Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: J&J, Lactiga, Mymd, PDS, Revance, Valneva.
An updated trial protocol providing expanded bridging therapies are part of the agreement between the U.S. FDA and Arcellx Inc. that allows the lifting of the partial clinical hold on the company’s pivotal phase II study of CAR T-cell therapy CART-ddBCMA in multiple myeloma (MM).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cantargia, Precigen, Pyc, Zumutor.
A recent bipartisan request for funding of a study on replacing U.S. drug patents with cash prizes is just one more symptom of a larger global malady that makes patents the scapegoat for bigger problems that have nothing to do with intellectual property (IP), David Kappos, board co-chair of the Council for Innovation Promotion (C4IP), told BioWorld.
The U.S. FDA has approved Daxxify (daxibotulinumtoxinA-lanm) for treating cervical dystonia in adults nearly a week ahead of its Aug. 19 PDUFA date. Approval of the sBLA for the injectable, peptide-formulated neuromodulator went to Revance Therapeutics Inc. The drug’s original approval was for treating glabellar lines, better known as frown lines, came in September 2022. Daxxify is the first neuromodulator stabilized with Revance’s peptide exchange technology. It is created without human serum albumin or animal-based components.
Oricell Therapeutics Co. Ltd. has become the latest Chinese biotech to advance an independently developed CAR T therapy, announcing Aug. 10 that China’s regulatory body gave IND approval for Oricar-017. Oricar-017 is the Shanghai-based biotech’s GPRC5D-directed CAR T therapy developed to treat patients with relapsed or refractory multiple myeloma.
“Show us your work” is basically the message the U.S. Court of Appeals for the Federal Circuit sent to the Patent Trial and Appeal Board (PTAB) when it vacated a decision by the board in an ex parte review of rejected patent claims submitted by Theripion Inc. While the Aug. 10 Federal Circuit opinion that remanded the case is nonprecedential, the appellate court made it clear that the PTAB must explain its reasoning for whatever conclusions it reaches.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Galera, Genprex, Janssen, Oricell.
A complete response letter (CRL) from the U.S. FDA for GC-4419 (avasopasem) is causing Galera Therapeutics Inc. to dramatically change course to survive, with the company laying off about 70% of its workforce. That layoff, which will reach across several company departments, is designed to extend the cash runway into the second quarter of 2024. The adjustment comes after Galera expanded its commercial leadership in May to prep for a potential launch of avasopasem before the end of 2023.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Futura, Georgiamune, Lemonex, Precigen, Virios.
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