Seeking Biotech Alpha October 2019 Insight

TRIKAFTA™ (elexacaftor/tezacaftor/ivacaftor and ivacaftor)

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Phase 3 Results from Two Studies of TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Triple Combination Treatment for Cystic Fibrosis Concurrently Published in The New England Journal of Medicine and The Lancet

Thu October 31, 2019 12:15 PM|Business Wire|About: VRTX 


 https://www.businesswire.com/news/home/20191031005294/en/ 


 https://investors.vrtx.com/news-releases/news-release-details/phase-3-results-two-studies-trikafta 



What is TRIKAFTA™ (elexacaftor/tezacaftor/ivacaftor and ivacaftor)? TRIKAFTA is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Valiant Navion™ Thoracic Stent Graft

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Medtronic Announces Shonin Approval and Launch of the Valiant Navion™ Thoracic Stent Graft System in Japan

Thu October 31, 2019 10:00 AM|GlobeNewswire|About: MDT

Lower-Profile Thoracic Endovascular Aortic Repair (TEVAR) Device Continues to Broaden Global Treatable Patient Population with Thoracic Aortic Disease

DUBLIN, Oct. 31, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (MDT)


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


Select the Valiant Navion™ thoracic stent graft system for your thoracic endovascular aortic repair (TEVAR) procedures. The low-profile delivery system with FreeFlo and CoveredSeal proximal stent graft options are designed for versatility, uncompromising conformability, control, and accuracy. The reimagined design offers enhanced vascular access with a broad set of options to treat a wide range of patient anatomies. The reimagined design, built on proven platforms, offers enhanced vascular access with:

XIFAXAN® (rifaximin) 550 mg tablets to treat symptoms of Irritable Bowel Syndrome (IBS)

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Salix Announces Issuance of an Additional XIFAXAN® Patent

Thu October 31, 2019 6:55 AM|PR Newswire|About: BHCPR Newswire

LAVAL, Quebec, Oct. 31, 2019 /PRNewswire/ -- Bausch Health Companies Inc. (BHC) ("Bausch Health" or the "Company") and its gastroenterology business, Salix Pharmaceuticals (SLXP), ("Salix"


 https://www.bauschhealth.com/news-room/news-releases/news-details/201910310655pr_news_uspr_____ny21622 


 https://www.salix.com/research-development/pipeline 

XIFAXAN® (rifaximin) 550 mg tablets are indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

filgotinib

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Gilead and Galapagos to Present New Data on Filgotinib at 2019 ACR/ARP Annual Meeting

Thu October 31, 2019 4:01 PM|Business Wire|About: GILD, GLPG 

 

New analyses from filgotinib clinical development program reinforce the investigational medicine’s consistent efficacy and safety profile in the treatment of inflammatory diseases

FOSTER CITY, Calif. & MECHELEN, Belgium--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD) and Galapagos NV (GLPGF) (Euronext & NASDAQ: GLPG)


 https://www.businesswire.com/news/home/20191031005841/en/ 


 https://acrabstracts.org/ 



Filgotinib is a highly selective JAK1 inhibitor, discovered and developed by Galapagos

UVADEX® (Methoxsalen)

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Mallinckrodt Announces UVADEX® (Methoxsalen) Approved in Australia for use with the THERAKOS® CELLEX® Photopheresis System for Treatment of Chronic Graft Versus Host Disease (cGvHD) and Skin Manifestations of Cutaneous T-Cell Lymphoma (CTCL) in Adults

Thu October 31, 2019 4:35 PM|PR Newswire|About: MNKPR Newswire

STAINES-UPON-THAMES, United Kingdom, Oct. 31, 2019 /PRNewswire/ -- Mallinckrodt plc (MNK)


 https://www.therakos.co.uk/ 


 https://www.terumobct.com/ 


 https://www.prnewswire.com/news-releases/mallinckrodt-announces-uvadex-methoxsalen-approved-in-australia-for-use-with-the-therakos-cellex-photopheresis-system-for-treatment-of-chronic-graft-versus-host-disease-cgvhd-and-skin-manifestations-of-cutaneous-t-cell-lymp-300949440.html 

Mallinckrodt Announces UVADEX® (Methoxsalen) Approved in Australia for use with the THERAKOS® CELLEX® Photopheresis System for Treatment of Chronic Graft Versus Host Disease (cGvHD) and Skin Manifestations of Cutaneous T-Cell Lymphoma (CTCL) in Adults -Approval marks first combined indication label and first regulatory approval in the world for UVADEX in conjunction with the THERAKOS Extracorporeal Photopheresis (ECP) System for the treatment of chronic GvHD in adults- STAINES-UPON-THAMES, United Kingdom, Oct. 31, 2019 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK)

Hemlibra®

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Chugai’s Hemlibra Launched for Hemophiia A with Inhibitors in Taiwan

Fri November 1, 2019 2:00 AM|Business Wire|About: CHGCY, RHHBY

  • Hemlibra is launched for hemophilia A with inhibitors in Taiwan on 1 November 2019

TOKYO--(BUSINESS WIRE)-- Chugai Pharmaceutical Co., Ltd. (CHGCF) (TOKYO: 4519) announced today that Chugai Pharma Taiwan Ltd., a wholly owned subsidiary of Chugai, launched Hemlibra®


 https://www.chugai-pharm.co.jp/english/index.html 


 https://www.businesswire.com/news/home/20191031005984/en/ 



HEMLIBRA® is a prescription medicine used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A with or without factor VIII inhibitors.

Seeking Biotech Alpha October 2019 Insight

Satralizumab

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FDA Accepts Genentech’s Biologics License Application for Satralizumab for Neuromyelitis Optica Spectrum Disorder

Wed October 30, 2019 2:00 AM|Business Wire|About: RHHBY

– Satralizumab represents a potential new approach to treating neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating disease often misdiagnosed as multiple sclerosis (MS) –

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


 https://www.businesswire.com/news/home/20191029006190/en/ 


 https://seekingalpha.com/pr/17679456-ema-fda-accept-marketing-applications-chugais-satralizumab-neuromyelitis-optica-spectrum 


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

Oct 30, 2019 EMA and FDA Accept Marketing Applications for Chugai's Satralizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD) NMOSD is a rare disease where repeated relapses may result in visual impairment and motor disability in the course of disease progression. The applications are based on the results from two positive global phase III studies evaluating satralizumab monotherapy and add-on therapy to baseline immunosuppressant therapy. The applications will be reviewed under Accelerated Assessment by EMA. TOKYO, October 30, 2019 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519)

VUMERITY™ (diroximel fumarate)

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Biogen and Alkermes Announce FDA Approval of VUMERITY™ (diroximel fumarate) for Multiple Sclerosis

Wed October 30, 2019 7:30 AM|PR Newswire|About: ALKS, BIIBPR Newswire

CAMBRIDGE, Mass. and DUBLIN, Oct. 30, 2019 /PRNewswire/ -- Biogen Inc. (BIIB) (Nasdaq: BIIB) and Alkermes plc (ALKS) (Nasdaq: ALKS) 


 https://www.prnewswire.com/news-releases/biogen-and-alkermes-announce-fda-approval-of-vumerity-diroximel-fumarate-for-multiple-sclerosis-300947775.html 


 https://investor.alkermes.com/news-releases/news-release-details/biogen-and-alkermes-announce-fda-approval-vumeritytm-diroximel 



BIOGEN AND ALKERMES ANNOUNCE FDA APPROVAL OF VUMERITY™ (DIROXIMEL FUMARATE) FOR MULTIPLE SCLEROSIS October 30, 2019 at 7:30 AM EDT Supporting Materials: VUMERITY (diroximel fumarate) product image VUMERITY™ (diroximel fumarate) Approved for Relapsing Multiple Sclerosis – VUMERITY, a New Oral Treatment Option for Relapsing Forms of MS, Offers a Combination of Well-Characterized Efficacy, Safety and Tolerability – CAMBRIDGE, Mass. and DUBLIN, Ireland, Oct. 30, 2019 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Alkermes plc (Nasdaq: ALKS)

Roxadustat

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AstraZeneca to Present Pivotal Roxadustat Phase III Data at the American Society of Nephrology Kidney Week 2019

Wed October 30, 2019 7:00 AM|Business Wire|About: AZN 


 https://www.businesswire.com/news/home/20191030005285/en/ 


 https://www.astrazeneca.com/media-centre/press-releases/2019/roxadustat-approved-in-china-for-the-treatment-of-anaemia-in-non-dialysis-dependent-patients-with-chronic-kidney-disease-22082019.html 

AstraZeneca to present pivotal roxadustat Phase III data at the American Society of Nephrology Kidney Week 2019

AMG 510, a small molecule inhibitor of KRASG12C

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The Discovery Of Amgen's Novel Investigational KRAS(G12C) Inhibitor AMG 510 Published In Nature

Wed October 30, 2019 6:00 PM|PR Newswire|About: AMGN 


 https://www.prnewswire.com/news-releases/the-discovery-of-amgens-novel-investigational-krasg12c-inhibitor-amg-510-published-in-nature-300948664.html 


 https://www.amgen.com/media/news-releases/2019/10/the-discovery-of-amgens-novel-investigational-krasg12c-inhibitor-amg-510-published-in-nature/ 

The Discovery Of Amgen’s Novel Investigational KRASG12C Inhibitor AMG 510 Published In Nature Publication Showcases how First-to-Clinic Investigational AMG 510 Exploits a Cryptic Groove of the Previously Undruggable KRAS Protein Surface THOUSAND OAKS, Calif. (Oct. 30, 2019) — Amgen (NASDAQ:AMGN)

Impella 5.5™ with SmartAssist®

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First U.S. Patients Treated with Impella 5.5 with SmartAssist, a Minimally Invasive, Forward Flow Heart Pump

Thu October 31, 2019 7:02 AM|Business Wire|About: ABMD

DANVERS, Mass.--(BUSINESS WIRE)


 https://www.businesswire.com/news/home/20191031005267/en/ 


 https://www.impella.com/ 


 http://www.abiomed.com/ 

Impella 5.5™ with SmartAssist®

RINVOQ™ (upadacitinib)

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RINVOQ™ (upadacitinib) Meets Primary and All Ranked Secondary Endpoints in Phase 3 Study in Psoriatic Arthritis

Thu October 31, 2019 8:45 AM|PR Newswire|About: ABBV

- At week 12, 57/64 percent of patients receiving 15/30 mg of RINVOQ achieved ACR20, respectively, compared to 24 percent in the placebo group[1]

- At week 16, 52/57 percent of patients on 15/30 mg of RINVOQ achieved a PASI 75 response, respectively, compared to 16 percent on placebo[1]

- At week 24, 25/29 percent of 15/30 mg RINVOQ-treated patients achieved minimal disease activity, respectively, compared to 3 percent in the placebo group[1]

- The safety profile of RINVOQ was consistent with that of previous studies across indications, with no new safety risks detected[1,2]

PR Newswire

NORTH CHICAGO, Ill., Oct. 31, 2019 /PRNewswire/ -- AbbVie (ABBV)


 https://www.rxabbvie.com/pdf/rinvoq_medguide.pdf 

 https://www.prnewswire.com/news-releases/rinvoq-upadacitinib-meets-primary-and-all-ranked-secondary-endpoints-in-phase-3-study-in-psoriatic-arthritis-300948804.html 


 https://clinicaltrials.gov/ct2/show/NCT03104374 



Pipeline Advanced medicines that demonstrate both strong clinical performance and strong economic value (Select pipeline highlights as of January 2019)

Seeking Biotech Alpha October 2019 Insight

HTX-011

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Heron Therapeutics Announces FDA Acceptance of New Drug Application Resubmission for HTX-011 for Management of Postoperative Pain

Mon October 28, 2019 8:30 AM|PR Newswire|About: HRTXPR Newswire

SAN DIEGO, Oct. 28, 2019 /PRNewswire/ -- Heron Therapeutics, Inc. (HRTX),


 https://www.prnewswire.com/news-releases/heron-therapeutics-announces-fda-acceptance-of-new-drug-application-resubmission-for-htx-011-for-management-of-postoperative-pain-300946012.html 


 https://www.herontx.com/ 



Heron Therapeutics Announces FDA Acceptance of New Drug Application Resubmission for HTX-011 for Management of Postoperative Pain - FDA Sets Prescription Drug User Fee Act (PDUFA) Goal Date of March 26, 2020 - SAN DIEGO, Oct. 28, 2019 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX)

BAVENCIO® (avelumab)

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European Commission Approves BAVENCIO® (avelumab) Plus Axitinib Combination for First-Line Treatment of Patients With Advanced Renal Cell Carcinoma

Mon October 28, 2019 2:00 PM|PR Newswire|About: MKKGY, PFE

-- EU approval based on JAVELIN Renal 101 trial results demonstrating significant improvement in progression-free survival with BAVENCIO in combination with axitinib compared with sunitinib

-- Combination regimen approved across all IMDC prognostic risk groups and irrespective of PD-L1 expression

PR Newswire

ROCKLAND, Massachusetts and NEW YORK, Oct. 28, 2019 /PRNewswire/


 https://www.prnewswire.com/news-releases/european-commission-approves-bavencio-avelumab-plus-axitinib-combination-for-first-line-treatment-of-patients-with-advanced-renal-cell-carcinoma-300946479.html 


 https://www.bavencio.com/patients-and-caregivers 

BAVENCIO is a prescription medicine used to treat: A type of skin cancer called Merkel cell carcinoma (MCC) in adults and children 12 years of age and older. BAVENCIO may be used when your skin cancer has spread A type of cancer in the bladder or urinary tract called urothelial cancer (UC). BAVENCIO may be used when your cancer has spread or cannot be removed by surgery (advanced UC), and you have received chemotherapy that contains a platinum and it did not work or is no longer working These indications are approved under accelerated approval based on clinical trials that measured how many patients responded and how long they responded. Continued approval may depend on benefit demonstrated in ongoing clinical trials.

