BioSpace News Archive

Drug Development

Merck’s Keytruda Flops in Late-Stage Endometrial Carcinoma Study

For the second time in as many days, Merck has reported a Phase III failure for its blockbuster PD-1 inhibitor Keytruda, this time as a first-line treatment with Eisai’s Lenvima for cancer in the uterus lining.

December 8, 2023
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2 min read
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Tristan Manalac
Drug Development

Rebranded Spyre Therapeutics Secures $180M to Advance IBD Antibody Pipeline

The private placement from existing and new investors extends the company’s cash runway into the second half of 2026 and will help take two candidates for inflammatory bowel disease into the clinic in 2024.

December 8, 2023
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1 min read
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Kate Goodwin
FDA

Casgevy vs. Lyfgenia: The Battle of the Sickle Cell Gene Therapies Has Begun

Friday’s FDA approval of Vertex-CRISPR’s Casgevy and bluebird bio’s Lyfgenia has immediately revealed startling differences between these two gene therapies: price and a black-box warning.

December 8, 2023
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2 min read
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Greg Slabodkin
Biopharma Funding, Deals Fall Sharply in 2023 in ‘Strategic’ Shift: PitchBook

The biopharma industry is projected to raise $24 billion this year, a steep decline from the “high-water marks” of 2020 through 2022, according to a new report from market data firm PitchBook.

December 8, 2023
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2 min read
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Tristan Manalac
Policy

Daiichi Sankyo Reaches $182M Settlement with Novartis in Tafinlar Patent Case

Plexxikon, which was acquired by Daiichi Sankyo, and Novartis have agreed to settle a patent case involving the cancer drug Tafinlar and its sale in the U.S.

December 8, 2023
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1 min read
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Tyler Patchen
FDA

FDA Approves Two Gene Therapies for Sickle Cell, First CRISPR-Based Medicine

Along with CRISPR/Cas9-based Casgevy—developed by Vertex Pharmaceuticals and CRISPR Therapeutics—the regulator on Friday approved bluebird bio’s Lyfgenia, a second gene therapy for sickle cell disease.

December 8, 2023
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3 min read
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Heather McKenzie
Drug Development

BMS Builds Case for Opdivo, Yervoy Combo in First-Line Colorectal Cancer

Results from a Phase III trial showed the combination improves progression-free survival compared to chemotherapy when used as a first-line treatment in metastatic colorectal cancer.

December 8, 2023
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2 min read
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Tristan Manalac
Policy

FDA Weighs Gene-Editing Treatments’ Curative Possibilities Against Potential Risks

As Vertex and CRISPR Therapeutics’ exa-cel and Verve Therapeutics’ VERVE-101 move forward, questions remain about possible drawbacks of such therapies.

December 8, 2023
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6 min read
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Heather McKenzie
Vanda Buys US, Canadian Rights to J&J’s MS Drug Ponvory in $100M Deal

Under an agreement with Johnson & Johnson’s Actelion Pharmaceuticals, the rights to the multiple sclerosis drug Ponvory in the U.S. and Canada will be transferred to Vanda Pharmaceuticals.

December 8, 2023
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2 min read
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Tyler Patchen
Drug Development

Axcella Health Becomes the Latest Flagship Company to Close its Doors

Another Flagship-founded company is shutting down its operations, according to an SEC filing. Axcella Health, which was focused on the development of a long COVID therapeutic, is no more.

December 8, 2023
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1 min read
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Tyler Patchen