Organization declares the coronavirus outbreak a global pandemic

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AbbVie Receives European Commission Approval of VENCLYXTO® Combination Regimen for Patients with Previously-Untreated Chronic Lymphocytic Leukemia

Thu March 12, 2020 7:00 AM|PR Newswire|About: ABBV

- Approval is based on data from the Phase 3 CLL14 trial, which showed that patients treated with obinutuzumab plus one year of treatment with VENCLYXTO had superior progression-free survival (PFS) and higher rates of undetectable minimal residual disease compared to patients receiving a standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil[1],[5]

PR Newswire

NORTH CHICAGO, Ill., March 12, 2020 /PRNewswire/ -- AbbVie (ABBV)


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


 https://www.abbvie.com/ 


 https://www.prnewswire.com/news-releases/abbvie-receives-european-commission-approval-of-venclyxto-combination-regimen-for-patients-with-previously-untreated-chronic-lymphocytic-leukemia-301021997.html 


 https://news.abbvie.com/news/press-releases/abbvie-receives-european-commission-approval-venclyxto-combination-regimen-for-patients-with-previously-untreated-chronic-lymphocytic-leukemia.htm 


 https://seekingalpha.com/symbol/ABBV 


 https://seekingalpha.com/symbol/RHHBY 

SKYRIZI® (risankizumab)

World Health Organization declares the coronavirus outbreak a global pandemic

Inhaled Nitric Oxide to Treat COVID-19 Associated Lung Complications

image64

 

AbbVie Announces New Formulary Listings for SKYRIZI® in the Treatment of Moderate to Severe Plaque Psoriasis

Wed March 11, 2020 1:07 PM|Canada Newswire|About: ABBV

  • SKYRIZI® is an interleukin-23 (IL-23) inhibitor used for the treatment of moderate to severe psoriasis.1  
  • In clinical studies, SKYRIZI® significantly improved levels of skin clearance after just 16 weeks and maintained clearance at one year (52 weeks).1
  • Non-Insured Health Benefits program lists SKYRIZI® on its formulary effective February 21, 2020.
  • Manitoba lists SKYRIZI® on its provincial formulary effective March 02, 2020.
  • SKYRIZI® is the only IL-23 inhibitor to arrive at a positive conclusion with the pCPA and is currently listed on the formularies of Alberta, Saskatchewan, Manitoba, Ontario, Quebec, Nova Scotia and the Non-Insured Health Benefits program.

MONTRÉAL, March 11, 2020 /CNW/ - AbbVie (ABBV),


 https://abbviecare.ca/ 


 https://www.abbvie.com/ 


 https://seekingalpha.com/symbol/ABBV 


Inhaled Nitric Oxide to Treat COVID-19 Associated Lung Complications

Inhaled Nitric Oxide to Treat COVID-19 Associated Lung Complications

Inhaled Nitric Oxide to Treat COVID-19 Associated Lung Complications

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Mallinckrodt Evaluates the Potential Role for Inhaled Nitric Oxide to Treat COVID-19 Associated Lung Complications, Engages with Scientific, Governmental and Regulatory Agencies

Thu March 12, 2020 6:45 AM|PR Newswire|About: MNK

STAINES-UPON-THAMES, United Kingdom, March 12, 2020 /PRNewswire/ -- Mallinckrodt plc (MNK) (NYSE: MNK)


 https://www.inomax.com/wp-content/themes/inomax-website/dist/downloads/Inomax-PI.pdf 


 http://www.mallinckrodt.com/ 


 http://www.mallinckrodt.com/about/news-and-media/news-detail/?id=26576 


 https://www.prnewswire.com/news-releases/mallinckrodt-evaluates-the-potential-role-for-inhaled-nitric-oxide-to-treat-covid-19-associated-lung-complications-engages-with-scientific-governmental-and-regulatory-agencies-301022189.html 


 https://seekingalpha.com/symbol/MNK 



leronlimab is a viral-entry inhibitor

Inhaled Nitric Oxide to Treat COVID-19 Associated Lung Complications

leronlimab is a viral-entry inhibitor

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CytoDyn’s First mTNBC Patient in Phase 1b/2 is in Remission and Oncologist Ordered Termination of Treatment with Carboplatin (chemotherapy drug) and Remains on Leronlimab Only as Monotherapy; Patient’s Testimony about Her Condition After Nearly 6 Months of Leronlimab Treatment is Very Strong

Thu March 12, 2020 9:18 AM|GlobeNewswire|About: CYDYGlobeNewswire

VANCOUVER, Washington, March 12, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)


 https://www.cytodyn.com/ 


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



 https://seekingalpha.com/symbol/CYDY 

Jardiance® (empagliflozin)

Inhaled Nitric Oxide to Treat COVID-19 Associated Lung Complications

leronlimab is a viral-entry inhibitor

image67

 

US FDA grants Fast Track designation to Jardiance® for the treatment of chronic kidney disease

Thu March 12, 2020 8:00 AM|PR Newswire|About: LLYPR Newswire

RIDGEFIELD, Conn. and INDIANAPOLIS, March 12, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of Jardiance® (empagliflozin) to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease, Boehringer Ingelheim and Eli Lilly and Company (LLY)


 

EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)

 https://clinicaltrials.gov/ct2/show/NCT03594110 


 https://www.jardiance.com/ 


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


 https://www.lillydiabetes.com/ 


 https://www.prnewswire.com/news-releases/us-fda-grants-fast-track-designation-to-jardiance-for-the-treatment-of-chronic-kidney-disease-301022021.html 


 https://www.boehringer-ingelheim.us/press-release/us-fda-grants-fast-track-designation-jardiance-treatment-chronic-kidney-disease?itid=US%20FDA%20grants%20Fast%20Track%20designation%20to%20Jardiance%C2%AE%C2%A0for%20the%20treatment%20of%20chronic%20kidney%20disease 


 https://seekingalpha.com/symbol/LLY 


Seeking Biotech Alpha February/MARCH 2020 Insight

Kaletra/Aluvia (lopinavir/ritonavir)

JNJ-61186372 (JNJ-6372) for the treatment of patients with metastatic non-small cell lung cancer

Kaletra/Aluvia (lopinavir/ritonavir)

 

AbbVie Partnering with Global Authorities to Determine Efficacy of HIV Drug in Treating COVID-19

Mon March 9, 2020 8:45 AM|PR Newswire|About: ABBV

- AbbVie does not have access to Chinese clinical information and therefore cannot confirm its accuracy

- AbbVie donated Aluvia to the Chinese government for experimental use against COVID-19

- AbbVie is working with global health authorities to determine the efficacy and safety of lopinavir/ritonavir against COVID-19

- AbbVie does not anticipate disruption to the medicine supply for HIV patients as a result of the investigation of the effectiveness against COVID-19

PR Newswire

NORTH CHICAGO, Ill., March 9, 2020 /PRNewswire/ -- AbbVie (ABBV)


 https://www.prnewswire.com/news-releases/abbvie-partnering-with-global-authorities-to-determine-efficacy-of-hiv-drug-in-treating-covid-19-301019533.html 


 https://www.abbvie.com/ 


 https://news.abbvie.com/news/press-releases/abbvie-announces-extension-expiration-date-for-exchange-offers-for-allergan-notes-1-2-3-4.htm 


 https://seekingalpha.com/symbol/ABBV 


Descovy® for HIV PrEP

JNJ-61186372 (JNJ-6372) for the treatment of patients with metastatic non-small cell lung cancer

Kaletra/Aluvia (lopinavir/ritonavir)

image68


 https://seekingalpha.com/symbol/GILD  

Gilead Presents 96-week DISCOVER Trial Data Demonstrating Favorable Renal and Bone Safety Profile of Descovy® for HIV PrEP in At-Risk Populations

Tue March 10, 2020 11:32 AM|Business Wire|About: GILD

BOSTON--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD


 https://www.businesswire.com/news/home/20200310005729/en/ 


 https://www.gilead.com/ 


 https://www.gilead.com/news-and-press/press-room/press-releases/2020/3/gilead-presents-96-week-discover-trial-data-demonstrating-favorable-renal-and-bone-safety-profile-of-descovy-for-hiv-prep-in-at-risk-populations 


 https://seekingalpha.com/symbol/GILD 


 https://www.descovy.com/prep 

JNJ-61186372 (JNJ-6372) for the treatment of patients with metastatic non-small cell lung cancer

JNJ-61186372 (JNJ-6372) for the treatment of patients with metastatic non-small cell lung cancer

JNJ-61186372 (JNJ-6372) for the treatment of patients with metastatic non-small cell lung cancer

 

Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for JNJ-6372 for the Treatment of Non-Small Cell Lung Cancer

Tue March 10, 2020 4:01 PM|PR NewswirePR Newswire

RARITAN, N.J., March 10, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson 


 

Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

 https://clinicaltrials.gov/ct2/show/NCT02609776 


 https://www.janssen.com/ 

 DuoBody® is a registered trademark of Genmab A/S. 


 https://www.janssen.com/janssen-announces-us-fda-breakthrough-therapy-designation-granted-jnj-6372-treatment-non-small-cell 


 https://www.jnj.com/ 


 https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics 


 https://www.prnewswire.com/news-releases/janssen-announces-us-fda-breakthrough-therapy-designation-granted-for--jnj-6372-for-the-treatment-of-non-small-cell-lung-cancer-301020992.html 


 https://seekingalpha.com/symbol/JNJ 


CINtec PLUS Cytology test to aid clinicians in improving cervical cancer prevention

CINtec PLUS Cytology test to aid clinicians in improving cervical cancer prevention

JNJ-61186372 (JNJ-6372) for the treatment of patients with metastatic non-small cell lung cancer

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Roche receives FDA approval for CINtec PLUS Cytology test to aid clinicians in improving cervical cancer prevention

  • Next-generation cytology test provides additional information for HPV-positive women who may have cervical pre-cancer
  • More sensitive than Pap cytology testing when used as triage test for HPV-positive screening results, helping to improve the detection of cervical pre-cancer
  • The first biomarker-based test specifically approved by the FDA to triage women with HPV-positive / Pap cytology-negative co-testing results, providing clinicians with a new option to guide patient management
  • Launch supports the goal of the World Health Organization to eliminate cervical cancer,  which is nearly 100 percent preventable

Basel, 11 March 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY)


 https://diagnostics.roche.com/#selectProfile 


 https://www.roche.com/ 


 

FDA OKs Roche cervical cancer test

Mar. 11, 2020 6:53 AM ET|About: Roche Holding Ltd ADR (RHHBY)|By: , SA News Editor  


 https://seekingalpha.com/news/3550440-fda-oks-roche-cervical-cancer-test 


 https://seekingalpha.com/symbol/RHHBY 


receptor 7 (TLR7) agonist vesatolimod

CINtec PLUS Cytology test to aid clinicians in improving cervical cancer prevention

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)

image70

 

Treatment With Gilead’s Vesatolimod Is Evaluated for Safety and Virologic and Immunologic Response Versus Placebo in Phase 1B HIV Functional Cure Study

Tue March 10, 2020 2:33 PM|Business Wire|About: GILD

-- Results Presented at CROI 2020 Support Further Evaluation of Vesatolimod as Part of Investigational Curative Regimens Aimed at Achieving ART-Free Control of HIV --

BOSTON--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD)


 https://www.gilead.com/ 


 https://www.businesswire.com/news/home/20200310005875/en/ 


 https://www.gilead.com/news-and-press/press-room/press-releases/2020/3/treatment-with-gileads-vesatolimod-is-evaluated-for-safety-and-virologic-and-immunologic-response-versus-placebo-in-phase-1b-hiv-functional-cure-stud 

 

A Study of the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated

 https://clinicaltrials.gov/ct2/show/NCT02579382 


 

Gilead's vesatolimod shows modest effect early-stage HIV study

Mar. 10, 2020 3:39 PM ET|About: Gilead Sciences, Inc. (GILD)|By: , SA News Editor 

 https://seekingalpha.com/news/3550263-gileads-vesatolimod-shows-modest-effect-early-stage-hiv-study 


 https://seekingalpha.com/symbol/GILD 

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)

CINtec PLUS Cytology test to aid clinicians in improving cervical cancer prevention

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)

image71

 

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) for Patients with Hepatocellular Carcinoma (HCC) Previously Treated with Sorafenib

Wed March 11, 2020 6:59 AM|Business Wire|About: BMY

Opdivo + Yervoy is the first and only dual immunotherapy approved in this setting

Approval based on CheckMate -040 trial in which Opdivo + Yervoy showed an overall response rate of 33% (16/49; 95% CI: 20-48) in this patient population1

Opdivo + Yervoy combination is now approved to treat four types of cancer

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


 https://www.businesswire.com/news/home/20200311005141/en/ 


 

