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. Read More
Harmony Biosciences Holdings Inc.’s agreement to acquire Zynerba Pharmaceuticals Inc. for $60 million cash plus as much as $140 million in contingent value rights (CVRs) didn’t register as one of the larger potential outlays recently, but Wall Street had questions about the term sheet just the same. Plymouth Meeting, Pa.-based Harmony is paying about $1.10 per share in cash for Zynerba, of Devon, Pa., plus one non-tradeable CVR tied to clinical, regulatory and sales milestones. Read More
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. Read More
How long does it take for a U.S.-based biopharma company to complete a bankruptcy? In the case of privately held Purdue Pharma LP, the answer is likely five years or longer, depending on when the Supreme Court rules on the matter and whether it orders a do-over. The Supreme Court is the next chapter in the court saga that began in 2019 when the Stamford, Conn.-based company filed for bankruptcy in its first step toward reorganizing as a public benefit company. Read More
Kelun-Biotech Biopharmaceutical Co. Ltd.’s trophoblast cell-surface antigen 2 (Trop2)-targeted antibody-drug conjugate (ADC), SKB-264, met the primary endpoint of progression-free survival (PFS) in a phase III trial in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC), according to an interim analysis. The randomized, controlled, open-label, multicenter phase III trial compared injectable SKB-264 (also known as KL-A264 and MK-2870) vs. investigator-selected regimens in patients who failed second-line or above prior standard-of-care therapies. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioxcel, Lilly, HDL, Impact, Incyte, Menarini, Novartis, Radius, Sigilon, Syros, Versanis. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cantargia, Precigen, Pyc, Zumutor. Read More
