BioSpace News Archive

Pliancy

Sanofi's Distribution Center in Quebec, Canada

Sanofi, Denali Abandon Mid-Stage Multiple Sclerosis Study on Disappointing Data

Oditrasertib, which blocks the inflammatory RIPK1 protein, earlier this year also failed a Phase II trial in amyotrophic lateral sclerosis, forcing the company to discontinue its development a few months later.

October 11, 2024

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2 min read

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Tristan Manalac

Pictured: Entrance to the FTC's office in Washington, DC

Editorial

Pressure Mounts on Novo’s $16.5B Catalent Buy Amid FTC Review

Senator Elizabeth Warren told the Federal Trade Commission that the acquisition of contract manufacturer Catalent could increase Novo’s dominance over the hot GLP-1 market, reducing competition and increasing prices.

October 11, 2024

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3 min read

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Greg Slabodkin

Approvals

Roche Wins First-Line Breast Cancer Nod for Oral PI3K Blocker, Projects $2.3B in Peak Sales

With the regulatory approval for advanced breast cancer, Roche’s inavolisib is a potential challenger to Novartis’ PI3K inhibitor Piqray, which last year generated $505 million in revenue.

October 11, 2024

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2 min read

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Tristan Manalac

Employees Walking In And Out Of The Door, Some Were Leaving Their Job And Some Were Being Hired At The Same Time. Full Length, Isolated On Solid Color Background. Vector, Illustration, Flat Design, Character.

Layoffs

Turnstone Biologics to Lay Off 60% of Workforce, Overhaul C-Suite

Turnstone is shifting resources to focus on clinical advancement of its selected tumor-infiltrating lymphocyte therapy as three C-suite members exit their roles.

October 11, 2024

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2 min read

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Angela Gabriel

Pictured: Teva Pharmaceuticals USA headquarters in

Legal

Teva to Pay $450M in Settlement With DOJ Over Kickback and Price-Fixing Allegations

The U.S. Department of Justice alleged that Teva violated the Anti-Kickback Statute and the False Claims Act. The payment is in addition to the criminal penalty paid by Teva USA under its deferred prosecution agreement.

October 11, 2024

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2 min read

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Tristan Manalac

Outside view of an empty meeting and a city view in the window beyond

Adcomms

Stealth Wins Adcomm’s Unexpected Support for Ultra-Rare Disease Drug Candidate

Despite substantial variability in the presented data and no well-controlled trial, the FDA advisory committee voted in favor of Stealth BioTherapeutics’ Barth syndrome therapy elamipretide, citing the urgent unmet need.

October 11, 2024

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2 min read

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Tristan Manalac

Art collage, coins, and arrow up on the red and paper background. Concept of business and financial growth.

IPO

Upstream Raises $255M IPO for Inflammatory Drugs; CAMP4 Nets $75M for RNA Work

Two biotechs set out for the public markets this week, with Upstream Bio raising $255 million for its inflammatory disease work, while CAMP4 Therapeutics picked up $75 million to develop RNA-targeting drugs.

October 11, 2024

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1 min read

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Annalee Armstrong

Press Releases

Tempest Announces Agreement with Roche to Support Advancement of Amezalpat Combination Therapy into First-Line Hepatocellular Carcinoma Pivotal Trial

October 11, 2024

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7 min read