Moorestown, New Jersey, United States
Seeking Biotech Alpha October 2019 Insight
TRIKAFTA™ (elexacaftor/tezacaftor/ivacaftor and ivacaftor)
XIFAXAN® (rifaximin) 550 mg tablets to treat symptoms of Irritable Bowel Syndrome (IBS)
TRIKAFTA™ (elexacaftor/tezacaftor/ivacaftor and ivacaftor)
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
XIFAXAN® (rifaximin) 550 mg tablets to treat symptoms of Irritable Bowel Syndrome (IBS)
TRIKAFTA™ (elexacaftor/tezacaftor/ivacaftor and ivacaftor)
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)
XIFAXAN® (rifaximin) 550 mg tablets to treat symptoms of Irritable Bowel Syndrome (IBS)
XIFAXAN® (rifaximin) 550 mg tablets to treat symptoms of Irritable Bowel Syndrome (IBS)
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"
filgotinib
UVADEX® (Methoxsalen)
XIFAXAN® (rifaximin) 550 mg tablets to treat symptoms of Irritable Bowel Syndrome (IBS)
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/
UVADEX® (Methoxsalen)
UVADEX® (Methoxsalen)
UVADEX® (Methoxsalen)
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)
Hemlibra®
UVADEX® (Methoxsalen)
UVADEX® (Methoxsalen)
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
Satralizumab
VUMERITY™ (diroximel fumarate)
VUMERITY™ (diroximel fumarate)
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/
VUMERITY™ (diroximel fumarate)
VUMERITY™ (diroximel fumarate)
VUMERITY™ (diroximel fumarate)
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)
Roxadustat
VUMERITY™ (diroximel fumarate)
AMG 510, a small molecule inhibitor of KRASG12C
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/
AMG 510, a small molecule inhibitor of KRASG12C
AMG 510, a small molecule inhibitor of KRASG12C
AMG 510, a small molecule inhibitor of KRASG12C
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
Impella 5.5™ with SmartAssist®
AMG 510, a small molecule inhibitor of KRASG12C
Impella 5.5™ with SmartAssist®
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/
RINVOQ™ (upadacitinib)
AMG 510, a small molecule inhibitor of KRASG12C
Impella 5.5™ with SmartAssist®
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://clinicaltrials.gov/ct2/show/NCT03104374
Seeking Biotech Alpha October 2019 Insight
HTX-011
Imfinzi and Imfinzi plus tremelimumab
BAVENCIO® (avelumab)
BAVENCIO® (avelumab)
Imfinzi and Imfinzi plus tremelimumab
BAVENCIO® (avelumab)
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/
Imfinzi and Imfinzi plus tremelimumab
Imfinzi and Imfinzi plus tremelimumab
GSK candidate vaccine sustained level of protection against active pulmonary tuberculosis
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: Douglas W. House, SA News Editor
https://clinicaltrials.gov/ct2/show/NCT03164616?titles=poseidon&lead=astrazeneca&draw=2&rank=1
GSK candidate vaccine sustained level of protection against active pulmonary tuberculosis
GSK candidate vaccine sustained level of protection against active pulmonary tuberculosis
GSK candidate vaccine sustained level of protection against active pulmonary tuberculosis
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: Douglas W. House, SA News Editor
https://clinicaltrials.gov/ct2/show/NCT01755598?term=NCT01755598&rank=2
https://clinicaltrials.gov/ct2/show/NCT02097095?term=NCT02097095&rank=1
Dupixent® (dupilumab)
GSK candidate vaccine sustained level of protection against active pulmonary tuberculosis
Bavencio (avelumab), combined with Inlyta (axitinib)
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
Bavencio (avelumab), combined with Inlyta (axitinib)
GSK candidate vaccine sustained level of protection against active pulmonary tuberculosis
Bavencio (avelumab), combined with Inlyta (axitinib)
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.pfizer.com/products
Seeking Biotech Alpha October 2019 Insight
LUXTURNA® (voretigene neparvovec-rzyl).
