BioSpace News Archive

Pictured: GSK's office in Poznan, Poland/iStock, W

FDA

FDA Approves GSK’s Momelotinib for Myelofibrosis Patients with Anemia

Following a regulatory victory for Jemperli in endometrial cancer last month, GSK continued its oncology winning streak with an FDA approval for momelotinib in adult myelofibrosis patients with anemia.

September 18, 2023

·

2 min read

·

Tristan Manalac

Pictured: Bristol Myers Squibb office in California

Business

Samsung Biologics Strikes $242M Manufacturing Deal with BMS for Cancer Antibody

The deal is an expansion of an existing production agreement between the companies and just one of several deals with large pharma companies that the Korean biotech has scooped up this year.

September 18, 2023

·

2 min read

·

Connor Lynch

Pictured: U.S. Chamber of Commerce/Courtesy of Ado

Policy

DOJ, Chamber of Commerce Tussle in Court Over IRA’s Drug Price Negotiations

The legal battle over the Inflation Reduction Act’s price negotiation program moved to federal court in Ohio with the Department of Justice and U.S. Chamber of Commerce sparring about the law.

September 18, 2023

·

2 min read

·

Tristan Manalac

Pictured: Illustration of a blood clot in a blood

Drug Development

Anthos Stops Mid-Stage Atrial Fibrillation Trial Due to ‘Unprecedented’ Efficacy

After evidence of “overwhelming reduction” in bleeding compared to Bayer and J&J’s Xarelto, Anthos Therapeutics has ended its Phase II atrial fibrillation study for abelacimab ahead of schedule.

September 18, 2023

·

2 min read

·

Tristan Manalac

Pharm Country

GenScript Expands Range of Reagent Services, Adding Circular RNA and Lipid Nanoparticles Formulation

GenScript Biotech Corporation, the world’s leading provider of life-science research tools and services, has expanded its IVT mRNA synthesis portfolio with the addition of customized circular RNA and lipid nanoparticles formulation services.

September 18, 2023

·

4 min read

Business

ImmunoGen Appoints Lauren White as Senior Vice President and Chief Financial Officer

ImmunoGen, Inc., a leader in the expanding field of antibody-drug conjugates for the treatment of cancer, announced that Lauren White has been appointed Senior Vice President and Chief Financial Officer.

September 18, 2023

·

4 min read

BioNTech and CEPI Announce Partnership to Advance mRNA Mpox Vaccine Development and Support CEPI’s 100 Days Mission

BioNTech SE and the Coalition for Epidemic Preparedness Innovations announced a strategic partnership to advance mRNA-based vaccine candidates with the development of BNT166 for the prevention of mpox, an infectious disease that can lead to severe, life-threatening complications.

September 18, 2023

·

12 min read

Drug Development

Aclaris Therapeutics Announces Positive Results from Phase 1 Multiple Ascending Dose Trial of ATI-2138, an Investigational Oral Covalent ITK/JAK3 Inhibitor

Aclaris Therapeutics, Inc. today announced positive results from ATI-2138-PKPD-102, a Phase 1 Multiple Ascending Dose (MAD) trial of the investigational compound ATI-2138.

September 18, 2023

·

5 min read

Genetown

Kymera Therapeutics Receives U.S. FDA Fast Track Designation for KT-333, a First-in-Class, Investigational STAT3 Degrader for the Treatment of Relapsed/Refractory Cutaneous T-Cell Lymphoma and Relapsed/Refractory Peripheral T-Cell Lymphoma

Kymera Therapeutics, Inc. (NASDAQ: KYMR) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to KT-333 for the treatment of R/R Cutaneous T-cell Lymphoma (CTCL) and R/R Peripheral T-cell Lymphoma (PTCL).

September 18, 2023

·

8 min read

Deals

Virios Therapeutics Announces Termination of At-The-Market Sales Agreement

Virios Therapeutics, Inc. today announced that it provided notice of termination of the Capital on Demand™ Sales Agreement entered into between the Company and JonesTrading Institutional Services LLC on July 14, 2023 (the “Sales Agreement”).

September 18, 2023

·

4 min read