Imfinzi and Imfinzi plus tremelimumab

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Imfinzi and Imfinzi plus tremelimumab delayed disease progression in Phase III POSEIDON trial for 1st-line treatment of Stage IV non-small cell lung cancer

  

28 October 2019 15:15 GMT
 

POSEIDON included both non-squamous and squamous patients and a broad choice of standard chemotherapy options  


 

AstraZeneca's Imfinzi extends progression-free survival in first-line lung cancer

Oct. 28, 2019 12:02 PM ET|About: AstraZeneca PLC (AZN)|By: , SA News Editor  

 https://seekingalpha.com/news/3510145-astrazenecas-imfinzi-extends-progression-free-survival-first-line-lung-cancer 


 https://clinicaltrials.gov/ct2/show/NCT03164616?titles=poseidon&lead=astrazeneca&draw=2&rank=1 



IMFINZI® (durvalumab) is a prescription medicine used to treat a type of lung cancer called non-small cell lung cancer (NSCLC). IMFINZI may be used when your NSCLC has not spread outside your chest, cannot be removed by surgery, and has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy.

GSK candidate vaccine sustained level of protection against active pulmonary tuberculosis

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Glaxo's TB vaccine shows positive effect in mid-stage study; shares up 1%

Sep. 25, 2018 12:45 PM ET|About: GlaxoSmithKline plc (GSK)|By: , SA News Editor 


 https://clinicaltrials.gov/ct2/show/NCT01755598?term=NCT01755598&rank=2 


 https://clinicaltrials.gov/ct2/show/NCT02097095?term=NCT02097095&rank=1 



29 October 2019 GSK candidate vaccine demonstrates sustained level of protection against active pulmonary tuberculosis Final analysis of phase IIb study published today in the New England Journal of Medicine and presented at the 50th Union World Conference on Lung Health. Final results confirm the innovative TB candidate vaccine’s efficacy level and acceptable safety profile in three-year clinical trial conducted in sub-Saharan African regions. Issued: London, UK Today, GSK and IAVI reported that GSK’s M72/AS01E[1] candidate vaccine

Dupixent® (dupilumab)

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Dupixent® (dupilumab) Now Approved in European Union for Severe Chronic Rhinosinusitis with Nasal Polyposis

Tue October 29, 2019 8:15 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y. and PARIS, Oct. 29, 2019 /PRNewswire/ --  

First biologic approved in the European Union for adults with severe chronic rhinosinusitis with nasal polyposis (CRSwNP)

Dupixent now approved in the EU for three type 2 inflammatory diseases: severe CRSwNP, severe asthma and moderate-to-severe atopic dermatitis

Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi today announced that the European Commission (EC)


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


 https://www.regeneron.com/dupixent-injection 


 https://www.prnewswire.com/news-releases/dupixent-dupilumab-now-approved-in-european-union-for-severe-chronic-rhinosinusitis-with-nasal-polyposis-300947130.html 

DUPIXENT is a prescription medicine used: to treat people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 12 years of age. with other asthma medicines for the maintenance treatment of moderate-to-severe asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. DUPIXENT is not used to treat sudden breathing problems. It is not known if DUPIXENT is safe and effective in children with asthma under 12 years of age. with other medicines to treat chronic rhinosinusitis with nasal polyposis in adults whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyposis under 18 years of age.

Bavencio (avelumab), combined with Inlyta (axitinib)

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European Commission Approves BAVENCIO® (avelumab) Plus Axitinib Combination for First-Line Treatment of Patients With Advanced Renal Cell Carcinoma

Mon October 28, 2019 2:00 PM|PR Newswire|About: MKKGY, PFE

-- EU approval based on JAVELIN Renal 101 trial results demonstrating significant improvement in progression-free survival with BAVENCIO in combination with axitinib compared with sunitinib

-- Combination regimen approved across all IMDC prognostic risk groups and irrespective of PD-L1 expression

PR Newswire

ROCKLAND, Massachusetts and NEW YORK, Oct. 28, 2019 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (PFE)


 https://www.prnewswire.com/news-releases/european-commission-approves-bavencio-avelumab-plus-axitinib-combination-for-first-line-treatment-of-patients-with-advanced-renal-cell-carcinoma-300946479.html 


 https://www.pfizer.com/products 


 https://www.bavencio.com/patients-and-caregivers 

INLYTA is a prescription medicine used to treat advanced kidney cancer (advanced renal cell carcinoma or RCC) when one prior drug treatment regimen for your RCC has not worked.

Seeking Biotech Alpha October 2019 Insight

LUXTURNA® (voretigene neparvovec-rzyl).

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Spark Therapeutics Wins Prix Galien USA Award for LUXTURNA® (voretigene neparvovec-rzyl) as Best Biotechnology Product

Fri October 25, 2019 9:54 AM|GlobeNewswire|About: ONCE

PHILADELPHIA, Oct. 25, 2019 (GLOBE NEWSWIRE) -- Spark Therapeutics (ONCE)


 https://sparktx.com/ 



LUXTURNA (voretigene neparvovec-rzyl) is a prescription gene therapy product used for the treatment of patients with inherited retinal disease due to mutations in both copies of the RPE65 gene, which can only be confirmed through genetic testing. You must also have enough remaining cells in your retina (the thin layer of tissue in the back of your eyes) as determined by your healthcare professional.

FDA Post Approval Study Demonstrates Timely Identification of Right Heart Failure

 

CORRECTING and REPLACING GRAPHIC FDA Post Approval Study Demonstrates Timely Identification of Right Heart Failure and Early Use of Impella RP Leads to Higher Survival

Fri October 25, 2019 8:00 AM|Business Wire|About: ABMD 


 http://www.abiomed.com/ 


 https://www.businesswire.com/news/home/20191025005191/en/ 

Impella Impella is the only FDA-approved, non-surgical heart pump proven safe and effective to temporarily assist the pumping function of the heart during stent placement and ensure blood flow is maintained to critical organs. This procedure, known as a Protected PCI, reduces the risk of complications, decreases repeat heart procedures and improves quality of life.

ADUCANUMAB

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 HEALTH NEWSOCTOBER 25, 2019 / 6:15 AM / UPDATED 6 HOURS AGO

Biogen's secret campaign to bring its Alzheimer's drug back from the ashes

Julie Steenhuysen

7 MIN READ

CHICAGO (Reuters) - Biogen Inc’s (BIIB.O)


 

Reporting by Julie Steenhuysen in Chicago; Editing by Michele Gershberg and Bill Berkrot

Our Standards:The Thomson Reuters Trust Principles. 

BIOGEN PLANS REGULATORY FILING FOR ADUCANUMAB IN ALZHEIMER’S DISEASE BASED ON NEW ANALYSIS OF LARGER DATASET FROM PHASE 3 STUDIES October 22, 2019 at 6:30 AM EDT New analysis of larger dataset showed that aducanumab reduced clinical decline in patients with early Alzheimer’s disease as measured by the pre-specified primary and secondary endpoints Based on discussions with the FDA, the Company plans to submit a Biologics License Application in early 2020 Biogen aims to offer aducanumab to eligible patients previously enrolled in clinical studies The positive results of this new analysis were driven primarily by greater exposure to high dose aducanumab in the larger dataset as compared to data available at the time of the futility analysis CAMBRIDGE, Mass. and TOKYO, Oct. 22, 2019 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan)

evaluating gepotidacin, a new antibiotic = triazaacenaphthylene bacterial topoisomerase inhibitors

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Glaxo launches late-stage development of antibiotic gepotidacin

Oct. 28, 2019 8:36 AM ET|About: GlaxoSmithKline plc (GSK)|By: , SA News Editor  



 https://clinicaltrials.gov/ct2/show/NCT04010539?lead=glaxosmithkline&phase=2&draw=2&rank=9 


 https://clinicaltrials.gov/ct2/show/NCT04020341?lead=glaxosmithkline&phase=2&draw=2&rank=8 

28 October 2019 GSK starts a phase III clinical programme for a potential first-in-class antibiotic, gepotidacin First in a new chemical class of antibiotic with a mechanism of action distinct from any currently approved antibiotic. Investigating use for uncomplicated urinary tract infection and urogenital gonorrhoea, two infections not addressed by new oral antibiotics in 20 years. Issued: London, UK GlaxoSmithKline plc (LSE/NYSE: GSK)

Gilead & Glympse Bio - Strategic Collaboration for Biomarker Technology in NASH Clinical Development

 

Gilead and Glympse Bio Announce Strategic Collaboration for Use of Biomarker Technology in NASH Clinical Development

Mon October 28, 2019 8:00 AM|Business Wire|About: GILD 


 https://www.businesswire.com/news/home/20191028005145/en/ 


 https://www.gilead.com/ 

Transforming disease monitoring and treatment response

ZW25 in Combination with Chemotherapy

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Zymeworks Announces Phase 1 Data for ZW25 in Combination with Chemotherapy in Advanced Gastroesophageal Adenocarcinoma at AACR-NCI-EORTC International Conference

Mon October 28, 2019 8:30 AM|Business Wire|About: ZYME

  • ZW25 Plus Chemotherapy Shows Durable Activity in Patients with Heavily Pretreated Gastroesophageal Adenocarcinoma
  • Data Continue to Support Ongoing Phase 2 Trial of ZW25 Plus Standard of Care Chemotherapy Therapy as First-Line Treatment

BOSTON--(BUSINESS WIRE)-- Zymeworks Inc. (ZYME)


 https://clinicaltrials.gov/ct2/show/NCT03929666?cond=zw25&rank=2 


 https://www.businesswire.com/news/home/20191028005019/en/ 





We currently have two wholly-owned product candidates in clinical development and several wholly-owned product candidates in preclinical development that leverage our multiple therapeutic platforms to address areas of significant unmet medical need.

Seeking Biotech Alpha October 2019 Insight

Opdivo (nivolumab)

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European Commission Approves Opdivo (nivolumab) Four-Week Dosing Schedule for the Adjuvant Treatment of Adult Patients with Melanoma with Involvement of Lymph Nodes or Metastatic Disease Who Have Undergone Complete Resection

Thu October 24, 2019 6:59 AM|Business Wire|About: BMY

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


 https://www.businesswire.com/news/home/20191024005293/en/ 


 https://news.bms.com/press-release/corporatefinancial-news/european-commission-approves-opdivo-nivolumab-four-week-dosing 

OPDIVO® Immunotherapy: Giving People a Choice and a Chance Against Their Cancer

BOTOX® (onabotulinumtoxinA)

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FDA Approves BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Lower Limb Spasticity, Excluding Spasticity Caused by Cerebral Palsy

Thu October 24, 2019 7:30 AM|PR Newswire|About: AGNPR Newswire

DUBLIN, Oct. 24, 2019 /PRNewswire/ -- Allergan plc (AGN)


 https://media.allergan.com/actavis/actavis/media/allergan-pdf-documents/product-prescribing/20190620-BOTOX-100-and-200-Units-v3-0USPI1145-v2-0MG1145.pdf 


 https://www.prnewswire.com/news-releases/fda-approves-botox-onabotulinumtoxina-for-pediatric-patients-with-lower-limb-spasticity-excluding-spasticity-caused-by-cerebral-palsy-300944610.html 


 https://www.allergan.com/products/botox-cns 

BOTOX® is a prescription medicine that is injected into muscles and used: to treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken to treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to neurologic disease who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication to prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older to treat increased muscle stiffness in elbow, wrist, finger, thumb, ankle, and toe muscles in people 18 years and older with upper and lower limb spasticity to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older BOTOX® is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and

Varian Ethos™ therapy solutions

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Varian Receives Order for Six Ethos Therapy Solutions from Amsterdam UMC in The Netherlands

Wed October 23, 2019 4:15 PM|PR Newswire|About: VAR

PALO ALTO, Calif., Oct. 23, 2019 /PRNewswire/ 


 https://www.prnewswire.com/news-releases/varian-receives-order-for-six-ethos-therapy-solutions-from-amsterdam-umc-in-the-netherlands-300943900.html 


 https://www.varian.com/oncology/products/ethos#know-more 

AN ADAPTIVE INTELLIGENCE™ SOLUTION

Clearside Biomedical's XIPERE™ (Triamcinolone Acetonide Suprachoroidal Injectable Suspension)

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Bausch Health Licenses Clearside Biomedical's XIPERE™ (Triamcinolone Acetonide Suprachoroidal Injectable Suspension), An Investigational Treatment For Macular Edema Associated With Uveitis

Wed October 23, 2019 6:55 AM|Canada Newswire|About: BHC, CLSD

NDA Resubmission to the FDA Expected to Occur in the First Quarter of 2020

LAVAL, Quebec and ALPHARETTA, Ga., Oct. 23, 2019 /CNW/ -- Bausch Health Companies Inc. (BHC) 


 https://www.prnewswire.com/news-releases/bausch-health-licenses-clearside-biomedicals-xipere-triamcinolone-acetonide-suprachoroidal-injectable-suspension-an-investigational-treatment-for-macular-edema-associated-with-uveitis-300943568.html 


 https://www.bauschhealth.com/news-room/news-releases/news-details/201910230655pr_news_uspr_____ny12615 

Clearside Biomedical Receives Notification of FDA Acceptance of NDA Filing for XIPERE™ (triamcinolone acetonide ophthalmic suspension) for Suprachoroidal Injection with PDUFA Date Set for October 19, 2019 02/20/19 PDF Version ALPHARETTA, Ga., Feb. 20, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD),

Repatha® (evolocumab)

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Amgen To Make Repatha® (evolocumab) Available Exclusively At Its Lower List Price Option In 2020

Thu October 24, 2019 9:00 AM|PR Newswire|About: AMGN

Almost Half of All Medicare Patients Will Have an Affordable, Low Fixed Copay in 2020

PR Newswire

THOUSAND OAKS, Calif., Oct. 24, 2019 /PRNewswire/ -- Amgen (AMGN) 


 https://www.prnewswire.com/news-releases/amgen-to-make-repatha-evolocumab-available-exclusively-at-its-lower-list-price-option-in-2020-300944424.html 


 https://www.amgen.com/media/news-releases/2019/10/amgen-to-make-repatha-evolocumab-available-exclusively-at-its-lower-list-price-option-in-2020/ 

Repatha® helps the liver clear LDL bad cholesterol by limiting the actions of a protein called PCSK9—and less PCSK9 means less LDL in your blood.

