Moorestown, New Jersey, United States
Seeking Biotech Alpha APRIL/MARCH 2020 Insight
IMBRUVICA® (ibrutinib) Receives 11th FDA Approval
IMBRUVICA® (ibrutinib) Receives 11th FDA Approval
IMBRUVICA® (ibrutinib) Receives 11th FDA Approval
IMBRUVICA® (ibrutinib) Receives 11th FDA Approval
Tue April 21, 2020 3:22 PM|PR Newswire|About: ABBV
- This milestone marks the fifth study for IMBRUVICA to bring a chemo-free treatment option to patients with CLL and the sixth approval for IMBRUVICA in CLL
- Granted under FDA's Real-Time Oncology Review pilot program, Project Orbis and priority review
- IMBRUVICA has been used to treat more than 195,000 patients worldwide across approved indications
PR Newswire
NORTH CHICAGO, Ill., April 21, 2020 /PRNewswire/ -- AbbVie (ABBV),
IMBRUVICA® (ibrutinib) in combination with rituximab
https://www.rituxan.com/patient/what-is-rituxan.html
https://seekingalpha.com/symbol/RHHBY
https://news.abbvie.com/news/press-releases/imbruvica-ibrutinib-receives-11th-fda-approval.htm
https://seekingalpha.com/symbol/ABBV
Trodelvy™ (sacituzumab govitecan-hziy)
IMBRUVICA® (ibrutinib) Receives 11th FDA Approval
IMBRUVICA® (ibrutinib) Receives 11th FDA Approval
FDA Grants Accelerated Approval for Immunomedics’ Trodelvy in Previously-Treated Metastatic Triple-Negative Breast Cancer
Wed April 22, 2020 11:47 AM|GlobeNewswire|About: IMMU
First FDA-approved antibody-drug conjugate that targets the Trop-2 antigen
Trodelvy is the first antibody-drug conjugate approved by FDA specifically for the treatment of relapsed or refractory metastatic triple-negative breast cancer
Company to host conference call today at 5:00 p.m. Eastern Time
MORRIS PLAINS, N.J., April 22, 2020 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (IMMU) (NASDAQ: IMMU)
https://seekingalpha.com/symbol/IMMU
Pipeline
https://www.immunomedics.com/our-science/pipeline/
Kymriah® (tisagenlecleucel)
IMBRUVICA® (ibrutinib) Receives 11th FDA Approval
Pfizer and BioNTech on go with COVID-19 vaccine study in Germany
Novartis Kymriah® receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma
Wed April 22, 2020 1:29 AM|PR Newswire
- The Regenerative Medicine Advanced Therapy (RMAT) designation reflects the unmet need for patients with r/r follicular lymphoma
- US regulatory filing for Kymriah in r/r follicular lymphoma anticipated in 2021
PR Newswire
EAST HANOVER, N.J., April 22, 2020 /PRNewswire/
https://seekingalpha.com/symbol/NVS
Pfizer and BioNTech on go with COVID-19 vaccine study in Germany
RGX-314 for the treatment of wet age-related macular degeneration (wet AMD)
Pfizer and BioNTech on go with COVID-19 vaccine study in Germany
BioNTech and Pfizer announce regulatory approval from German authority Paul-Ehrlich-Institut to commence first clinical trial of COVID-19 vaccine candidates
Wed April 22, 2020 5:00 AM|GlobeNewswire|About: BNTX, PFE
- First COVID-19-related clinical trial to start in Germany
- Initial dose escalation phase to target dose range of 1µg to 100µg
- Clinical supply from BioNTech’s GMP-certified mRNA production facilities in Europe
- Four vaccine candidates to enter clinical development
MAINZ, Germany and NEW YORK, April 22, 2020 (GLOBE NEWSWIRE) -- BioNTech SE (BNTX) and Pfizer Inc. (PFE)
https://biontech.de/science/pipeline
https://seekingalpha.com/symbol/PFE
https://seekingalpha.com/symbol/BNTX
Pfizer and BioNTech on go with COVID-19 vaccine study in Germany
Apr. 22, 2020 6:37 AM ET|About: BioNTech SE (BNTX)|By: Douglas W. House, SA News Editor
RGX-314 for the treatment of wet age-related macular degeneration (wet AMD)
RGX-314 for the treatment of wet age-related macular degeneration (wet AMD)
RGX-314 for the treatment of wet age-related macular degeneration (wet AMD)
REGENXBIO Announces Additional Positive Long-term and Interim Phase I/IIa Trial Update for RGX-314 for the Treatment of Wet AMD
Wed April 22, 2020 6:30 AM|PR Newswire|About: RGNX
ROCKVILLE, Md., April 22, 2020 /PRNewswire/ --
- RGX-314 continues to be well-tolerated at all dose levels
- Long-term, durable treatment effect demonstrated over two years in Cohort 3
- Mean improvement in vision (+14 letters) and stable retinal thickness (+2 µm)
- 50% of patients (3/6) remain anti-VEGF injection-free over two years
- 67% of patients (4/6) are anti-VEGF injection-free from nine months to two years
- Stable intraocular RGX-314 protein expression over two years
- 73% of patients (8/11) in Cohort 5 remain anti-VEGF injection-free over nine months
- Intraocular RGX-314 protein levels at six months demonstrate dose-dependent expression across cohorts
- Company on track to provide one-year data from Cohorts 4 & 5 in mid-2020 and initiate RGX-314 subretinal delivery pivotal program in 2H 2020
- Webcast conference call to be hosted Wednesday, April 22 at 8:30 a.m. ET featuring wet AMD Key Opinion Leaders, Allen C. Ho, M.D., Robert Avery, M.D., and Peter Campochiaro, M.D.
REGENXBIO Inc. (RGNX)
https://seekingalpha.com/symbol/RGNX
PD-L1 IHC 22C3 pharmDx as a companion diagnostic (CDx)
RGX-314 for the treatment of wet age-related macular degeneration (wet AMD)
RGX-314 for the treatment of wet age-related macular degeneration (wet AMD)
Agilent Receives FDA Approval for PD-L1 Companion Diagnostic on Dako Omnis
Thu April 23, 2020 8:00 AM|Business Wire|About: A
SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (A) (NYSE: A)
https://www.businesswire.com/news/home/20200423005127/en/
https://www.agilent.com/en/product/dako-omnis-solution-for-ihc-ish/dako-omnis
https://www.agilent.com/about/newsroom/presrel/2020/23apr-ca20014.html
quadrivalent vaccine
Sintilimab in Combination with ALIMTA® (Pemetrexed) and Platinum
Sintilimab in Combination with ALIMTA® (Pemetrexed) and Platinum
FDA approves MenQuadfiTM, the latest innovation in meningococcal (MenACWY) vaccination
Fri April 24, 2020 1:00 AM|GlobeNewswire|About: SNY
FDA approves MenQuadfiTM, the latest innovation in meningococcal (MenACWY) vaccination
- Latest innovation in quadrivalent meningococcal vaccination designed for use in persons 2 years of age and older in the U.S.
- Safety and effectiveness studied in five double-blind, randomized clinical trials with nearly 5,000 individuals
- Helps protect an expanded age group and elicits a high immune response across multiple ages
- Under regulatory review in Europe and other countries to help support local immunization efforts
PARIS – April 24, 2020
https://www.vaccineshoppe.com/assets/pdf/395-MenQuadfi%E2%80%93USPI-clean-Apr%202020.pdf
https://seekingalpha.com/symbol/SNY
Sintilimab in Combination with ALIMTA® (Pemetrexed) and Platinum
Sintilimab in Combination with ALIMTA® (Pemetrexed) and Platinum
Sintilimab in Combination with ALIMTA® (Pemetrexed) and Platinum
Innovent and Eli Lilly Announce NMPA Acceptance of a Supplemental New Drug Application for Sintilimab in Combination with ALIMTA® (Pemetrexed) and Platinum as First-Line Therapy in Non-squamous NSCLC
Thu April 23, 2020 7:50 PM|PR Newswire|About: IVBIY, LLY
SUZHOU, China, April 23, 2020 /PRNewswire/ -- Innovent Biologics, Inc. (IVBIY) ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, today jointly announced with Eli Lilly and Company (LLY) ("Lilly", NYSE: LLY)
https://seekingalpha.com/symbol/LLY
Tyvyt® (Sintilimab Injection)
https://seekingalpha.com/symbol/IVBIY
Indications for ALIMTA® (pemetrexed for injection)
ALIMTA is indicated in combination with pembrolizumab (pembro) and platinum chemotherapy for the initial treatment of patients with nonsquamous metastatic non-small cell lung cancer (mNSCLC) with no EGFR or ALK genomic tumor aberrations.
ALIMTA is indicated in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC).
ALIMTA is indicated as a single agent for the maintenance treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
ALIMTA is indicated as a single agent for the treatment of patients with recurrent metastatic nonsquamous non-small cell lung cancer (NSCLC) after prior chemotherapy.
Lynparza (olaparib)
Sintilimab in Combination with ALIMTA® (Pemetrexed) and Platinum
Johnson & Johnson Announces Collaboration to Expand Manufacturing Capabilities For COVID-19 Vaccine
Lynparza demonstrated overall survival benefit in Phase III PROfound trial for BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer
PUBLISHED24 April 2020
24 April 2020 07:00 BST
Only PARP inhibitor to improve overall survival vs. new hormonal agent treatments for this advanced prostate cancer population with high unmet needs
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada)
AstraZeneca's Lynparza extends survival in certain prostate cancer patients
Apr. 24, 2020 7:02 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/symbol/AZN
https://seekingalpha.com/symbol/MRK
https://www.lynparza.com/ovarian-cancer/recurrent-ovarian-cancer.html
Johnson & Johnson Announces Collaboration to Expand Manufacturing Capabilities For COVID-19 Vaccine
Johnson & Johnson Announces Collaboration to Expand Manufacturing Capabilities For COVID-19 Vaccine
Johnson & Johnson Announces Collaboration to Expand Manufacturing Capabilities For COVID-19 Vaccine
Johnson & Johnson Announces Collaboration to Expand Manufacturing Capabilities For its COVID-19 Vaccine Candidate in Support of the Company's Goal to Supply More Than One Billion Vaccine Doses GloballyApr 23, 2020Company Signs Agreement with Emergent BioSolutions in the U.S. As Part of its InvestmentFirst in Series of Anticipated Strategic Collaborations Designed to Further the Company's Goal of Ensuring Global Supply of a Safe and Effective Vaccine for COVID-19
NEW BRUNSWICK, N.J., April 23, 2020 /PRNewswire/ -- Johnson & Johnson (the Company) (NYSE: JNJ) today announced a collaboration between the Janssen Pharmaceutical Companies of Johnson & Johnson and Emergent BioSolutions, Inc
.
