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Pfizer and BioNTech to supply the European Union with 100 million additional doses of COMIRNATY®

World Pharma News - Tue, 04/20/2021 - 10:00
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they will supply an additional 100 million doses of COMIRNATY®, the companies' COVID-19 vaccine, to the 27 European Union (EU) member states in 2021. This announcement is a result of the European Commission's (EC) decision to exercise its option to purchase an additional 100 million doses under its expanded Advanced Purchase Agreement signed on February 17, 2021.

Vertex Drops $900 Million to Expand Partnership with CRISPR Therapeutics

Biospace news - Tue, 04/20/2021 - 02:00
Under the terms of the expanded deal, Vertex will be responsible for 60% of the costs of developing, manufacturing and commercializing CTX001 with support from CRISPR Therapeutics, and will receive 60% of profits from global sales.

KalVista's Hereditary Angioedema Trial On Hold as FDA Requests Additional Data

Biospace news - Tue, 04/20/2021 - 02:00
The agency is requesting additional information and analysis of preclinical studies regarding KVD824 before giving the go-ahead to the Phase II trial.

Q&A: Foghorn SVP Expounds on "Tremendous Opportunity" in Chromatin Remodeling

Biospace news - Tue, 04/20/2021 - 02:00
BioSpace caught up Foghorn Therapeutics’ Steven Bellon, Ph.D., SVP, drug discovery, shortly before he chaired a panel on new epigenetic developments at the AACR Annual Meeting 2021.

J&J Shareholders Urged by Others to Reject CEO's $30 Million Payday

Biospace news - Tue, 04/20/2021 - 02:00
Several prominent investors are urging shareholders to reject the compensation package because it shields the executive from billions of dollars in opioid-related litigation costs to the company.

2021 COVID-19 News: Researchers Discover a New Variant, Antiviral Shows Promise in Hamsters and More

Biospace news - Tue, 04/20/2021 - 02:00
Please check out the biopharma industry's COVID-19 stories that are trending for April 20, 2021.

Amgen Awarded Breakthrough Designation for Acquired Cancer Antibody Drug

Biospace news - Tue, 04/20/2021 - 02:00
One month after snapping up Five Prime Therapeutics and its Phase III ready anti-FGFR2b antibody bemarituzumab for $1.9 billion, Amgen announced the U.S. FDA awarded Breakthrough Therapy Designation to the asset as a first-line treatment for certain types of gastric cancer.

Patients who are obese or overweight are at risk for a more severe course of COVID-19

World Pharma News - Mon, 04/19/2021 - 12:00
COVID-19 patients who are overweight or obese are more likely to develop a more severe infection than patients of healthy weight, and they require oxygen and invasive mechanical ventilation more often. There is no increased risk of death . These conclusions, for which more than 7,000 patients were studied, appear from international research in eleven countries, including the Netherlands (Radboud university medical center).

New COVID-19 vaccine may offer broad protection from coronaviruses

World Pharma News - Mon, 04/19/2021 - 10:00
A COVID-19 vaccine that could provide protection against existing and future strains of the COVID-19 coronavirus, and other coronaviruses, and cost about $1 a dose has shown promising results in early animal testing.

Vaccines created by UVA Health's Steven L. Zeichner, MD, PhD, and Virginia Tech's Xiang-Jin Meng, MD, PhD, prevented pigs from being becoming ill with a pig model coronavirus, porcine epidemic diarrhea virus (PEDV).

Tonix Seeks to Advance OyaGen’s COVID-19 Treatment Under New Global Licensing Deal

Biospace news - Mon, 04/19/2021 - 02:00
The companies also plan to develop the candidate for the treatment of other potential future viral diseases.

Lyndra Therapeutics' Once-Per-Week Schizophrenia Treatment Shines in Phase II

Biospace news - Mon, 04/19/2021 - 02:00
A Phase II schizophrenia treatment is showing promise for patients diagnosed with this complex and chronic brain disorder.

Bristol Myers’ Opdivo Receives FDA Approval for Gastric Cancer

Biospace news - Mon, 04/19/2021 - 02:00
Opdivo, the trade name for the generic Nivolumab, can now be used in combination with certain types of chemotherapy for initial treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.

Adagio Raises $336 Million to Support Development of COVID-19 Antibody Candidate

Biospace news - Mon, 04/19/2021 - 02:00
The new financing round was led by RA Capital Management, in tandem with new investors Redmile Group, Federated Hermes, Foresite Capital, ArrowMark Partners, PremjiInvest, and another unnamed investor from the health care space.

Fauci Says J&J Vaccine Likely to Resume by Friday

Biospace news - Mon, 04/19/2021 - 02:00
The vaccine distribution has been paused in the country because of six or seven cases of rare blood clots.

J&J, Teva and Other Opioid Drugmakers Face $50 Billion Lawsuit in California

Biospace news - Mon, 04/19/2021 - 02:00
Johnson & Johnson, Endo International, AbbVie’s Allergan unit and Teva Pharmaceutical will head to court this morning in California over claims the companies engaged in deceptive marketing practices that fueled the opioid crisis in America.

Clinical Catch-Up: April 12-16

Biospace news - Mon, 04/19/2021 - 02:00
It was a particularly busy week for clinical trial news, in part because of several big medical conferences. Here’s a look.

Q&A with Acting FDA Commissioner Janet Woodcock on the Future of the FDA

Biospace news - Mon, 04/19/2021 - 02:00
Acting FDA Commissioner Janet Woodcock shared her thoughts on pandemic issues and outlined FDA modernization plans in a recent Q&A session with the Alliance for a Stronger FDA (Alliance).

COVID-19 Brief: An Inhaled COVID-19 Vaccine, Expanded Antibody Access and Blood Clots

Biospace news - Mon, 04/19/2021 - 02:00
As the U.S. reports surges in COVID-19 infections despite increased enrollment in vaccines, news continues to break about therapies, vaccines, and the risks involved with the new vaccines. Here’s a look.

FDA revokes emergency use authorization for monoclonal antibody Bamlanivimab

World Pharma News - Fri, 04/16/2021 - 23:00
Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients.

Amgen successfully completes acquisition of Five Prime Therapeutics

World Pharma News - Fri, 04/16/2021 - 12:00
Amgen (NASDAQ:AMGN) today announced that it has successfully completed its previously announced tender offer to purchase all outstanding shares of common stock of Five Prime Therapeutics (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immuno-oncology and targeted cancer therapies, for $38.00 per share in cash.