Fiasp® Rapid Acting Insulin for Adults Now Approved for Use With the Omnipod Insulin Management

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Fiasp® Rapid Acting Insulin for Adults Now Approved for Use With the Omnipod Insulin Management System Platform in the United States

Fri October 25, 2019 6:00 AM|Business Wire|About: PODD

Insulet Further Demonstrating Commitment to Innovation and Patient Choice

ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation (PODD) (Insulet or the Company), the leader in tubeless insulin pump technology with its Omnipod®


 https://www.novo-pi.com/fiasp.pdf 


 http://www.insulet.com/ 


 https://www.businesswire.com/news/home/20191025005048/en/ 

INSULET CORPORATION

Seeking Biotech Alpha October 2019 Insight

Zolgensma (anasemnogene abeparvovec-xioi)

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Novartis off to strong start with Zolgensma

Oct. 22, 2019 8:43 AM ET|About: Novartis AG (NVS)|By: , SA News Editor 


 https://seekingalpha.com/article/4297779-novartis-ag-2019-q3-results-earnings-call-presentation 


 https://www.avexis.com/ 

ZOLGENSMA is a prescription gene therapy used to treat children less than 2 years old with spinal muscular atrophy (SMA). ZOLGENSMA is given as a one-time infusion into the vein. ZOLGENSMA was not evaluated in patients with advanced SMA. The safety information provided here is not comprehensive. Talk to the patient’s doctor about any side effects that bother the patient or that don’t go away. You are encouraged to report suspected side effects by contacting the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch, or AveXis at 833-828-3947.

First-Ever Noninvasive Nasal Swab Test Can Enable Early Lung Cancer Detection

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Veracyte Announces New Clinical Data Showing First-Ever Noninvasive Nasal Swab Test Can Enable Early Lung Cancer Detection and Diagnosis

Tue October 22, 2019 7:00 AM|Business Wire|About: VCYT

Data presented today at CHEST 2019 Annual Meeting; Company plans to begin making test available in early 2021

Conference call and webcast today at 5:00 p.m. ET to review third quarter 2019 Financial results and the new nasal swab test data

SOUTH SAN FRANCISCO--(BUSINESS WIRE)-- Veracyte, Inc (VCYT)


 https://www.businesswire.com/news/home/20191022005454/en/ 

Veracyte, Inc. 2019 Q3 - Results - Earnings Call Presentation Oct. 23, 2019 12:37 AM ET | About: Veracyte, Inc. (VCYT) Q3: 10-22-19 Earnings Summary

Propionic Acidemia Program (mRNA-3927)

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Moderna Receives FDA Fast Track Designation for Propionic Acidemia Program (mRNA-3927)

Tue October 22, 2019 4:15 PM|Business Wire|About: MRNA

mRNA-3927 is Moderna’s second rare disease program to receive Fast Track designation

mRNA-3927 uses the same proprietary LNP formulation as mRNA-1944 (antibody against Chikungunya virus) and mRNA-3704 (methylmalonic acidemia)

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


 https://www.modernatx.com/ 


 https://www.businesswire.com/news/home/20191022006101/en/ 

Moderna Announces Open IND for Propionic Acidemia Program (mRNA-3927) September 30, 2019 at 8:00 AM EDT PDF Version mRNA-3927 is Moderna’s second rare disease program with an open IND mRNA-3927 uses the same proprietary LNP formulation as mRNA-1944 (antibody against Chikungunya virus) CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep. 30, 2019-- Moderna, Inc., (Nasdaq: MRNA)

Zejula (niraparib)

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GSK Announces U.S. Food and Drug Administration Approval of Additional Indication for Zejula (niraparib) for Late-line Treatment for Women with Recurrent Ovarian Cancer

Wed October 23, 2019 5:36 PM|Business Wire|About: GSK

  • Expanded indication allows for treatment of women whose advanced ovarian cancer is associated with homologous recombination deficiency (HRD)
  • Zejula is now the only, once-daily PARP inhibitor approved as monotherapy treatment for recurrent ovarian cancer beyond those with a BRCA mutation in both the recurrent maintenance and late-line treatment settings

PHILADELPHIA--(BUSINESS WIRE)-- GlaxoSmithKline (GSK) 


 https://www.gsk.com/en-gb/ 


 https://www.tesarobio.com/products/zejula-niraparib 


 https://www.zejula.com/prescribing-information 


 https://www.businesswire.com/news/home/20191023005902/en/ 

ZEJULA is a once-daily, oral medicine used for the maintenance treatment of women with recurrent ovarian, fallopian tube, or primary peritoneal cancer when their cancer comes back. ZEJULA is the first and only once-daily PARP inhibitor used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy.1-3

Varian ProBeam 360 Proton Therapy System Selected by Penn Medicine

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Varian ProBeam 360 Proton Therapy System Selected by Penn Medicine for Use in Second Treatment Center

Wed October 23, 2019 4:20 PM|PR Newswire|About: VARPR Newswire

PALO ALTO, Calif., Oct. 23, 2019 /PRNewswire/ -- Varian (VSEA) (NYSE: VAR)


 https://www.prnewswire.com/news-releases/varian-probeam-360-proton-therapy-system-selected-by-penn-medicine-for-use-in-second-treatment-center-300943915.html 



 https://www.varian.com/oncology/products/treatment-delivery/probeam-360-proton-therapy-system 


 https://www.varian.com/ 

Proton Therapy The Most Precise Radiation Treatment

Varian ProBeam 360 System Selected by The Ohio State University

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Varian ProBeam 360 System Selected by The Ohio State University for New Proton Therapy Center

Thu October 24, 2019 8:15 AM|PR Newswire|About: VAR 


 https://www.prnewswire.com/news-releases/varian-probeam-360-system-selected-by-the-ohio-state-university-for-new-proton-therapy-center-300944519.html 


 https://www.varian.com/ 


 https://www.varian.com/oncology/products/treatment-delivery/probeam-360-proton-therapy-system 


 https://cancer.osu.edu/ 

PROBEAM 360° PROTON THERAPY SYSTEM Designed for next-generation proton therapy in a smaller footprint.

Seeking Biotech Alpha October 2019 Insight

Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab)

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CheckMate -9LA, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) Combined with Chemotherapy, Meets Primary Endpoint Demonstrating Superior Overall Survival Compared to Chemotherapy Alone in First-Line Lung Cancer

Tue October 22, 2019 6:59 AM|Business Wire|About: BMY

Study evaluated Opdivo plus low-dose Yervoy given concomitantly with two cycles of chemotherapy vs. chemotherapy alone for the first-line treatment of advanced non-small cell lung cancer

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


 https://www.businesswire.com/news/home/20191022005425/en/ 


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


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



FULL INDICATIONS For Patients With Previously Treated Metastatic Non-Small Cell Lung Cancer (1 of 10) OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. For Patients With Metastatic Melanoma (2 of 10) OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with unresectable or metastatic melanoma. OPDIVO, in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. OPDIVO is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. For Patients With Advanced Renal Cell Carcinoma (3 of 10) OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC). OPDIVO is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. For Patients With Small Cell Lung Cancer That Has Progressed After Two or More Lines of Therapy (4 of 10) OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. For Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck on or After Platinum-Based Therapy (5 of 10) OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. For Patients With Hepatocellular Carcinoma (HCC) Previously Treated With Sorafenib (6 of 10) OPDIVO® (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. For Patients With Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma Who Have Disease Progression During or Following Platinum-Based Chemotherapy (7 of 10) OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. For Adult Patients With MSI-H/dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment With a Fluoropyrimidine, Oxaliplatin, and Irinotecan (8 of 10) OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. For Patients (≥12 years) With MSI-H/dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment With a Fluoropyrimidine, Oxaliplatin, and Irinotecan (9 of 10) OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. For Adults With Relapsed or Progressed cHL After Autologous HSCT and Brentuximab Vedotin, or After 3 or More Lines of Therapy Including Autologous HSCT (10 of 10) OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

aducanumab, an investigational treatment for early Alzheimer’s disease (AD)

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Biogen Plans Regulatory Filing for Aducanumab in Alzheimer’s Disease Based on New Analysis of Larger Dataset from Phase 3 Studies

Tue October 22, 2019 6:30 AM|GlobeNewswire|About: BIIB

New analysis of larger dataset showed that aducanumab reduced clinical decline in patients with early Alzheimer’s disease as measured by the pre-specified primary and secondary endpoints

 

Based on discussions with the FDA, the Company plans to submit a Biologics License Application in early 2020

Biogen aims to offer aducanumab to eligible patients previously enrolled in clinical studies

The positive results of this new analysis were driven primarily by greater exposure to high dose aducanumab in the larger dataset as compared to data available at the time of the futility analysis

CAMBRIDGE, Mass. and TOKYO, Oct. 22, 2019 (GLOBE NEWSWIRE) -- Biogen (BIIB) and Eisai, Co., Ltd. (Tokyo, Japan)


 https://www.eisai.com/news/2019/news201979.html 


 https://biogenalzheimers.com/ 

BIOGEN PLANS REGULATORY FILING FOR ADUCANUMAB IN ALZHEIMER’S DISEASE BASED ON NEW ANALYSIS OF LARGER DATASET FROM PHASE 3 STUDIES October 22, 2019 at 6:30 AM EDT New analysis of larger dataset showed that aducanumab reduced clinical decline in patients with early Alzheimer’s disease as measured by the pre-specified primary and secondary endpoints Based on discussions with the FDA, the Company plans to submit a Biologics License Application in early 2020 Biogen aims to offer aducanumab to eligible patients previously enrolled in clinical studies The positive results of this new analysis were driven primarily by greater exposure to high dose aducanumab in the larger dataset as compared to data available at the time of the futility analysis CAMBRIDGE, Mass. and TOKYO, Oct. 22, 2019 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan)

TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor)

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FDA Approves TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older Who Have at Least One F508del Mutation

Mon October 21, 2019 3:55 PM|Business Wire|About: VRTX

- For the first time, approximately 6,000 patients with one minimal function mutation and one F508del mutation have a medicine to treat the underlying cause of their disease–

-12,000 people with one or two F508del mutations who are currently eligible for one of Vertex’s three other FDA-approved cystic fibrosis medicines are now also eligible for TRIKAFTA-

-Approval is based on two positive global Phase 3 studies in people with cystic fibrosis ages 12 and older with one F508del mutation and one minimal function mutation and in people with two F508del mutations-

BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (VRTX)


 https://www.businesswire.com/news/home/20191021005792/en/ 


 https://www.vertexgps.com/ 


 https://investors.vrtx.com/news-releases/news-release-details/fda-approves-trikafta-elexacaftortezacaftorivacaftor-and 

Oct 21, 2019 FDA Approves TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older Who Have at Least One F508del Mutation - For the first time, approximately 6,000 patients with one minimal function mutation and one F508del mutation have a medicine to treat the underlying cause of their disease– -12,000 people with one or two F508del mutations who are currently eligible for one of Vertex’s three other FDA-approved cystic fibrosis medicines are now also eligible for TRIKAFTA- -Approval is based on two positive global Phase 3 studies in people with cystic fibrosis ages 12 and older with one F508del mutation and one minimal function mutation and in people with two F508del mutations- BOSTON--(BUSINESS WIRE)--Oct. 21, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)

Fiasp® (insulin aspart injection) 100 u/mL to include use in insulin infusion pumps

 

FDA approves Fiasp® for use in insulin infusion pumps for adults with type 1 or type 2 diabetes

Tue October 22, 2019 9:10 AM|PR Newswire

PLAINSBORO, N.J., Oct. 22, 2019 /PRNewswire/ -- Novo Nordisk


 https://www.novocare.com/ 


 https://www.novo-pi.com/fiasp.pdf 


 https://www.prnewswire.com/news-releases/fda-approves-fiasp-for-use-in-insulin-infusion-pumps-for-adults-with-type-1-or-type-2-diabetes-300942998.html 

Fiasp® is an injectable prescription medication used to help improve blood sugar in adults with type 1 and type 2 diabetes.