J&J to pay Emergent $135 million as part of COVID-19 vaccine manufacturing deal
Published: April 24, 2020 at 8:32 a.m. ETBy
https://www.janssen.com/infectious-diseases-and-vaccines/patented-technologies
https://www.janssen.com/infectious-diseases-and-vaccines/patented-technologies
dostarlimab, an investigational anti-programmed death-1 (PD-1) monoclonal antibody,
Johnson & Johnson Announces Collaboration to Expand Manufacturing Capabilities For COVID-19 Vaccine
SIMPONI ARIA® (golimumab)= polyarticular juvenile idiopathic arthritis&juvenile psoriatic arthritis
GSK Presents New Data from the GARNET Study Demonstrating Potential of Dostarlimab to Treat a Subset of Women with Recurrent or Advanced Endometrial Cancer
Thu April 23, 2020 8:03 PM|Business Wire|About: GSK
- Data accepted as a late-breaking abstract and presented as a webinar as part of the Society of Gynecologic Oncology 2020 virtual congress
- Patients in the updated analysis of GARNET include women with recurrent or advanced endometrial cancer who have progressed on or after platinum-based chemotherapy
PHILADELPHIA--(BUSINESS WIRE)-- GlaxoSmithKline plc (GSK)
https://www.gsk.com/en-gb/about-us/
Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors (GARNET)
https://clinicaltrials.gov/ct2/show/NCT02715284
https://www.businesswire.com/news/home/20200423005979/en/
SIMPONI ARIA® (golimumab)= polyarticular juvenile idiopathic arthritis&juvenile psoriatic arthritis
Johnson & Johnson Announces Collaboration to Expand Manufacturing Capabilities For COVID-19 Vaccine
SIMPONI ARIA® (golimumab)= polyarticular juvenile idiopathic arthritis&juvenile psoriatic arthritis
Janssen Announces Submission of Two Applications to U.S. FDA Seeking Approval of SIMPONI ARIA® (golimumab) for the Treatment of Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis
Fri April 24, 2020 9:17 AM|PR NewswirePR Newswire
HORSHAM, Pa., April 24, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson
Juvenile idiopathic arthritis
https://ghr.nlm.nih.gov/condition/juvenile-idiopathic-arthritis
About Juvenile Idiopathic Arthritis
https://creakyjoints.org/education/juvenile-idiopathic-arthritis/
Seeking Biotech Alpha APRIL/MARCH 2020 Insight
U.S. to Boost Payment for Abbott’s Covid-19 Test to Increase Use
VIR-2218, a small interfering ribonucleic acid (siRNA) that mediates RNA interference
ONTRUZANT® (trastuzumab-dttb), a Biosimilar of Herceptin® (trastuzumab)
U.S. to Boost Payment for Abbott’s Covid-19 Test to Increase Use
By Michelle Fay CortezApril 15, 2020, 2:39 AM EDT
- Government will pay $100 per test, up from $51 to spur use
- Lack of technicians to run tests accounted for the shortfall
ONTRUZANT® (trastuzumab-dttb), a Biosimilar of Herceptin® (trastuzumab)
VIR-2218, a small interfering ribonucleic acid (siRNA) that mediates RNA interference
ONTRUZANT® (trastuzumab-dttb), a Biosimilar of Herceptin® (trastuzumab)
Merck Announces US Launch of ONTRUZANT® (trastuzumab-dttb), a Biosimilar of Herceptin® (trastuzumab)
Wed April 15, 2020 6:45 AM|Business Wire|About: MRK
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK)
https://www.merck.com/product/usa/pi_circulars/o/ontruzant/ontruzant_pi.pdf
https://www.merck.com/index.html
https://www.businesswire.com/news/home/20200415005021/en/
https://seekingalpha.com/symbol/MRK
VIR-2218, a small interfering ribonucleic acid (siRNA) that mediates RNA interference
VIR-2218, a small interfering ribonucleic acid (siRNA) that mediates RNA interference
QIAGEN Launches Therascreen BRAF Test as Companion Diagnostic to a BRAFTOVI® (encorafenib)
VIR-2218 Demonstrates Dose-Dependent and Durable Reductions of Hepatitis B Surface Antigen in Phase 1/2 Trial
Wed April 15, 2020 4:01 PM|GlobeNewswire|About: ALNY, VIRGlobeNewswire
SAN FRANCISCO, April 15, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (VIR)
https://www.vir.bio/pipeline/#focus
https://seekingalpha.com/symbol/ALNY
https://seekingalpha.com/symbol/VIR
Study of VIR-2218 in Healthy Volunteers and Patients With Chronic Hepatitis B
QIAGEN Launches Therascreen BRAF Test as Companion Diagnostic to a BRAFTOVI® (encorafenib)
QIAGEN Launches Therascreen BRAF Test as Companion Diagnostic to a BRAFTOVI® (encorafenib)
QIAGEN Launches Therascreen BRAF Test as Companion Diagnostic to a BRAFTOVI® (encorafenib)
QIAGEN Launches Therascreen BRAF Test as Companion Diagnostic to a BRAFTOVI® (encorafenib) Based Regimen in Metastatic Colorectal Cancer
Wed April 15, 2020 4:05 PM|Business Wire|About: QGEN
- U.S. FDA approves therascreen BRAF V600E RGQ PCR assay as companion diagnostic
- Test will help identify patients eligible for treatment with the BRAF inhibitor, BRAFTOVI, which the FDA has approved for use in combination with ERBITUX® (cetuximab) in adults with previously treated metastatic colorectal cancer with a BRAF V600E mutation
GERMANTOWN, Md. & HILDEN, Germany--(BUSINESS WIRE)--
QIAGEN N.V. (QGEN)
https://www.businesswire.com/news/home/20200415005666/en/
https://seekingalpha.com/symbol/QGEN
https://www.braftovimektovi.com/
https://seekingalpha.com/symbol/PFE
Jelmyto (mitomycin gel)
QIAGEN Launches Therascreen BRAF Test as Companion Diagnostic to a BRAFTOVI® (encorafenib)
REGN-EB3, an investigational triple antibody cocktail treatment for Ebola virus infection
FDA Approves First Therapy for Treatment of Low-Grade Upper Tract Urothelial Cancer
Wed April 15, 2020 2:59 PM|PR Newswire
https://www.urogen.com/pipeline/
Mitomycin is a chemotherapy drug, specifically, an alkylating agent that interferes with the transcription of DNA into RNA, stopping protein synthesis and stopping cancer cells' ability to proliferate.
REGN-EB3, an investigational triple antibody cocktail treatment for Ebola virus infection
QIAGEN Launches Therascreen BRAF Test as Companion Diagnostic to a BRAFTOVI® (encorafenib)
REGN-EB3, an investigational triple antibody cocktail treatment for Ebola virus infection
FDA Accepts for Priority Review Biologics License Application for REGN-EB3 to Treat Ebola
Thu April 16, 2020 7:00 AM|PR Newswire|About: REGN
TARRYTOWN, N.Y., April 16, 2020 /PRNewswire/ --
- REGN-EB3 developed via same rapid response platform currently being leveraged to develop novel COVID-19 antibody therapy
Regeneron Pharmaceuticals, Inc. (REGN)
https://seekingalpha.com/symbol/REGN
Lower-priced versions of Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen® now available
Lower-priced versions of Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen® now available
Lower-priced versions of Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen® now available
Lilly launches more low-priced insulin offerings in U.S.
Apr. 16, 2020 6:54 AM ET|About: Eli Lilly and Company (LLY)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/symbol/LLY
Lower-priced versions of Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen® now available
04/16/2020
KISQALI® (ribociclib)
Lower-priced versions of Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen® now available
Lower-priced versions of Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen® now available
Health Canada approves an extended indication for KISQALI® (ribociclib) in combination treatment
Thu April 16, 2020 7:00 AM|Canada Newswire
- Breast cancer is the most common female cancer in Canada.1
- Advanced breast cancer is the leading cause of cancer death in women 20-59 years old.2,3
- While overall 5-year survival rates for female breast cancer are relatively high, at 87%, women with advanced breast cancer face a 22.0% survival rate over 5 years.4
DORVAL, QC, April 16, 2020 /CNW Telbec/ - Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that KISQALI® (ribociclib) is now indicated when used in combination for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer regardless of their menopause status and in combination with various approved hormonal treatment options.