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) for Patients with Hepatocellular Carcinoma (HCC) Previously Treated with Sorafenib

Opdivo + Yervoy is the first and only dual immunotherapy approved in this setting

Approval based on CheckMate -040 trial in which Opdivo + Yervoy showed an overall response rate of 33% (16/49; 95% CI: 20-48) in this patient population1

Opdivo + Yervoy combination is now approved to treat four types of cancer

CATEGORY: 

CORPORATE/FINANCIAL NEWSWEDNESDAY, MARCH 11, 2020 6:59 AM EDT 


 https://www.opdivo.com/ 



 https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-approves-opdivo-nivolumab-ye-0 


 

Yervoy® (ipilimumab)

 https://www.yervoy.com/ 


 https://seekingalpha.com/symbol/BMY 





Seeking Biotech Alpha February/MARCH 2020 Insight

DURYSTA™ (bimatoprost implant)

Discovery of Broad-Spectrum Virus-Binding Ligands; Expected to Counter COVID-19

DURYSTA™ (bimatoprost implant)

image72

 

Allergan Receives FDA Approval for DURYSTA™ (bimatoprost implant) the First and Only Intracameral Biodegradable Sustained-Release Implant to lower Intraocular Pressure in Open-Angle Glaucoma or Ocular Hypertension Patients

Thu March 5, 2020 9:44 AM|PR Newswire|About: AGN

- Allergan continues five ongoing Phase 3 studies with DURYSTA™ to support further potential FDA label enhancement and rest of the world approvals -

PR Newswire

DUBLIN, March 5, 2020 /PRNewswire/ -- Allergan plc  (AGN)


 https://media.allergan.com/products/durysta_pi.pdf 


 https://www.durystahcp.com/ 


 https://www.allergan.com/ 


 https://www.prnewswire.com/news-releases/allergan-receives-fda-approval-for-durysta-bimatoprost-implant-the-first-and-only-intracameral-biodegradable-sustained-release-implant-to-lower-intraocular-pressure-in-open-angle-glaucoma-or-ocular-hypertension-patients-301017349.html 


 https://seekingalpha.com/symbol/AGN 


 

FDA OKs Allergan eye implant for glaucoma

Mar. 5, 2020 10:00 AM ET|About: Allergan plc (AGN)|By: , SA News Editor  

 https://seekingalpha.com/news/3549041-fda-oks-allergan-eye-implant-for-glaucoma 



Idylla™ MSI

Discovery of Broad-Spectrum Virus-Binding Ligands; Expected to Counter COVID-19

DURYSTA™ (bimatoprost implant)

image73

 
Biocartis Announces New Immuno-Oncology Project with Bristol-Myers Squibb Aimed at Registration of Idylla™ MSI test in China 

 March 05, 2020 01:01 ET | Source: Biocartis NVmultilang-release

PRESS RELEASE                                                                                           
5 March 2020, 07:01 CET

Biocartis Announces New Immuno-Oncology Project with Bristol-Myers Squibb Aimed at Registration of Idylla™ MSI test in China

Mechelen, Belgium, 5 March 2020 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’


 https://www.biocartis.com/en-US/meet-idylla/idylla-assays/idylla-msi-assay 


 https://seekingalpha.com/symbol/BMY 


 https://www.biocartis.com/en-US 


 https://investors.biocartis.com/sites/default/files/press-releases/2020/200304_pr_bms_china_eng_final.pdf 



 https://www.novartis.com/ 



Discovery of Broad-Spectrum Virus-Binding Ligands; Expected to Counter COVID-19

Discovery of Broad-Spectrum Virus-Binding Ligands; Expected to Counter COVID-19

Discovery of Broad-Spectrum Virus-Binding Ligands; Expected to Counter COVID-19

image74

 

NanoViricides, Inc. Reports Discovery of Broad-Spectrum Virus-Binding Ligands; Expected to Counter COVID-19

Thu March 5, 2020 4:11 PM|Newsfile|About: NNVCNewsfile Corp

The Company has been working on a drug candidate to address the COVID-19 and has made significant progress in this regard

New York, New York--(Newsfile Corp. - March 5, 2020) - NanoViricides, Inc. (NNVC


 https://smallcapsdaily.com/nanoviricides-to-produce-broad-spectrum-antiviral-clinical-trial-candidates-for-covid-19/ 


 

NanoViricides, Inc. Reports Discovery of Broad-Spectrum Virus-Binding Ligands; Expected to Counter COVID-19

The Company has been working on a drug candidate to address the COVID-19 and has made significant progress in this regard

 https://www.newsfilecorp.com/release/53198 


 http://www.nanoviricides.com/index.html 


 https://seekingalpha.com/symbol/NNVC 

MAVIRET® (glecaprevir/pibrentasvir)

Isturisa (osilodrostat) oral tablets

Discovery of Broad-Spectrum Virus-Binding Ligands; Expected to Counter COVID-19

image75

 

European Commission Grants AbbVie Marketing Authorization Shortening MAVIRET® (glecaprevir/pibrentasvir) Treatment Duration to Eight Weeks for Treatment-Naïve Chronic HCV Patients with Genotype 3 and Compensated Cirrhosis

Fri March 6, 2020 7:00 AM|PR Newswire|About: ABBV

- Today's EC decision makes MAVIRET the only pan-genotypic (genotypes 1-6) 8-week treatment option for treatment-naïve, chronic HCV patients, without cirrhosis or with compensated cirrhosis

PR Newswire

NORTH CHICAGO, Ill., March 6, 2020 /PRNewswire/ -- AbbVie (ABBV)


 https://www.abbvie.com/ 


 https://www.mavyret.com/ 


 https://www.prnewswire.com/news-releases/european-commission-grants-abbvie-marketing-authorization-shortening-maviret-glecaprevirpibrentasvir-treatment-duration-to-eight-weeks-for-treatment-naive-chronic-hcv-patients-with-genotype-3-and-compensated-cirrhosis-301018922.html 


 March 6, 2020

European Commission Grants AbbVie Marketing Authorization Shortening MAVIRET® (glecaprevir/pibrentasvir) Treatment Duration to Eight Weeks for Treatment-Naïve Chronic HCV Patients with Genotype 3 and Compensated Cirrhosis

 https://news.abbvie.com/news/press-releases/european-commission-grants-abbvie-marketing-authorization-shortening-maviret-glecaprevirpibrentasvir-treatment-duration-to-eight-weeks-for-treatment-nave-chronic-hcv-patients-with-genotype-3-and-compensated-cirrhosis.htm 


 https://seekingalpha.com/symbol/ABBV 

 

Enanta’s HCV Collaboration Partner AbbVie Receives Marketing Authorization from European Commission to Shorten MAVIRET® (glecaprevir/pibrentasvir) Duration to Eight Weeks for Treatment-Naïve Genotype 3 HCV Patients with Compensated Cirrhosis

Fri March 6, 2020 7:05 AM|Business Wire|About: ENTA

  • MAVIRET now available in the EU as an 8-week treatment option for treatment-naïve, chronic hepatitis C virus (HCV) patients without cirrhosis or with compensated cirrhosis, regardless of genotype*
  • European Commission’s decision makes MAVIRET the only 8-week treatment regimen indicated for all common HCV genotypes (GT1—6) in treatment-naïve, chronic HCV patients both without cirrhosis or with compensated cirrhosis, without the need for HCV genotype testing
  • Glecaprevir, one of the two direct-acting antivirals (DAAs) in MAVIRET, was discovered by Enanta and developed and commercialized by AbbVie

WATERTOWN, Mass.--(BUSINESS WIRE)-- Enanta Pharmaceuticals, Inc. (ENTA),

 https://seekingalpha.com/pr/17802094-enanta-s-hcv-collaboration-partner-abbvie-receives-marketing-authorization-from-european 


 https://seekingalpha.com/symbol/ENTA 


Isturisa (osilodrostat) oral tablets

Isturisa (osilodrostat) oral tablets

Isturisa (osilodrostat) oral tablets

image76

 

FDA Approves New Treatment for Adults with Cushing's Disease

NEWS PROVIDED BY

U.S. Food and Drug Administration 

Mar 06, 2020, 18:41 ET

SHARE THIS ARTICLE

SILVER SPRING, Md., March 6, 2020 /PRNewswire/ 


 

FDA Approves Osilodrostat, A Non-Surgical Option for Cushing's Disease

MARCH 07, 2020Patrick Campbell 

 https://www.mdmag.com/medical-news/isturisa-fda-approves-osilodrostat-nonsurgical-option-cushings-disease-novartis 


 https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-orphan-product-drugs-and-biological-products 


 Osilodrostat. Osilodrostat, sold under the brand name Isturisa, a medication for the treatment for adults with Cushing's disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease. It is taken by mouth 


 https://seekingalpha.com/news/3549544-fda-oks-novartis-osilodrostat-for-adrenal-gland-disorder 

leronlimab (PRO 140)

Isturisa (osilodrostat) oral tablets

Isturisa (osilodrostat) oral tablets

image77

 

CytoDyn Files IND and Protocol for Phase 2 Clinical Trial for Treatment of Patients with Coronavirus with Leronlimab (PRO 140)

Sun March 8, 2020 5:52 PM|GlobeNewswire|About: CYDY

Coronavirus Can Quickly Progress to Severe Pneumonia and Even Death Due to Immune Hyperactivity Including Acute Respiratory Distress Syndrome (ARDS); CytoDyn's Trial Focuses on Patients Who Develop Mild-To-Moderate Respiratory Illness After Contracting Coronavirus

CytoDyn Negotiating to Expedite Setup of Treatment Clinics in New York and San Francisco

VANCOUVER, Washington, March 08, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)


 https://www.cytodyn.com/ 

 

CytoDyn Files IND and Protocol for Phase 2 Clinical Trial for Treatment of Coronavirus Patients with Leronlimab (PRO 140)

 https://www.cytodyn.com/newsroom/press-releases/detail/392/cytodyn-files-ind-and-protocol-for-phase-2-clinical-trial


 https://www.cdc.gov/coronavirus/2019-ncov/index.html 


 https://seekingalpha.com/symbol/CYDY 


 

Vancouver-based company awaits approval to go to clinical trials with coronavirus drug

The president and CEO of CytoDyn Inc. believes leronlimab will help people with moderate to severe cases of coronavirus.Author: Mike BennerPublished: 10:21 PM PDT March 9, 2020Updated: 11:06 PM PDT March 9, 2020

PORTLAND, Ore. —

 https://www.kgw.com/article/news/health/coronavirus/coronavirus-drug-leronlimab-cytodyn-inflammatory/283-84bd963b-3451-443e-a17d-623c7318ce2a 





Seeking Biotech Alpha February/MARCH 2020 Insight

leronlimab (PRO 140)

Acthar® Gel (Repository Corticotropin Injection)

leronlimab (PRO 140)

image78

 

CytoDyn Treats First Patient with Leronlimab in Phase 2 Trial for GvHD under Modified Trial Protocol

Wed March 4, 2020 6:00 AM|GlobeNewswire|About: CYDY

VANCOUVER, Washington, March 04, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)


 https://www.cytodyn.com/ 


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


 https://www.cytodyn.com/newsroom/press-releases/detail/390/cytodyn-treats-first-patient-with-leronlimab-in-phase-2 


 https://seekingalpha.com/symbol/CYDY 

Elecsys® GALAD score

Acthar® Gel (Repository Corticotropin Injection)

leronlimab (PRO 140)

image79

 

FDA grants Breakthrough Device Designation for Roche's Elecsys GALAD score to support earlier diagnosis of hepatocellular carcinoma

  • The Elecsys GALAD score aims to support clinicians in diagnosing hepatocellular carcinoma by giving them more timely and accurate information to make earlier interventions
  • When hepatocellular carcinoma is detected and managed at the very earliest, patient’s 5-year survival rates can increase to over 70%1
  • Utilizing blood-based biomarkers, as part of the Elecsys GALAD score, is minimally invasive to patients

Basel, 4 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY)


 https://www.roche.com/ 


 https://www.nytimes.com/reuters/2020/03/04/world/europe/04reuters-roche-device.html 


 https://seekingalpha.com/symbol/RHHBY 

Acthar® Gel (Repository Corticotropin Injection)

Acthar® Gel (Repository Corticotropin Injection)

Acthar® Gel (Repository Corticotropin Injection)

image80

 

Mallinckrodt Announces Publication of New Data on Acthar® Gel (Repository Corticotropin Injection) in Rheumatoid Arthritis, Systemic Lupus Erythematosus and Dermatomyositis/Polymyositis Published in Open Access Rheumatology: Research and Reviews