CINVANTI (aprepitant) injectable emulsion for intravenous (IV) use

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Heron Announces FDA Approval of Supplemental New Drug Application to Expand CINVANTI® Label for Single-Dose Regimen for Patients Receiving Moderately Emetogenic Chemotherapy (MEC)

Tue October 22, 2019 8:30 AM|PR Newswire|About: HRTX

SAN DIEGO, Oct. 22, 2019 /PRNewswire/ -- Heron Therapeutics, Inc. (HRTX)


 https://www.prnewswire.com/news-releases/heron-announces-fda-approval-of-supplemental-new-drug-application-to-expand-cinvanti-label-for-single-dose-regimen-for-patients-receiving-moderately-emetogenic-chemotherapy-mec-300942506.html 


 http://www.cinvanti.com/ 


 https://www.herontx.com/cinvanti 

CINVANTI is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

Aetna Medicare Advantage

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Medicare Star Ratings show 3 out of 4 Aetna Medicare Advantage members enrolled in a 4.5 Star-rated plan or higher

Tue October 22, 2019 8:30 AM|PR Newswire|About: CVSPR Newswire

HARTFORD, Conn., Oct. 22, 2019 /PRNewswire/ -- Aetna, a CVS Health (CVS) company (NYSE: CVS)


 https://www.aetnamedicare.com/?icid=int-aetnacom 


 https://www.aetna.com/ 

Medicare Star Ratings show 3 out of 4 Aetna Medicare Advantage members enrolled in a 4.5 Star-rated plan or higher Commitment to quality leads to improved member health outcomes and helps Aetna earn its first 5-star plan and highest overall weighted average rating among national health insurers* HARTFORD, Conn., Oct. 22, 2019 /PRNewswire/ -- Aetna, a CVS Health company (NYSE: CVS)

Seeking Biotech Alpha October 2019 Insight

FARXIGA (dapagliflozin)

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FARXIGA Approved in the US to Reduce the Risk of Hospitalization for Heart Failure in Patients With Type 2 Diabetes

Mon October 21, 2019 7:00 AM|Business Wire|About: AZN

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca


 https://www.astrazeneca-us.com/media/press-releases/2019/farxiga-approved-in-the-US-to-reduce-the-risk-of-hospitalization-for-heart-failure-in-patients-with-type-2-diabetes-10212019.html 


 https://www.businesswire.com/news/home/20191021005194/en/ 


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


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

FARXIGA is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. FARXIGA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in your blood or urine).

tucatinib

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Seattle Genetics Announces Positive Topline Results from Pivotal Trial of Tucatinib in Locally Advanced or Metastatic HER2-Positive Breast Cancer

Mon October 21, 2019 6:45 AM|Business Wire|About: SGEN

-HER2CLIMB Trial Met Primary Endpoint and Both Key Secondary Endpoints-

-Global Regulatory Strategy Includes NDA Submission to U.S. FDA Planned for First Quarter of 2020-

-Data to be Presented at the 2019 San Antonio Breast Cancer Symposium-

-Company to Host Conference Call Today at 9:00 a.m. EST-

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


 https://investor.seattlegenetics.com/press-releases/news-details/2019/Seattle-Genetics-Announces-Initiation-of-Phase-3-Clinical-Trial-of-Tucatinib-in-Combination-with-Ado-trastuzumab-Emtansine-T-DM1-Kadcyla-for-Patients-with-Advanced-or-Metastatic-HER2-Positive-Breast-Cancer/default.aspx 


 https://www.businesswire.com/news/home/20191021005169/en/ 

Tucatinib was added to our pipeline in March 2018 with the acquisition of Cascadian Therapeutics. It is an orally bioavailable, small molecule tyrosine kinase inhibitor (TKI) that is highly selective for HER2, a growth factor receptor that is over-expressed in multiple cancers, including breast, colorectal, esophageal, gastric, lung and ovarian cancers. It is over-expressed in approximately 20% of breast cancers.

FLIXABI™ (infliximab) and IMRALDI™ (adalimumab)

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Biogen and Samsung Bioepis to Present Data for Infliximab and Adalimumab Biosimilars at United European Gastroenterology Week

Mon October 21, 2019 7:30 AM|GlobeNewswire|About: BIIB

  • Data highlights real-world evidence confirming the safety and efficacy of anti-TNF biosimilars for patients with inflammatory bowel disease (IBD)

CAMBRIDGE, Mass. and INCHEON, Korea, Oct. 21, 2019 (GLOBE NEWSWIRE) -- Biogen Inc. (BIIB) (Nasdaq: BIIB) and Samsung Bioepis


 https://www.samsungbioepis.com/en/index.do 


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


 https://www.biospace.com/article/releases/biogen-and-samsung-bioepis-to-present-data-for-infliximab-and-adalimumab-biosimilars-at-united-european-gastroenterology-week/ 



IMRALDI™, BIOGEN’S ADALIMUMAB BIOSIMILAR REFERENCING HUMIRA®, IS LAUNCHED IN THE EUROPEAN UNION October 17, 2018 at 2:00 AM EDT IMRALDITM is approved in the European Union for the same 14 complex autoimmune conditions as its reference product In 2017 Biogen became the first company in Europe with approved biosimilars referencing the three most prescribed anti-TNF biologic treatments BAAR, Switzerland, Oct. 17, 2018 (GLOBE NEWSWIRE) -- Samsung Bioepis Co. Ltd, a joint venture between Samsung BioLogics and Biogen (Nasdaq: BIIB) today announced the European launch of IMRALDITM, an adalimumab biosimilar referencing Humira®.1

Symdeko (tezacaftor/ivacaftor and ivacaftor)

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 Oct 19, 2019

Vertex Announces Reimbursement of Cystic Fibrosis Medicines SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) for Eligible Patients Ages 12 and Older, and ORKAMBI® (lumacaftor/ivacaftor) in Children Ages 2 to 5, With Certain CFTR Mutations in Australia

LONDON--(BUSINESS WIRE)--Oct. 19, 2019-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)


 https://www.businesswire.com/news/home/20191019005040/en/ 


 https://seekingalpha.com/news/3507203-vertexs-symdeko-nabs-reimbursement-australia 


 https://www.symdeko.com/ 

SYMDEKO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have two copies of the F508del mutation, or who have at least one mutation in the CF gene that is responsive to treatment with SYMDEKO. Talk to your doctor to learn if you have an indicated CF gene mutation.

STELARA® (ustekinumab)

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Janssen Announces U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

Mon October 21, 2019 7:58 AM|PR Newswire

STELARA is the first and only approved treatment for ulcerative colitis to demonstrate improvement of the colon as measured by a novel histologic-endoscopic mucosal improvement endpoint

PR Newswire

HORSHAM, Pa., Oct. 21, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson 


 https://www.multivu.com/players/English/8627251-janssen-stelara-fda-approval-ulcerative-colitis/ 


 https://www.prnewswire.com/news-releases/janssen-announces-us-fda-approval-of-stelara-ustekinumab-for-the-treatment-of-adults-with-moderately-to-severely-active-ulcerative-colitis-300941913.html 


 https://www.stelarainfo.com/ 

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

ALKS 4230 is a novel, engineered fusion protein

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Alkermes Announces Clinical Collaboration With Fred Hutchinson Cancer Research Center for Novel Immuno-Oncology Drug Candidate ALKS 4230

Mon October 21, 2019 7:00 AM|PR Newswire|About: ALKSPR Newswire

DUBLIN, Oct. 21, 2019 /PRNewswire/ -- Alkermes plc (ALKS) (Nasdaq: ALKS)


 https://www.prnewswire.com/news-releases/alkermes-announces-clinical-collaboration-with-fred-hutchinson-cancer-research-center-for-novel-immuno-oncology-drug-candidate-alks-4230-300941356.html 


 https://www.fredhutch.org/en.html 


 http://www.alkermes.com/research-and-development/pipeline 


 https://seekingalpha.com/news/3507185-alkermes-teams-fred-hutchinson-cancer-research-center-immuno-oncology-drug-candidate 

Alkermes Announces Clinical Collaboration With Fred Hutchinson Cancer Research Center for Novel Immuno-Oncology Drug Candidate ALKS 4230 Published: Oct 21, 2019 Planned Phase 2 Multi-Site Trial to Evaluate ALKS 4230 in Combination With Pembrolizumab in Patients With Advanced or Recurrent Head and Neck Squamous Cell Cancer DUBLIN, Oct. 21, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS)

Seeking Biotech Alpha October 2019 Insight

Nplate® (romiplostim)

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Nplate® (romiplostim) Now Approved For Earlier Use In Adults With Immune Thrombocytopenia

Fri October 18, 2019 9:00 AM|PR Newswire|About: AMGN

93% of Patients Achieved a Platelet Response

PR Newswire

THOUSAND OAKS, Calif., Oct. 18, 2019 /PRNewswire/ -- Amgen (AMGN) 


 https://www.prnewswire.com/news-releases/nplate-romiplostim-now-approved-for-earlier-use-in-adults-with-immune-thrombocytopenia-300941074.html 


 https://www.amgen.com/media/news-releases/2019/10/nplate-romiplostim-now-approved-for-earlier-use-in-adults-with-immune-thrombocytopenia/ 

Nplate® is a prescription medicine used to treat low blood platelet counts (thrombocytopenia) in: adults with chronic immune thrombocytopenia (ITP) when certain medicines or surgery to remove your spleen have not worked well enough.

KALYDECO® (ivacaftor)

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Vertex Receives European CHMP Positive Opinion for KALYDECO® (ivacaftor) to Treat Eligible Infants with Cystic Fibrosis as Early as 6 Months of Age

Fri October 18, 2019 8:37 AM|Business Wire|About: VRTX

- If approved, ivacaftor will be the first and only medicine to treat the underlying cause of cystic fibrosis for children this young -

LONDON--(BUSINESS WIRE)-- Vertex Pharmaceuticals (Europe) Limited


 https://www.businesswire.com/news/home/20191018005285/en/ 

KALYDECO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 months and older who have at least one mutation in their CF gene that is responsive to KALYDECO.

Toujeo (previously Optisulin)

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 Toujeo (previously Optisulin)   insulin glargine 


 On 17 October 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Toujeo. The marketing authorisation holder for this medicinal product is Sanofi-Aventis Deutschland GmbH. 


 https://seekingalpha.com/news/3506873-european-advisory-group-backs-expanded-use-sanofis-insulin-glargine 

What is Toujeo® (insulin glargine injection) 300 Units/mL? Prescription Toujeo is a long-acting insulin used to control blood sugar in adults with diabetes mellitus. Toujeo contains 3 times as much insulin in 1 mL as standard insulin (100 Units/mL) Toujeo is not for use to treat diabetic ketoacidosis Toujeo should not be used in children

ULTOMIRIS® (ravulizumab-cwvz)

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Alexion Receives FDA Approval for ULTOMIRIS® (ravulizumab-cwvz) for Atypical Hemolytic Uremic Syndrome (aHUS)

Fri October 18, 2019 7:45 PM|Business Wire|About: ALXN

- At 26 weeks, 54% of adults and 71% of children treated with ULTOMIRIS demonstrated Complete Thrombotic Microangiopathy (TMA) Response -

BOSTON--(BUSINESS WIRE)-- Alexion Pharmaceuticals, Inc. (ALXN)


 https://www.businesswire.com/news/home/20191018005600/en/ 

ULTOMIRIS® (RAVULIZUMAB-CWVZ) ULTOMIRIS is the first and only long-acting C5 inhibitor administered every eight weeks in adults. ULTOMIRIS works by inhibiting the C5 protein in the terminal complement cascade, a part of the body’s immune system. ULTOMIRIS is indicated for the treatment of adult patients with paroxsymal nocturnal hemoglobinuria (PNH) and the treatment of adults and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS). ULTOMIRIS has received Orphan Drug Designation (ODD) for the treatment of patients with PNH in the U.S. and Japan.