https://seekingalpha.com/symbol/NVS
TUKYSA™ (tucatinib)
Lower-priced versions of Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen® now available
Pemazyre™ (pemigatinib)
FDA OKs Seattle Genetics' tucatinib for HER+ breast cancer
Apr. 17, 2020 2:27 PM ET|About: Seattle Genetics, Inc. (SGEN)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/symbol/SGEN
https://www.seattlegenetics.com/
Pemazyre™ (pemigatinib)
Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
Pemazyre™ (pemigatinib)
FDA Approves Incyte’s Pemazyre™ (pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma
17 April, 2020
- Pemazyre received Orphan Drug, Breakthrough Therapy and Priority Review designations based on the significant needs of people living with this devastating cancer -
- Investor conference call and webcast scheduled for Monday, April 20, 2020, at 8:00 a.m. ET -
WILMINGTON, Del.--(BUSINESS WIRE)--Apr. 17, 2020-- Incyte (Nasdaq:INCY)
Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
https://clinicaltrials.gov/ct2/show/NCT02924376
FDA Approves Incyte’s Pemazyre™ (pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma
Fri April 17, 2020 8:53 PM|Business Wire|About: INCY
- Pemazyre received Orphan Drug, Breakthrough Therapy and Priority Review designations based on the significant needs of people living with this devastating cancer -
- Investor conference call and webcast scheduled for Monday, April 20, 2020, at 8:00 a.m. ET -
WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (INCY)
https://www.mayoclinic.org/diseases-conditions/cholangiocarcinoma/symptoms-causes/syc-20352408
https://seekingalpha.com/symbol/INCY
Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
Bristol Myers Squibb and Exelixis Announce Positive Topline Results from Pivotal Phase 3 CheckMate -9ER Trial Evaluating Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) in Previously Untreated Advanced Renal Cell Carcinoma
Mon April 20, 2020 6:59 AM|Business Wire|About: BMY, EXEL
Study met primary endpoint of significantly improving progression-free survival, and secondary endpoints of overall survival and objective response rate vs. sunitinib
Opdivo in combination with CABOMETYX demonstrates clinically meaningful efficacy results across all endpoints and preliminary assessment showing a favorable safety profile
PRINCETON, N.J. & ALAMEDA, Calif.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (EXEL) (NASDAQ: EXEL)
A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 9ER)
https://clinicaltrials.gov/ct2/show/NCT03141177?term=checkmate-9er&draw=2&rank=1
https://www.businesswire.com/news/home/20200420005248/en/
https://seekingalpha.com/symbol/EXEL
https://seekingalpha.com/symbol/BMY
Opdivo/Cabometyx combo successful in first-line kidney cancer
Apr. 20, 2020 7:19 AM ET|About: Bristol-Myers Squibb C... (BMY)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3561978-opdivo-cabometyx-combo-successful-in-first-line-kidney-cancer
Ocrevus® (ocrelizumab)
Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
FDA and EMA Accept Applications for Genentech’s Ocrevus (ocrelizumab) Shorter 2-hour Infusion Time
Mon April 20, 2020 1:00 AM|Business Wire|About: RHHBY
– Reduces infusion time to 2 hours from the current 3.5 hours for patients with relapsing or primary progressive multiple sclerosis, if approved –
– Applications are based on data from the randomized, double-blind ENSEMBLE PLUS study, showing consistent safety to the currently approved Ocrevus dosing regimen –
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)
https://www.gene.com/download/pdf/ocrevus_prescribing.pdf
https://seekingalpha.com/symbol/RHHBY
Sunday, Apr 19, 2020
FDA and EMA Accept Applications for Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion Time
Reduces infusion time to 2 hours from the current 3.5 hours for patients with relapsing or primary progressive multiple sclerosis, if approved
Applications are based on data from the randomized, double-blind ENSEMBLE PLUS study, showing consistent safety to the currently approved Ocrevus dosing regimen
South San Francisco, CA -- April 19, 2020 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
https://www.gene.com/media/press-releases/14846/2020-04-19/fda-and-ema-accept-applications-for-gene
Seeking Biotech Alpha APRIL/MARCH 2020 Insight
Koselugo (selumetinib)
BioCryst launches early-stage study of galidesivir for COVID-19
Baricitinib, an oral JAK1/JAK2 inhibitor marketed as OLUMIANT®
FDA OKs AstraZeneca and Merck's selumetinib for rare nervous system disorder
Apr. 10, 2020 4:55 PM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor
https://www.reuters.com/article/brief-fda-approves-first-therapy-for-chi-idUSASA00KGS
https://seekingalpha.com/symbol/AZN
https://seekingalpha.com/symbol/MRK
https://www.cancer.gov/publications/dictionaries/cancer-drug/def/selumetinib
Baricitinib, an oral JAK1/JAK2 inhibitor marketed as OLUMIANT®
BioCryst launches early-stage study of galidesivir for COVID-19
Baricitinib, an oral JAK1/JAK2 inhibitor marketed as OLUMIANT®
Lilly Begins Clinical Testing of Therapies for COVID-19
Fri April 10, 2020 5:11 PM|PR Newswire|About: LLY
- Lilly Starts Phase 2 Trial with Anti-Ang2 in COVID-19
PR Newswire
INDIANAPOLIS, April 10, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY)
https://seekingalpha.com/symbol/LLY
BioCryst launches early-stage study of galidesivir for COVID-19
BioCryst launches early-stage study of galidesivir for COVID-19
BioCryst launches early-stage study of galidesivir for COVID-19
BioCryst launches early-stage study of galidesivir for COVID-19
Apr. 10, 2020 10:40 AM ET|About: BioCryst Pharmaceutica... (BCRX)|By: Douglas W. House, SA News Editor
A Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effects of Galidesivir in Yellow Fever
https://clinicaltrials.gov/ct2/show/NCT03891420?term=NCT03891420&draw=2&rank=1
https://seekingalpha.com/symbol/BCRX
ENHANZE® Technology For Patients With Multiple Myeloma
AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity
BioCryst launches early-stage study of galidesivir for COVID-19
Halozyme Announces Janssen Submits New Drug Application In Japan For Daratumumab Subcutaneous Formulation Utilizing Halozyme's ENHANZE® Technology For Patients With Multiple Myeloma
Sun April 26, 2020 9:40 PM|PR Newswire|About: HALO
SAN DIEGO, April 26, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (HALO)
https://www.halozyme.com/homepage/default.aspx
https://seekingalpha.com/symbol/JNJ
Libtayo® (cemiplimab)
AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity
AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity
Sanofi: Phase 3 trial of Libtayo® (cemiplimab) as monotherapy for first-line advanced non-small cell lung cancer stopped early due to highly significant improvement in overall survival
Mon April 27, 2020 7:00 AM|GlobeNewswire|About: SNY
Phase 3 trial of Libtayo® (cemiplimab) as monotherapy for first-line advanced non-small cell lung cancer stopped early due to highly significant improvement in overall survival
- Libtayo decreased the risk of death by 32.4% compared to chemotherapy
- Sanofi (SNY) and Regeneron plan regulatory submissions in 2020
Paris and Tarrytown, N.Y. - April 27, 2020 – Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
https://seekingalpha.com/symbol/SNY
https://seekingalpha.com/symbol/REGN
AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity
AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity
AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity
Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in the ADVANCE-1 Pivotal Phase 2/3 Trial in Alzheimer’s Disease Agitation
Mon April 27, 2020 6:00 AM|GlobeNewswire|About: AXSM
Statistically significant improvement in Alzheimer’s disease agitation, as measured by the CMAI total score compared to placebo (p=0.010, primary endpoint)
Demonstrated rapid and substantial improvement in Alzheimer’s disease agitation starting at week 2 with statistical significance at week 3 compared to placebo (p=0.007)
Statistically significant rates of clinical response (p=0.005) on the CMAI and improvement on the modified Alzheimer’s Disease Cooperative Study-CGIC scale for agitation (p=0.036) compared to placebo
Well-tolerated and not associated with cognitive impairment or sedation
No treatments are currently approved for Alzheimer’s disease agitation
Company to host conference call today at 8:00 AM ET
NEW YORK, April 27, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (AXSM)
https://seekingalpha.com/symbol/AXSM
https://axsome.com/axs-pipeline/about-axs-05/
Addressing Dementia Via Agitation-Centered Evaluation (ADVANCE)
https://clinicaltrials.gov/ct2/show/NCT03226522?term=alzheimer%27s+disease+agitation&draw=2&rank=34
tislelizumab with either paclitaxel and carboplatin or nab-paclitaxel (ABRAXANE®) & carboplatin
Roche = FDA approval for cobas HPV test for cobas 6800/8800 Systems to identify cervical cancer
tislelizumab with either paclitaxel and carboplatin or nab-paclitaxel (ABRAXANE®) & carboplatin
China authorities accept BeiGene application for expanded use of tislelizumab
Apr. 20, 2020 4:34 PM ET|About: BeiGene, Ltd. (BGNE)|By: Douglas W. House, SA News Editor
BeiGene Announces Acceptance of a Supplemental New Drug Application for Tislelizumab in Combination with Chemotherapy in First-Line Advanced Squamous Non-Small Cell Lung Cancer in China
April 20, 2020 at 4:05 PM EDT
BEIJING, China and CAMBRIDGE, Mass., April 20, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160),
https://seekingalpha.com/symbol/BGNE
https://www.beigene.com/science-and-product-portfolio/pipeline/tislelizumab
ORKAMBI® (lumacaftor/ivacaftor) and SYMDEKO® (tezacaftor/ivacaftor and ivacaftor)
Roche = FDA approval for cobas HPV test for cobas 6800/8800 Systems to identify cervical cancer
tislelizumab with either paclitaxel and carboplatin or nab-paclitaxel (ABRAXANE®) & carboplatin
Vertex Announces Innovative Reimbursement Agreement in Switzerland for ORKAMBI® (lumacaftor/ivacaftor) and SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) for Eligible Cystic Fibrosis Patients
Tue April 21, 2020 2:00 AM|Business Wire|About: VRTX
Agreement also enables the possibility of rapid patient access to future triple combination regimen (elexacaftor/tezacaftor/ivacaftor and ivacaftor) once approved in Switzerland
LONDON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (VRTX)
https://www.businesswire.com/news/home/20200420005992/en/
https://www.vrtx.com/research-development/pipeline/
https://seekingalpha.com/symbol/VRTX
Roche = FDA approval for cobas HPV test for cobas 6800/8800 Systems to identify cervical cancer
Roche = FDA approval for cobas HPV test for cobas 6800/8800 Systems to identify cervical cancer
Roche = FDA approval for cobas HPV test for cobas 6800/8800 Systems to identify cervical cancer
Roche receives FDA approval for cobas HPV test for use on the cobas 6800/8800 Systems to identify women at risk for cervical cancer
- More than 99 percent of cervical cancers are caused by persistent high-risk HPV infection1
- Cervical cancer is nearly 100 percent preventable with proper HPV vaccination, screening and treatment; expanding access helps reach more women2,3
- cobas 6800/8800 Systems deliver full automation, helping laboratories meet the throughput and efficiencies that high-volume, HPV DNA screening programs require
Basel, 21 April 2020 - Roche (SIX: RO, ROG; OTCQX:RHHBY)
https://www.hpv16and18.com/index.html
Roche receives FDA approval for CINtec® PLUS Cytology test to aid clinicians in improving cervical cancer prevention
https://diagnostics.roche.com/
FDA OKs Roche HPV test for high-throughput systems
Apr. 21, 2020 6:42 AM ET|About: Roche Holding Ltd ADR (RHHBY)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3562411-fda-oks-roche-hpv-test-for-high-throughput-systems
https://seekingalpha.com/symbol/RHHBY
Tislelizumab
Vutrisiran is an investigational, subcutaneously-administered RNAi therapeutic
Roche = FDA approval for cobas HPV test for cobas 6800/8800 Systems to identify cervical cancer
BeiGene Announces that the Phase 3 Trial of Tislelizumab Combined with Chemotherapy in Patients with First-Line Non-Squamous Non-Small Cell Lung Cancer Met the Primary Endpoint of Progression-Free Survival at Interim Analysis
Mon April 13, 2020 4:05 PM|GlobeNewswire|About: BGNE
BEIJING, China, and CAMBRIDGE, Mass., April 13, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE)
https://www.beigene.com/science-and-product-portfolio/pipeline
Tislelizumab
https://www.beigene.com/science-and-product-portfolio/pipeline/tislelizumab
https://clinicaltrials.gov/ct2/show/NCT03663205?cond=Nsclc&lead=beigene&phase=2&draw=2&rank=1
Vutrisiran is an investigational, subcutaneously-administered RNAi therapeutic
Vutrisiran is an investigational, subcutaneously-administered RNAi therapeutic
Vutrisiran is an investigational, subcutaneously-administered RNAi therapeutic
Alnylam Receives Fast Track Designation for Vutrisiran for the Treatment of the Polyneuropathy of hATTR Amyloidosis
Tue April 14, 2020 7:00 AM|Business Wire|About: ALNY
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Alnylam Pharmaceuticals, Inc. (ALNY) (Nasdaq: ALNY)
https://www.alnylam.com/wp-content/uploads/pdfs/ONPATTRO-Prescribing-Information.pdf
https://www.businesswire.com/news/home/20200414005125/en/
https://www.alnylam.com/alnylam-rnai-pipeline/
https://seekingalpha.com/symbol/ALNY
Familial transthyretin amyloidosis
https://rarediseases.info.nih.gov/diseases/656/familial-transthyretin-amyloidosis
HELIOS-A: A Study of Vutrisiran (ALN-TTRSC02) in Patients With Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)
https://clinicaltrials.gov/ct2/show/NCT03759379?term=helios-a&draw=2&rank=1
AstraZeneca initiates CALAVI clinical trial with Calquence against COVID-19
Vutrisiran is an investigational, subcutaneously-administered RNAi therapeutic
Vutrisiran is an investigational, subcutaneously-administered RNAi therapeutic
AstraZeneca initiates CALAVI clinical trial with Calquence against COVID-19
PUBLISHED14 April 2020
Trial will assess the effect of Calquence on the exaggerated immune response of patients hospitalised with COVID-19 infection
What is CALQUENCE?
