In a 10-1 vote, the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee said Otsuka Pharmaceutical Co. Ltd.’s studies of its combination post-traumatic stress disorder (PTSD) treatment did not show enough efficacy. Had the adcom felt otherwise, the path may have been smoother for a new treatment in an indication that hasn’t seen regulatory advancement in decades. The committee’s conclusion, however, is not binding on the FDA, which will make its own decision whether to approve.
Johnson & Johnson beat analysts’ expectations for its second quarter results, led by medical device sales of $8.54 billion. All med-tech segments performed better than anticipated, with cardiology reporting exceptionally strong 22.3% growth. In addition, the innovative medicines division shocked the Street with 4.9% growth, despite the loss of patent protection for the blockbuster drug, Stelara.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amphix, Biocon, Bio-Thera, Endeavor, Genascence, Kalvista, Kezar, Sanofi.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Chemspace, Debiopharm, Ikena, Inmagene, Ioncologi, Ocuvex, Onconetix, Orogen, Repare, Sandboxaq.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Cantargia, Cognition, Cue, Okyo, Zevra.
Expanding on guidance issued a dozen years ago, the U.S. FDA released a draft guidance to help sponsors developing cancer drugs for use in novel combinations determine the contribution of the individual drugs’ effect.
Scientists at Newcastle University U.K., have reported the births of eight healthy babies following mitochondrial transfer, in which the fertilized egg of a woman carrying mutations in their mitochondrial DNA was placed in the enucleated egg of a non-carrier.
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