GENOTROPIN® (somatropin) for injection

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OPKO and Pfizer Announce Positive Phase 3 Top-Line Results for Somatrogon, an Investigational Long-Acting Human Growth Hormone to Treat Children with Growth Hormone Deficiency

Mon October 21, 2019 8:00 AM|GlobeNewswire|About: OPK, PFE

— Results demonstrated potential to reduce current dosing frequency from once-daily to a single weekly injection —

MIAMI and NEW YORK, Oct. 21, 2019 (GLOBE NEWSWIRE) -- OPKO Health Inc. (OPK) and Pfizer Inc. (PFE)


 www.OPKO.com. 


 www.pfizer.com 


 https://www.genotropin.com/ 


OPKO and Pfizer Announce Positive Phase 3 Top-Line Results for Somatrogon, an Investigational Long-Acting Human Growth Hormone to Treat Children with Growth Hormone Deficiency Download as PDFOctober 21, 2019 — Results demonstrated potential to reduce current dosing frequency from once-daily to a single weekly injection — MIAMI and NEW YORK, Oct. 21, 2019 (GLOBE NEWSWIRE) -- OPKO Health Inc. (NASDAQ: OPK) and Pfizer Inc. (NYSE: PFE)

Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab)

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Genentech’s Tecentriq in Combination With Avastin Increased Overall Survival and Progression-free Survival in People With Unresectable Hepatocellular Carcinoma

Mon October 21, 2019 1:00 AM|Business Wire|About: RHHBY

– First Phase III cancer immunotherapy study to show an improvement in overall survival and progression-free survival for the treatment of the most common form of liver cancer –

– Data will be submitted to health authorities globally, including the U.S. Food and Drug Administration (FDA) –

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


 https://www.businesswire.com/news/home/20191020005095/en/ 


 https://www.tecentriq.com/ 


  https://www.avastin.com/ 


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

TECENTRIQ is a prescription medicine used to treat adults with: A type of bladder and urinary tract cancer called urothelial carcinoma. TECENTRIQ may be used when your bladder cancer: has spread or cannot be removed by surgery, and if you have any one of the following conditions: you are not able to take chemotherapy that contains a medicine called cisplatin, and your cancer tests positive for "PD-L1", or you are not able to take chemotherapy that contains any platinum regardless of "PD-L1" status, or you have tried chemotherapy that contains platinum, and it did not work or is no longer working The approval of TECENTRIQ in these patients is based on a study that measured response rate and duration of response. There is an ongoing study to confirm clinical benefit. A type of lung cancer called non-small cell lung cancer (NSCLC). TECENTRIQ may be used with bevacizumab and the chemotherapy medicines carboplatin and paclitaxel as your first treatment when your lung cancer: has spread or grown, and is a type of lung cancer called "non-squamous NSCLC", and your tumor does not have an abnormal “EGFR” or “ALK” gene TECENTRIQ may be used when your lung cancer: has spread or grown, and you have tried chemotherapy that contains platinum, and it did not work or is no longer working, and if your tumor has an abnormal "EGFR" or "ALK" gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working A type of breast cancer called triple-negative breast cancer (TNBC). TECENTRIQ may be used with the medicine paclitaxel protein-bound when your breast cancer: has spread or cannot be removed by surgery, and your cancer tests positive for “PD-L1” The approval of TECENTRIQ in these patients is based on a study that measured progression-free survival. There is an ongoing study to confirm clinical benefit. A type of lung cancer called small cell lung cancer (SCLC). TECENTRIQ may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment when your lung cancer: is a type called “extensive-stage small cell lung cancer,” which means that it has spread or grown

Seeking Biotech Alpha October 2019 Insight

RINVOQ™ (upadacitinib)

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AbbVie Receives CHMP Positive Opinion for Upadacitinib (RINVOQ™) for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis

Fri October 18, 2019 7:30 AM|PR Newswire|About: ABBV

- In Phase 3 trials, upadacitinib improved signs and symptoms of rheumatoid arthritis, inhibited radiographic progression and improved physical function, both as a monotherapy and in combination with conventional synthetic DMARDs[1-5]

- Upadacitinib (under the trade name RINVOQ™) is a selective and reversible JAK inhibitor discovered and developed by AbbVie[6]

PR Newswire

NORTH CHICAGO, Ill., Oct. 18, 2019 /PRNewswire/ -- AbbVie (ABBV)


 https://www.prnewswire.com/news-releases/abbvie-receives-chmp-positive-opinion-for-upadacitinib-rinvoq-for-the-treatment-of-adults-with-moderate-to-severe-active-rheumatoid-arthritis-300940994.html 

RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated.

DARZALEX® (daratumumab)

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CHMP Issues Positive Opinion Recommending DARZALEX® (Daratumumab) in Combination with Lenalidomide and Dexamethasone in Frontline Multiple Myeloma

Fri October 18, 2019 7:09 AM|GlobeNewswire|About: GMAB

Company Announcement

  • CHMP issued a positive opinion for DARZALEX® in combination with lenalidomide and dexamethasone as treatment for newly diagnosed adult patients with multiple myeloma who are ineligible for autologous stem cell transplant
  • Final decision from European Commission expected in the coming months
  • Opinion based on data from Phase III MAIA study

Copenhagen, Denmark; October 18, 2019 – Genmab A/S (GNMSF) (Nasdaq: GMAB)


 http://www.genmab.com/product-pipeline/products-in-development/daratumumab 

DARZALEX® (daratumumab) IS NOW APPROVED ACROSS NEWLY DIAGNOSED PATIENTS WITH MULTIPLE MYELOMA DARZALEX® (daratumumab) in combination with the medicines Revlimid® (lenalidomide) and dexamethasone (DRd) for adult patients with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant). THE DRd REGIMEN DARZALEX® (daratumumab) in combination with the medicines Velcade® (bortezomib) + thalidomide + dexamethasone (DVTd) for adult patients with newly diagnosed multiple myeloma who can receive an autologous stem cell transplant.

KEYTRUDA® (pembrolizumab)

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Merck Receives Positive EU CHMP Opinion for Two New Regimens of KEYTRUDA® (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma

Fri October 18, 2019 7:00 AM|Business Wire|About: MRK

Opinion Supports Use of KEYTRUDA, as Monotherapy or in Combination with Platinum and 5-Fluorouracil Chemotherapy, in Patients Whose Tumors Express PD-L (CPS ≥1)

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


 https://www.businesswire.com/news/home/20191018005205/en/ 

KEYTRUDA WORKS WITH YOUR IMMUNE SYSTEM TO HELP FIGHT CANCER CELLS

ERVEBO® V920 Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live)

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Merck Receives EU CHMP Positive Opinion for Investigational V920 Ebola Zaire Vaccine for Protection Against Ebola Virus Disease

Fri October 18, 2019 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.businesswire.com/news/home/20191018005198/en/ 

Ervebo Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live) On 17 October 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation1 for the medicinal product Ervebo, intended for prophylaxis against Zaire Ebola virus disease (EVD). Ervebo was reviewed under EMA’s accelerated assessment programme. The applicant for this medicinal product is Merck Sharp & Dohme B.V.

EVENITY® (Romosozumab)

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EVENITY® (Romosozumab) Receives Positive CHMP Opinion For The Treatment Of Severe Osteoporosis In Postmenopausal Women At High Risk Of Fracture

Fri October 18, 2019 1:00 AM|PR Newswire|About: AMGN, UCBJY

THOUSAND OAKS, Calif. and BRUSSELS, Oct. 17, 2019 /PRNewswire/ -- Amgen (AMGN) and UCB (Euronext Brussels: UCB)


 https://www.prnewswire.com/news-releases/evenity-romosozumab-receives-positive-chmp-opinion-for-the-treatment-of-severe-osteoporosis-in-postmenopausal-women-at-high-risk-of-fracture-300941029.html 

EVENITY® is a prescription medicine used to treat osteoporosis in women after menopause who are at high risk of fracture, or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.

Baqsimi (glucagon)

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 First non-injectable treatment for severe low blood sugar levels 

 Press release 18/10/2019

EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Baqsimi (glucagon), the first treatment for severe hypoglycaemia (low blood sugar levels) that can be administered without an injection to patients with diabetes aged four years and older.


 https://seekingalpha.com/news/3506826-european-advisory-group-backs-lillys-nasally-administered-glucagon 

BAQSIMI is the first and only dry nasal spray that can treat severe hypoglycemia. It is a form of glucagon given as a puff in the nose. In a study, BAQSIMI raised blood sugar successfully* in 100%† of patients ages 4 through 16 within an average time of about 12 minutes.

Seeking Biotech Alpha October 2019 Insight

t:slim X2 Insulin Pump with Control-IQ Technology

 

Tandem Diabetes Care Announces NEJM Publication of Landmark Study Demonstrating Increased Time-In-Range with the t:slim X2 Insulin Pump with Control-IQ Technology

Wed October 16, 2019 5:15 PM|Business Wire|About: TNDM

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


 https://www.businesswire.com/news/home/20191016005902/en/ 

The Basal-IQ feature helps reduce the frequency and duration of low-glucose events by predicting glucose levels 30 minutes ahead and suspending insulin if they are expected to drop below 80 mg/dL.

Xofluza™ (baloxavir marboxil)

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Genentech Announces FDA Approval of Xofluza (Baloxavir Marboxil) for People at High Risk of Developing Influenza-Related Complications

Thu October 17, 2019 11:35 AM|Business Wire|About: RHHBY

– Single-dose Xofluza is the first and only antiviral medicine indicated specifically for patients at high risk of developing serious complications from influenza (flu) –

– The Centers for Disease Control and Prevention (CDC) defines people at high risk of serious flu complications as those who have conditions such as asthma, chronic lung disease, diabetes, heart disease, morbid obesity or adults 65 years of age or older –

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

XOFLUZA™ is indicated for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours.

ELIDEL® (pimecrolimus cream1%)

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Bausch Health Announces Updated Health Canada Safety Information for ELIDEL®

Thu October 17, 2019 10:15 AM|Canada Newswire|About: BHC

TOPICAL ATOPIC DERMATITIS TREATMENT, ELIDEL® NOW AVAILABLE
FOR CHILDREN THREE MONTHS AND OVER

LAVAL, QC, Oct. 17, 2019 /CNW/ - Bausch Health Companies Inc. (BHC)


 https://www.helprx.info/elidel-discounts-coupons?&utm_medium=paid-search&utm_source=google-hr&utm_campaign=125364102&utm_adgroup=5602707342&utm_term=elidel&utm_content=200334433843&matchtype=e&pos=1t1&device=c&mkwid=s|dc_pcrid_200334433843_pkw_elidel_pmt_e&segments=&gclid=Cj0KCQjwoqDtBRD-ARIsAL4pviA47prBcLE5aWy_Ar0xZDaRvANiFTN6ENSuyLuS_WfrPrvNakWarjQaAmrdEALw_wcB 

Wellbeing means feeling healthy inside and out. Bausch Health, Canada offers a vast portfolio of products to help Canadians achieve their goals for wellbeing. We invite you to search our product list below, or use our search tool. For any product information, please click here to refer to the Health Canada Drug Product Database or request from Manufacturer at: 1-800-361-4261.

GI Genius™ intelligent endoscopy module

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Medtronic Launches the First Artificial Intelligence System for Colonoscopy at United European Gastroenterology Week 2019

Thu October 17, 2019 5:45 PM|GlobeNewswire|About: MDTGlobeNewswire

DUBLIN and BARCELONA, Spain, Oct. 17, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (MDT) (NYSE:MDT)


 https://www.crcprevention.eu/index.php?pg=colorectal-cancer-epidemiology 

ARTIFICIAL INTELLIGENCE IN COLONOSCOPY Sunday, October 20th 18:00-20:00 Expert panel discussion on GI GeniusTM

Spravato (esketamine) nasal spray

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 On 17 October 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Spravato, intended for combination treatment in adults with treatment-resistant major depressive disorder. The applicant for this medicinal product is Janssen-Cilag International N.V. 


 https://seekingalpha.com/news/3506852-european-advisory-group-backs-j-and-j-antidepressant-spravato 

SPRAVATO™ is a prescription medicine, used along with an antidepressant taken by mouth, for treatment-resistant depression (TRD) in adults. SPRAVATO™ is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO™ is safe or effective as an anesthetic medicine.

TREMFYA® (guselkumab)

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Janssen Presents New Four-Year TREMFYA® (guselkumab) Data Demonstrating Maintained Rates of Skin Clearance in Adult Patients with Moderate to Severe Plaque Psoriasis

Thu October 17, 2019 4:01 PM|PR NewswirePR Newswire

LAS VEGAS, Oct. 17, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson 


 https://www.prnewswire.com/news-releases/janssen-presents-new-four-year-tremfya-guselkumab-data-demonstrating-maintained-rates-of-skin-clearance-in-adult-patients-with-moderate-to-severe-plaque-psoriasis-300940894.html 

TREMFYA® is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light or UV light).

Seeking Biotech Alpha October 2019 Insight

Ruxolitinib (Jakafi®)

 

Incyte Announces that the REACH2 Pivotal Trial of Ruxolitinib (Jakafi®) Meets Primary Endpoint in Patients with Steroid-Refractory Acute Graft-Versus-Host Disease

Wed October 16, 2019 7:00 AM|Business Wire|About: INCY

- Results of randomized Phase 3 REACH2 trial show that ruxolitinib significantly improves overall response rate (ORR) at 28 days vs. best available therapy in patients with steroid-refractory acute graft-versus-host disease (GvHD)

- Full results expected to be submitted to an upcoming scientific meeting

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


 https://clinicaltrials.gov/ct2/show/NCT03112603 


. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-reach2-pivotal-trial-ruxolitinib-jakafir-meets 

Jakafi is a prescription medicine used to treat adults with polycythemia vera who have already taken a medicine called hydroxyurea and it did not work well enough or they could not tolerate it. Jakafi is used to treat adults with certain types of myelofibrosis. Jakafi is also used to treat adults and children 12 years of age and older with acute graft-versus-host disease (GVHD) who have taken corticosteroids and they did not work well enough.