CALQUENCE is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer, or adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
It is not known if CALQUENCE is safe and effective in children.
Please see full Prescribing Information, including Patient Information.
https://seekingalpha.com/symbol/AZN
Seeking Biotech Alpha APRIL/MARCH 2020 Insight
Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets)
Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine
Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets)
Gilead Canada Submits Supplemental New Drug Submission to Health Canada for Descovy® for HIV Pre-Exposure Prophylaxis
Thu April 9, 2020 8:00 AM|Canada Newswire
-- Submission supported by data from the DISCOVER trial, which evaluated the safety and efficacy of Descovy® compared to Truvada® in people at risk for sexually acquired HIV-1 infection --
MISSISSAUGA, ON, April 9, 2020 /CNW/ - Gilead Sciences Canada, Inc. (Gilead Canada)
RYBELSUS® (semaglutide tablets)
Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine
Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets)
Health Canada approves RYBELSUS® (semaglutide tablets) the first and only GLP-1 analogue in a pill for the treatment of adults with type 2 diabetes
Thu April 9, 2020 8:01 AM|Canada Newswire
RYBELSUS® offers convenience to support diabetes management along with diet and exercise for adults1
MISSISSAUGA, ON, April 9, 2020 /CNW/ - Health Canada has approved RYBELSUS® (semaglutide tablets)
https://www.novonordisk.ca/our-products.html
Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine
Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine
Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine
Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine Development
Thu April 9, 2020 7:50 AM|Business Wire|About: BNTX, PFE
- Pfizer (PFE) and BioNTech (BNTX) to jointly develop COVID-19 vaccine, initially in the United States and Europe, and scale-up manufacturing capacity to support global supply
- Potential to supply millions of vaccine doses by the end of 2020 subject to technical success of the development program and approval by regulatory authorities, and then rapidly scale up capacity to produce hundreds of millions of doses in 2021.
- BioNTech will contribute multiple mRNA vaccine candidates as part of its BNT162 COVID-19 vaccine program, which are expected to enter human testing in April 2020
- Pfizer will contribute its leading global vaccine clinical research and development, regulatory, manufacturing and distribution infrastructure and capabilities
- BioNTech will receive an upfront payment of $185 million, including an equity investment of approximately $113 million, and be eligible to receive future milestone payments of up to $563 million for a potential total consideration of $748 million
MAINZ, Germany & NEW YORK--(BUSINESS WIRE)-- BioNTech SE, and Pfizer Inc.
https://www.businesswire.com/news/home/20200409005405/en/
https://seekingalpha.com/news/3559589-pfizer-identifies-lead-covidminus-19-candidate
https://seekingalpha.com/symbol/BNTX
https://seekingalpha.com/symbol/PFE
Pfizer Identifies Lead Coronavirus Drug Candidate
Experimental medicine to be tested on patients this summer; arthritis therapy Xeljanz considered, too
By Jared S. Hopkins
Updated April 9, 2020 3:56 pm ET
ONGENTYS® (opicapone)
Mobocertinib (TAK-788)
Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine
Neurocrine Biosciences Announces FDA Approval of Once-Daily ONGENTYS® (opicapone) as an Add-On Treatment for Patients with Parkinson's Disease Experiencing "Off" Episodes
Mon April 27, 2020 7:30 AM|PR Newswire|About: NBIX
- Neurocrine Biosciences Plans to Make ONGENTYS Available to Patients Later This Year
PR Newswire
SAN DIEGO, April 27, 2020 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NBIX)
https://seekingalpha.com/symbol/NBIX
https://www.multivu.com/players/English/8719751-neurocrine-biosciences-ongentys/
http://www.neurocrine.com//assets/ongentyspi.pdf
https://www.ninds.nih.gov/Disorders/All-Disorders/Parkinsons-Disease-Challenges-Progress-and-Promise
Pipeline Overview
https://www.neurocrine.com/pipeline/pipeline-overview/
Mobocertinib (TAK-788)
Mobocertinib (TAK-788)
Mobocertinib (TAK-788)
Takeda Announces U.S. FDA Breakthrough Therapy Designation for Mobocertinib (TAK-788) for the Treatment of NSCLC Patients with EGFR Exon 20 Insertion Mutations
Mon April 27, 2020 8:00 AM|Business Wire|About: TAK
– Designation Represents Positive Progress for a Unique Patient Population in Need of Targeted Therapy Options
CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK)
https://www.businesswire.com/news/home/20200427005219/en/
https://seekingalpha.com/symbol/TAK
https://www.takeda.com/investors/
Actemra (tocilizumab)
Mobocertinib (TAK-788)
Mobocertinib (TAK-788)
Roche's Actemra scores early win in COVID-19 study in France
Apr. 27, 2020 9:51 AM ET|About: Roche Holding Ltd ADR (RHHBY)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/symbol/RHHBY
https://www.roche.com/products/product-details.htm?productId=42bf9d08-8573-491a-944a-fdbc030ec44b
oligomannate
oligomannate
oligomannate
Apr 27, 2020 03:08 PMBUSINESS & TECH
Chinese Alzheimer’s Drug Gets U.S. Approval for Stateside Trial
Shanghai Green Valley Pharmaceutical Co. got clearance on April 8 for the U.S. part of a global trial that seeks to enroll more than 2,000 patients with mild-to-moderate Alzheimer’s across North America, Europe and Asia, according to a company statement Sunday.
https://www.usagainstalzheimers.org/press/usagainstalzheimers-welcomes-chinas-approval-alzheimers-drug-oligomannate
Sodium Oligomannate: First Approval.
Syed YY1.
oligomannate
oligomannate
oligomannate
TriClip™ Transcatheter Tricuspid Valve Repair System
TriClip™ Transcatheter Tricuspid Valve Repair System
iBio Expands COVID-19 Vaccine Collaboration to Include the Infectious Disease Research Institute
TriClip™ Transcatheter Tricuspid Valve Repair System
Abbott's TriClip™ Becomes First Device of its Kind to Receive CE Mark for Minimally Invasive Tricuspid Valve Repair
Thu April 9, 2020 9:00 AM|PR Newswire|About: ABT
- New system offers a proven safe and effective minimally invasive non-surgical solution
- The TriClip System leverages Abbott's proven clip-based technology used in its MitraClip™ transcatheter mitral valve therapy
PR Newswire
ABBOTT PARK, Ill., April 9, 2020 /PRNewswire/ -- Abbott (ABT)
Transcatheter edge-to-edge repair for reduction of tricuspid regurgitation: 6-month outcomes of the TRILUMINATE single-arm stu
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32600-5/fulltext
https://seekingalpha.com/symbol/ABT
iBio Expands COVID-19 Vaccine Collaboration to Include the Infectious Disease Research Institute
iBio Expands COVID-19 Vaccine Collaboration to Include the Infectious Disease Research Institute
iBio Expands COVID-19 Vaccine Collaboration to Include the Infectious Disease Research Institute
iBio Expands COVID-19 Vaccine Collaboration to Include the Infectious Disease Research Institute
Thu April 9, 2020 7:30 AM|GlobeNewswire|About: IBIOGlobeNewswire
NEW YORK, April 09, 2020 (GLOBE NEWSWIRE) -- iBio, Inc. (IBIO)
https://seekingalpha.com/symbol/IBIO
XOSPATA® (gilteritinib)
iBio Expands COVID-19 Vaccine Collaboration to Include the Infectious Disease Research Institute
iBio Expands COVID-19 Vaccine Collaboration to Include the Infectious Disease Research Institute
Astellas Announces Acceptance of XOSPATA® (gilteritinib) for Regulatory Review in China by the National Medical Products Administration
Thu April 9, 2020 8:01 PM|PR Newswire|About: ALPMY
TOKYO, April 9, 2020 /PRNewswire/ -- Astellas Pharma Inc. (ALPMF) (
https://www.astellas.com/en/science/pipeline
https://seekingalpha.com/symbol/ALPMY
https://www.cancer.gov/news-events/cancer-currents-blog/2019/aml-flt3-gilteritinib-improved-survival
Seeking Biotech Alpha APRIL/MARCH 2020 Insight
lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase (GO)
Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier for SMA
lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase (GO)
Alnylam Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration and Submits Marketing Authorization Application to the European Medicines Agency for Lumasiran for the Treatment of Primary Hyperoxaluria Type 1
Tue April 7, 2020 7:00 AM|Business Wire|About: ALNY
− Lumasiran is the First Potential Therapeutic to Demonstrate Substantial Reduction in Urinary Oxalate Excretion –
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Alnylam Pharmaceuticals, Inc. (ALNY) (Nasdaq: ALNY)
.