FDA Post Approval Study Demonstrates Timely Identification of Right Heart Failure
FDA Post Approval Study Demonstrates Timely Identification of Right Heart Failure
FDA Post Approval Study Demonstrates Timely Identification of Right Heart Failure
FDA Post Approval Study Demonstrates Timely Identification of Right Heart Failure
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
ADUCANUMAB
FDA Post Approval Study Demonstrates Timely Identification of Right Heart Failure
evaluating gepotidacin, a new antibiotic = triazaacenaphthylene bacterial topoisomerase inhibitors
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
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.
evaluating gepotidacin, a new antibiotic = triazaacenaphthylene bacterial topoisomerase inhibitors
Gilead & Glympse Bio - Strategic Collaboration for Biomarker Technology in NASH Clinical Development
evaluating gepotidacin, a new antibiotic = triazaacenaphthylene bacterial topoisomerase inhibitors
Glaxo launches late-stage development of antibiotic gepotidacin
Oct. 28, 2019 8:36 AM ET|About: GlaxoSmithKline plc (GSK)|By: Douglas W. House, 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
Gilead & Glympse Bio - Strategic Collaboration for Biomarker Technology in NASH Clinical Development
Gilead & Glympse Bio - Strategic Collaboration for Biomarker Technology in NASH Clinical Development
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/
ZW25 in Combination with Chemotherapy
Gilead & Glympse Bio - Strategic Collaboration for Biomarker Technology in NASH Clinical Development
Gilead & Glympse Bio - Strategic Collaboration for Biomarker Technology in NASH Clinical Development
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)
Varian Ethos™ therapy solutions
BOTOX® (onabotulinumtoxinA)
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/
BOTOX® (onabotulinumtoxinA)
Varian Ethos™ therapy solutions
BOTOX® (onabotulinumtoxinA)
Varian Ethos™ therapy solutions
Varian Ethos™ therapy solutions
Clearside Biomedical's XIPERE™ (Triamcinolone Acetonide Suprachoroidal Injectable Suspension)
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/
Clearside Biomedical's XIPERE™ (Triamcinolone Acetonide Suprachoroidal Injectable Suspension)
Fiasp® Rapid Acting Insulin for Adults Now Approved for Use With the Omnipod Insulin Management
Clearside Biomedical's XIPERE™ (Triamcinolone Acetonide Suprachoroidal Injectable Suspension)
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)
Repatha® (evolocumab)
Fiasp® Rapid Acting Insulin for Adults Now Approved for Use With the Omnipod Insulin Management
Fiasp® Rapid Acting Insulin for Adults Now Approved for Use With the Omnipod Insulin Management
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)
Fiasp® Rapid Acting Insulin for Adults Now Approved for Use With the Omnipod Insulin Management
Fiasp® Rapid Acting Insulin for Adults Now Approved for Use With the Omnipod Insulin Management
Fiasp® Rapid Acting Insulin for Adults Now Approved for Use With the Omnipod Insulin Management
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
Seeking Biotech Alpha October 2019 Insight
Zolgensma (anasemnogene abeparvovec-xioi)
First-Ever Noninvasive Nasal Swab Test Can Enable Early Lung Cancer Detection
First-Ever Noninvasive Nasal Swab Test Can Enable Early Lung Cancer Detection
Novartis off to strong start with Zolgensma
Oct. 22, 2019 8:43 AM ET|About: Novartis AG (NVS)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/article/4297779-novartis-ag-2019-q3-results-earnings-call-presentation
First-Ever Noninvasive Nasal Swab Test Can Enable Early Lung Cancer Detection
First-Ever Noninvasive Nasal Swab Test Can Enable Early Lung Cancer Detection
First-Ever Noninvasive Nasal Swab Test Can Enable Early Lung Cancer Detection
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)
Propionic Acidemia Program (mRNA-3927)
First-Ever Noninvasive Nasal Swab Test Can Enable Early Lung Cancer Detection
Propionic Acidemia Program (mRNA-3927)
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),
Zejula (niraparib)
Varian ProBeam 360 Proton Therapy System Selected by Penn Medicine
Propionic Acidemia Program (mRNA-3927)
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.tesarobio.com/products/zejula-niraparib
https://www.zejula.com/prescribing-information
Varian ProBeam 360 Proton Therapy System Selected by Penn Medicine
Varian ProBeam 360 Proton Therapy System Selected by Penn Medicine
Varian ProBeam 360 Proton Therapy System Selected by Penn Medicine
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.varian.com/oncology/products/treatment-delivery/probeam-360-proton-therapy-system
Varian ProBeam 360 System Selected by The Ohio State University
Varian ProBeam 360 Proton Therapy System Selected by Penn Medicine
Varian ProBeam 360 Proton Therapy System Selected by Penn Medicine
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.varian.com/oncology/products/treatment-delivery/probeam-360-proton-therapy-system
Seeking Biotech Alpha October 2019 Insight
Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab)
aducanumab, an investigational treatment for early Alzheimer’s disease (AD)
aducanumab, an investigational treatment for early Alzheimer’s disease (AD)
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
aducanumab, an investigational treatment for early Alzheimer’s disease (AD)
aducanumab, an investigational treatment for early Alzheimer’s disease (AD)
aducanumab, an investigational treatment for early Alzheimer’s disease (AD)
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
TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor)
aducanumab, an investigational treatment for early Alzheimer’s disease (AD)
Fiasp® (insulin aspart injection) 100 u/mL to include use in insulin infusion pumps
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/
Fiasp® (insulin aspart injection) 100 u/mL to include use in insulin infusion pumps
Fiasp® (insulin aspart injection) 100 u/mL to include use in insulin infusion pumps
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.novo-pi.com/fiasp.pdf
CINVANTI (aprepitant) injectable emulsion for intravenous (IV) use
Fiasp® (insulin aspart injection) 100 u/mL to include use in insulin infusion pumps
CINVANTI (aprepitant) injectable emulsion for intravenous (IV) use
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)
Aetna Medicare Advantage
Fiasp® (insulin aspart injection) 100 u/mL to include use in insulin infusion pumps
CINVANTI (aprepitant) injectable emulsion for intravenous (IV) use
.