Dovato (dolutegravir and lamivudine)

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ViiV Healthcare Submits Supplemental New Drug Application to US FDA for Use of Dovato in Virologically Suppressed Adults with HIV-1

Wed October 16, 2019 7:00 AM|Business Wire|About: GSK, PFE

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. (PFE)

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

(BALANCE-CF™ 1) BI ENaC inhibitor delivered twice daily via the Respimat®, a handheld inhaler

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Boehringer Ingelheim Announces First Patient Enrolled in Phase II Trial of Novel Cystic Fibrosis Treatment (BALANCE-CF™ 1)

Wed October 16, 2019 8:00 AM|PR NewswirePR Newswire

RIDGEFIELD, Conn., Oct. 16, 2019 /PRNewswire/ -- Boehringer Ingelheim

Boehringer Ingelheim Announces First Patient Enrolled in Phase II Trial of Novel Cystic Fibrosis Treatment (BALANCE-CF™ 1) - Investigational compound BI ENaC inhibitor delivered twice daily via the Respimat®, a handheld inhaler RIDGEFIELD, Conn., Oct. 16, 2019 /PRNewswire/ -- Boehringer Ingelheim

NKTR-255, an IL-15 Agonist

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Nektar Therapeutics Announces Initiation of First-in-Human Phase 1 Clinical Study of NKTR-255, an IL-15 Agonist, in Adults with Relapsed or Refractory Non-Hodgkin Lymphoma or Multiple Myeloma

Wed October 16, 2019 9:00 AM|PR Newswire|About: NKTR

SAN FRANCISCO, Oct. 16, 2019 /PRNewswire/ -- Nektar Therapeutics (NKTR)


 https://www.prnewswire.com/news-releases/nektar-therapeutics-announces-initiation-of-first-in-human-phase-1-clinical-study-of-nktr-255-an-il-15-agonist-in-adults-with-relapsed-or-refractory-non-hodgkin-lymphoma-or-multiple-myeloma-300939332.html 

Nektar Therapeutics has a deep and diverse portfolio of investigational medicines in different stages of clinical development. We are focused on using new chemistry approaches to make better medicines to treat cancer, chronic pain and auto-immune disease. Nektar Therapeutics also has a number of strategic partnerships ranging from joint discovery and co-development to licensing and royalty arrangements with numerous companies.

[fam-] trastuzumab deruxtecan (DS-8201)

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[Fam-] Trastuzumab Deruxtecan Granted FDA Priority Review for Treatment of Patients With HER2-positive Metastatic Breast Cancer

Thu October 17, 2019 7:00 AM|Business Wire|About: AZN

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca (AZN) and Daiichi Sankyo Company, Limited (Daiichi Sankyo)


 https://www.businesswire.com/news/home/20191017005387/en/ 

[Fam-] Trastuzumab Deruxtecan (DS-8201) Granted FDA Priority Review for Treatment of Patients with HER2 Positive Metastatic Breast Cancer Tokyo, Munich and Basking Ridge, NJ – (October 17, 2019) – Daiichi Sankyo Company, Limited

Vascepa® (icosapent ethyl)

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Independent Drug-Pricing Assessment Finds Vascepa® (icosapent ethyl) Cost-Effective as an Adjunct to Statins in Treating Patients at High Risk of Cardiovascular Events, such as Heart Attack, Stroke and Cardiac Death

Thu October 17, 2019 9:48 AM|GlobeNewswire|About: AMRN

DUBLIN, Ireland and BRIDGEWATER, N.J., Oct. 17, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN)


 https://www.vascepa.com/ 


The REDUCE-IT (Reduction of Cardiovascular Events Outcomes) trial: A prospective, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effectiveness of Vascepa® (icosapent ethyl) capsules as an add-on to statin therapy in reducing the first major cardiovascular event in a high-risk patient population compared to statin therapy alone. REDUCE-IT results were presented as a late breaker at the 2018 Scientific Sessions of the American Heart Association (AHA) on November 10, 2018 in Chicago, Illinois. This acceptance as a presentation of late-breaking clinical trial results was granted based on the ability of REDUCE-IT to address a critical question in cardiovascular prevention.

Seeking Biotech Alpha October 2019 Insight

XARELTO® (rivaroxaban)

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 U.S. FDA Approves XARELTO® (rivaroxaban) to Help Prevent Blood Clots in Acutely Ill Medical PatientsXARELTO® provides a new oral option to help prevent venous thromboembolism (VTE) and VTE-related death during hospitalization and post-hospital discharge in acutely ill medical patients at risk for VTE and not at high risk of bleedingDespite being largely preventable, VTE, or blood clots, remains a significant risk for millions of Americans hospitalized with an acute medical illness

RARITAN, N.J., October 14, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson

XARELTO® is a prescription medicine used to: reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation that is not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to the formation of blood clots, which can travel to the brain, causing a stroke, or to other parts of the body treat blood clots in the veins of your legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism or PE) reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months help prevent a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery

Ebola vaccine

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 HEALTH NEWSOCTOBER 13, 2019 / 10:22 AM / A DAY AGO

Congo to start using Johnson & Johnson Ebola vaccine in November

 KINSHASA (Reuters) - Health authorities in Democratic Republic of Congo will introduce a Johnson & Johnson Ebola vaccine in November in the country’s eastern provinces, to counter the current outbreak, they said. 

The Democratic Republic of Congo (DRC) is currently facing the world’s second-largest Ebola outbreak on record. Johnson & Johnson remains committed to supporting communities in the fight against Ebola through the development of an investigational vaccine regimen in development at our Janssen Pharmaceutical Companies. In May 2019, the Strategic Advisory Group of Experts (SAGE) on Immunization recommended that Janssen’s vaccine be evaluated in clinical studies focused on certain populations in the country who are at some risk of Ebola infection. The World Health Organization (WHO) has expressed support that these guidelines be implemented to help address the DRC crisis. Johnson & Johnson will continue to maintain a transparent line of communication with key stakeholders and stands ready to closely coordinate with governments and partners on how and where Janssen’s vaccine regimen can be deployed alongside other interventions.

ruxolitinib cream

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Incyte's ruxolitinib cream shows sustained benefit in mid-stage vitiligo study

Oct. 14, 2019 7:28 AM ET|About: Incyte Corporation (INCY)|By: , SA News Editor  

Incyte Announces Positive 52-Week Results From a Randomized Phase 2 Study of Ruxolitinib Cream in Patients With Vitiligo Sat October 12, 2019 2:32 AM|Business Wire|About: INCY - Data presented at EADV demonstrate continued improvement in repigmentation of vitiligo lesions upon longer treatment duration with ruxolitinib cream WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (INCY)

next-generation sequencing (NGS) in the growing field of RNA research.

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QIAGEN Launches New QIAseq FastSelect Solutions to Accelerate RNA-seq

Mon October 14, 2019 4:05 PM|Business Wire|About: QGEN

Highlighting broad portfolio of universal NGS solutions at American Society for Human Genetics (ASHG) 2019 genomic research conference

HILDEN, Germany & GERMANTOWN, Md--(BUSINESS WIRE)-- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA)

For details on QIAGEN’s presence, visit https://ashg.qiagen.com

Cell Therapy Programs in Oncology

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CRISPR Therapeutics and KSQ Therapeutics Announce License Agreement to Advance Companies’ Respective Cell Therapy Programs in Oncology

Tue October 15, 2019 7:00 AM|Business Wire|About: CRSP

- CRISPR Therapeutics (CRSP) to receive non-exclusive access to certain KSQ IP for its allogeneic CAR-T programs -

- KSQ Therapeutics to receive non-exclusive access to certain CRISPR IP for its autologous cell therapies, including its existing eTILTM cell franchise -

ZUG, Switzerland & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- CRISPR Therapeutics


 https://ksqtx.com/#home 

We have established a portfolio of programs by selecting disease targets based on a number of criteria, including unmet medical need, technical feasibility, advantages of CRISPR/Cas9 relative to other approaches and time required to advance the product candidate into and through clinical trials.

New portable micro gas chromatograph

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Agilent Expands Portfolio of Smart-Connected GC Instruments

Tue October 15, 2019 8:00 AM|Business Wire|About: A

New portable micro gas chromatograph redefines efficiency

SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (A) (NYSE: A)

Agilent is available at www.agilent.com.

Seeking Biotech Alpha October 2019 Insight

filgotinib, an investigational, oral, selective JAK1 inhibitor

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Gilead and Galapagos Announce Efficacy and Safety Results of Filgotinib Through 52 Weeks in FINCH 1 and FINCH 3 Studies in Rheumatoid Arthritis

Thu October 10, 2019 6:00 PM|Business Wire|About: GILD, GLPG

FOSTER CITY, Calif. & MECHELEN, Belgium--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD) and Galapagos NV (GLPGF) (Euronext & NASDAQ: GLPG)

Gilead and Galapagos Announce Efficacy and Safety Results of Filgotinib Through 52 Weeks in FINCH 1 and FINCH 3 Studies in Rheumatoid Arthritis October 10, 2019 06:00 PM Eastern Daylight Time FOSTER CITY, Calif. & MECHELEN, Belgium--(BUSINESS WIRE)--Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG)

imetelstat, a first-in-class telomerase inhibitor

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Geron Announces First Patient Dosed in IMerge Phase 3 Clinical Trial in Lower Risk Myelodysplastic Syndromes

Thu October 10, 2019 5:30 PM|GlobeNewswire|About: GERN

MENLO PARK, Calif., Oct. 10, 2019 (GLOBE NEWSWIRE) -- Geron Corporation (GERN) 

Geron Announces First Patient Dosed in IMerge Phase 3 Clinical Trial in Lower Risk Myelodysplastic Syndromes MENLO PARK, Calif., Oct. 10, 2019 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq: GERN)

REYVOW™ (lasmiditan)

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Lilly's REYVOW™ (lasmiditan), The First and Only Medicine in a New Class of Acute Treatment for Migraine, Receives FDA Approval

Fri October 11, 2019 3:48 PM|PR Newswire|About: LLYPR Newswire

INDIANAPOLIS, Oct. 11, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY)

Lilly's REYVOW™ (lasmiditan), The First and Only Medicine in a New Class of Acute Treatment for Migraine, Receives FDA Approval 10/11/2019 Download PDF - The approval of REYVOW is significant because it represents the first new class of acute migraine treatment approved by the FDA in more than two decades INDIANAPOLIS, Oct. 11, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)

Investigational Abicipar pegol

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Allergan and Molecular Partners Present Late-Breaking Data from Phase 3 Studies of Investigational Abicipar pegol in Neovascular Wet Age-Related Macular Degeneration

Fri October 11, 2019 7:40 PM|PR Newswire|About: AGN

- Abicipar sustained vision gains in year two with quarterly injections compared to monthly ranibizumab -

- Reductions in central retinal thickness were lower in year two compared to year one for both quarterly and 8-week dosing arms of Abicipar and comparable to monthly ranibizumab -

- Data presented during Retina Subspecialty Day at American Academy of Ophthalmology Annual Meeting -

PR Newswire

DUBLIN, Oct. 11, 2019 /PRNewswire/ -- Allergan plc (AGN), (NYSE: AGN)

Allergan and Molecular Partners Present Late-Breaking Data from Phase 3 Studies of Investigational Abicipar pegol in Neovascular Wet Age-Related Macular Degeneration - Two-year results from CEDAR and SEQUOIA demonstrate that vision gains observed after one year with every 8-week and every 12-week dosing were maintained in the second year - - Abicipar sustained vision gains in year two with quarterly injections compared to monthly ranibizumab - - Reductions in central retinal thickness were lower in year two compared to year one for both quarterly and 8-week dosing arms of Abicipar and comparable to monthly ranibizumab - - Data presented during Retina Subspecialty Day at American Academy of Ophthalmology Annual Meeting - Allergan plc logo

Abrocitinib, an investigational oral Janus kinase 1 (JAK1) inhibitor,

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Pfizer Presents Positive Phase 3 Data at the 28th Congress of the European Academy of Dermatology and Venereology for Abrocitinib in Moderate to Severe Atopic Dermatitis

Sat October 12, 2019 4:45 AM|Business Wire|About: PFE

–Abrocitinib met all co-primary and secondary endpoints in JADE MONO-1 study–

–Findings follow recent positive top-line results for second abrocitinib Phase 3 pivotal study, JADE MONO-2–

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

Pfizer Presents Positive Phase 3 Data at the 28th Congress of the European Academy of Dermatology and Venereology for Abrocitinib in Moderate to Severe Atopic Dermatitis –Abrocitinib met all co-primary and secondary endpoints in JADE MONO-1 study– –Findings follow recent positive top-line results for second abrocitinib Phase 3 pivotal study, JADE MONO-2– October 12, 2019 04:45 AM Eastern Daylight Time NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE)

RGX-314

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REGENXBIO Announces Additional Positive Interim Phase I/IIa Trial Update for RGX-314 for the Treatment of Wet AMD at the American Academy of Ophthalmology 2019 Annual Meeting

Fri October 11, 2019 7:15 PM|PR Newswire|About: RGNX

- 75% of subjects (9/12) in Cohort 5 remain free of anti-VEGF injections, with mean improvement in vision and retinal thickness

- Durable effects on vision and retinal thickness demonstrated over 1.5 years in Cohort 3; 50% of subjects (3/6) remain free of anti-VEGF injections at 1.5 years after RGX-314 administration

- Company on track to initiate a Phase IIb trial for wet AMD in late 2019

PR Newswire

ROCKVILLE, Md., Oct. 11, 2019 /PRNewswire/ -- REGENXBIO Inc. (RGNX)

REGENXBIO Announces Additional Positive Interim Phase I/IIa Trial Update for RGX-314 for the Treatment of Wet AMD at the American Academy of Ophthalmology 2019 Annual Meeting - RGX-314 continues to be well-tolerated - 75% of subjects (9/12) in Cohort 5 remain free of anti-VEGF injections, with mean improvement in vision and retinal thickness - Durable effects on vision and retinal thickness demonstrated over 1.5 years in Cohort 3; 50% of subjects (3/6) remain free of anti-VEGF injections at 1.5 years after RGX-314 administration - Company on track to initiate a Phase IIb trial for wet AMD in late 2019

Seeking Biotech Alpha Oct 2019 Insight

CALQUENCE® (acalabrutinib)

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Health Canada approves CALQUENCE® (acalabrutinib) for adult patients with previously-treated mantle cell lymphoma (MCL)

Tue October 8, 2019 7:59 AM|Canada Newswire

Approval of the highly selective Bruton's tyrosine kinase (BTK)
inhibitor in MCL marks AstraZeneca's entry into the treatment of blood cancers