Alnylam Reports Positive Topline Results from ILLUMINATE-A Phase 3 Study of Lumasiran for the Treatment of Primary Hyperoxaluria Type 1
Dec 17, 2019
https://investors.alnylam.com/press-release?id=24376
A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1 (ILLUMINATE-A)
https://clinicaltrials.gov/ct2/show/NCT03681184
https://www.businesswire.com/news/home/20200407005239/en/
https://seekingalpha.com/symbol/ALNY
balstilimab (anti-PD-1) for the treatment of cervical cancer.
Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier for SMA
lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase (GO)
Agenus Receives Fast Track Designation for Balstilimab in Advanced Cervical Cancer
Tue April 7, 2020 1:04 PM|PR Newswire|About: AGEN
LEXINGTON, Mass., April 7, 2020 /PRNewswire/ -- Agenus Inc. (AGEN)
https://agenusbio.com/pipeline/
https://seekingalpha.com/symbol/AGEN
BALSTILIMAB (AGEN2034)
PD-1 (programmed cell death protein 1) is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market. In 2018, the Nobel Prize in Medicine was awarded for the establishment of PD-1 as a cancer immunotherapy target. Agenus has applied these scientific principles to create a therapy designed to treat cancer, AGEN2034
AGEN2034 is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 from interacting with its ligands PD-L1 and PD-L2.
AGEN2034 is clinically active in patients with advanced or refractory cancer.
Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier for SMA
Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier for SMA
Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier for SMA
Genentech Provides Regulatory Update on Risdiplam for the Treatment of Spinal Muscular Atrophy (SMA)
Tue April 7, 2020 4:05 PM|Business Wire|About: RHHBY
– U.S. Food and Drug Administration (FDA) extends review time for risdiplam following agreed submission of additional data, including SUNFISH Part 2 –
– Risdiplam is being investigated in infants, children and adults with Type 1, 2 or 3 SMA –
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)
https://www.businesswire.com/news/home/20200407005769/en/
https://seekingalpha.com/symbol/RHHBY
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)
BRAFTOVI® (ENCORAFENIB) IN COMBINATION W/ CETUXIMAB = BRAFV600E-MUTANT METASTATIC COLORECTAL CANCER
Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier for SMA
Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy in First-Line Lung Cancer
Wed April 8, 2020 6:59 AM|Business Wire|About: BMY
FDA application granted Priority Review designation with PDUFA date of August 6, 2020
Submissions based on results from Phase 3 CheckMate -9LA trial
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY)
https://www.businesswire.com/news/home/20200408005057/en/
https://seekingalpha.com/symbol/BMY
Indications
YERVOY® (ipilimumab) is a prescription medicine used in adults and children 12 years of age and older to treat melanoma (a kind of skin cancer) that has spread (metastatic) or cannot be removed by surgery (unresectable).
It is not known if YERVOY is safe and effective in children less than 12 years of age.
YERVOY® (ipilimumab) is a prescription medicine used in adults to help prevent melanoma (a kind of skin cancer) from coming back after it and lymph nodes that contain cancer have been removed by surgery.
It is not known if YERVOY is safe and effective in children.
YERVOY will not work for every patient. Individual results may vary.
Information provided in this website is not a substitute for talking with your healthcare professional. Your healthcare professional is the best source of information about your disease.
Sotatercept is an investigational product in patients w/ pulmonary arterial hypertension (PAH)
BRAFTOVI® (ENCORAFENIB) IN COMBINATION W/ CETUXIMAB = BRAFV600E-MUTANT METASTATIC COLORECTAL CANCER
BRAFTOVI® (ENCORAFENIB) IN COMBINATION W/ CETUXIMAB = BRAFV600E-MUTANT METASTATIC COLORECTAL CANCER
Acceleron Receives FDA Breakthrough Therapy Designation for Sotatercept in Pulmonary Arterial Hypertension
Wed April 8, 2020 7:05 AM|Business Wire|About: XLRN
Sotatercept granted first FDA Breakthrough Therapy designation in pulmonary arterial hypertension since the Agency established the designation in 2012
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Acceleron Pharma Inc. (XLRN)
https://www.businesswire.com/news/home/20200408005276/en/
http://acceleronpharma.com/science-pipeline/sotatercept/
https://seekingalpha.com/symbol/XLRN
BRAFTOVI® (ENCORAFENIB) IN COMBINATION W/ CETUXIMAB = BRAFV600E-MUTANT METASTATIC COLORECTAL CANCER
BRAFTOVI® (ENCORAFENIB) IN COMBINATION W/ CETUXIMAB = BRAFV600E-MUTANT METASTATIC COLORECTAL CANCER
BRAFTOVI® (ENCORAFENIB) IN COMBINATION W/ CETUXIMAB = BRAFV600E-MUTANT METASTATIC COLORECTAL CANCER
U.S. FDA Approves BRAFTOVI® (Encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (CRC) After Prior Therapy
Wed April 8, 2020 6:27 PM|Business Wire|About: PFE
BRAFTOVI plus cetuximab is the first-and-only FDA-approved targeted regimen specifically for adults with previously treated metastatic CRC with a BRAFV600E mutation
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE
http://labeling.pfizer.com/ShowLabeling.aspx?id=12990
https://www.braftovimektovi.com/hcp/
https://www.businesswire.com/news/home/20200408005791/en/
https://seekingalpha.com/symbol/PFE
https://www.nasdaq.com/market-activity/stocks/pfe/dividend-history
Seeking Biotech Alpha APRIL/MARCH 2020 Insight
Vosoritide to Treat Children with Achondroplasia
Vosoritide to Treat Children with Achondroplasia
Vosoritide to Treat Children with Achondroplasia
BioMarin Plans Regulatory Submissions for Marketing Authorization of Vosoritide to Treat Children with Achondroplasia in 3Q 2020 in both US and Europe
Mon April 6, 2020 8:31 AM|PR Newswire|About: BMRNPR Newswire
SAN RAFAEL, Calif., April 6, 2020 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)
https://seekingalpha.com/symbol/BMRN
https://www.biomarin.com/products/pipeline/bmn-111/
Achondroplasia
NUSTENDI™ (bempedoic acid and ezetimibe) Tablet
Vosoritide to Treat Children with Achondroplasia
Vosoritide to Treat Children with Achondroplasia
Esperion Announces European Commission Approval of the NUSTENDI™ (bempedoic acid and ezetimibe) Tablet for the Treatment of Hypercholesterolemia and Mixed Dyslipidemia
Mon April 6, 2020 7:05 AM|GlobeNewswire|About: ESPR
– First Non-Statin, LDL-C Lowering Combination Medicine Ever Approved in Europe –
– NUSTENDI Is Approved for Patients Who Require Additional LDL-Cholesterol Lowering on a Background Statin, Other Lipid-Lowering Therapies, or Considered Statin Intolerant –
– Daiichi Sankyo Europe to Lead EU Commercialization, Cardiovascular Sales Organization Exceeds 1,000 Professionals –
– Esperion to Receive $150 Million Milestone Payment Upon First Commercial Sale –
ANN ARBOR, Mich., April 06, 2020 (GLOBE NEWSWIRE) -- Esperion (ESPR) announced today the European Commission approved the NUSTENDI™ (bempedoic acid and ezetimibe) tablet, an oral, once-daily, non-statin LDL-cholesterol (LDL-C) lowering medicine for hypercholesterolemia and dyslipidemia in Europe. NUSTENDI contains bempedoic acid and ezetimibe and lowers elevated LDL-C through complementary mechanisms of action by inhibiting cholesterol synthesis in the liver and absorption in the intestine.
The European Commission approved NUSTENDI for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
- in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe,
- alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone, or
- in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.