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
Seeking Biotech Alpha October 2019 Insight
FARXIGA (dapagliflozin)
FLIXABI™ (infliximab) and IMRALDI™ (adalimumab)
FARXIGA (dapagliflozin)
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.businesswire.com/news/home/20191021005194/en/
https://www.azpicentral.com/farxiga/farxiga_med.pdf#page=1
tucatinib
FLIXABI™ (infliximab) and IMRALDI™ (adalimumab)
FARXIGA (dapagliflozin)
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)
FLIXABI™ (infliximab) and IMRALDI™ (adalimumab)
FLIXABI™ (infliximab) and IMRALDI™ (adalimumab)
FLIXABI™ (infliximab) and IMRALDI™ (adalimumab)
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
Symdeko (tezacaftor/ivacaftor and ivacaftor)
ALKS 4230 is a novel, engineered fusion protein
FLIXABI™ (infliximab) and IMRALDI™ (adalimumab)
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
STELARA® (ustekinumab)
ALKS 4230 is a novel, engineered fusion protein
ALKS 4230 is a novel, engineered fusion protein
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/
ALKS 4230 is a novel, engineered fusion protein
ALKS 4230 is a novel, engineered fusion protein
ALKS 4230 is a novel, engineered fusion protein
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.fredhutch.org/en.html
http://www.alkermes.com/research-and-development/pipeline
Seeking Biotech Alpha October 2019 Insight
Nplate® (romiplostim)
Toujeo (previously Optisulin)
Nplate® (romiplostim)
KALYDECO® (ivacaftor)
Toujeo (previously Optisulin)
Nplate® (romiplostim)
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
Toujeo (previously Optisulin)
Toujeo (previously Optisulin)
Toujeo (previously Optisulin)
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.
ULTOMIRIS® (ravulizumab-cwvz)
Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab)
Toujeo (previously Optisulin)
.
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)
GENOTROPIN® (somatropin) for injection
Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab)
Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab)
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)
Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab)
Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab)
Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab)
.
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/
Seeking Biotech Alpha October 2019 Insight
RINVOQ™ (upadacitinib)
KEYTRUDA® (pembrolizumab)
DARZALEX® (daratumumab)
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)
DARZALEX® (daratumumab)
KEYTRUDA® (pembrolizumab)
DARZALEX® (daratumumab)
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)
KEYTRUDA® (pembrolizumab)
ERVEBO® V920 Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live)
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
ERVEBO® V920 Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live)
ERVEBO® V920 Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live)
ERVEBO® V920 Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live)
EVENITY® (Romosozumab)
ERVEBO® V920 Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live)
EVENITY® (Romosozumab)
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)
Baqsimi (glucagon)
ERVEBO® V920 Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live)
EVENITY® (Romosozumab)
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.