Wed March 4, 2020 6:45 AM|PR Newswire|About: MNKPR Newswire

STAINES-UPON-THAMES, United Kingdom, March 4, 2020 /PRNewswire/ -- Mallinckrodt plc (MNK) (NYSE: MNK)


 https://www.mallinckrodt.com/investors/presentation-documents/ 


 https://www.acthar.com/pdf/Acthar-PI.pdf 


 http://www.mallinckrodt.com/ 


 https://www.mallinckrodt.com/about/news-and-media/news-detail/?id=26546 


 https://www.acthar.com/patient 


 https://www.prnewswire.com/news-releases/mallinckrodt-announces-publication-of-new-data-on-acthar-gel-repository-corticotropin-injection-in-rheumatoid-arthritis-systemic-lupus-erythematosus-and-dermatomyositispolymyositis-published-in-open-access-rheumatology-resea-301016020.html 


 https://seekingalpha.com/symbol/MNK 

Trofinetide is an investigational drug

AGN-151587 (EDIT-101) is the first in vivo CRISPR medicine to be administered to patients

Acthar® Gel (Repository Corticotropin Injection)

image81

 

ACADIA Pharmaceuticals and Neuren Pharmaceuticals Announce Rare Pediatric Disease Designation for Trofinetide for the Treatment of Rett Syndrome

Tue March 3, 2020 5:50 PM|Business Wire|About: ACAD 


 Trofinetide is an investigational drug. It is a novel synthetic analog of the amino‐terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function. 


 https://www.acadia-pharm.com/ 


 https://www.businesswire.com/news/home/20200303006075/en/ 


 https://seekingalpha.com/symbol/ACAD 


 http://www.neurenpharma.com/irm/content/default.aspx 


 https://seekingalpha.com/symbol/NURPF 


 

Acadia's trofinetide nabs RPD tag in U.S. for rare neurological disorder

Mar. 4, 2020 7:13 AM ET|About: ACADIA Pharmaceuticals... (ACAD)|By: , SA News Editor 

 https://seekingalpha.com/news/3548471-acadias-trofinetide-nabs-rpd-tag-in-u-s-for-rare-neurological-disorder 



AGN-151587 (EDIT-101) is the first in vivo CRISPR medicine to be administered to patients

AGN-151587 (EDIT-101) is the first in vivo CRISPR medicine to be administered to patients

AGN-151587 (EDIT-101) is the first in vivo CRISPR medicine to be administered to patients

image82

 

Allergan and Editas Medicine Announce Dosing of First Patient in Landmark Phase 1/2 Clinical Trial of CRISPR Medicine AGN-151587 (EDIT-101) for the Treatment of LCA10

Wed March 4, 2020 5:00 AM|GlobeNewswire|About: AGN, EDIT 

 

AGN-151587 (EDIT-101) is the first in vivo CRISPR medicine to be administered to patients

Additional patient enrollment to the BRILLIANCE Clinical Trial is ongoing

DUBLIN, Ireland and CAMBRIDGE, Mass., March 04, 2020 (GLOBE NEWSWIRE) -- Allergan plc (AGN), a leading global pharmaceutical company, and Editas Medicine, Inc. (EDIT)

 

Allergan and Editas Medicine dose first patient mid-stage study of blindness medicine

Mar. 4, 2020 7:40 AM ET|About: Allergan plc (AGN)|By: , SA News Editor 

Allergan (NYSE:AGN) and Editas Medicine (NASDAQ:EDIT

 https://seekingalpha.com/news/3548489-allergan-and-editas-medicine-dose-first-patient-mid-stage-study-of-blindness-medicine 


 www.clinicaltrials.gov (NCT#03872479) 


 https://www.allergan.com/ 


 https://www.editasmedicine.com/ 


 https://www.editasmedicine.com/gene-editing-pipeline/ 


 https://seekingalpha.com/symbol/EDIT 


 https://seekingalpha.com/symbol/AGN 


 https://clinicaltrials.gov/ct2/show/NCT03872479?term=agn-151587&draw=2&rank=1 

Omnipod® DASH Insulin Management System (Omnipod DASH™ System)

AGN-151587 (EDIT-101) is the first in vivo CRISPR medicine to be administered to patients

AGN-151587 (EDIT-101) is the first in vivo CRISPR medicine to be administered to patients

 

Insulet’s Omnipod DASH™ System Voted 2020 Product of the Year in Health Systems Category by 40,000 U.S. Consumers

Thu March 5, 2020 6:00 AM|Business Wire|About: PODD

Product Innovation Award Further Validates Omnipod as a Consumer Preferred Solution

ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation (PODD


 https://productoftheyearusa.com/ 


 https://www.womansday.com/life/a30517486/product-of-the-year-2020-winners/ 


 http://www.insulet.com/ 


 https://www.myomnipod.com/home 


 https://www.businesswire.com/news/home/20200305005044/en/ 


 https://seekingalpha.com/symbol/PODD 


 

Insulet (PODD) Presents At Raymond James Institutional Investors Conference - Slideshow

Mar. 4, 2020 3:19 PM ET | About: Insulet Corporation (PODD) 

 https://seekingalpha.com/article/4329595-insulet-podd-presents-raymond-james-institutional-investors-conference-slideshow 

Seeking Biotech Alpha February/MARCH 2020 Insight

EPIDIOLEX® (cannabidiol) oral solution, CV

(AAV)-RPGR gene therapy for treatment of inherited retinal disease X-linked retinitis pigmentosa

(AAV)-RPGR gene therapy for treatment of inherited retinal disease X-linked retinitis pigmentosa

image83

 

JAMA Neurology Publishes Results from Positive Phase 3 Trial of EPIDIOLEX® (cannabidiol) oral solution in Children with Seizures Associated with Dravet Syndrome

Mon March 2, 2020 11:13 AM|GlobeNewswire|About: GWPH 

 GlobeNewswire

CARLSBAD, Calif., March 02, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (GWPRF) (NASDAQ: GWPH, GW, the Company or the Group)


 https://www.epidiolex.com/ 


 https://www.gwpharm.com/ 


 http://ir.gwpharm.com/news-releases/news-release-details/jama-neurology-publishes-results-positive-phase-3-trial 


 https://seekingalpha.com/symbol/GWPH 




(AAV)-RPGR gene therapy for treatment of inherited retinal disease X-linked retinitis pigmentosa

(AAV)-RPGR gene therapy for treatment of inherited retinal disease X-linked retinitis pigmentosa

(AAV)-RPGR gene therapy for treatment of inherited retinal disease X-linked retinitis pigmentosa

image84

 

European Medicines Agency Grants PRIME and Advanced Therapy Medicinal Product Designations to Janssen's RPGR Gene Therapy for X-Linked Retinitis Pigmentosa

Mon March 2, 2020 8:30 AM|PR Newswire

Designations will accelerate the regulatory review timeline of this potential gene therapy for European patients living with X-linked retinitis pigmentosa

PR Newswire

RARITAN, N.J., March 2, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson 


 

Gene Therapy for X-linked Retinitis Pigmentosa (XLRP) Retinitis Pigmentosa GTPase Regulator (RPGR)

 https://clinicaltrials.gov/ct2/show/NCT03252847?term=rpgr&draw=2&rank=1 


 https://www.janssen.com/ 


 https://www.jnj.com/ 


 https://www.prnewswire.com/news-releases/european-medicines-agency-grants-prime-and-advanced-therapy-medicinal-product-designations-to-janssens-rpgr-gene-therapy-for-x-linked-retinitis-pigmentosa-301014359.html 


 https://clinicaltrials.gov/ct2/show/NCT03252847?term=rpgr&draw=2&rank=1 


 https://www.prnewswire.com/news-releases/european-medicines-agency-grants-prime-and-advanced-therapy-medicinal-product-designations-to-janssens-rpgr-gene-therapy-for-x-linked-retinitis-pigmentosa-301014359.html 


 https://seekingalpha.com/symbol/JNJ 

 

J&J gene therapy nabs accelerated review status in Europe for vision loss disorder

Mar. 2, 2020 11:32 AM ET|About: Johnson & Johnson (JNJ)|By: , SA News Editor 


 https://ghr.nlm.nih.gov/condition/retinitis-pigmentosa  

Remdesivir (GS-5734, Nuc inhibitor)

(AAV)-RPGR gene therapy for treatment of inherited retinal disease X-linked retinitis pigmentosa

Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone

 

China slaps down local biotech over claims it could produce Gilead’s experimental coronavirus drug

Published: Mar 2, 2020 10:27 a.m. ET


 

Chinese Biotech Censured for False Claim on Gilead’s Virus Drug

Bloomberg NewsBloombergMarch 1, 2020 

 https://finance.yahoo.com/news/chinese-biotech-censured-false-claim-040207427.html 


 

Severe 2019-nCoV Remdesivir RCT

 https://clinicaltrials.gov/ct2/show/NCT04257656?term=remdesivir&draw=2&rank=1 


 

First Case of 2019 Novel Coronavirus in the United States

 January 31, 2020
DOI: 10.1056/NEJMoa2001191
Chinese Translation 中文翻译 

 https://www.nejm.org/doi/10.1056/NEJMoa2001191 


 

February 26, 2020

Gilead Sciences Initiates Two Phase 3 Studies of Investigational Antiviral Remdesivir for the Treatment of COVID-19

-- U.S. FDA Grants Investigational New Drug Authorization to Study Remdesivir for the Treatment of COVID-19 --

FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 26, 2020-- Gilead Sciences, Inc. (Nasdaq: GILD) 



 https://www.gilead.com/news-and-press/press-room/press-releases/2020/2/gilead-sciences-initiates-two-phase-3-studies-of-investigational-antiviral-remdesivir-for-the-treatment-of-covid-19 

Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone

Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone

Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone

image85

 

FDA Approves New Therapy for Patients with Previously Treated Multiple Myeloma

 March 02, 2020 


 https://seekingalpha.com/symbol/SNY 

 

FDA OKs Sanofi drug for previously treated multiple myeloma

Mar. 2, 2020 12:51 PM ET|About: Sanofi (SNY)|By: , SA News Editor 

 https://seekingalpha.com/news/3547590-fda-oks-sanofi-drug-for-previously-treated-multiple-myeloma 

 

What is POMALYST® (pomalidomide)?

POMALYST® (pomalidomide) is a prescription medicine, taken along with the medicine dexamethasone, used to treat people with multiple myeloma who have previously received at least 2 medicines to treat multiple myeloma, including a proteasome inhibitor and lenalidomide, and whose disease has become worse during treatment or within 60 days of finishing the last treatment. It is not known if POMALYST is safe and effective in children.

 https://pomalyst.com/ 


 https://seekingalpha.com/symbol/BMY 


 

Sanofi : FDA approves Sarclisa® (isatuximab-irfc) for patients with relapsed refractory multiple myeloma

Mon March 2, 2020 1:51 PM|GlobeNewswire|About: SNY

FDA approves Sarclisa® (isatuximab-irfc) for patients with relapsed refractory multiple myeloma

  • Sarclisa in combination with pomalidomide and dexamethasone (pom-dex) significantly reduced the risk of disease progression or death by 40% compared to pom-dex alone in a pivotal trial
  • FDA approval based on data from the only randomized Phase 3 trial (ICARIA-MM) to evaluate an anti-CD38 in combination with pom-dex that has presented results to date
  • Multiple myeloma is the second most common blood cancer, affecting more than 130,000 patients in the U.S.; approximately 32,000 Americans are diagnosed with multiple myeloma each year

PARIS – March 2, 2020 – The U.S. Food and Drug Administration (FDA) has approved Sarclisa® (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa is expected to be available to patients in the U.S. shortly.

 https://seekingalpha.com/pr/17796656-sanofi-fda-approves-sarclisa-isatuximab-irfc-for-patients-relapsed-refractory-multiple 

Mayzent™ (siponimod)

Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone

Esbriet® (pirfenidone)

image86

 

Novartis receives Health Canada approval for Mayzent™ (siponimod) to treat secondary progressive multiple sclerosis with active disease

Tue March 3, 2020 6:00 AM|Canada Newswire

  • MayzentTM (siponimod) is the first oral treatment approved for people living with secondary progressive multiple sclerosis (SPMS) with active disease, and the first treatment approved for SPMS with active disease in almost 15 years1
  • Most people living with relapsing remitting MS (RRMS) will develop SPMS2
  • Approval is based on the Phase III EXPAND trial, the largest controlled clinical study of people living with SPMS, showing MayzentTM significantly reduced the risk of disease progression, including impact on physical disability3

DORVAL, QC, March 3, 2020 /CNW/ - Novartis Pharmaceuticals Canada Inc. (Novartis)


 https://www.mayzent.com/isi 


 https://www.mayzent.com/index.jsp?utm_medium=paid&utm_term=mayzent%2520siponimod&utm_content=paidsearch&utm_source=google&utm_campaign=Mayzent.com_HCPBrand_Google_10.2019 


 https://www.novartis.com/ 


 https://www.novartis.ca/en 


 https://seekingalpha.com/symbol/NVS 



Esbriet® (pirfenidone)

Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone

Esbriet® (pirfenidone)

image87

FDA Grants Breakthrough Therapy Designation for Genentech’s Esbriet (pirfenidone) in Unclassifiable Interstitial Lung Disease

Tue March 3, 2020 1:00 AM|Business Wire|About: RHHBY

– There are currently no FDA-approved treatments for unclassifiable ILD (uILD), a debilitating, severe respiratory condition –

– The designation is based on results from a Phase II trial, which suggested Esbriet slowed disease progression in patients with uILD at 24 weeks –

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


 https://www.esbriet.com/ 


 https://www.gene.com/ 


 https://www.businesswire.com/news/home/20200302006109/en/ 


 https://seekingalpha.com/symbol/RHHBY 


 

Monday, Mar 2, 2020

FDA Grants Breakthrough Therapy Designation for Genentech’s Esbriet (pirfenidone) in Unclassifiable Interstitial Lung Disease

There are currently no FDA-approved treatments for unclassifiable ILD (uILD), a debilitating, severe respiratory condition
The designation is based on results from a Phase II trial, which suggested Esbriet slowed disease progression in patients with uILD at 24 weeks

South San Francisco, CA -- March 2, 2020 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

 https://www.gene.com/media/press-releases/14840/2020-03-02/fda-grants-breakthrough-therapy-designat 

Seeking Biotech Alpha February/MARCH 2020 Insight

terlipressin, an investigational agent for the treatment of hepatorenal syndrome type 1 (HRS-1)

terlipressin, an investigational agent for the treatment of hepatorenal syndrome type 1 (HRS-1)

terlipressin, an investigational agent for the treatment of hepatorenal syndrome type 1 (HRS-1)

image88

  

Data on Acthar® Gel (Repository Corticotropin Injection) Therapy in Immunoglobulin A Nephropathy (IgAN) Published in Kidney International Reports

Thu March 5, 2020 6:45 AM|PR Newswire|About: MNKPR Newswire

STAINES-UPON-THAMES, United Kingdom, March 5, 2020 /PRNewswire/ -- Mallinckrodt plc (MNK) (NYSE: MNK),

Mallinckrodt Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Patients with Hepatorenal Syndrome Type 1 (HRS-1)

Mon March 2, 2020 6:45 AM|PR Newswire|About: MNK 

 PR Newswire

STAINES-UPON-THAMES, United Kingdom, March 2, 2020 /PRNewswire/ -- Mallinckrodt plc (MNK) (NYSE: MNK)

 https://www.prnewswire.com/news-releases/mallinckrodt-initiates-rolling-submission-of-new-drug-application-to-the-us-food-and-drug-administration-fda-for-terlipressin-for-the-treatment-of-patients-with-hepatorenal-syndrome-type-1-hrs-1-301014108.html 


 https://www.dovepress.com/a-randomized-placebo-controlled-double-blind-study-to-confirm-the-reve-peer-reviewed-article-OAJCT 


 https://www.prnewswire.com/news-releases/mallinckrodt-initiates-rolling-submission-of-new-drug-application-to-the-us-food-and-drug-administration-fda-for-terlipressin-for-the-treatment-of-patients-with-hepatorenal-syndrome-type-1-hrs-1-301014108.html 


 https://seekingalpha.com/symbol/MNK 


 https://www.prnewswire.com/news-releases/data-on-acthar-gel-repository-corticotropin-injection-therapy-in-immunoglobulin-a-nephropathy-igan-published-in-kidney-international-reports-301016912.html 

Rubraca® (rucaparib) Tablets

terlipressin, an investigational agent for the treatment of hepatorenal syndrome type 1 (HRS-1)

terlipressin, an investigational agent for the treatment of hepatorenal syndrome type 1 (HRS-1)

image89

 

Clovis Oncology Announces Availability and Reimbursement for Rubraca® (rucaparib) Tablets for Women with Relapsed Ovarian Cancer in Spain

Mon March 2, 2020 4:00 AM|Business Wire|About: CLVS 


 https://www.clovisoncology.com/ 


 https://www.businesswire.com/news/home/20200302005009/en/ 


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


 https://seekingalpha.com/symbol/CLVS 

KEYTRUDA ® (pembrolizumab) Injection, 100 mg

terlipressin, an investigational agent for the treatment of hepatorenal syndrome type 1 (HRS-1)

KEYTRUDA ® (pembrolizumab) Injection, 100 mg

image90

 

Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Progression-Free Survival Compared with Brentuximab Vedotin in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)

Mon March 2, 2020 6:30 AM|Business Wire|About: MRK

Data from Pivotal Phase 3 KEYNOTE-204 Study to be Presented at an Upcoming Medical Meeting and Submitted to Regulatory Authorities

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada,


 

Study of Pembrolizumab (MK-3475) vs. Brentuximab Vedotin in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-204/KEYNOTE-204)

 https://clinicaltrials.gov/ct2/show/NCT02684292 


 https://www.merck.com/index.html 


 https://www.businesswire.com/news/home/20200302005320/en/ 


 https://www.mrknewsroom.com/news-release/oncology/mercks-keytruda-pembrolizumab-significantly-improved-progression-free-survival 


 

Merck's Keytruda tops Seattle Genetics' Adcetris in late-stage lymphoma study

Mar. 2, 2020 8:23 AM ET|About: Merck & Co., Inc. (MRK)|By: , SA News Editor  

 https://seekingalpha.com/news/3547387-mercks-keytruda-tops-seattle-genetics-adcetris-in-late-stage-lymphoma-study 


 https://seekingalpha.com/symbol/MRK 



tanezumab 2.5 mg

Gilead to Acquire Forty Seven for $4.9 Billion

KEYTRUDA ® (pembrolizumab) Injection, 100 mg

image91

 

U.S. FDA Accepts Regulatory Submission for Tanezumab, a Potential First-in-Class Treatment for Patients with Chronic Pain Due to Moderate-to-Severe Osteoarthritis

Mon March 2, 2020 6:45 AM|PR Newswire|About: LLY, PFE

NEW YORK and INDIANAPOLIS, March 2, 2020 /PRNewswire/ -- Pfizer Inc. (PFE) and Eli Lilly and Company (LLY)


 Tanezumab is an investigational monoclonal antibody that works by selectively targeting, binding to and inhibiting NGF. NGF levels increase in the body as a result of injury, inflammation or in chronic pain states. 


 https://www.pfizer.com/ 


 https://www.lilly.com/ 


 https://www.prnewswire.com/news-releases/us-fda-accepts-regulatory-submission-for-tanezumab-a-potential-first-in-class-treatment-for-patients-with-chronic-pain-due-to-moderate-to-severe-osteoarthritis-301013995.html 


 https://seekingalpha.com/symbol/PFE 


 https://seekingalpha.com/symbol/LLY 


ALUNBRIG® (brigatinib)

Gilead to Acquire Forty Seven for $4.9 Billion

Gilead to Acquire Forty Seven for $4.9 Billion

 

Takeda Receives Positive CHMP Opinion for ALUNBRIG® (brigatinib) as a First-Line Treatment for ALK+ Non-Small Cell Lung Cancer

Mon March 2, 2020 8:00 AM|Business Wire|About: TAK

– If Approved by the European Medicines Agency, ALUNBRIG Would Become an Important First-Line Treatment Option for ALK+ NSCLC Patients –

– Positive Opinion is Based on Data from Phase 3 ALTA-1L Trial, in which ALUNBRIG Demonstrated Superiority in both Overall and Intracranial Efficacy Compared to Crizotinib –

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK)


 https://www.alunbrig.com/ 


 https://www.takeda.com/ 


 https://www.businesswire.com/news/home/20200302005068/en/ 


 https://seekingalpha.com/symbol/TAK 

Gilead to Acquire Forty Seven for $4.9 Billion

Gilead to Acquire Forty Seven for $4.9 Billion

Gilead to Acquire Forty Seven for $4.9 Billion

image92

 

March 02, 2020

Gilead to Acquire Forty Seven for $4.9 Billion

– Gilead Gains Forty Seven’s Investigational Immuno-Oncology Therapy in Multiple Clinical Studies for Diseases Including Myelodysplastic Syndrome, Acute Myeloid Leukemia and Diffuse Large B-Cell Lymphoma –

– Transaction Supports Gilead’s Strategic Focus in Oncology and Gives Access to Potential New First-in-Class Program and Innovative Pipeline –

FOSTER CITY, Calif. & MENLO PARK, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and Forty Seven, Inc. (Nasdaq: FTSV)


 https://www.fortyseveninc.com/ 


 https://www.fortyseveninc.com/science 


 https://seekingalpha.com/symbol/GILD 


 https://seekingalpha.com/symbol/FTSV 


 

Gilead takes out Forty Seven for $4.9B

Mar. 2, 2020 7:38 AM ET|About: Forty Seven, Inc. (FTSV)|By: , SA News Editor 

 https://seekingalpha.com/news/3547352-gilead-takes-out-forty-seven-for-4_9b 

Seeking Biotech Alpha February 2020 Insight

BGB-3245, an investigational, next-generation B-RAF inhibitor

BGB-3245, an investigational, next-generation B-RAF inhibitor

BGB-3245, an investigational, next-generation B-RAF inhibitor

image93

 

MapKure, BeiGene and SpringWorks Announce Initiation of Phase 1 Clinical Trial of BGB-3245, a Selective Next-Generation B-RAF Inhibitor, in Adult Patients with Advanced or Refractory Solid Tumors

Thu February 27, 2020 7:14 AM|GlobeNewswire|About: BGNE, SWTX

-- Phase 1 Study Initiated in Australia with IND Cleared to Expand Study to the U.S.--

-- Industry-Leading Scientific Advisory Board Formed to Support Advancement of BGB-3245 --

CAMBRIDGE, Mass. and BEIJING and STAMFORD, Conn., Feb. 27, 2020 (GLOBE NEWSWIRE) -- MapKure, LLC, a clinical-stage company developing precision medicines for patients with life-threatening diseases, together with BeiGene, Ltd. (BGNE) and SpringWorks Therapeutics, Inc. (SWTX), who are joint owners of MapKure


 

Study of Safety, Pharmacokinetics, and Antitumor Activity of BGB-3245 in Participants With Advanced or Refractory Tumors

 https://clinicaltrials.gov/ct2/show/NCT04249843?term=BGB-3245&draw=2&rank=1#wrapper 


 https://www.beigene.com/ 


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


 https://www.springworkstx.com/ 


 https://www.springworkstx.com/pipeline/ 


 https://seekingalpha.com/symbol/BGNE 


 https://seekingalpha.com/symbol/SWTX 


 http://ir.beigene.com/static-files/ac21f420-ebe7-4627-a9c2-c38bd7940b8d 



Acthar® Gel (Repository Corticotropin Injection)

BGB-3245, an investigational, next-generation B-RAF inhibitor

BGB-3245, an investigational, next-generation B-RAF inhibitor

image94

 

Mallinckrodt to Present New Data from two Studies on Acthar® Gel (Repository Corticotropin Injection) Therapy in Multiple Sclerosis (MS) Relapse at Fifth Annual ACTRIMS Forum 2020

Thu February 27, 2020 6:45 AM|PR Newswire|About: MNK 

 PR Newswire

STAINES-UPON-THAMES, United Kingdom, Feb. 27, 2020 /PRNewswire/ -- Mallinckrodt plc (MNK) (NYSE: MNK)


 https://www.acthar.com/pdf/Acthar-PI.pdf 


 http://www.mallinckrodt.com/ 


 http://www.mallinckrodt.com/about/news-and-media/news-detail/?id=26516 


 https://seekingalpha.com/symbol/MNK 



 https://www.prnewswire.com/news-releases/mallinckrodt-to-present-new-data-from-two-studies-on-acthar-gel-repository-corticotropin-injection-therapy-in-multiple-sclerosis-ms-relapse-at-fifth-annual-actrims-forum-2020-301012267.html 



resiniferatoxin (RTX)

BGB-3245, an investigational, next-generation B-RAF inhibitor

Advil Dual Action= two-medicine tablets each contain 250 mg acetaminophen and 125 mg ibuprofen.

image95

 

Sorrento Therapeutics Presents Interim Positive Results of Phase 1b Resiniferatoxin (RTX) in Cancer Pain Trial

Thu February 27, 2020 3:30 PM|GlobeNewswire|About: SRNE

  • Fourteen subjects with advanced cancer pain received epidural RTX (04 to 15 ug)
  • Most common treatment-related adverse event was transient post-procedure related pain
  • Three subjects at the higher doses had rapid and marked pain reduction after treatment
  • One additional cohort was added to further evaluate a 25 ug dose for upcoming Phase 3 studies

SAN DIEGO, Feb. 27, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (SRNE


 https://sorrentotherapeutics.com/pipeline/ 


 More information on this trial can be found at www.clinicaltrials.gov (NCT03226574). 