https://www.esperion.com/science/bempedoic-acid-ezetimibe-combo-tablet/
sacituzumab govitecan
Vosoritide to Treat Children with Achondroplasia
sacituzumab govitecan
IMMUNOMEDICS ANNOUNCES ASCENT STUDY TO BE STOPPED FOR COMPELLING EFFICACY
Mon April 6, 2020 8:00 AM|GlobeNewswire|About: IMMU
Decision based on recommendation from DSMC following study data review
Sacituzumab govitecan has the potential to be the first FDA-approved antibody-drug conjugate for the treatment of metastatic triple-negative breast cancer
Conference call and webcast today at 8:00 a.m. Eastern Time
MORRIS PLAINS, N.J., April 06, 2020 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (IMMU)
https://www.immunomedics.com/our-science/pipeline/
https://clinicaltrials.gov/ct2/show/NCT02574455?term=NCT02574455&rank=1
ASCENT Trial for Metastatic Triple-Negative Breast Cancer
https://www.immunomedics.com/our-science/clinical-trials/
ALUNBRIG® (brigatinib)
KEYTRUDA® (pembrolizumab) Injection, 100 mg
sacituzumab govitecan
European Commission Approves Takeda’s ALUNBRIG® (brigatinib) as a First-Line Treatment for ALK+ NSCLC
Mon April 6, 2020 8:00 AM|Business Wire|About: TAK
– Approval Based on Positive Results from the Phase 3 ALTA-1L Trial Showing ALUNBRIG Demonstrated Superior Overall and Intracranial Effectiveness over Crizotinib in the First-line Setting –
– Expanded Indication Provides Additional First-Line Treatment Option for the Approximately 10,000 People with ALK+ NSCLC in Europe –
CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK)
https://www.businesswire.com/news/home/20200406005146/en/
https://www.takedaoncology.com/
Alunbrig
brigatinib
https://www.ema.europa.eu/en/medicines/human/EPAR/alunbrig
https://seekingalpha.com/symbol/TAK
ARIES® SARS-CoV-2 Assay
KEYTRUDA® (pembrolizumab) Injection, 100 mg
KEYTRUDA® (pembrolizumab) Injection, 100 mg
Luminex Receives FDA Emergency Use Authorization for ARIES® SARS-CoV-2 Assay to Detect Virus Responsible for COVID-19 Disease
Mon April 6, 2020 7:30 AM|PR Newswire|About: LMNXPR Newswire
AUSTIN, Texas, April 6, 2020 /PRNewswire/ -- Luminex Corporation (LMNX)
https://seekingalpha.com/symbol/LMNX
KEYTRUDA® (pembrolizumab) Injection, 100 mg
KEYTRUDA® (pembrolizumab) Injection, 100 mg
KEYTRUDA® (pembrolizumab) Injection, 100 mg
Merck Receives Priority Review from FDA for Second Application for KEYTRUDA® (pembrolizumab) Based on Biomarker, Regardless of Tumor Type
Tue April 7, 2020 6:45 AM|Business Wire|About: MRK
Supplemental Biologics License Application (sBLA) Accepted for KEYTRUDA Monotherapy in Patients Whose Tumors Are Tumor Mutational Burden-High (TMB-H) Who Have Progressed Following Prior Treatment
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada,
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)
https://clinicaltrials.gov/ct2/show/NCT02628067
https://www.merck.com/index.html
Merck Announces KEYTRUDA® (pembrolizumab) Significantly Improved Progression-Free Survival as First-Line Treatment for Advanced Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer
First Positive Head-to-Head Phase 3 Trial Comparing a Single-Agent Cancer Medicine to Standard of Care Chemotherapy as First-line Treatment for MSI-H or dMMR Colorectal Cancer
Merck to Share Data from KEYNOTE-177 with Global Regulatory Authorities and at an Upcoming Medical Congress
Thursday, April 2, 2020 6:45 am EDT
Merck Receives Priority Review from FDA for Second Application for KEYTRUDA® (pembrolizumab) Based on Biomarker, Regardless of Tumor Type
Supplemental Biologics License Application (sBLA) Accepted for KEYTRUDA Monotherapy in Patients Whose Tumors Are Tumor Mutational Burden-High (TMB-H) Who Have Progressed Following Prior Treatment
Tuesday, April 7, 2020 6:45 am EDT
https://www.businesswire.com/news/home/20200407005141/en/
https://seekingalpha.com/symbol/MRK
Seeking Biotech Alpha APRIL/MARCH 2020 Insight
RUXIENCE™ (rituximab)
oral prostacyclin pathway agents (PPAs), including UPTRAVI® (selexipag)
RUXIENCE™ (rituximab)
Pfizer Receives European Approval for Oncology Biosimilar, RUXIENCE™ (rituximab)
Thu April 2, 2020 2:04 PM|Business Wire|About: PFE
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE) today announced that the European Commission (EC) has approved RUXIENCE™ (rituximab), a monoclonal antibody (mAb) and biosimilar to MabThera® (rituximab), for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and pemphigus vulgaris (PV).1,2,3
https://www.businesswire.com/news/home/20200402005733/en/
https://seekingalpha.com/symbol/PFE
PFIZER RECEIVES EUROPEAN APPROVAL FOR ONCOLOGY BIOSIMILAR, RUXIENCE™ (RITUXIMAB)
Thursday, April 2, 2020 - 2:04pmEDT
Dupixent® (dupilumab)
oral prostacyclin pathway agents (PPAs), including UPTRAVI® (selexipag)
RUXIENCE™ (rituximab)
Dupixent® (dupilumab) Phase 3 Data at Revolutionizing Atopic Dermatitis Conference Show Significant Improvement in Severe Atopic Dermatitis for Children Aged 6 to 11 Years
Fri April 3, 2020 12:59 AM|PR Newswire|About: REGN
TARRYTOWN, N.Y. and PARIS, April 3, 2020 /PRNewswire/
https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf
https://seekingalpha.com/symbol/REGN
oral prostacyclin pathway agents (PPAs), including UPTRAVI® (selexipag)
oral prostacyclin pathway agents (PPAs), including UPTRAVI® (selexipag)
oral prostacyclin pathway agents (PPAs), including UPTRAVI® (selexipag)
Results from Expert Delphi Consensus Survey on Treatment of Pulmonary Arterial Hypertension (PAH) with Oral Prostacyclin Pathway Agents (PPAs) Published in CHEST Journal
Fri April 3, 2020 9:00 AM|PR Newswire|About: JNJPR Newswire
SOUTH SAN FRANCISCO, Calif., April 3, 2020 /PRNewswire/ -- Actelion Pharmaceuticals US, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson (JNJ)
https://journal.chestnet.org/article/S0012-3692(19)34214-X/fulltext
https://seekingalpha.com/symbol/ALIOF
https://seekingalpha.com/symbol/JNJ
https://www.actelion.us/products/index
Nucala (mepolizumab)
Reblozyl® (luspatercept-aamt)
oral prostacyclin pathway agents (PPAs), including UPTRAVI® (selexipag)
Glaxo's Nucala successful in pivotal nasal polyp study
Apr. 3, 2020 9:24 AM ET|About: GlaxoSmithKline plc (GSK)|By: Douglas W. House, SA News Editor
03 April 2020
Nucala (mepolizumab) is the first anti-IL5 biologic to report positive phase 3 results in patients with nasal polyps
https://www.gsk.com/en-gb/media/press-releases/nucala-mepolizumab-is-the-first-anti-il5-biologic-to-report-positive-phase-3-results-in-patients-with-nasal-polyps/
https://www.nucala.com/
Effect of Mepolizumab in Severe Bilateral Nasal Polyps
https://clinicaltrials.gov/ct2/show/NCT03085797?titles=synapse&lead=glaxosmithkline&phase=2&draw=2&rank=1
https://seekingalpha.com/symbol/GSK
https://seekingalpha.com/symbol/BMY
Reblozyl® (luspatercept-aamt)
Reblozyl® (luspatercept-aamt)
Reblozyl® (luspatercept-aamt)
U.S. Food and Drug Administration (FDA) Approves Reblozyl® (luspatercept-aamt), the First and Only Erythroid Maturation Agent, to Treat Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS)
Fri April 3, 2020 5:08 PM|Business Wire|About: BMY, XLRN
The FDA approval marks the second indication for Reblozyl and the first new treatment option in over a decade for patients with MDS who require red blood cell (RBC) transfusions and have failed an erythropoiesis stimulating agent
Reblozyl regulates late-stage RBC maturation to relieve patients from the burden of regular RBC transfusions
PRINCETON, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) and Acceleron Pharma Inc. (XLRN) (NASDAQ: XLRN)
https://media2.celgene.com/content/uploads/reblozyl-pi.pdf
https://www.businesswire.com/news/home/20200403005530/en/
https://seekingalpha.com/symbol/XLRN
https://seekingalpha.com/symbol/BMY
Ruxolitinib Cream
Reblozyl® (luspatercept-aamt)
Reblozyl® (luspatercept-aamt)
Incyte Announces First Presentation of Phase 3 Data from the TRuE-AD Program of Ruxolitinib Cream at the Revolutionizing Atopic Dermatitis Virtual Symposium
Sun April 5, 2020 8:00 AM|Business Wire|About: INCY
- Ruxolitinib cream resulted in a rapid and robust clinical response, with significantly more patients achieving Investigator’s Global Assessment (IGA) Treatment Success (IGA-TS; primary endpoint), defined as an IGA score of 0 (clear) or 1 (almost clear), and EASI75 (key secondary endpoint), defined as the proportion of patients who achieved a ≥ 75% improvement in the Eczema Area and Severity Index Score
- Treatment with ruxolitinib cream also resulted in a rapid, substantial and sustained reduction in itch, a key quality of life measure for patients with atopic dermatitis
- Data support the planned submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration before the end of 2020
WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (INCY)
https://virtual.revolutionizingad.com/events/6
TRuE AD1 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis
https://clinicaltrials.gov/ct2/show/NCT03745638
TRuE AD2 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis
https://clinicaltrials.gov/ct2/show/NCT03745651
https://www.businesswire.com/news/home/20200405005012/en/
https://seekingalpha.com/symbol/INCY
Seeking Biotech Alpha APRIL/MARCH 2020 Insight
leronlimab (PRO 140)
Sevenfact [coagulation factor VIIa (recombinant)-jncw]
Sevenfact [coagulation factor VIIa (recombinant)-jncw]
CytoDyn Files a Clinical Trial Protocol with the FDA to Treat Severely Ill COVID-19 Patients with Leronlimab where the Primary Endpoint is Mortality Rate at Two Weeks
Wed April 1, 2020 6:00 AM|GlobeNewswire|About: CYDYGlobeNewswire
VANCOUVER, Washington, April 01, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)
https://www.cytodyn.com/pipeline
https://seekingalpha.com/symbol/CYDY
Treatment with CytoDyn's Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients
Thu April 2, 2020 6:00 AM|GlobeNewswire|About: CYDYGlobeNewswire
VANCOUVER, Washington, April 02, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)
Updates Surrounding Leronlimab Use in Patients With COVID-19 Appear Promising
Apr 09, 2020, 7:51pmDanielle Ternyila
Sevenfact [coagulation factor VIIa (recombinant)-jncw]
Sevenfact [coagulation factor VIIa (recombinant)-jncw]
Sevenfact [coagulation factor VIIa (recombinant)-jncw]
FDA Approves Additional Treatment for Adults and Adolescents with Hemophilia A or B and Inhibitors
Wed April 1, 2020 1:12 PM|PR NewswirePR Newswire
SILVER SPRING, Md., April 1, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Sevenfact [coagulation factor VIIa (recombinant)-jncw] for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies)
https://www.cdc.gov/ncbddd/hemophilia/data.html
FDA OKs new hemophilia treatment
Apr. 1, 2020 1:51 PM ET|About: uniQure N.V. (QURE)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3557408-fda-oks-new-hemophilia-treatment
https://www.groupe-lfb.com/en/
KEYTRUDA ® (pembrolizumab) Injection, 100 mg
Sevenfact [coagulation factor VIIa (recombinant)-jncw]
KEYTRUDA ® (pembrolizumab) Injection, 100 mg
Merck Announces KEYTRUDA® (pembrolizumab) Significantly Improved Progression-Free Survival as First-Line Treatment for Advanced Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer
Thu April 2, 2020 6:45 AM|Business Wire|About: MRK
First Positive Head-to-Head Phase 3 Trial Comparing a Single-Agent Cancer Medicine to Standard of Care Chemotherapy as First-line Treatment for MSI-H or dMMR Colorectal Cancer
Merck (MRK) to Share Data from KEYNOTE-177 with Global Regulatory Authorities and at an Upcoming Medical Congress
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck
Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177)
https://clinicaltrials.gov/ct2/show/NCT02563002
https://www.merck.com/index.html
https://www.businesswire.com/news/home/20200402005209/en/
https://seekingalpha.com/symbol/MRK
Cologuard® Through Telehealth
Kite & Teneobio Collaborate on Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb®
KEYTRUDA ® (pembrolizumab) Injection, 100 mg
Exact Sciences Highlights The Opportunity To Seek Screening With Cologuard® Through Telehealth
Thu April 2, 2020 6:00 AM|PR Newswire|About: EXASPR Newswire
MADISON, Wis., April 2, 2020 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS)
https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/survival-rates.html
https://www.exactsciences.com/
PADCEV (enfortumab vedotin-ejfv), combined with Merck's Keytruda (pembrolizumab)
Kite & Teneobio Collaborate on Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb®
Kite & Teneobio Collaborate on Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb®
Seattle Genetics Announces Potential Accelerated Approval Pathway in the U.S. for PADCEV™ (enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab as First-Line Treatment for Advanced Urothelial Cancer
Thu April 2, 2020 8:00 AM|Business Wire|About: SGEN
BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) (Nasdaq:SGEN)
Seattle Genetics' PADCEV may nab accelerated review for first-line urothelial cancer
Apr. 2, 2020 8:48 AM ET|About: Seattle Genetics, Inc. (SGEN)|By: Douglas W. House, SA News Editor
https://www.seattlegenetics.com/
A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer (EV-103)
https://clinicaltrials.gov/ct2/show/NCT03288545?term=ev-103&draw=2&rank=1
https://seekingalpha.com/symbol/SGEN
Kite & Teneobio Collaborate on Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb®
Kite & Teneobio Collaborate on Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb®
Kite & Teneobio Collaborate on Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb®
Kite Licenses Antibodies and Establishes Collaboration With Teneobio in Multiple Myeloma
Thu April 2, 2020 8:30 AM|Business Wire|About: GILD
-- Kite and Teneobio will Collaborate on Next-Generation Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb® Antibodies --
SANTA MONICA, Calif. & NEWARK, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), and Teneobio, Inc.
