FDA
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
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.
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This week, the FDA will release its verdict on Biogen and Ionis’ ALS candidate tofersen and three other investigational medicines for psychiatric disorders, hormonal insufficiency and gut infection.
Polivy is approved for front-line DLBCL as part of a combination regimen including Rituxan, cyclophosphamide, doxorubicin and prednisone.
Qulipta’s label expansion makes it the first oral CGRP receptor antagonist approved for episodic and chronic migraine.
Omisirge is approved for patients who receive cord blood transplantation following myeloablative therapy.
A unanimous FDA committee vote supported the favorable risk-benefit profile of Innoviva’s sulbactam-durlobactam for hospital-acquired A. baumannii infections.
Thursday, the FDA greenlit Ostuka and Lundbeck’s Rexulti as the first treatment in the U.S. for agitation associated with dementia due to Alzheimer’s disease.
The Supreme Court extended the stay deadline to Friday at midnight to keep mifepristone on the market in the interim without conditions.
In an open letter published Monday, more than 480 biopharma industry leaders expressed their support for the FDA after a Texas federal judge ruled to hold the approval of the abortion pill mifepristone.
AbbVie and Johnson & Johnson will withdraw the accelerated approvals for Imbruvica in mantle cell lymphoma and marginal zone lymphoma, the companies announced Thursday.
The FDA is set to decide on a Humira biosimilar and hold an Adcomm meeting for an Alzheimer’s agitation treatment. Also on its calendar for April are decision dates for two vaccine hopefuls.