Study to Evaluate Safety and MTD of Epidural Resiniferatoxin Injection for Treatment of Intractable Cancer Pain

 https://clinicaltrials.gov/ct2/show/NCT03226574?term=NCT03226574&draw=2&rank=1 


 https://sorrentotherapeutics.com/ 


 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC398431/ 


 https://seekingalpha.com/symbol/SRNE 



Advil Dual Action= two-medicine tablets each contain 250 mg acetaminophen and 125 mg ibuprofen.

islatravir w/ doravirine (100 mg) & lamivudine (3TC, 300 mg) or w/ a dose combination of doravirine

Advil Dual Action= two-medicine tablets each contain 250 mg acetaminophen and 125 mg ibuprofen.

image96

 

Pfizer gets OK for Advil Dual Action

Feb. 28, 2020 4:43 PM ET|About: Pfizer Inc. (PFE)|By: , SA News Editor 


 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211733Orig1s000ltr.pdf 

VENCLEXTA® (venetoclax) in Combination with Low-Dose Cytarabine

islatravir w/ doravirine (100 mg) & lamivudine (3TC, 300 mg) or w/ a dose combination of doravirine

islatravir w/ doravirine (100 mg) & lamivudine (3TC, 300 mg) or w/ a dose combination of doravirine

 

AbbVie Provides Update from Phase 3 Study Evaluating VENCLEXTA® (venetoclax) in Combination with Low-Dose Cytarabine in Newly-Diagnosed Patients with Acute Myeloid Leukemia (AML)

Fri February 28, 2020 6:53 PM|PR Newswire|About: ABBV

- At the time of the primary analysis median OS was 7.2 months in the venetoclax arm and 4.1 months in the comparator arm

- Results are indicative of clinical activity of venetoclax in combination with low-dose cytarabine

- AML is one of the most aggressive and difficult-to-treat blood cancers with a very low survival rate and few treatment options¹ ²

- Results will be published in a peer-reviewed journal and presented at an upcoming medical meeting

- Phase 3 VIALE-A trial evaluating venetoclax in combination with azacytidine is ongoing; at this time, indications for venetoclax remain unchanged

PR Newswire

NORTH CHICAGO, Ill., Feb. 28, 2020 /PRNewswire/ -- AbbVie (ABBV)


 https://news.abbvie.com/news/press-releases/abbvie-receives-us-fda-accelerated-approval-for-venclexta-venetoclax-for-treatment-newly-diagnosed-acute-myeloid-leukemia-patients-ineligible-for-intensive-chemotherapy.htm 


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


 https://www.abbvie.com/ 


 https://www.prnewswire.com/news-releases/abbvie-provides-update-from-phase-3-study-evaluating-venclexta-venetoclax-in-combination-with-low-dose-cytarabine-in-newly-diagnosed-patients-with-acute-myeloid-leukemia-aml-301013711.html 


 https://seekingalpha.com/symbol/ABBV 


 

AbbVie venetoclax combo trial misses endpoint

Feb. 28, 2020 7:10 PM ET|About: AbbVie Inc. (ABBV)|By: , SA News Editor 

 https://seekingalpha.com/news/3547230-abbvie-venetoclax-combo-trial-misses-endpoint 

islatravir w/ doravirine (100 mg) & lamivudine (3TC, 300 mg) or w/ a dose combination of doravirine

islatravir w/ doravirine (100 mg) & lamivudine (3TC, 300 mg) or w/ a dose combination of doravirine

islatravir w/ doravirine (100 mg) & lamivudine (3TC, 300 mg) or w/ a dose combination of doravirine

 

Merck Announces New Data from Broad HIV Program at CROI 2020

Mon March 2, 2020 6:45 AM|Business Wire|About: MRK

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada,


 https://www.croiconference.org/ 


 https://www.merck.com/index.html 


 https://www.businesswire.com/news/home/20200302005284/en/ 


 https://seekingalpha.com/symbol/MRK 





Seeking Biotech Alpha February 2020 Insight

CABOMETYX® (cabozantinib)

Gilead Sciences Inc. has been granted three patents in China for its antiviral drug remdesivir

Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML)

image97

 

Exelixis Announces First 100 Patients Enrolled in Phase 3 COSMIC-311 Pivotal Trial of Cabozantinib in Relapsed Radioiodine-Refractory Differentiated Thyroid Cancer

Tue February 25, 2020 4:06 PM|Business Wire|About: EXEL

– Analysis for the co-primary endpoint of objective response rate and an interim analysis of progression-free survival expected in the second half of 2020 –

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


 https://www.businesswire.com/news/home/20200225005987/en/ 


 

A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior VEGFR-targeted Therapy

 https://clinicaltrials.gov/ct2/show/NCT03690388 


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


 https://www.exelixis.com/ 


 https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-first-100-patients-enrolled-phase-3-cosmic 


 https://www.businesswire.com/news/home/20200225005987/en/ 


 https://seekingalpha.com/symbol/EXEL 



Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML)

Gilead Sciences Inc. has been granted three patents in China for its antiviral drug remdesivir

Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML)

image98

 

SELLAS Announces Positive Follow-Up Phase 1/2 Clinical Data for Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML)

Wed February 26, 2020 8:30 AM|GlobeNewswire|About: SLS

- Final analysis shows statistically significant median overall survival of 21 months in patients who received GPS compared to previously reported 5.4 months in the control arm (p-value < 0.02) -

- Data provides additional support for ongoing pivotal Phase 3 REGAL study of GPS in patients with AML -

NEW YORK, Feb. 26, 2020 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (SLS


 

GPS Compared With BAT in AML CR2/CR2p

 https://www.clinicaltrials.gov/ct2/show/NCT04229979?term=galinpepimut-S&draw=2&rank=3 


 https://www.sellaslifesciences.com/Home/default.aspx 


 https://seekingalpha.com/symbol/SLS 




Gilead Sciences Inc. has been granted three patents in China for its antiviral drug remdesivir

Gilead Sciences Inc. has been granted three patents in China for its antiviral drug remdesivir

NEXLIZET™ (bempedoic acid & ezetimibe) Tablet, Oral, Once-Daily, Non-Statin LDL-Cholesterol Med

image99

 

Gilead Sciences Inc. has been granted three patents in China for its antiviral drug remdesivir, which has been undergoing clinical tests to determine if it can effectively treat the coronavirus, He Zhimin, deputy director of the National Intellectual Property Administration said (link in Chinese) at a press conference on Tuesday.

The U.S. drugmaker has applied for eight patents for the drug and the other five are still being reviewed, according to He. The eight patents cover areas including compounds, manufacturing methods and drug usage.


 

Antiviral drug Remdesivir gains 3 patents in China

 http://www.china.org.cn/china/2020-02/26/content_75745874.htm 


 

Antiviral drug Remdesivir gains three patents in China: official

Source: Xinhua| 2020-02-25 19:05:41|Editor: huaxia

BEIJING, Feb. 25 (Xinhua) 

 http://www.xinhuanet.com/english/2020-02/25/c_138817801.htm 

NEXLIZET™ (bempedoic acid & ezetimibe) Tablet, Oral, Once-Daily, Non-Statin LDL-Cholesterol Med

NEXLIZET™ (bempedoic acid & ezetimibe) Tablet, Oral, Once-Daily, Non-Statin LDL-Cholesterol Med

NEXLIZET™ (bempedoic acid & ezetimibe) Tablet, Oral, Once-Daily, Non-Statin LDL-Cholesterol Med

image100

 

Esperion Announces FDA Approval of the NEXLIZET™ (bempedoic acid and ezetimibe) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine

Wed February 26, 2020 5:30 PM|GlobeNewswire|About: ESPR

- NEXLIZET Lowered LDL-C by 38 Percent Compared to Placebo when Added on to Maximally Tolerated Statins -
- First Non-Statin, LDL-Cholesterol Lowering Combination Medicine Ever Approved -
- Esperion’s Second Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine Approved in the U.S. Following NEXLETOL™ (bempedoic acid) Tablet Approval on February 21, 2020 -
- Further Underscores Esperion’s Commitment to Patient Affordability -
- Conference Call and Webcast on Thursday, February 27 at 8:00 a.m. Eastern Time -

ANN ARBOR, Mich., Feb. 26, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR)


 Feb 26, 2020

Esperion Announces FDA Approval of the NEXLIZET™ (bempedoic acid and ezetimibe) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine

 https://pi.esperion.com/nexlizet/nexlizet-pi.pdf 


 https://www.esperion.com/ 


 NEXLETOL™ (bempedoic acid) Tablet 


 https://seekingalpha.com/symbol/ESPR 


 https://www.esperion.com/investors-media/press-releases/?request=aHR0cHM6Ly9lc3Blcmlvbi5nY3Mtd2ViLmNvbS8vbmV3cy1yZWxlYXNlcy9uZXdzLXJlbGVhc2UtZGV0YWlscy9lc3Blcmlvbi1hbm5vdW5jZXMtZmRhLWFwcHJvdmFsLW5leGxpemV0dG0tYmVtcGVkb2ljLWFjaWQtYW5k 



CYRAMZA® (ramucirumab)

NEXLIZET™ (bempedoic acid & ezetimibe) Tablet, Oral, Once-Daily, Non-Statin LDL-Cholesterol Med

Remdesivir for the Treatment of COVID-19

image101

 

FDA Advisory Committee Votes in Favor of Lilly's CYRAMZA® (ramucirumab) as First-Line Treatment for Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

02/26/2020Download PDFRegulatory submission based on the positive Phase 3 RELAY study of CYRAMZA in combination with erlotinib for the first-line treatment of adult patients with metastatic non-small cell lung cancer with activating EGFR mutations

INDIANAPOLIS, Feb. 26, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)


 https://www.cyramza.com/ 


  VOLUME 20, ISSUE 12, P1655-1669, DECEMBER 01, 2019

Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial

 https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30634-5/fulltext 


 http://uspl.lilly.com/cyramza/cyramza.html 


 https://www.lilly.com/ 


 https://www.lillyoncology.com/ 


 https://www.prnewswire.com/news-releases/fda-advisory-committee-votes-in-favor-of-lillys-cyramza-ramucirumab-as-first-line-treatment-for-metastatic-egfr-mutated-non-small-cell-lung-cancer-301012180.html 


 

A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)

 https://clinicaltrials.gov/ct2/show/NCT02411448 


 https://seekingalpha.com/symbol/LLY 

Important Facts About CYRAMZA® (sigh-RAM-zuh). It is also known as ramucirumab. CYRAMZA is a prescription medicine used to treat certain types of cancer. It is given by intravenous (IV) infusion. An IV infusion is when a needle is placed into your vein and a medicine is given slowly. CYRAMZA is prescribed in these ways: By itself or with a chemotherapy medicine called paclitaxel to treat certain kinds of stomach cancer or cancer of the area where the stomach and esophagus (food pipe) meet that is advanced or has spread to other parts of the body. The area where the stomach and esophagus meet is often called the gastroesophageal (GE) junction. CYRAMZA is for people whose stomach cancer got worse during or after certain other types of chemotherapy. With a chemotherapy medicine called docetaxel to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body and has gotten worse during or after another type of chemotherapy. People who have tumors with certain abnormal genes should not receive CYRAMZA unless they have already been treated with medicine that targets those changes and their cancer became worse during treatment. With a combination of chemotherapy medicines called FOLFIRI (irinotecan, folinic acid, and fluorouracil). This is given to treat colorectal cancer (CRC) that has spread to other parts of the body and has gotten worse during or after certain other types of chemotherapy. By itself to treat a type of liver cancer called hepatocellular carcinoma (HCC). CYRAMZA is for people who have levels of alpha-fetoprotein of at least 400 nanograms per milliliter (ng/mL) in their blood and have been treated with another type of chemotherapy medicine called sorafenib.

