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Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.
TOP STORIES
Zymeworks announced a new plan to become a royalty-driven company last year, making Theravance a perfect match.
The star of Ipsen’s acquisition is an MDM2 blocker being proposed as an add-on therapy to ruxolitinib for myelofibrosis. The drug could be available to patients “as early as 2028,” according to Ipsen CEO David Loew.
Viridian Therapeutics’ Lumvoa is the first FDA-approved treatment for thyroid eye disease that includes data for both active and chronic forms of the illness.
BridgeBio Pharma plans to file for approval in the third quarter. If granted, the oral drug could present a “highly differentiated” option over current achondroplasia therapies, according to Jefferies.
Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
Replimune’s resubmission for RP1 for melanoma comes after the departures of FDA leaders in place at the time of the drug’s first two rejections. The FDA expects to hold an advisory committee meeting in late July.
Dealmaking across biopharma is shifting dramatically as the SEC rolls out new regulations to ease burdens on newly public companies and antitrust review is replaced by drug pricing as the policy concern du jour.
When the variance can’t be modeled, even disciplined biotech investors stop deploying. Here’s the cheapest fix for biotech’s investability problem.
The positive ADHD data for Otsuka Pharmaceutical’s centanafadine is good news in what has of late been a mixed bag for the neuropsychiatric space.
Jefferies expects Moderna to have around seven commercial products in the coming years which, along with a projected 10% revenue growth, could help the company break even in 2028.
PRESS RELEASES
New study in the Journal of Clinical Endocrinology & Metabolism demonstrates that NeuroDex’s ExoSORT platform can detect central Akt–mTOR signaling changes in response to metabolic drugs — from a routine blood draw.
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