BioSpace News Archive

Pictured: 3D rendering of antibody-drug conjugate/

BioNTech, DualityBio Move ADC into Phase III for HER2-Low Breast Cancer

The antibody-drug conjugate will be pitted against chemotherapy in a heavily treated breast cancer subpopulation, with hopes of challenging AstraZeneca and Daiichi Sankyo’s blockbuster Enhertu.

September 1, 2023

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Kate Goodwin

Pictured: Amgen's office in Tampa, Florida

Policy

FTC Agreement Clears Amgen to Proceed with $27.8B Horizon Deal

Under a consent order agreement announced Friday, Amgen is prohibited from bundling any of its products with Horizon’s Tepezza or Krystexxa, allaying the FTC’s primary concerns.

September 1, 2023

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Heather McKenzie

Pictured: Syringe Drawing Up Drug from Vial/iStock

Drug Development

Bavarian Nordic Drops COVID Booster After Poor Phase III Results

The vaccine was effective against previous COVID-19 variants but lacked efficacy against new ones, the company announced Thursday, leaving the booster no commercially viable options.

September 1, 2023

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Connor Lynch

External view of the U.S. Capitol building

Policy

Lawmakers Press Lilly, Novo, Sanofi for Details on Insulin Assistance Programs

Two Democratic senators on Thursday sent a letter to the companies’ CEOs informing them that they have until Sept. 15 to disclose the application processes for their insulin assistance programs.

September 1, 2023

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Tristan Manalac

Policy

Alvotech Tries Again for FDA Interchangeable Designation for Humira Biosimilar

After shoring up quality control at its Reykjavik manufacturing facility, the biotech has resubmitted a BLA to the FDA seeking an interchangeability designation for its Humira biosimilar.

September 1, 2023

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Tristan Manalac

Pictured: Federal Trade Commission Sign/Courtesy o

Business

Week in Review: Amgen-Horizon Deal Moves Forward, First 10 Drugs for IRA Price Negotiation, Layoffs and More

$27.8B Amgen-Horizon deal gets FTC clearance with restrictions; the White House names first 10 drugs subject to Medicare price negotiations; Sage Therapeutics axes 40% of staff.

September 1, 2023

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Greg Slabodkin

Drug Development

Genentech’s Alecensa Delivers Unprecedented Phase III Results for People With ALK-Positive Early-Stage Lung Cancer

Genentech, a member of the Roche Group, announced that the Phase III ALINA study evaluating Alecensa®, compared with platinum-based chemotherapy, met its primary endpoint of disease-free survival at a prespecified interim analysis.

September 1, 2023

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Medivir Hosts Expert Perspectives Webcast on the Evolving Treatment Landscape and the Unique Treatment Challenges in HCC

Medivir AB announced that it will host a key opinion leader webcast on the current and future HCC treatment landscape, including how treatment challenges and needs in HCC differs from most other cancers.

September 1, 2023

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4 min read

Elastin Biosciences Announces Breakthrough Discovery in Elastin Restoration: Paving the Way for Treatment of Elastin-Deficiency Diseases

Longaevus Technologies, announces the spin-off of Elastin Biosciences following breakthrough preclinical results of 3 of its assets.

September 1, 2023

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Job Trends

Bristol Myers Squibb to Participate in the Morgan Stanley 21st Annual Global Healthcare Conference

Bristol Myers Squibb (NYSE: BMY) today announced that the company will participate in the Morgan Stanley 21st Annual Global Healthcare Conference in New York City on Monday, September 11, 2023.

September 1, 2023

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