BioSpace News Archive

Business

Sage Stock Drops Despite Promising Phase III Depression Data

With partner Biogen mum on zuranolone’s prospects as an FDA August 5 review deadline approaches, Sage Therapeutics’ stock fell Wednesday to its lowest level in months.

July 27, 2023
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2 min read
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Tristan Manalac
Business

Alkermes Gets $248M Boost from J&J, Gives Bullish Outlook on Teva Legal Fight

The company reported second-quarter revenue Wednesday that included $248.4 million of back royalties and associated interest related to the successful outcome of an arbitration case with J&J’s Janssen.

July 27, 2023
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2 min read
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Nick Paul Taylor
Business

BMS Reports Q2 Sales Miss Amid Generic Competition, Lowers Full-Year Guidance

Revenue for 2023 is now expected to decline to the low single digits instead of the 2% growth projected. Leadership pointed to the company’s multiple myeloma drugs as the main drags on earnings.

July 27, 2023
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2 min read
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Kate Goodwin
Business

Roche Drops Hemophilia A Candidate, Prepares for the Impacts of IRA

Amid the impending drug pricing pressures from the Inflation Reduction Act, Roche is discontinuing a mid-stage hemophilia A gene therapy candidate and four early-stage hopefuls.

July 27, 2023
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2 min read
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Tristan Manalac
Drug Development

Demise of Intercept’s NASH Program Highlights Safety Hurdles Facing the Space

Intercept’s failure to secure FDA approval for obeticholic acid (OCA) tablets in non-alcoholic steatohepatitis shines a light on safety challenges in the space, experts told BioSpace.

July 27, 2023
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5 min read
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Hayley Shasteen
Policy

FDA Action Alert: Mesoblast, Sage/Biogen and Galera

The FDA has three upcoming action dates in the next two weeks, including a highly anticipated decision regarding Biogen and Sage’s depression drug zuranolone.

July 27, 2023
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4 min read
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Tristan Manalac
Drug Development

Lilly’s Tirzepatide Cuts Weight of Enrollees by 26% in Phase III Trials

Data from two late-stage studies show that participants on Eli Lilly’s tirzepatide, which targets both GIP and GLP-1 receptors, achieved up to 26.6% mean weight loss.

July 27, 2023
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2 min read
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Connor Lynch
Policy

5 Highly Anticipated FDA Decisions for Rare Diseases Coming This Year

The first half of this year saw milestone approvals for rare disease therapies, and the FDA has several more such decisions on its calendar in the second half of 2023.

July 27, 2023
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6 min read
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Heather McKenzie
Business

Pfizer Announces Executive Leadership to Advance Oncology Research and Development Strategy

Pfizer Inc. (NYSE: PFE) today announced changes to its executive leadership team to further advance its aspirations to discover and develop new medicines and vaccines, with an emphasis on oncology.

July 27, 2023
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7 min read
Pharm Country

Helius Medical Technologies, Inc. Expands Stroke Trial at the Medical University of South Carolina

Helius Medical Technologies, Inc., a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, announced the expansion of the previously announced trial in stroke from 12 to 60 patients.

July 27, 2023
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7 min read