Seeking Biotech Alpha October 2019 Insight
t:slim X2 Insulin Pump with Control-IQ Technology
t:slim X2 Insulin Pump with Control-IQ Technology
t:slim X2 Insulin Pump with Control-IQ Technology
Xofluza™ (baloxavir marboxil)
t:slim X2 Insulin Pump with Control-IQ Technology
t:slim X2 Insulin Pump with Control-IQ Technology
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)
ELIDEL® (pimecrolimus cream1%)
t:slim X2 Insulin Pump with Control-IQ Technology
GI Genius™ intelligent endoscopy module
GI Genius™ intelligent endoscopy module
GI Genius™ intelligent endoscopy module
GI Genius™ intelligent endoscopy module
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
Spravato (esketamine) nasal spray
GI Genius™ intelligent endoscopy module
Spravato (esketamine) nasal spray
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
TREMFYA® (guselkumab)
GI Genius™ intelligent endoscopy module
Spravato (esketamine) nasal spray
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
Seeking Biotech Alpha October 2019 Insight
Ruxolitinib (Jakafi®)
(BALANCE-CF™ 1) BI ENaC inhibitor delivered twice daily via the Respimat®, a handheld inhaler
Dovato (dolutegravir and lamivudine)
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
Dovato (dolutegravir and lamivudine)
(BALANCE-CF™ 1) BI ENaC inhibitor delivered twice daily via the Respimat®, a handheld inhaler
Dovato (dolutegravir and lamivudine)
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
(BALANCE-CF™ 1) BI ENaC inhibitor delivered twice daily via the Respimat®, a handheld inhaler
(BALANCE-CF™ 1) BI ENaC inhibitor delivered twice daily via the Respimat®, a handheld inhaler
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
NKTR-255, an IL-15 Agonist
[fam-] trastuzumab deruxtecan (DS-8201)
(BALANCE-CF™ 1) BI ENaC inhibitor delivered twice daily via the Respimat®, a handheld inhaler
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)
[fam-] trastuzumab deruxtecan (DS-8201)
[fam-] trastuzumab deruxtecan (DS-8201)
[fam-] trastuzumab deruxtecan (DS-8201)
Vascepa® (icosapent ethyl)
[fam-] trastuzumab deruxtecan (DS-8201)
[fam-] trastuzumab deruxtecan (DS-8201)
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)
Seeking Biotech Alpha October 2019 Insight
XARELTO® (rivaroxaban)
XARELTO® (rivaroxaban)
XARELTO® (rivaroxaban)
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
Ebola vaccine
XARELTO® (rivaroxaban)
XARELTO® (rivaroxaban)
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.
ruxolitinib cream
XARELTO® (rivaroxaban)
next-generation sequencing (NGS) in the growing field of RNA research.
Incyte's ruxolitinib cream shows sustained benefit in mid-stage vitiligo study
Oct. 14, 2019 7:28 AM ET|About: Incyte Corporation (INCY)|By: Douglas W. House, SA News Editor
next-generation sequencing (NGS) in the growing field of RNA research.
next-generation sequencing (NGS) in the growing field of RNA research.
next-generation sequencing (NGS) in the growing field of RNA research.
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
next-generation sequencing (NGS) in the growing field of RNA research.
New portable micro gas chromatograph
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
New portable micro gas chromatograph
next-generation sequencing (NGS) in the growing field of RNA research.
New portable micro gas chromatograph
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
filgotinib, an investigational, oral, selective JAK1 inhibitor
filgotinib, an investigational, oral, selective JAK1 inhibitor
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
filgotinib, an investigational, oral, selective JAK1 inhibitor
filgotinib, an investigational, oral, selective JAK1 inhibitor
REYVOW™ (lasmiditan)
filgotinib, an investigational, oral, selective JAK1 inhibitor
Investigational Abicipar pegol
Investigational Abicipar pegol
Abrocitinib, an investigational oral Janus kinase 1 (JAK1) inhibitor,
Investigational Abicipar pegol
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,
Abrocitinib, an investigational oral Janus kinase 1 (JAK1) inhibitor,
Abrocitinib, an investigational oral Janus kinase 1 (JAK1) inhibitor,
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
Abrocitinib, an investigational oral Janus kinase 1 (JAK1) inhibitor,
Abrocitinib, an investigational oral Janus kinase 1 (JAK1) inhibitor,
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)
filgotinib, an investigational, oral, selective JAK1 inhibitor
filgotinib, an investigational, oral, selective JAK1 inhibitor
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
filgotinib, an investigational, oral, selective JAK1 inhibitor
filgotinib, an investigational, oral, selective JAK1 inhibitor
filgotinib, an investigational, oral, selective JAK1 inhibitor
Taltz® (ixekizumab), Olumiant® (baricitinib) and mirikizumab
filgotinib, an investigational, oral, selective JAK1 inhibitor
Taltz® (ixekizumab), Olumiant® (baricitinib) and mirikizumab
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
BEOVU® (brolucizumab-dbll) injection
Taltz® (ixekizumab), Olumiant® (baricitinib) and mirikizumab
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)
BEOVU® (brolucizumab-dbll) injection
KEYTRUDA® (pembrolizumab)
KEYTRUDA® (pembrolizumab)
BEOVU® (brolucizumab-dbll) injection
KEYTRUDA® (pembrolizumab)
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: Carl Surran, SA News Editor
Seeking Biotech Alpha Sept & Oct 2019 Insight
INGREZZA® (valbenazine)
Investigational KRAS(G12C) Inhibitor
Investigational KRAS(G12C) Inhibitor
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)
Investigational KRAS(G12C) Inhibitor
Investigational KRAS(G12C) Inhibitor
Investigational KRAS(G12C) Inhibitor
LYNPARZA (olaparib)
Investigational KRAS(G12C) Inhibitor
LYNPARZA (olaparib)
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
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)
LYNPARZA (olaparib)
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
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)
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
Selpercatinib (LOXO-292)
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)
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
BRAFTOVI® (Encorafenib), MEKTOVI® (Binimetinib) and Cetuximab
BRAFTOVI® (Encorafenib), MEKTOVI® (Binimetinib) and Cetuximab
.