Remdesivir for the Treatment of COVID-19

NEXLIZET™ (bempedoic acid & ezetimibe) Tablet, Oral, Once-Daily, Non-Statin LDL-Cholesterol Med

Remdesivir for the Treatment of COVID-19

image102

 

Gilead Sciences Initiates Two Phase 3 Studies of Investigational Antiviral Remdesivir for the Treatment of COVID-19

Wed February 26, 2020 5:00 PM|Business Wire|About: GILD

-- U.S. FDA Grants Investigational New Drug Authorization to Study Remdesivir for the Treatment of COVID-19 --

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD)


 https://www.gilead.com/purpose/advancing-global-health/covid-19 


 https://www.gilead.com/ 


 https://www.businesswire.com/news/home/20200226005955/en/ 


 Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens including Ebola, Marburg, MERS and SARS. 


 https://seekingalpha.com/symbol/GILD 


Seeking Biotech Alpha February 2020 Insight

OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)

OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)

OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)

image103

 

Japan Ministry of Health, Labor and Welfare Approves Opdivo (nivolumab) for the Treatment of Patients with Unresectable Advanced or Recurrent Esophageal Cancer

Fri February 21, 2020 6:59 AM|Business Wire|About: BMY

First approval of Opdivo for treatment of advanced esophageal cancer

First Immuno-Oncology treatment option approved for patients with esophageal cancer in Japan

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


 https://www.businesswire.com/news/home/20200221005172/en/ 


 https://news.bms.com/press-release/corporatefinancial-news/japan-ministry-health-labor-and-welfare-approves-opdivo-nivo-0 


 https://www.opdivo.com/ 


 https://www.bms.com/ 


 https://seekingalpha.com/symbol/BMY 

Nexletol (bempedoic acid)

OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)

YESCARTA® (Axicabtagene Ciloleucel)

 

Esperion Wins FDA Approval for First Heart Medicine, Nexletol

Feb. 21, 2020, 2:30 PM 


 

FDA OKs Esperion's cholesterol med Nexletol

Feb. 21, 2020 3:08 PM ET|About: Esperion Therapeutics,... (ESPR)|By: , SA News Editor 

 https://seekingalpha.com/news/3544573-fda-oks-esperions-cholesterol-med-nexletol 


 https://seekingalpha.com/symbol/ESPR 


 https://pi.esperion.com/nexletol/nexletol-pi.pdf 


 https://www.esperion.com/science/bempedoic-acid/ 


 

Esperion Announces FDA Approval of NEXLETOL™ (bempedoic acid) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine

Fri February 21, 2020 4:38 PM|GlobeNewswire|About: ESPR

– First Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine Approved in the U.S. in Nearly 20 Years for Indicated Patients –
– NEXLETOL Lowers LDL-Cholesterol with a First-in-Class Mechanism –
– Fills an Unmet Need for Affordable Medicines for Millions of Patients with ASCVD or HeFH –
– NEXLETOL will be Commercially Available in the U.S. March 30, 2020
– Conference Call and Webcast on Monday, February 24 at 8:00 a.m. Eastern Time

ANN ARBOR, Mich., Feb. 21, 2020 (GLOBE NEWSWIRE) -- Esperion (ESPR)

 https://seekingalpha.com/pr/17787122-esperion-announces-fda-approval-of-nexletol-bempedoic-acid-tablet-oral-daily-non-statin-ldl 

YESCARTA® (Axicabtagene Ciloleucel)

ANAVEX®2-73 (blarcamesine) in Multiple Sclerosis (MS)

YESCARTA® (Axicabtagene Ciloleucel)

image104

 Fosun Kite’s New Drug Application (NDA) Filing for Axicabtagene Ciloleucel Accepted for Review by China NMPA 

 (24 February, 2020, Shanghai) Today, Fosun Kite Biotechnology(“Fosun Kite”) based in Shanghai, a company invested by Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma” or “Group”; Stock Code: 600196.SH, 02196.HK), 


 Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* Announcement in Relation to Acceptance of New Drug Application Filing from Fosun Kite Biotechnology Co., Ltd.* 

 https://www1.hkexnews.hk/listedco/listconews/sehk/2020/0224/2020022400822.pdf 


 

Gilead JV application for CAR-T cancer therapy accepted in China

Feb. 24, 2020 7:46 AM ET|About: Gilead Sciences, Inc. (GILD)|By: , SA News Editor 

 https://seekingalpha.com/news/3544746-gilead-jv-application-for-car-t-cancer-therapy-accepted-in-china 


 https://www.yescarta.com/ 


 https://seekingalpha.com/symbol/GILD 



ALUNBRIG® (brigatinib)

ANAVEX®2-73 (blarcamesine) in Multiple Sclerosis (MS)

ANAVEX®2-73 (blarcamesine) in Multiple Sclerosis (MS)

image105

 

Takeda Announces U.S. FDA Grants Priority Review for Supplemental New Drug Application for ALUNBRIG® (brigatinib) as a First-Line Treatment for ALK+ Metastatic Non-Small Cell Lung Cancer

Mon February 24, 2020 8:00 AM|Business Wire|About: TAK

– ALUNBRIG has Potential to Expand its Indication in ALK+ Metastatic Non-Small Cell Lung Cancer –

– Prescription Drug User Fee Act (PDUFA) Target Action Date Set for June 23, 2020 –

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK)


 https://www.alunbrig.com/ 


 https://www.takeda.com/ 


 https://www.takeda.com/newsroom/newsreleases/2019/takeda-announces-u.s.-fda-acceptance-of-supplemental-new-drug-application-for-alunbrig-brigatinib-as-a-first-line-treatment-for-alk-metastatic-non-small-cell-lung-cancer/ 


 https://www.businesswire.com/news/home/20200224005128/en/ 


 https://seekingalpha.com/symbol/TAK 



ANAVEX®2-73 (blarcamesine) in Multiple Sclerosis (MS)

ANAVEX®2-73 (blarcamesine) in Multiple Sclerosis (MS)

ANAVEX®2-73 (blarcamesine) in Multiple Sclerosis (MS)

image106

 

Anavex Life Sciences Announces Publication of Foundational Data for ANAVEX®2-73 (blarcamesine) in Multiple Sclerosis (MS)

Mon February 24, 2020 7:00 AM|GlobeNewswire|About: AVXL

Published in Journal of Neuroimmunology, Results Highlight ANAVEX®2-73 (blarcamesine) Shown to Protect and Repair Myelin Forming Cells

ANAVEX®2-73 (blarcamesine) Provides optimal Protection of Oligodendroglia against Glutamate Toxicity

NEW YORK, Feb. 24, 2020 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (AVXL) (“Anavex” or the “Company”) (Nasdaq: AVXL)


 https://www.sciencedirect.com/science/article/abs/pii/S0165572819305831 


 https://www.anavex.com/ 


 https://seekingalpha.com/symbol/AVXL 


 https://www.anavex.com/anavex-life-sciences-announces-publication-of-foundational-data-for-anavex2-73-blarcamesine-in-multiple-sclerosis-ms/ 



Seeking Biotech Alpha February 2020 Insight

KEYTRUDA® (pembrolizumab) Injection, 100 mg

PADCEV™ (enfortumab vedotin-ejfv) and Merck’s KEYTRUDA® (pembrolizumab)

KEYTRUDA® (pembrolizumab) Injection, 100 mg

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Merck Receives Complete Response Letter from the US FDA for Supplemental Biologics License Applications (sBLAs) for KEYTRUDA® (pembrolizumab) Six-Week Dosing Schedule

Tue February 18, 2020 7:17 PM|Business Wire|About: MRK

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


 https://www.merck.com/clinical-trials/index.html 


 https://www.merck.com/index.html 


 https://www.businesswire.com/news/home/20200218006165/en/ 


 https://www.mrknewsroom.com/news-release/corporate-news/merck-receives-complete-response-letter-us-fda-supplemental-biologics-li 


 https://seekingalpha.com/symbol/MRK 


 https://www.keytruda.com/ 



ruxolitinib cream 0.75% or 1.5%

PADCEV™ (enfortumab vedotin-ejfv) and Merck’s KEYTRUDA® (pembrolizumab)

KEYTRUDA® (pembrolizumab) Injection, 100 mg

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Incyte Announces Positive Topline Results From Phase 3 TRuE-AD Program Evaluating Ruxolitinib Cream in Patients With Atopic Dermatitis

Wed February 19, 2020 7:30 AM|Business Wire|About: INCY 


 

For more information about the TRuE-AD studies, please visit http://clinicaltrials.gov/ct2/show/NCT03745638 and http://clinicaltrials.gov/ct2/show/NCT03745651.

About Ruxolitinib Cream

 Ruxolitinib cream is a proprietary formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application. Ruxolitinib cream is currently in Phase 3 development for the treatment of patients with mild-to-moderate atopic dermatitis (TRuE-AD) and for the treatment of adolescents and adults with vitiligo (TRuE-V). Incyte has worldwide rights for the development and commercialization of ruxolitinib cream. 


 https://www.incyte.com/ 


 https://www.businesswire.com/news/home/20200219005204/en/ 


 https://seekingalpha.com/symbol/INCY 



PADCEV™ (enfortumab vedotin-ejfv) and Merck’s KEYTRUDA® (pembrolizumab)

PADCEV™ (enfortumab vedotin-ejfv) and Merck’s KEYTRUDA® (pembrolizumab)

PADCEV™ (enfortumab vedotin-ejfv) and Merck’s KEYTRUDA® (pembrolizumab)

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Seattle Genetics and Astellas Receive FDA Breakthrough Therapy Designation for PADCEV™ (enfortumab vedotin-ejfv) in Combination with Pembrolizumab in First-Line Advanced Bladder Cancer

Wed February 19, 2020 8:12 AM|Business Wire|About: ALPMY, SGEN

- Breakthrough Therapy Designation Based on Initial Results from Phase 1b/2 EV-103 Clinical Trial -

BOTHELL, Wash. & TOKYO--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) (Nasdaq:SGEN) and Astellas Pharma Inc. (ALPMF) (TSE: 4503


 https://www.seattlegenetics.com/ 


 https://www.astellas.com/en/ 


 https://www.businesswire.com/news/home/20200219005512/en/ 


 https://seekingalpha.com/symbol/ALPMY 


 https://seekingalpha.com/symbol/SGEN 



FreeStyle Libre system

AXS-07 is a novel, oral, investigational medicine

PADCEV™ (enfortumab vedotin-ejfv) and Merck’s KEYTRUDA® (pembrolizumab)

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New Real-World Data Show that Abbott's FreeStyle Libre System Delivers Positive Health Outcomes for People with Type 1 and Type 2 Diabetes

Thu February 20, 2020 8:00 AM|PR Newswire|About: ABT

- People in Germany living with Type 1 or Type 2 diabetes on insulin showed a sustained reduction in HbA1c over one year following use of the FreeStyle Libre technology

PR Newswire

MADRID, Feb. 20, 2020 /PRNewswire/ -- Abbott (ABT)


 https://www.abbott.com/ 


 https://www.prnewswire.com/news-releases/new-real-world-data-show-that-abbotts-freestyle-libre-system-delivers-positive-health-outcomes-for-people-with-type-1-and-type-2-diabetes-301007694.html 


 https://seekingalpha.com/symbol/ABT 



AXS-07 is a novel, oral, investigational medicine

AXS-07 is a novel, oral, investigational medicine

AXS-07 is a novel, oral, investigational medicine

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Axsome Therapeutics Completes Patient Enrollment in the INTERCEPT Phase 3 Trial of AXS-07 in the Early Treatment of Migraine

Thu February 20, 2020 7:00 AM|GlobeNewswire|About: AXSM

NEW YORK, Feb. 20, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (AXSM)


 https://axsome.com/ 


 https://axsome.com/axs-pipeline/about-axs-07/ 


 https://seekingalpha.com/symbol/AXSM 

valoctocogene roxaparvovec

AXS-07 is a novel, oral, investigational medicine

AXS-07 is a novel, oral, investigational medicine

image112

 

BioMarin's Biologics License Application for Valoctocogene Roxaparvovec Accepted for Priority Review by FDA with Review Action Date of August 21, 2020

Thu February 20, 2020 4:05 PM|PR Newswire|About: BMRN

If approved, 1st Gene Therapy in U.S. for the Treatment of Any Type of Hemophilia

FDA Also Accepts Premarket Approval (PMA) Application for Companion Diagnostic Test, a 1st for a Gene Therapy

PR Newswire

SAN RAFAEL, Calif., Feb. 20, 2020 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)


 https://www.biomarin.com/products/pipeline/bmn-270/ 


 https://investors.biomarin.com/2020-02-20-BioMarins-Biologics-License-Application-for-Valoctocogene-Roxaparvovec-Accepted-for-Priority-Review-by-FDA-with-Review-Action-Date-of-August-21-2020 


 https://www.prnewswire.com/news-releases/biomarins-biologics-license-application-for-valoctocogene-roxaparvovec-accepted-for-priority-review-by-fda-with-review-action-date-of-august-21-2020-301008771.html 


 https://seekingalpha.com/symbol/BMRN 

Seeking Biotech Alpha February 2020 Insight

Beovu® (brolucizumab) injection

Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)

Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)

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Novartis receives EC Approval for Beovu®, a next-generation anti-VEGF treatment for wet AMD, a leading cause of blindness worldwide

Feb 17, 2020

  • Beovu (brolucizumab) is the only anti-VEGF treatment approved in Europe for wet AMD that offers the option to start eligible patients on three-month dosing intervals immediately after the loading phase1
     