MISSISSAUGA, ON, Oct. 8, 2019 /CNW/ - AstraZeneca Canada 


 https://www.astrazeneca.ca/en 

CALQUENCE is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer.

filgotinib, an investigational, oral, selective JAK1 inhibitor

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Gilead Sciences Submits New Drug Application for Filgotinib for the Treatment of Adults With Rheumatoid Arthritis in Japan

Tue October 8, 2019 2:00 AM|Business Wire|About: GILD

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


 https://www.businesswire.com/news/home/20191007005875/en/ 

Filgotinib is a highly selective JAK1 inhibitor, discovered and developed by Galapagos using its target and drug discovery technology platform. In more than 3,000 patient years of rheumatoid arthritis (RA) and Crohn's disease clinical study experience,

Taltz® (ixekizumab), Olumiant® (baricitinib) and mirikizumab

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Lilly to Unveil New Data for the Treatments of Complex Dermatological Conditions at the 28th Annual European Academy of Dermatology and Venereology (EADV) Congress

Tue October 8, 2019 6:45 AM|PR Newswire|About: INCY, LLYPR Newswire

INDIANAPOLIS, Oct. 8, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY)

Lilly to Unveil New Data for the Treatments of Complex Dermatological Conditions at the 28th Annual European Academy of Dermatology and Venereology (EADV) Congress 10/08/2019 Research from Taltz®, Olumiant® and mirikizumab highlight the impact Lilly's medicines may have for patients around the world INDIANAPOLIS, Oct. 8, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)

BEOVU® (brolucizumab-dbll) injection

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Novartis receives FDA approval for BEOVU®, offering wet AMD patients vision gains and greater fluid reductions vs aflibercept

Tue October 8, 2019 7:15 AM|PR Newswire

- BEOVU demonstrated greater reductions in central subfield thickness (CST, a key indicator of fluid in the retina) as early as week 16 and at one year versus aflibercept[2]

- BEOVU is the only anti-VEGF in wet AMD recommended to maintain eligible patients on up to three-month dosing intervals immediately after the loading phase with no compromise in efficacy[1,2]

- In both clinical trials, at year one over half of patients were maintained on the three-month dosing interval (56% in HAWK and 51% in HARRIER)[1,2]

- Frequent injection intervals are a common reason patients drop off treatment for wet age-related macular degeneration (AMD), a leading cause of blindness, affecting more than 20M people worldwide[3-5]

PR Newswire

EAST HANOVER, N.J., Oct. 8, 2019 /PRNewswire/ 

Novartis receives FDA approval for BEOVU®, offering wet AMD patients vision gains and greater fluid reductions vs aflibercept

EVENITY® (romosozumab)

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Health Canada Approves EVENITY® For the Treatment of Osteoporosis in Postmenopausal Women at High Risk for Fracture

Tue October 8, 2019 8:00 AM|Canada Newswire|About: AMGN

MISSISSAUGA, ON, Oct. 8, 2019 /CNW/ - Today Amgen (AMGN) Canada

EVENITY™ is a prescription medicine used to treat osteoporosis in women after menopause who are at high risk of fracture, or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.

KEYTRUDA® (pembrolizumab)

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Keytruda on path to become world's no. 1 selling drug, research firm says

Oct. 4, 2019 7:01 PM ET|About: Merck & Co., Inc. (MRK)|By: , SA News Editor 


 https://www.keytruda.com/ 

Keytruda Set to Become World’s Top-Selling Drug, Forecast Shows Published: Oct 04, 2019 By Alex Keown

Seeking Biotech Alpha Sept & Oct 2019 Insight

INGREZZA® (valbenazine)

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Neurocrine Biosciences Presents New Data Analyses Demonstrating Long-Term Effects of INGREZZA® (valbenazine) 40 mg Once-Daily in Patients with Tardive Dyskinesia at the 2019 Annual Psych Congress

Fri October 4, 2019 6:00 PM|PR Newswire|About: NBIX

- Data Analysis Indicates that INGREZZA Improved Tardive Dyskinesia Movements as Early as Two Weeks in 50% of Patients

- Long-Term Meaningful Reductions in Tardive Dyskinesia Movement Severity Were Demonstrated Regardless of Whether Patients Responded After Two Weeks

PR Newswire

SAN DIEGO, Oct. 4, 2019 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NBIX)


 https://www.prnewswire.com/news-releases/neurocrine-biosciences-presents-new-data-analyses-demonstrating-long-term-effects-of-ingrezza-valbenazine-40-mg-once-daily-in-patients-with-tardive-dyskinesia-at-the-2019-annual-psych-congress-300931489.html 

INGREZZA® (valbenazine) capsules is a prescription medicine used to treat adults with movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

Investigational KRAS(G12C) Inhibitor

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Amgen Announces New Clinical Data Evaluating Novel Investigational KRAS(G12C) Inhibitor In Patients With Solid Tumors At ESMO 2019

Sat September 28, 2019 1:00 AM|PR Newswire|About: AMGNPR Newswire

THOUSAND OAKS, Calif., Sept. 27, 2019 /PRNewswire/ -- Amgen (AMGN)


 https://www.prnewswire.com/news-releases/amgen-announces-new-clinical-data-evaluating-novel-investigational-krasg12c-inhibitor-in-patients-with-solid-tumors-at-esmo-2019-300927215.html 

Amgen Announces New Clinical Data Evaluating Novel Investigational KRAS(G12C) Inhibitor In Larger Patient Group At WCLC 2019 54% of 13 Evaluable Non-Small Cell Lung Cancer Patients Experienced a Partial Response at the Target Dose of 960 mg in the Ongoing Phase 1 Study 46% of Patients had Stable Disease for a Disease Control Rate of 100% at the Target Dose FDA Grants AMG 510 Fast Track Designation for Previously Treated Metastatic NSCLC With KRAS G12C Mutation THOUSAND OAKS, Calif., Sept. 8, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN)

LYNPARZA (olaparib)

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LYNPARZA (olaparib) Improved the Time Women Lived Without Disease Progression to 22 Months in the Broad Population and 37 Months in HRD-positive Patients as 1st-line Maintenance Treatment with Bevacizumab for Newly Diagnosed Advanced Ovarian Cancer

Sat September 28, 2019 12:23 PM|Business Wire|About: AZN

AstraZeneca and Merck’s LYNPARZA added to bevacizumab reduced the risk of disease progression or death by 41% in the overall trial population

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) 

LYNPARZA is a prescription medicine used to treat adults who have: advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, as maintenance treatment, when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy advanced ovarian cancer with a certain type of abnormal inherited BRCA gene, and have received treatment with 3 or more prior types of chemotherapy medicines. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you a certain type of abnormal inherited BRCA gene, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic). You should have received chemotherapy medicines, either before or after your cancer has spread. If you have hormone receptor (HR)-positive disease, you should have been treated with hormonal therapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you

TAGRISSO

TAGRISSO Is the Only 1st-line Treatment for EGFR-Mutated Non-Small Cell Lung Cancer to Deliver a Med

 

TAGRISSO Is the Only 1st-line Treatment for EGFR-Mutated Non-Small Cell Lung Cancer to Deliver a Median Overall Survival of More Than Three Years

Sat September 28, 2019 12:48 PM|Business Wire|About: AZN

28% of patients in the global FLAURA trial were still receiving TAGRISSO at three years vs. 9% on either gefitinib or erlotinib

TAGRISSO showed a 52% reduction in risk of central nervous system disease progression or death

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca


 https://www.businesswire.com/news/home/20190928005023/en/ 

TAGRISSO is a targeted therapy for EGFR+ lung cancer TAGRISSO is a once-daily prescription medicine for people with metastatic non-small cell lung cancer with certain types of abnormal EGFR genes.* *For tumors with EGFR exon 19 deletions or exon 21 (L858R) mutations, as detected by an FDA-approved test.

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)

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Final Study Results Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Combination Treatment in Advanced Endometrial Cancer Presented at ESMO 2019 Congress

Sun September 29, 2019 2:30 AM|Business Wire|About: MRK

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


 https://www.businesswire.com/news/home/20190928005025/en/ 

FDA Approves KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma SEPTEMBER 17, 2019 Combination Treatment Approved for Patients with Advanced Endometrial Carcinoma That Is Not Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR), Who Have Disease Progression Following Prior Systemic Therapy and Are Not Candidates for Curative Surgery or Radiation Under New FDA-Initiated Program, Combination Treatment Is the First to Receive Simultaneous Review Decisions in the U.S., Australia and Canada KENILWORTH, N.J., & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisa

Selpercatinib (LOXO-292)

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Lilly Announces Positive Registrational Data for Selpercatinib (LOXO-292) in Heavily Pretreated RET-Altered Thyroid Cancers

Sun September 29, 2019 10:30 AM|PR Newswire|About: LLY

- 56 percent objective response rate (ORR) in the registration dataset (n=55) of RET-mutant medullary thyroid cancer (MTC) patients who had previously received cabozantinib and/or vandetanib

- 59 percent ORR in cabozantinib/vandetanib-naïve RET-mutant MTC patients

- 62 percent ORR in heavily pretreated RET fusion-positive thyroid cancer patients

- Sustained durability, measured by both Duration of Response and Progression-Free Survival

- Well-tolerated safety profile; low rate of discontinuation (1.7%) for treatment-related adverse events

- New Drug Application to be submitted by year-end

PR Newswire

INDIANAPOLIS, Sept. 29, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY)

Lilly Announces Positive Registrational Data for Selpercatinib (LOXO-292) in Heavily Pretreated RET-Altered Thyroid Cancers 09/29/2019 INDIANAPOLIS, Sept. 29, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)

Seeking Biotech Alpha Sept & Oct 2019 Insight

BRAFTOVI® (Encorafenib), MEKTOVI® (Binimetinib) and Cetuximab

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Pfizer Presents Interim Analysis Results from Phase 3 BEACON CRC Trial of BRAFTOVI® (Encorafenib), MEKTOVI® (Binimetinib) and Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer

Mon September 30, 2019 2:30 AM|Business Wire|About: PFE

- Results to be presented during a late-breaking oral session at the 2019 ESMO Congress and simultaneously published in The New England Journal of Medicine –

- As previously announced, BRAFTOVI combinations showed statistically significant improvements in OS and ORR versus control –

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


 https://www.businesswire.com/news/home/20190929005046/en/ 

BRAFTOVI and MEKTOVI are prescription medicines used together to treat people with a type of skin cancer called melanoma: that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal “BRAF” gene BRAFTOVI should not be used to treat people with wild-type BRAF melanoma. Your healthcare provider will perform a test to make sure that BRAFTOVI + MEKTOVI is right for you. It is not known if BRAFTOVI or MEKTOVI is safe

Jevtana® (cabazitaxel)

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New England Journal of Medicine publishes data showing improved survival with Jevtana® (cabazitaxel) over second androgen receptor-targeted agent in metastatic castration-resistant prostate cancer

Mon September 30, 2019 10:30 AM|PR Newswire|About: SNY

- Jevtana more than doubled radiographic progression-free survival (primary endpoint) and significantly reduced risk of death (key secondary endpoint) by 36%

- Study results presented during Presidential Symposium at the 2019 European Society of Medical Oncology Congress

PR Newswire

PARIS, Sept. 30, 2019 /PRNewswire/ -


 https://www.prnewswire.com/news-releases/new-england-journal-of-medicine-publishes-data-showing-improved-survival-with-jevtana-cabazitaxel-over-second-androgen-receptor-targeted-agent-in-metastatic-castration-resistant-prostate-cancer-300927039.html 

JEVTANA is a prescription anti-cancer medicine used with the steroid medicine prednisone. JEVTANA is used to treat men with castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone) that has worsened (progressed) after treatment with other medicines, including docetaxel.

DIFICID® (fidaxomicin)

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FDA Accepts Two Applications for Merck’s DIFICID® (fidaxomicin) to Treat Children Aged Six Months Up to 18 years with Clostridium difficile Infections

Wed October 2, 2019 6:30 AM|Business Wire|About: MRK

DIFICID® Pediatric Filings Receive Priority Review Classification

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


 https://www.businesswire.com/news/home/20191002005132/en/ 

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

KEYTRUDA® (pembrolizumab)

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Merck’s KEYTRUDA® (pembrolizumab) Now Approved as Monotherapy in China for First-Line Treatment of Certain Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Express PD-L1

Wed October 2, 2019 6:45 AM|Business Wire|About: MRK

KEYTRUDA is First Anti-PD-1 Therapy Approved as Monotherapy and in Combination with Chemotherapy in First-Line Setting for NSCLC in China

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


 https://www.businesswire.com/news/home/20191002005162/en/ 


 https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf 

Merck’s KEYTRUDA® (pembrolizumab) Now Approved as Monotherapy in China for First-Line Treatment of Certain Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Express PD-L1 KEYTRUDA is First Anti-PD-1 Therapy Approved as Monotherapy and in Combination with Chemotherapy in First-Line Setting for NSCLC in China Wednesday, October 2, 2019 6:45 am EDT

EMGALITY™ (galcanezumab)

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EMGALITY™ (galcanezumab) now available in Canada for preventive treatment of migraine

Wed October 2, 2019 11:45 AM|Canada Newswire|About: LLY

New anti-CGRP treatment for the prevention of migraine in adults
with at least 4 migraine days per month1

TORONTO, Oct. 2, 2019 /CNW/ - Eli Lilly Canada Inc. (Lilly Canada



Emgality is a prescription medicine used in adults for: The preventive treatment of migraine. The medicine (120 mg) comes in a prefilled pen or syringe and is taken once a month. The treatment of episodic cluster headache. The medicine (300 mg) comes in three (100 mg) prefilled syringes, which are taken one after the other at the start of a cluster period and then every month until the end of the cluster period.

