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 



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 


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 

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/ 



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/ 



Seeking Biotech Alpha October 2019 Insight

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/ 

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 



Seeking Biotech Alpha October 2019 Insight

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 

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 



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 

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 

Seeking Biotech Alpha October 2019 Insight

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/ 

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/ 

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/ 





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 

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 

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 

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 

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/ 

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/ 

Seeking Biotech Alpha October 2019 Insight

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/ 

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/ 

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/ 

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/ 

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/ 

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 

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 

Seeking Biotech Alpha October 2019 Insight

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/ 

Symdeko (tezacaftor/ivacaftor and ivacaftor)

image240

 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/ 

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/ 

Seeking Biotech Alpha October 2019 Insight

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/ 

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/ 


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 

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 

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/ 

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 

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 

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/ 

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)

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 

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 

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 

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)

(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

[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/ 

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

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)

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 

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)

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)

imetelstat, a first-in-class telomerase inhibitor

image272

 

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

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)

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)

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

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)

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 

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/ 

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)

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/ 

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

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/ 

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 

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) 

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/ 

Selpercatinib (LOXO-292)

image287

 

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)

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/ 

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 

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/ 

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 

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



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 

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

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)



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)

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)

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.
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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.