  • For the more than 20 million people worldwide who are living with wet AMD, frequent injections are a common reason patients drop off existing treatments2-4
     
  • Approval is based on two head-to-head clinical trials, HAWK and HARRIER, in which Beovu achieved robust vision gains that were non-inferior to aflibercept at year one (primary endpoint)1,5
     
  • Beovu also demonstrated superior fluid resolution versus aflibercept at week 16 and year one (secondary endpoints)1,5

 Basel, February 17, 2020 


 https://www.beovu.com/?utm_medium=paid&utm_term=Branded_Exact%20|%20beovu&utm_source=google&utm_campaign=Branded_Exact 


 https://www.novartis.com/ 


 https://seekingalpha.com/symbol/NVS 



Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)

Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)

Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)

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FDA approves GSK's Voltaren Arthritis Pain for over-the-counter use in the United States

Mon February 17, 2020 10:00 AM|PR Newswire|About: GSKPR Newswire

WARREN, N.J., Feb. 17, 2020 /PRNewswire/ -- GlaxoSmithKline (GLAXF) (LSE/NYSE: GSK)


 https://www.voltarengel.com/ 


 https://www.voltarengel.com/ 


 https://www.gsk.com/ 


 https://seekingalpha.com/symbol/GSK 

VYNDAQEL® (tafamidis)

Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)

Gallant™ implantable cardioverter defibrillator & cardiac resynchronization therapy defibrillator

 

European Commission Approves VYNDAQEL®, the First Treatment in the EU for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Tue February 18, 2020 6:45 AM|Business Wire|About: PFE

—VYNDAQEL is the only EC-approved medicine proven to reduce mortality and frequency of cardiovascular-related hospitalizations in adults with wild-type or hereditary ATTR-CM—

—VYNDAQEL is the first approved medicine in the EU to treat both ATTR-CM and stage 1 symptomatic transthyretin amyloid polyneuropathy (ATTR-PN)—

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE)


 http://labeling.pfizer.com/ShowLabeling.aspx?id=11685 


 https://www.pfizer.com/ 


 https://www.pfizer.com/news/press-release/press-release-detail/european_commission_approves_vyndaqel_the_first_treatment_in_the_eu_for_transthyretin_amyloid_cardiomyopathy_attr_cm 


 https://www.businesswire.com/news/home/20200218005225/en/ 


 https://seekingalpha.com/symbol/PFE 



Gallant™ implantable cardioverter defibrillator & cardiac resynchronization therapy defibrillator

Gallant™ implantable cardioverter defibrillator & cardiac resynchronization therapy defibrillator

Gallant™ implantable cardioverter defibrillator & cardiac resynchronization therapy defibrillator

 

Abbott Introduces Next-Generation Heart Rhythm Management Devices in Europe, Featuring State-of-the-Art Patient App and Bluetooth Connectivity

Tue February 18, 2020 7:45 AM|PR Newswire|About: ABT

- Gallant ICD and CRT-D devices feature a more comfortable design, preferred by patients without compromising on battery longevity or high-voltage output, which remain among the highest in the industry

PR Newswire

ABBOTT PARK, Ill., Feb. 18, 2020 /PRNewswire/ -- Abbott (ABT)


 https://www.abbott.com/ 


 https://www.prnewswire.com/news-releases/abbott-introduces-next-generation-heart-rhythm-management-devices-in-europe-featuring-state-of-the-art-patient-app-and-bluetooth-connectivity-301006253.html 


 https://seekingalpha.com/symbol/ABT 


 https://www.abbott.com/consumer/cardiovascular.html 

PROCYSBI® (Cysteamine Bitartrate)

Gallant™ implantable cardioverter defibrillator & cardiac resynchronization therapy defibrillator

PROCYSBI® (Cysteamine Bitartrate)

image115

 

Horizon Therapeutics plc Announces U.S. FDA Approval of New Dosage Form for PROCYSBI® (Cysteamine Bitartrate) Delayed-Release Oral Granules

Tue February 18, 2020 8:00 AM|Business Wire|About: HZNP

-- Oral granules in packets provide an additional, tear-open option for people living with cystinosis --

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


 https://www.businesswire.com/news/home/20200218005293/en/ 


 https://www.hzndocs.com/PROCYSBI-Prescribing-Information.pdf 


 https://www.horizontherapeutics.com/ 


 https://seekingalpha.com/symbol/HZNP 


 

Our Pipeline

We are relentless in pursuing breakthroughs that boldly change the lives of the communities we serve.

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

Tecentriq® (atezolizumab)

Gallant™ implantable cardioverter defibrillator & cardiac resynchronization therapy defibrillator

PROCYSBI® (Cysteamine Bitartrate)

image116

 

FDA Grants Priority Review to Genentech’s Tecentriq Monotherapy as First-line Treatment of Certain People With Advanced Non-small Cell Lung Cancer

Wed February 19, 2020 1:00 AM|Business Wire|About: RHHBY

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


 https://www.businesswire.com/news/home/20200218006211/en/ 


 https://www.gene.com/ 


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


 https://www.tecentriq.com/ 


 https://seekingalpha.com/symbol/RHHBY 

Seeking Biotech Alpha February 2020 Insight

Tecentriq in combination with chemotherapy

Tecentriq in combination with chemotherapy

Tecentriq in combination with chemotherapy

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China National Medical Products Administration grants approval of Roche’s Tecentriq in combination with chemotherapy as first-line treatment of people with extensive-stage small cell lung cancer

  • This marks the first approval for a Tecentriq-based therapy in China, less than a year after the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals in this indication
  • Tecentriq with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy combination approved for the initial treatment of extensive-stage small cell lung cancer (ES-SCLC)
  • The combination significantly improved overall survival (OS) and progression-free survival (PFS) for the first time in over 20 years

Basel, 14 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) 


 https://www.tecentriq.com/ 


 

Roche's Tecentriq OK'd in China for first-line lung cancer

Feb. 14, 2020 7:00 AM ET|About: Roche Holding AG (RHHBY)|By: , SA News Editor  

 https://seekingalpha.com/news/3542132-roches-tecentriq-okd-in-china-for-first-line-lung-cancer 


 https://seekingalpha.com/symbol/RHHBY 


 https://www.gene.com/medical-professionals/pipeline 



STELARA® (ustekinumab)

Tecentriq in combination with chemotherapy

Tecentriq in combination with chemotherapy

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New Phase 3b Interim Data from STARDUST Study Show Two-Thirds of Patients with Moderately to Severely Active Crohn's Disease Achieved Clinical Remission After Two Doses of STELARA® (ustekinumab)

Fri February 14, 2020 2:00 AM|PR Newswire

First Study to Evaluate Intestinal Ultrasound Monitoring in an Interventional Setting

PR Newswire

VIENNA, Feb. 14, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson 


 http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf 


 https://www.janssen.com/ 


 https://www.jnj.com/ 


 

Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab (STARDUST)

 https://clinicaltrials.gov/ct2/show/NCT03107793 


 https://www.prnewswire.com/news-releases/new-phase-3b-interim-data-from-stardust-study-show-two-thirds-of-patients-with-moderately-to-severely-active-crohns-disease-achieved-clinical-remission-after-two-doses-of-stelara-ustekinumab-301005006.html 


 

Overview of Crohn's Disease

ESPAÑOL

Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract. Understanding Crohn’s disease can help you and your loved ones navigate the uncertainty that comes with a new diagnosis.

 https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview 


 

New Phase 3b Interim Data from STARDUST Study Show Two-Thirds of Patients with Moderately to Severely Active Crohn's Disease Achieved Clinical Remission After Two Doses of STELARA® (ustekinumab)

Feb 14, 2020Austria 

 https://www.janssen.com/new-phase-3b-interim-data-stardust-study-show-two-thirds-patients-moderately-severely-active-crohns 


 https://seekingalpha.com/symbol/JNJ 

nelipepimut-S (NPS)

Tecentriq in combination with chemotherapy

ERVEBO® (Ebola Zaire Vaccine, Live)

image119

 

SELLAS Life Sciences Provides Regulatory Update for Nelipepimut-S (NPS) for Triple Negative Breast Cancer (TNBC) Following FDA Feedback

Fri February 14, 2020 8:30 AM|GlobeNewswire|About: SLSGlobeNewswire

NEW YORK, Feb. 14, 2020 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (SLS)


 https://www.sellaslifesciences.com/Home/default.aspx 


 https://seekingalpha.com/symbol/SLS 



ERVEBO® (Ebola Zaire Vaccine, Live)

ERVEBO® (Ebola Zaire Vaccine, Live)

ERVEBO® (Ebola Zaire Vaccine, Live)

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ERVEBO® (Ebola Zaire Vaccine, Live) Now Registered in Four African Countries, Within 90 Days of Reference Country Approval and WHO Prequalification

Fri February 14, 2020 11:20 AM|Business Wire|About: MRK

Democratic Republic of the Congo One of the First African Countries to Register ERVEBO

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


 https://www.businesswire.com/news/home/20200214005376/en/ 


 https://www.merck.com/index.html 


 https://www.fda.gov/vaccines-blood-biologics/ervebo 



Remdesivir (GS-5734, Nuc inhibitor)

ERVEBO® (Ebola Zaire Vaccine, Live)

Remdesivir (GS-5734, Nuc inhibitor)

image122

 Feb 16, 2020 11:16 AM

Second Batch of Experimental Gilead Coronavirus Drug Arrives in Wuhan

By Jia Tianqiong, Di Ning, Lu Yutong and Flynn Murphy 

 The remdesivir trials are backed by Capital Medical University in collaboration with the Chinese Academy of Medical Sciences. 


Seeking Biotech Alpha February 2020 Insight

OTEZLA® (apremilast)

Two Antibodies That Bind to the Spike Protein of 2019-nCoV, Newly Named as SARS-CoV-2

Two Antibodies That Bind to the Spike Protein of 2019-nCoV, Newly Named as SARS-CoV-2

image123

 

Amgen Canada Receives Approval of Marketing Authorization Transfer of OTEZLA® for the Treatment of Moderate to Severe Plaque Psoriasis and Psoriatic Arthritis

Wed February 12, 2020 7:00 AM|Canada Newswire|About: AMGN

Addition of OTEZLA Strengthens Amgen (AMGN)'s Long-Standing Expertise in Inflammation

MISSISSAUGA, ON, Feb. 12, 2020 /CNW/ - Today, Amgen Canada Inc.


 https://www.amgen.ca/ 


 https://www.otezla.com/ 


 https://seekingalpha.com/symbol/AMGN 


Two Antibodies That Bind to the Spike Protein of 2019-nCoV, Newly Named as SARS-CoV-2

Two Antibodies That Bind to the Spike Protein of 2019-nCoV, Newly Named as SARS-CoV-2

Two Antibodies That Bind to the Spike Protein of 2019-nCoV, Newly Named as SARS-CoV-2

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Vir Biotechnology Identifies Two Antibodies That Bind to the Spike Protein of 2019-nCoV, Newly Named as SARS-CoV-2

Wed February 12, 2020 8:30 AM|GlobeNewswire|About: VIR

SAN FRANCISCO, Feb. 12, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (VIR)


 https://www.vir.bio/ 


 https://investors.vir.bio/news-releases/news-release-details/vir-biotechnology-identifies-two-antibodies-bind-spike-protein 


 https://www.vir.bio/pipeline/ 


 https://seekingalpha.com/symbol/VIR 



KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy

Two Antibodies That Bind to the Spike Protein of 2019-nCoV, Newly Named as SARS-CoV-2

KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy

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Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Progression-Free Survival (PFS) as First-Line Treatment for Metastatic Triple-Negative Breast Cancer (mTNBC)

Wed February 12, 2020 6:45 AM|Business Wire|About: MRK 


 KEYNOTE-355 is a randomized, two-part, Phase 3 trial (ClinicalTrials.gov, NCT02819518) evaluating KEYTRUDA in combination with one of three different chemotherapies (investigator’s choice of either nab-paclitaxel, paclitaxel or gemcitabine/carboplatin) 

 

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355)

 https://clinicaltrials.gov/ct2/show/NCT02819518 


 https://www.businesswire.com/news/home/20200212005254/en/ 


 https://www.merck.com/clinical-trials/index.html 


 https://seekingalpha.com/symbol/MRK 

tucatinib in combination with trastuzumab and capecitabine

tucatinib in combination with trastuzumab and capecitabine

tucatinib in combination with trastuzumab and capecitabine

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Seattle Genetics Announces FDA Filing Acceptance for Priority Review of Tucatinib New Drug Application (NDA) for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

Thu February 13, 2020 8:00 AM|Business Wire|About: SGEN 


 https://www.nejm.org/doi/full/10.1056/NEJMoa1914609?query=featured_home 


 