https://www.businesswire.com/news/home/20200402005067/en/
https://www.teneobio.com/pipeline/
https://seekingalpha.com/symbol/GILD
NGS-based Discovery of UniAb® and UniDAb®
Seeking Biotech Alpha MARCH 2020 Insight
VASCEPA® (Icosapent Ethyl)
Idecabtagene Vicleucel (Ide-cel, bb2121)
XIFAXAN® (rifaximin) 550 mg tablets
Amarin Highlights VASCEPA® (Icosapent Ethyl)-Related Data Presented at American College of Cardiology’s Annual Scientific Session Together With World Congress of Cardiology (ACC.20/WCC)
Tue March 31, 2020 7:00 AM|GlobeNewswire|About: AMRN
DUBLIN, Ireland and BRIDGEWATER, N.J., March 31, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN)
https://virtual.acc.org/on-demand/acc-videos#nav_jump
https://cslide-us.ctimeetingtech.com/acc2020_eposter/attendee/eposter/poster/157?q=1263-090
https://cslide-us.ctimeetingtech.com/acc2020_eposter/attendee/eposter/poster/367?q=1212-205
https://cslide-us.ctimeetingtech.com/acc2020_eposter/attendee/eposter/poster/388?q=1364-202
INDICATION AND IMPORTANT SAFETY INFORMATION
WHAT IS VASCEPA?
VASCEPA is a prescription medicine used:
- along with certain medicines (statins) to reduce the risk of heart attack, stroke and certain types of heart issues requiring hospitalization in adults with heart (cardiovascular) disease, or diabetes and 2 or more additional risk factors for heart disease.
- along with a low-fat and low-cholesterol diet to lower high levels of triglycerides (fats) in adults.
XIFAXAN® (rifaximin) 550 mg tablets
Idecabtagene Vicleucel (Ide-cel, bb2121)
XIFAXAN® (rifaximin) 550 mg tablets
Bausch Health Announces Favorable Topline Results From Study Evaluating Investigative Formulation of Rifaximin SSD IR to Treat Overt Hepatic Encephalopathy
Tue March 31, 2020 7:00 AM|PR Newswire|About: BHC
Study Arm Evaluating 40 MG BID of Rifaximin SSD IR In Combination with Standard of Care Therapy Met Primary Endpoint
LAVAL, Quebec, March 31, 2020 /PRNewswire/ -- Bausch Health Companies Inc. (BHC)
https://seekingalpha.com/symbol/BHC
Idecabtagene Vicleucel (Ide-cel, bb2121)
Idecabtagene Vicleucel (Ide-cel, bb2121)
Idecabtagene Vicleucel (Ide-cel, bb2121)
Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application (BLA) for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121) to FDA
Tue March 31, 2020 6:59 AM|Business Wire|About: BLUE, BMY
BLA submission includes results from pivotal Phase 2 KarMMa study evaluating ide-cel in a heavily pre-treated patient population with relapsed and refractory multiple myeloma
PRINCETON, NJ. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE)
https://www.businesswire.com/news/home/20200331005194/en/
https://seekingalpha.com/symbol/BMY
https://seekingalpha.com/symbol/BLUE
ADCETRIS® (brentuximab vedotin)
CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate
Idecabtagene Vicleucel (Ide-cel, bb2121)
Takeda Receives Positive CHMP Opinion for ADCETRIS® (brentuximab vedotin) in Combination with CHP (Cyclophosphamide, Doxorubicin and Prednisone) for Treatment of Adult Patients with Previously Untreated Systemic Anaplastic Large Cell Lymphoma
Tue March 31, 2020 8:00 AM|Business Wire|About: TAK
– Opinion Based on Phase 3 ECHELON-2 Study Which Demonstrated ADCETRIS Plus Chemotherapy Resulted in a Statistically Significant Improvement in Progression-Free Survival Compared to a Standard of Care –
CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)--
Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK)
https://www.takeda.com/investors/
https://www.takedaoncology.com/
https://www.businesswire.com/news/home/20200331005020/en/
https://seekingalpha.com/symbol/TAK
CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate
CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate
CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate
FDA Accepts Investigational New Drug Application for CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate Developed Under Collaboration with Intellia Therapeutics
Tue March 31, 2020 7:30 AM|GlobeNewswire|About: NTLA
CAMBRIDGE, Mass., March 31, 2020 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NTLA)
https://www.intelliatx.com/pipeline-2/
https://www.intelliatx.com/publications-and-presentations-2/
All News2020201920182017201620152014
- MAR 31, 2020
FDA Accepts Investigational New Drug Application for CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate Developed Under Collaboration with Intellia Therapeutics
CAMBRIDGE, Mass. , March 31, 2020 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA),
https://ir.intelliatx.com/news-releases
https://seekingalpha.com/symbol/NTLA
FDA signs off on study of CRISPR drug for sickle cell disease
Mar. 31, 2020 10:19 AM ET|About: Intellia Therapeutics,... (NTLA)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3556807-fda-signs-off-on-study-of-crispr-drug-for-sickle-cell-disease
https://seekingalpha.com/symbol/NVS
remdesivir for the treatment of COVID-19
CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate
CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate
01-Apr-2020
GILEAD SCIENCES ANNOUNCES TWO PHASE 3 RANDOMISED STUDIES TO EVALUATE THE SAFETY AND ANTIVIRAL ACTIVITY OF REMDESIVIR (GS-5734™) IN PARTICIPANTS WITH MODERATE TO SEVERE COVID-19
- Remdesivir is an investigational agent – it is not approved anywhere globally and has not been demonstrated to be safe or effective for any use.
