BioSpace News Archive

Drug Development

FDA Rejects Cytokinetics’ Heart Failure Drug, Requests Another Trial

Citing lack of efficacy evidence, the FDA rejected Cytokinetics’ heart failure hopeful omecamtiv mecarbil in a decision announced Tuesday evening.

March 1, 2023
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2 min read
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Tristan Manalac
Drug Development

Chroma Scores $135M for Epigenetic Editing Approach

Backed by Google Ventures, ARCH Venture Partners and more, Chroma Medicine announced the closing of a $135 million Series B financing Wednesday.

March 1, 2023
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2 min read
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Kate Goodwin
Business

Novavax Warns Investors it May Not be Able to Continue Operations

Novavax expressed doubts about its ability to continue operations beyond this year in its Q4 and full year 2022 financial report issued Tuesday.

March 1, 2023
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2 min read
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Hayleigh Evans and Heather McKenzie
Drug Development

Keytruda Offsets Back-to-Back Flops with Phase III NSCLC Win

Phase III KEYNOTE-671 study data showed Merck’s Keytruda improved event-free survival, one of the trial’s primary endpoints, in patients with stage II, IIIA or IIIB non-small cell lung cancer.

March 1, 2023
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2 min read
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Tristan Manalac
Drug Development

GSK’s RSV Vaccine Wins Adcomm Backing One Day after Pfizer

Wednesday, the FDA’s VRBPAC agreed that GSK’s respiratory syncytial virus vaccine candidate is safe and effective in older adults.

March 1, 2023
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2 min read
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Tristan Manalac
BioCapital

AMPEL BioSolutions’ Breakthrough Predicts Drug Options to Slow End Stage Renal Disease

AMPEL BioSolutions today announced a genomic precision medicine test for chronic kidney diseases, such as Lupus Nephritis, that could save lives by predicting kidney damage before it is irreversible and providing decision support for prophylactic therapies.

March 1, 2023
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8 min read
Deals

Xtant Medical Acquires Coflex® Product Line from Surgalign for $17 Million

Xtant Medical Holdings, Inc. and Surgalign Holdings, Inc. announced the completion of a transaction between the companies.

March 1, 2023
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7 min read
ZyVersa Therapeutics to Participate in a Fireside Chat at Oppenheimer Healthcare Conference

ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”) announced today that Stephen C. Glover, Co-Founder, Chairman, Chief Executive Officer, and President will participate in a fireside chat at the 33rd Annual Oppenheimer Healthcare Conference to be held virtually March 13-15.

March 1, 2023
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4 min read
Biotech Bay

CARGO Therapeutics Raises $200 Million in Oversubscribed, Upsized Series A Financing to Advance its Pipeline of Next Generation CAR T-Cell Therapies

CARGO Therapeutics, Inc. (CARGO), a biotechnology company advancing a next generation of CAR T-cell therapies for cancer, today announced the close of a $200 million oversubscribed and upsized Series A financing.

March 1, 2023
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11 min read
Genetown

Axena Health Commends Obstetrics and Gynecology Publication Showing Leva® Pelvic Health System’s Long-Term Efficacy for Female Urinary Incontinence

Axena Health, Inc. announced the results of a one-year longitudinal follow up to its pivotal randomized controlled superiority trial of the Leva® Pelvic Health System as a treatment for urinary incontinence in women.

March 1, 2023
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7 min read