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)
Jevtana® (cabazitaxel)
BRAFTOVI® (Encorafenib), MEKTOVI® (Binimetinib) and Cetuximab
BRAFTOVI® (Encorafenib), MEKTOVI® (Binimetinib) and Cetuximab
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/ -
DIFICID® (fidaxomicin)
BRAFTOVI® (Encorafenib), MEKTOVI® (Binimetinib) and Cetuximab
KEYTRUDA® (pembrolizumab)
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
KEYTRUDA® (pembrolizumab)
KEYTRUDA® (pembrolizumab)
KEYTRUDA® (pembrolizumab)
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)
KEYTRUDA® (pembrolizumab)
EMGALITY™ (galcanezumab)
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)
KEYTRUDA® (pembrolizumab)
EMGALITY™ (galcanezumab)
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)
Seeking Biotech Alpha Sept & Oct 2019 Insight
Verzenio® (abemaciclib)
investigational Abicipar and Bimatoprost Sustained Release (SR)
RECARBRIO™ (imipenem, cilastatin, and relebactam)
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)
RECARBRIO™ (imipenem, cilastatin, and relebactam)
investigational Abicipar and Bimatoprost Sustained Release (SR)
RECARBRIO™ (imipenem, cilastatin, and relebactam)
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
investigational Abicipar and Bimatoprost Sustained Release (SR)
investigational Abicipar and Bimatoprost Sustained Release (SR)
investigational Abicipar and Bimatoprost Sustained Release (SR)
CYRAMZA® (ramucirumab)
InterStim™ Micro Neurostimulator and SureScan™ MRI Leads
investigational Abicipar and Bimatoprost Sustained Release (SR)
InterStim™ Micro Neurostimulator and SureScan™ MRI Leads
InterStim™ Micro Neurostimulator and SureScan™ MRI Leads
InterStim™ Micro Neurostimulator and SureScan™ MRI Leads
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)
REFRESH® RELIEVA™ Lubricant Eye Drop Product Line
InterStim™ Micro Neurostimulator and SureScan™ MRI Leads
InterStim™ Micro Neurostimulator and SureScan™ MRI Leads
Seeking Biotech Alpha Sept & Oct 2019 Insight
Blincyto (blinatumomab)
Tecentriq (atezolizumab) and Avastin (bevacizumab)
MAVYRET® (glecaprevir/pibrentasvir)
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)
Tecentriq (atezolizumab) and Avastin (bevacizumab)
MAVYRET® (glecaprevir/pibrentasvir)
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)
Tecentriq (atezolizumab) and Avastin (bevacizumab)
Enfortumab Vedotin in Combination with Immune Therapy Pembrolizumab
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: Douglas W. House, SA News Editor
Enfortumab Vedotin in Combination with Immune Therapy Pembrolizumab
Enfortumab Vedotin in Combination with Immune Therapy Pembrolizumab
Enfortumab Vedotin in Combination with Immune Therapy Pembrolizumab
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)
INVOKANA® (canagliflozin)
Enfortumab Vedotin in Combination with Immune Therapy Pembrolizumab
INVOKANA® (canagliflozin)
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
Rituxan (rituximab)
Enfortumab Vedotin in Combination with Immune Therapy Pembrolizumab
INVOKANA® (canagliflozin)
FDA OKs Roche's Rituxan for rare blood vessel inflammation diseases
Sep. 27, 2019 1:53 PM ET|About: Roche Holding AG (RHHBY)|By: Douglas W. House, SA News Editor
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
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.