- The UK is one of the countries where Gilead is running clinical trials to evaluate remdesivir for the treatment of COVID-19
London, April 1st 2020 – Gilead Sciences
Gilead Sciences launches two remdesivir studies in UK
Apr. 1, 2020 7:57 AM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3557138-gilead-sciences-launches-two-remdesivir-studies-in-uk
Seeking Biotech Alpha MARCH 2020 Insight
Evinacumab
NEXLETOL™ (bempedoic acid) Tablet
Taltz® (ixekizumab)
Regeneron Announces American College of Cardiology Presentation of Positive Phase 3 Evinacumab Results in Patients with Severe Inherited Form of High Cholesterol
Mon March 30, 2020 11:46 AM|PR Newswire|About: REGN
TARRYTOWN, N.Y., March 30, 2020 /PRNewswire/ --
Results from separate positive Phase 3 trial of Praluent® (alirocumab) in patients with HoFH also presented; FDA regulatory submission planned for Q2 2020
Regeneron Pharmaceuticals, Inc. (REGN) (NASDAQ: REGN)
https://www.nejm.org/doi/full/10.1056/NEJMoa1612790
https://seekingalpha.com/symbol/REGN
Taltz® (ixekizumab)
NEXLETOL™ (bempedoic acid) Tablet
Taltz® (ixekizumab)
Lilly's Taltz® (ixekizumab) Receives U.S. FDA Approval for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis
Mon March 30, 2020 6:45 AM|PR Newswire|About: LLYPR Newswire
INDIANAPOLIS, March 30, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY)
http://pi.lilly.com/us/taltz-uspi.pdf
https://www.psoriasis.org/content/statistics
NEXLETOL™ (bempedoic acid) Tablet
NEXLETOL™ (bempedoic acid) Tablet
QIAGEN Receives U.S. FDA EUA for QIAstat-Dx test kit, Detection of SARS-CoV-2 Coronavirus
Esperion Announces Commercial Availability of the NEXLETOL™ (bempedoic acid) Tablet and Pledges a Conscientious Launch During Unprecedented Moment in Healthcare
Mon March 30, 2020 4:15 PM|GlobeNewswire|About: ESPR
– First Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine in the U.S. in Nearly 20 Years for Indicated Patients Awaiting a New Option –
– Esperion Aims to Set New Industry Standard by Pricing NEXLETOL for Patient Affordability and Access –
– Company Repurposes Healthcare Provider Education and Support Material Encouraging Remote Education and Virtual Visits with our Lipid Experts During This Extraordinary Time –
ANN ARBOR, Mich., March 30, 2020 (GLOBE NEWSWIRE) -- Esperion (ESPR)
https://pi.esperion.com/nexletol/nexletol-pi.pdf
https://www.esperion.com/product/nexletol/
QIAGEN Receives U.S. FDA EUA for QIAstat-Dx test kit, Detection of SARS-CoV-2 Coronavirus
FDA clears CytoDyn’s mid-stage leronlimab trial for mild-to-moderately ill COVID-19 patients
QIAGEN Receives U.S. FDA EUA for QIAstat-Dx test kit, Detection of SARS-CoV-2 Coronavirus
QIAGEN Receives U.S. FDA EUA for QIAstat-Dx test kit, First and Only Syndromic Solution Integrating Detection of SARS-CoV-2 Coronavirus
Tue March 31, 2020 4:05 AM|Business Wire|About: QGEN
- First syndromic testing solution to be deployed in epidemic can differentiate novel coronavirus from 21 other serious respiratory infections
- QIAstat-Dx Respiratory SARS-CoV-2 Panel delivers results in about one hour
- Adds an important tool for clinicians as part of QIAGEN’s global mobilization to scale up testing supplies for the COVID-19 response
GERMANTOWN, Md. & HILDEN, Germany--(BUSINESS WIRE)-- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA)
https://www.businesswire.com/news/home/20200331005294/en/
FDA clears CytoDyn’s mid-stage leronlimab trial for mild-to-moderately ill COVID-19 patients
FDA clears CytoDyn’s mid-stage leronlimab trial for mild-to-moderately ill COVID-19 patients
FDA clears CytoDyn’s mid-stage leronlimab trial for mild-to-moderately ill COVID-19 patients
FDA Clears CytoDyn’s Phase 2 Randomized Trial to Treat Mild-to-Moderately Ill Coronavirus Patients with Leronlimab; Enrollment to Begin Immediately
Tue March 31, 2020 6:00 AM|GlobeNewswire|About: CYDY
VANCOUVER, Washington, March 31, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)
https://www.cytodyn.com/pipeline
EPIDIOLEX® (cannabidiol)
FDA clears CytoDyn’s mid-stage leronlimab trial for mild-to-moderately ill COVID-19 patients
FDA clears CytoDyn’s mid-stage leronlimab trial for mild-to-moderately ill COVID-19 patients
GW Pharmaceuticals and Greenwich Biosciences Announce FDA Acceptance of sNDA Filing with Priority Review for EPIDIOLEX® (cannabidiol) in the Treatment of Seizures Associated with Tuberous Sclerosis Complex
Tue March 31, 2020 7:00 AM|GlobeNewswire|About: GWPHGlobeNewswire
CARLSBAD, Calif., March 31, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (GWPRF) (Nasdaq: GWPH)
https://seekingalpha.com/symbol/GWPH
https://www.greenwichbiosciences.com/
https://ghr.nlm.nih.gov/condition/tuberous-sclerosis-complex
Seeking Biotech Alpha MARCH 2020 Insight
BRILINTA
Dual-Antiplatelet Therapy
Imfinzi (durvalumab)
BRILINTA reduced bleeding vs dual therapy in high-risk coronary patients in sub-analyses from Phase IV TWILIGHT trial
Mon March 30, 2020 9:16 AM|Business Wire|About: AZN
BRILINTA monotherapy reduced bleeding complications with no increased risk of ischemic events in patients with diabetes undergoing percutaneous coronary intervention
Consistent results were also observed in patients undergoing complex percutaneous coronary intervention
WILMINGTON, Del.--(BUSINESS WIRE)
https://www.azpicentral.com/brilinta/brilinta.pdf#page=1
https://www.astrazeneca-us.com/
https://www.businesswire.com/news/home/20200330005412/en/
Brilinta reduced bleeding vs dual therapy in high-risk coronary patients in sub-analyses from Phase IV TWILIGHT trial
Imfinzi (durvalumab)
Dual-Antiplatelet Therapy
Imfinzi (durvalumab)
Imfinzi approved in the US for extensive-stage small cell lung cancer
PUBLISHED30 March 2020
30 March 2020 07:00 BST
Only PD-1/PD-L1 immunotherapy to demonstrate a significant survival benefit in combination with etoposide and a choice of carboplatin or cisplatin chemotherapy
AstraZeneca’s Imfinzi (durvalumab
https://seekingalpha.com/symbol/AZN
Our approach to Oncology
Dual-Antiplatelet Therapy
Dual-Antiplatelet Therapy
Dual-Antiplatelet Therapy
March 30, 2020 10:00 ET | Source: Medtronic plc
Medtronic Onyx ONE Clear Study of One-Month Dual-Antiplatelet Therapy in High Bleeding Risk Stent Patients Beats Performance Goal
DUBLIN, March 30, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT
https://www.medtronic.com/uk-en/index.html
https://seekingalpha.com/symbol/MDT
soticlestat (OV935/TAK935)
Agilent Announces New Class 1 Triple Quadrupole LC/MS System
Dual-Antiplatelet Therapy
Ovid Therapeutics Announces Initial Data with Soticlestat in CDKL5 Deficiency Disorder and Dup15q Syndrome
Mon March 30, 2020 8:00 AM|GlobeNewswire|About: OVID
Soticlestat continues to appear to be safe and well-tolerated; the majority of the 11 patients showed a reduction in seizures
All patients that have completed the Phase 2 ARCADE study to date have opted to enroll in the ENDYMION open-label extension study
NEW YORK, March 30, 2020 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (OVID)
https://seekingalpha.com/symbol/TKPHF
https://seekingalpha.com/symbol/OVID
A Multicenter, Open-label, Pilot Study of TAK-935 (OV935) in Participants With 15Q Duplication Syndrome or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)
https://clinicaltrials.gov/ct2/show/NCT03694275?cond=CDKL5+Deficiency+Disorder&phase=1&draw=2&rank=2
A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of TAK-935 (OV935) as Adjunctive Therapy in Patients With Rare Epilepsy (Endymion)
https://clinicaltrials.gov/ct2/show/NCT03635073?cond=CDKL5+Deficiency+Disorder&phase=1&draw=2&rank=1
Agilent Announces New Class 1 Triple Quadrupole LC/MS System
Agilent Announces New Class 1 Triple Quadrupole LC/MS System
Agilent Announces New Class 1 Triple Quadrupole LC/MS System
Agilent Announces New Class 1 Triple Quadrupole LC/MS System
Mon March 30, 2020 8:00 AM|Business Wire|About: A
Purpose-built and validated for clinical laboratories
SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (A) (NYSE: A) today introduced the Agilent K6460S Clinical Edition TQ LC/MS system, designed to improve in vitro diagnostic workflows in clinical labs.
https://www.businesswire.com/news/home/20200330005195/en/
VASCEPA® (Icosapent Ethyl)
Agilent Announces New Class 1 Triple Quadrupole LC/MS System
Agilent Announces New Class 1 Triple Quadrupole LC/MS System
Eicosapentaenoic Acid (EPA) Levels From VASCEPA® (Icosapent Ethyl) in REDUCE-IT® Strongly Correlated with Cardiovascular Outcomes
Mon March 30, 2020 11:45 AM|GlobeNewswire|About: AMRN
- Serum EPA Levels Showed Approximately 400% Increase Following Administration of VASCEPA
- High EPA Levels Associated with Substantial Reductions in Multiple Cardiovascular Endpoints Including Heart Failure and Total Mortality
Amarin to Webcast Discussion of Presented Data March 30, 5:30 - 6:30 p.m., Eastern Time
DUBLIN, Ireland and BRIDGEWATER, N.J., March 30, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN)
https://www.vascepa.com/assets/pdf/Vascepa_PI.pdf
https://seekingalpha.com/symbol/AMRN
Seeking Biotech Alpha MARCH 2020 Insight
FARXIGA (dapagliflozin)
Evolut™ transcatheter aortic valve replacement (TAVR) system
Evolut™ transcatheter aortic valve replacement (TAVR) system
FARXIGA reduced the incidence of heart failure worsening or cardiovascular death in a sub-analysis from landmark Phase III DAPA-HF trial
Sat March 28, 2020 9:53 AM|Business Wire|About: AZN
New data showed consistent effect of FARXIGA in patients with heart failure with reduced ejection fraction, regardless of background therapy
WILMINGTON, Del.-
https://www.astrazeneca-us.com/
https://www.businesswire.com/news/home/20200328005007/en/
https://www.azpicentral.com/farxiga/farxiga.pdf#page=1
https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehaa183/5813081
https://seekingalpha.com/symbol/AZN
Evolut™ transcatheter aortic valve replacement (TAVR) system
Evolut™ transcatheter aortic valve replacement (TAVR) system
Evolut™ transcatheter aortic valve replacement (TAVR) system
Medtronic Evolut TAVR System Demonstrates Excellent Outcomes in Study of Low-Risk Patients with Bicuspid Aortic Stenosis
Sun March 29, 2020 9:00 AM|GlobeNewswire|About: MDT
ACC.20/WCC: Low Rates of Paravalvular Leak and High Survival Observed in Late-breaking Clinical Trial of Low-Risk Bicuspid Aortic Stenosis Patients
DUBLIN, March 29, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (MDT)
https://www.medtronic.com/us-en/index.html
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2999052/
https://seekingalpha.com/symbol/MDT
Symplicity Spyral™ Renal Denervation System
Evolut™ transcatheter aortic valve replacement (TAVR) system
Symplicity Spyral™ Renal Denervation System
Landmark SPYRAL HTN-OFF MED Pivotal Trial Shows Superiority for Renal Denervation in Patients with High Blood Pressure Compared to Sham Procedure
Sun March 29, 2020 11:45 AM|GlobeNewswire|About: MDT
ACC.20/WCC: Study Finds Significant Blood Pressure Reductions Achieved with RDN in Absence of Anti-Hypertensive Medication
Medtronic Receives FDA “Breakthrough Device Designation” for Symplicity Spyral™ Renal Denervation System
DUBLIN, March 29, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (MDT) (NYSE:MDT)
https://www.medtronic.com/us-en/index.html
Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation (Symplicity AF)
https://clinicaltrials.gov/ct2/show/study/NCT02064764?term=Symplicity+AF&rank=1#contacts