Opdivo (nivolumab)

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Bristol-Myers Squibb Announces Pooled Five-Year Survival Results for Opdivo (nivolumab) in Previously-Treated Advanced Non-Small Cell Lung Cancer Patients

Tue September 10, 2019 5:30 AM|Business Wire|About: BMY

Longest survival follow-up from a pooled analysis of randomized Phase 3 trials of an Immuno-Oncology therapy in this setting demonstrated a greater than five-fold increase in five-year overall survival rates; 13.4% for Opdivo and 2.6% for docetaxel

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


 https://www.businesswire.com/news/home/20190910005328/en/ 

For people with previously treated advanced non-small cell lung cancer OPDIVO® (nivolumab) is a prescription medicine used to treat people with a type of advanced stage lung cancer (called non-small cell lung cancer) that has spread or grown and you have tried chemotherapy that contains platinum, and it did not work or is no longer working. If your tumor has an abnormal EGFR or ALK gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working. For people with previously treated advanced small cell lung cancer OPDIVO® (nivolumab) is a prescription medicine used to treat people with a type of advanced stage lung cancer (called small cell lung cancer) that has spread or grown and you have tried at least two different types of chemotherapy, including one that contains platinum, and it did not work or is no longer working. OPDIVO was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO for this use. For people with advanced melanoma OPDIVO® (nivolumab) is a prescription medicine used to treat people with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma). OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat people with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma). OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

Seeking Biotech Alpha Sept & Oct 2019 Insight

Verzenio® (abemaciclib)

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Verzenio® (abemaciclib) Significantly Extends Life by a Median of 9.4 Months for Women with HR+, HER2- Advanced Breast Cancer in MONARCH 2 Study

Sun September 29, 2019 10:30 AM|PR Newswire|About: LLY

Overall survival results were consistent across subgroups, including in women with poor prognostic factors - whose cancer quickly returned or spread to their organs, such as liver or lungs

Data presented at the European Society for Medical Oncology (ESMO) 2019 Congress in the Presidential Symposium and simultaneously published in JAMA Oncology

PR Newswire

INDIANAPOLIS, Sept. 29, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY)


 https://www.prnewswire.com/news-releases/verzenio-abemaciclib-significantly-extends-life-by-a-median-of-9-4-months-for-women-with-hr-her2--advanced-breast-cancer-in-monarch-2-study-300927340.html 

Verzenio is a prescription medicine used to treat a type of breast cancer. It is a medicine you can take if: You have a type of breast cancer called HR+/HER2– (hormone receptor positive/human epidermal growth factor receptor 2–negative) and the cancer has spread to other parts of the body (metastasized) Verzenio is given along with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women, along with fulvestrant in women whose disease has progressed after hormonal therapy, or by itself in adults whose disease has progressed after hormone therapy and prior chemotherapy

RECARBRIO™ (imipenem, cilastatin, and relebactam)

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Pivotal RESTORE-IMI 2 Phase 3 Study of Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) in Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) Met Primary Endpoint

Mon September 30, 2019 6:45 AM|Business Wire|About: MRK

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

Pivotal RESTORE-IMI 2 Phase 3 Study of Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) in Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) Met Primary Endpoint Monday, September 30, 2019 6:45 am EDT

investigational Abicipar and Bimatoprost Sustained Release (SR)

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Allergan to Showcase Late-Stage Data in Age-Related Macular Degeneration and Glaucoma at American Academy of Ophthalmology Annual Meeting

Thu October 3, 2019 7:30 AM|PR Newswire|About: AGNPR Newswire

DUBLIN, Oct. 3, 2019 /PRNewswire/ -- Allergan plc, (AGN)


 https://www.prnewswire.com/news-releases/allergan-to-showcase-late-stage-data-in-age-related-macular-degeneration-and-glaucoma-at-american-academy-of-ophthalmology-annual-meeting-300930350.html 

Allergan to Showcase Late-Stage Data in Age-Related Macular Degeneration and Glaucoma at American Academy of Ophthalmology Annual Meeting - Presentations include a late-breaking Abicipar abstract and topline Phase 3 results of Bimatoprost SR - DUBLIN, Oct. 3, 2019 /PRNewswire/ -- Allergan plc, (NYSE: AGN)

CYRAMZA® (ramucirumab)

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Lilly's CYRAMZA® (ramucirumab) Phase 3 Data in First-Line EGFR-Mutated Non-Small Cell Lung Cancer Published in The Lancet Oncology

Mon October 7, 2019 6:45 AM|PR Newswire|About: LLYPR Newswire

INDIANAPOLIS, Oct. 7, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY)


 https://www.prnewswire.com/news-releases/lillys-cyramza-ramucirumab-phase-3-data-in-first-line-egfr-mutated-non-small-cell-lung-cancer-published-in-the-lancet-oncology-300932733.html 

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

InterStim™ Micro Neurostimulator and SureScan™ MRI Leads

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Medtronic Announces FDA Submission for InterStim™ Micro Neurostimulator and SureScan™ MRI Leads

Mon October 7, 2019 8:00 AM|GlobeNewswire|About: MDT

Smaller, Rechargeable Device Will Provide More Choices for Patients Suffering with 
Bladder and Bowel Control Issues

SureScan™ MRI Leads Will Provide Full-Body MRI Conditional Labeling

DUBLIN, Oct. 07, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (MDT)



Medtronic Announces FDA Submission for InterStim™ Micro Neurostimulator and SureScan™ MRI Leads Smaller, Rechargeable Device Will Provide More Choices for Patients Suffering with Bladder and Bowel Control Issues SureScan™ MRI Leads Will Provide Full-Body MRI Conditional Labeling DUBLIN, Oct. 07, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT)

REFRESH® RELIEVA™ Lubricant Eye Drop Product Line

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Allergan Expands REFRESH® Portfolio With New REFRESH® RELIEVA™ Lubricant Eye Drop Product Line

Mon October 7, 2019 7:30 AM|PR Newswire|About: AGNPR Newswire

DUBLIN, Oct. 7, 2019 /PRNewswire/ -- Allergan plc (AGN), 


 https://www.prnewswire.com/news-releases/allergan-expands-refresh-portfolio-with-new-refresh-relieva-lubricant-eye-drop-product-line-300931148.html 

THERE'S RELIEF AND THEN THERE'S RELIEVA™ REFRESH® RELIEVA™ is available in preserved, preservative-free multidose, and a formula for contact lens wearers. The trio is specially formulated to relieve discomfort due to eye dryness and prevent further irritation. It features our proprietary HydroCell™ technology, which enables hydration and maintains the volume of cells on the ocular surface.

Seeking Biotech Alpha Sept & Oct 2019 Insight

Blincyto (blinatumomab)

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Amgen Announces Positive Results From Two Phase 3 BLINCYTO® (blinatumomab) Studies In Pediatric Patients With Relapsed Acute Lymphoblastic Leukemia

Phase 3 '215 and Children's Oncology Group (COG) Studies Both Stopped Early Due to Treatment Benefit of BLINCYTO Over Chemotherapy  

THOUSAND OAKS, Calif., Sept. 24, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN)

BLINCYTO® (blinatumomab) is a prescription medicine used to treat B-cell precursor acute lymphoblastic leukemia (ALL) in patients who still have detectable traces of cancer after chemotherapy. The approval of BLINCYTO® in these patients is based on a study that measured response rate and duration of response. There are ongoing studies to confirm clinical benefit.

MAVYRET® (glecaprevir/pibrentasvir)

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 September 26, 2019

AbbVie Receives FDA Approval of MAVYRET® (glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks for Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis Across All Genotypes

  MAVYRET® (glecaprevir/pibrentasvir) is now available as the only 8-week pan-genotypic treatment option for treatment-naïve chronic hepatitis C (HCV) patients, without cirrhosis or with compensated cirrhosis* †
- FDA approval is supported by an overall 98 percent cure** rate across this patient population[1]

NORTH CHICAGO, Ill., Sept. 26, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV)

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

Tecentriq (atezolizumab) and Avastin (bevacizumab)

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Roche's Tecentriq + Avastin shows positive effect in early-stage liver cancer study

Sep. 27, 2019 9:11 AM ET|About: Roche Holding AG (RHHBY)|By: , SA News Editor  


 https://www.roche.com/media/releases/med-cor-2019-09-27.htm 

TECENTRIQ is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: Are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (PD-L1–stained tumor-infiltrating immune cells [IC] covering ≥5% of the tumor area), as determined by an FDA-approved test, or Are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status, or Have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Metastatic non-small cell lung cancer TECENTRIQ, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous, non-small cell lung cancer (nsqNSCLC) with no EGFR or ALK genomic tumor aberrations. TECENTRIQ, as a single agent, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ. Metastatic triple-negative breast cancer TECENTRIQ, in combination with paclitaxel protein-bound, is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1–stained tumor-infiltrating immune cells [IC] of any intensity covering ≥1% of the tumor area), as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Extensive-stage small cell lung cancer TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). ALK=anaplastic lymphoma kinase; EGFR=epidermal growth factor receptor; PD-L1=programmed death-ligand 1.

Enfortumab Vedotin in Combination with Immune Therapy Pembrolizumab

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Seattle Genetics and Astellas Announce Results from Phase 1 Trial of Investigational Agent Enfortumab Vedotin in Combination with Immune Therapy Pembrolizumab as First-Line Treatment for Advanced Bladder Cancer

Sat September 28, 2019 2:30 AM|PR Newswire|About: ALPMY, SGEN

- Findings Presented Today at an Oral Session at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona -

PR Newswire

BOTHELL, Wash. and TOKYO, Sept. 28, 2019 /PRNewswire/ -- Seattle Genetics, Inc. (SGEN) (Nasdaq: SGEN) and Astellas Pharma Inc. (ALPMF)



 https://www.prnewswire.com/news-releases/seattle-genetics-and-astellas-announce-results-from-phase-1-trial-of-investigational-agent-enfortumab-vedotin-in-combination-with-immune-therapy-pembrolizumab-as-first-line-treatment-for-advanced-bladder-cancer-300927171.html 

Enfortumab vedotin is an antibody-drug conjugate (ADC) composed of an anti-Nectin-4 monoclonal antibody attached to our synthetic cell-killing agent, monomethyl auristatin E (MMAE), a microtubule-disrupting agent, using our proprietary linker technology. Enfortumab vedotin is the first agent to target Nectin-4, which is expressed on many solid tumors, with especially uniform expression on bladder cancers. Preclinical studies showed that enfortumab vedotin effectively binds to target cells, internalizes and induces cell-killing activity. We are co-developing enfortumab vedotin with Astellas.

INVOKANA® (canagliflozin)

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U.S. FDA Approves INVOKANA® (canagliflozin) to Treat Diabetic Kidney Disease (DKD) and Reduce the Risk of Hospitalization for Heart Failure in Patients with Type 2 Diabetes (T2D) and DKD

Mon September 30, 2019 8:30 AM|PR Newswire

Approval is based on the landmark Phase 3 CREDENCE renal outcomes study - the only completed renal outcomes study of a diabetes medicine

PR Newswire

RARITAN, N.J., Sept. 30, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson 


 https://www.prnewswire.com/news-releases/us-fda-approves-invokana-canagliflozin-to-treat-diabetic-kidney-disease-dkd-and-reduce-the-risk-of-hospitalization-for-heart-failure-in-patients-with-type-2-diabetes-t2d-and-dkd-300927348.html 

INVOKANA® is a prescription medicine used: along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes who have known cardiovascular disease to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic kidney disease (nephropathy) with a certain amount of protein in

Rituxan (rituximab)

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FDA OKs Roche's Rituxan for rare blood vessel inflammation diseases

Sep. 27, 2019 1:53 PM ET|About: Roche Holding AG (RHHBY)|By: , SA News Editor 


 https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-children-rare-diseases-cause-inflammation-small-blood-vessels 

RITUXAN® (rituximab) is a prescription medicine used to treat adults with: Non-Hodgkin’s Lymphoma (NHL): alone or with other chemotherapy medicines. Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide.
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MOM

IT IS SO

 

It Is So

Cancer took my mom in 1998. She died of throat/thyroid cancer at the age of 67. On September 29, 2019 this article appeared in Seeking Alpha with the following headline = "Lilly Announces Positive Registrational Data for Selpercatinib (LOXO-292) in Heavily Pretreated RET-Altered Thyroid Cancers" 

Sun September 29, 2019 10:30 AM|PR Newswire About: LLY

 

Lilly Announces Positive Registrational Data for Selpercatinib (LOXO-292) in Heavily Pretreated RET-Altered Thyroid Cancers

Lilly Announces Positive Registrational Data for Selpercatinib (LOXO-292) in Heavily Pretreated RET-Altered Thyroid Cancers | Eli Lilly and Company

It Is So

 Regardless of the Politicos, irrespective of all the negative political commentary, these are extraordinary times for the development of new medicines for the entire biotech industry. And many of these medicines target cancer. 

It Is So Oct. 8, 2019 1:17 PM ET|About: Eli Lilly and Company (LLY), Includes: AMGN, AZN, BMY, CELG, GILD, JNJ, MDT, MRK