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://investor.seattlegenetics.com/press-releases/news-details/2019/Initial-Results-from-MOUNTAINEER-Trial-Show-Antitumor-Activity-of-Tucatinib-Combination-in-HER2-Positive-Metastatic-Colorectal-Cancer/default.aspx 


 

Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer

 https://www.clinicaltrials.gov/ct2/show/NCT03043313?term=MOUNTAINEER&draw=2&rank=1 


 https://www.seattlegenetics.com/ 


 https://www.businesswire.com/news/home/20200213005275/en/ 


 Herceptin (trastuzumab) 

 https://www.herceptin.com/ 


 https://seekingalpha.com/symbol/SGEN 



ADXS-PSA in combination with KEYTRUDA®

tucatinib in combination with trastuzumab and capecitabine

tucatinib in combination with trastuzumab and capecitabine

image128

 

Advaxis Announces Updated Survival Data in Phase 1/2 ADXS-PSA Trial at the ASCO Genitourinary Cancers Symposium

Thu February 13, 2020 8:00 AM|GlobeNewswire|About: ADXS

Median overall survival of 16.4 months for advanced prostate cancer patients with visceral metastases treated with ADXS-PSA in combination with KEYTRUDA® compared to an estimated 11 months with Standard of Care

Median overall survival of 33.7 months in all patients treated with ADXS-PSA in combination with KEYTRUDA®

PRINCETON, N.J., Feb. 13, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (ADXS)


 https://advaxis.com/ 


 https://advaxis.com/clinical-trials/ 


 About KEYNOTE-046
KEYNOTE-046 (NCT02325557) was a Phase 1/2 open-label, multicenter, dose-determination and expansion trial that evaluates the safety, tolerability and preliminary clinical activity of ADXS-PSA as monotherapy (Part A; n=14 [13 treated]), and in combination with KEYTRUDA® (Part B; n= 37) in heavily pretreated patients with progressive and refractory mCRPC. 


 https://seekingalpha.com/symbol/ADXS 



Seeking Biotech Alpha February 2020 Insight

Xtandi (enzalutamide) plus androgen deprivation therapy (ADT)

Xtandi (enzalutamide) plus androgen deprivation therapy (ADT)

Xtandi (enzalutamide) plus androgen deprivation therapy (ADT)

image129

 

XTANDI® (enzalutamide) Demonstrates Significant Improvement in Overall Survival in Phase 3 PROSPER Trial of Patients with nmCRPC

Tue February 11, 2020 8:00 AM|PR Newswire|About: ALPMY, PFE

TOKYO and NEW YORK, Feb. 11, 2020 /PRNewswire/ -- Astellas Pharma Inc. (ALPMF) (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Pfizer Inc. (PFE


 

Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer (PROSPER)

 https://clinicaltrials.gov/ct2/show/NCT02003924 


 https://www.astellas.us/docs/us/12A005-ENZ-WPI.pdf 


 https://www.astellas.com/en/ 


 https://seekingalpha.com/symbol/MDVN 


 https://www.pfizer.com/ 


 https://www.prnewswire.com/news-releases/xtandi-enzalutamide-demonstrates-significant-improvement-in-overall-survival-in-phase-3-prosper-trial-of-patients-with-nmcrpc-301002463.html 


 https://www.pfizer.com/news/press-release/press-release-detail/xtandi_enzalutamide_demonstrates_significant_improvement_in_overall_survival_in_phase_3_prosper_trial_of_patients_with_nmcrpc 


 https://seekingalpha.com/symbol/ALPMY 


 https://seekingalpha.com/symbol/PFE 



PB2452

Xtandi (enzalutamide) plus androgen deprivation therapy (ADT)

Xtandi (enzalutamide) plus androgen deprivation therapy (ADT)

image130

 

PhaseBio Announces European Regulatory Update for PB2452

Tue February 11, 2020 8:00 AM|GlobeNewswire|About: PHAS

PB2452 granted PRIME Designation by the European Medicines Agency

PhaseBio receives written scientific advice confirming PB2452 clinical development plan

In Phase 1 and Phase 2a clinical trials, PB2452 provided immediate and sustained reversal of the antiplatelet effects of ticagrelor

MALVERN, Pa. and SAN DIEGO, Feb. 11, 2020 (GLOBE NEWSWIRE) -- PhaseBio Pharmaceuticals, Inc (PHAS). (Nasdaq: PHAS)


 https://phasebio.com/ 


 https://phasebio.com/pipeline/ 


 The European Medicines Agency has granted PRIME status to PhaseBio Pharmaceuticals' (PHAS -2.1%) PB2452 as a reversal agent of AstraZeneca's (AZN) anticoagulant Brilinta (ticagrelor). 


 https://seekingalpha.com/symbol/PHAS 



FDA clears Varian Medical's Ethos therapy

Xtandi (enzalutamide) plus androgen deprivation therapy (ADT)

FDA clears Varian Medical's Ethos therapy

image131

JAK Inhibitor Baricitinib

Johnson & Johnson’s Response to the 2019-nCoV Crisis

FDA clears Varian Medical's Ethos therapy

image132

 

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

Tue February 11, 2020 6:24 PM|GlobeNewswire|About: LLY

  • Study met the primary endpoint of at least 75% improvement of skin inflammation and key secondary endpoints
  • 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 regulatory submissions

TORONTO, Feb. 11, 2020 (GLOBE NEWSWIRE) -- Eli Lilly and Company (LLY) and Incyte 


 https://www.lilly.ca/en/index.aspx 


 https://www.incyte.com/ 


 https://seekingalpha.com/symbol/LLY 


 https://seekingalpha.com/symbol/JNJ 

roxadustat

Johnson & Johnson’s Response to the 2019-nCoV Crisis

Johnson & Johnson’s Response to the 2019-nCoV Crisis

image133

 

FibroGen Announces U.S. FDA Acceptance of New Drug Application for Roxadustat for the Treatment of Anemia of Chronic Kidney Disease

Tue February 11, 2020 5:00 PM|GlobeNewswire|About: AZN, FGEN

SAN FRANCISCO, Feb. 11, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (FGEN)


 https://www.fibrogen.com/ 


 https://fibrogen.gcs-web.com/news-releases/news-release-details/fibrogen-announces-us-fda-acceptance-new-drug-application 


 https://seekingalpha.com/symbol/FGEN 


 https://seekingalpha.com/symbol/AZN 

Johnson & Johnson’s Response to the 2019-nCoV Crisis

Johnson & Johnson’s Response to the 2019-nCoV Crisis

Johnson & Johnson’s Response to the 2019-nCoV Crisis

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Johnson & Johnson Announces Collaboration with U.S. Department of Health & Human Services to Accelerate Development of a Potential Novel Coronavirus Vaccine

Tue February 11, 2020 4:30 PM|PR Newswire|About: JNJPR Newswire

NEW BRUNSWICK, N.J., Feb. 11, 2020 /PRNewswire/ -- Johnson & Johnson (JNJ) today announced that its Janssen Pharmaceutical Companies will further expedite its investigational coronavirus vaccine program through an expanded collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services.


 https://www.jnj.com/johnson-johnson-launches-multi-pronged-response-to-coronavirus-global-public-health-threat 


 https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-collaboration-with-us-department-of-health-and-human-services-to-fight-influenza 


 https://www.jnj.com/coronavirus 


 https://www.jnj.com/ 


 https://www.janssen.com/ 


 https://www.prnewswire.com/news-releases/johnson--johnson-announces-collaboration-with-us-department-of-health--human-services-to-accelerate-development-of-a-potential-novel-coronavirus-vaccine-301003251.html 

Seeking Biotech Alpha February 2020 Insight

cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®)

(enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab

cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®)

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Exelixis Announces Encouraging Results for Cabozantinib in Combination With Atezolizumab in Metastatic Castration-Resistant Prostate Cancer

Mon February 10, 2020 5:00 PM|Business Wire|About: EXEL

Data from the COSMIC-021 trial will be presented on Thursday, February 13, 2020 at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium

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


 Exelixis Further Expands Prostate Cancer Cohort in Phase 1b COSMIC-021 Trial of Cabozantinib in Combination with Atezolizumab in Patients with Advanced Solid TumorsPDF Version

Based on continued encouraging efficacy and safety data, metastatic castration-resistant prostate cancer cohort further expanded to 130 patients

– Initial data to be presented on February 13 at the 2020 American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO GU 2020) in San Francisco, CA

ALAMEDA, Calif.--(BUSINESS WIRE)--Jan. 7, 2020-- Exelixis, Inc. (NASDAQ: EXEL)


 https://clinicaltrials.gov/ct2/show/NCT03170960 


 https://www.exelixis.com/ 


 https://www.businesswire.com/news/home/20200210005731/en/ 


 https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-encouraging-results-cabozantinib-combination 

 https://ir.exelixis.com/news-releases/news-release-details/exelixis-further-expands-prostate-cancer-cohort-phase-1b-cosmic 


 https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-encouraging-results-cabozantinib-combination 


 https://www.tecentriq.com/ 

Intuitive Acquires Orpheus Medical

(enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab

cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®)

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Intuitive Acquires Orpheus Medical to Expand Informatics Platform for Hospitals

Mon February 10, 2020 4:01 PM|GlobeNewswire|About: ISRG

SUNNYVALE, Calif., Feb. 10, 2020 (GLOBE NEWSWIRE) -- Intuitive (Nasdaq: ISRG)


 https://www.intuitive.com/en-us 


 https://seekingalpha.com/symbol/ISRG 

(enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab

(enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab

(enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab

 

Seattle Genetics and Astellas Announce Updated Results from Phase 1b/2 Trial of PADCEV™ (enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab as Investigational First-Line Treatment for Advanced Bladder Cancer

Mon February 10, 2020 5:00 PM|PR Newswire|About: ALPMY, SGEN 

 PR Newswire

BOTHELL, Wash. and TOKYO, Feb. 10, 2020 /PRNewswire/ -- Seattle Genetics, Inc. (SGEN) (Nasdaq: SGEN) and Astellas Pharma Inc. (ALPMF


 https://www.seattlegenetics.com/ 


 https://www.astellas.com/ 


 https://www.prnewswire.com/news-releases/seattle-genetics-and-astellas-announce-updated-results-from-phase-1b2-trial-of-padcev-enfortumab-vedotin-ejfv-in-combination-with-immune-therapy-pembrolizumab-as-investigational-first-line-treatment-for-advanced-bladder-cancer-301002275.html 


 https://www.seattlegenetics.com/pipeline/enfortumab-vedotin 


 https://seekingalpha.com/symbol/SGEN 

MET inhibitor capmatinib (INC280)

myChoice® CDx test to help identify women with advanced ovarian cancer

(enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab

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Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review

Tue February 11, 2020 1:18 AM|PR Newswire

- Substantial unmet need exists among patients with METex14 mutated advanced NSCLC as there are no treatment options approved to specifically target this aggressive form of lung cancer

- Capmatinib review expected to be completed within six months

PR Newswire

EAST HANOVER, N.J., Feb. 11, 2020 /PRNewswire


 https://www.novartis.com/ 


 https://www.prnewswire.com/news-releases/novartis-announces-met-inhibitor-capmatinib-inc280-the-first-potential-treatment-for-metex14-mutated-advanced-non-small-cell-lung-cancer-granted-priority-fda-review-301002504.html 


 https://seekingalpha.com/symbol/NVS 


 https://www.incyte.com/ 


 https://www.businesswire.com/news/home/20200210005864/en/ 


 https://seekingalpha.com/symbol/INCY 

 

Incyte Announces Acceptance and Priority Review of NDA for Capmatinib for Advanced Non-Small Cell Lung Cancer

Tue February 11, 2020 1:17 AM|Business Wire|About: INCY

  • The U.S. Food and Drug Administration (FDA) Priority Review for capmatinib is based on Phase 2 data in first-line and previously treated patients with MET exon 14 skipping (METex14) mutated advanced non-small cell lung cancer (NSCLC)1
  • Novartis has exclusive worldwide development and commercialization rights to capmatinib

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

 https://seekingalpha.com/pr/17774676-incyte-announces-acceptance-and-priority-review-of-nda-for-capmatinib-for-advanced-non-small 

myChoice® CDx test to help identify women with advanced ovarian cancer

myChoice® CDx test to help identify women with advanced ovarian cancer

myChoice® CDx test to help identify women with advanced ovarian cancer

TALTZ® (ixekizumab)

myChoice® CDx test to help identify women with advanced ovarian cancer

myChoice® CDx test to help identify women with advanced ovarian cancer

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Health Canada has approved TALTZ® (ixekizumab) for the Treatment of Active Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)

Tue February 11, 2020 6:45 AM|GlobeNewswire|About: LLY

TORONTO, Feb. 11, 2020 (GLOBE NEWSWIRE) -- Eli Lilly Canada