The FDA on Friday alerted healthcare providers and the public that it’s seeing reports of unintended overdoses of the compounded version of self-injected weight loss drug semaglutide, which can be manufactured by facilities that aren’t directly regulated by the federal agency. The FDA cited several cases in which healthcare providers incorrectly calculated doses when converting from milligrams to units or milliliters, resulting in doses significantly higher than intended. Some of those patients experienced nausea and severe vomiting, the agency said. In some cases, people were hospitalized. “T ..read more

Pharma has a message to investors about the results of the first round of drug price negotiations under the Inflation Reduction Act: It’s fine. Over the last two weeks, many of the drugmakers subject to IRA pricing have, for the first time, said what they think of the prices they’ve ended up with after negotiations with the Centers for Medicare & Medicaid Services. While they continue to fight the law in court and warn of the long-term consequences to R&D, the companies also took steps to emphasize that the pricing results have long been baked into their nearer-term financial guidance ..read more

Pfizer and BioNTech have called GSK’s patent lawsuit “groundless,” accusing the British drugmaker of “improperly contorting” its claims to say their blockbuster Covid vaccine is covered by GSK patents. GSK in April filed suit against Pfizer and BioNTech, alleging the companies benefited from mRNA research conducted years before the pandemic. GSK said it secured the patent rights to those discoveries in 2015, when it acquired a portion of Novartis’ vaccines business. Pfizer and BioNTech have denied infringement by Comirnaty and are now seeking to invalidate GSK’s asserted patents in counte ..read more

Bristol Myers Squibb has resumed recruitment for its lead radiopharmaceutical trial after an isotope shortage forced a pause earlier this year, chief medical officer Samit Hirawat said on the company’s second-quarter earnings call. While the large pharma has resumed the Phase 3 study from its $4.1 billion RayzeBio buyout, it has now delayed the Phase 3 trial’s readout from 2025 to 2026, according to a quarterly update on Friday morning. Samit Hirawat The Phase 3 trial has been closely watched by those in the radiopharma space: It’s the actinium-225-based medicine that’s the furthest along in d ..read more

For years, Andrew Left and his short-selling fund Citron Research were a swashbuckling presence on social media, accusing companies of fraud and misdeeds, and making stock bets that he was right. On Friday, the Securities and Exchange Commission accused Left and Citron of fraud themselves, saying they misled investors with stock recommendations to the amount of $20 million. At the heart of the SEC lawsuit is the allegation that Left and Citron repeatedly made bold claims about investments — both short and long — in companies, and then attached aggressive price targets to the associated stocks ..read more

Plus, news about Innovent Biologics and Acticor: ProMIS Neurosciences inks $122.7M placement after sharing Alzheimer’s data: The biotech said its amyloid beta monoclonal antibody was safe and crossed the blood-brain barrier in an early-stage trial. On the back of the PMN310 results, it disclosed a private placement of $30.3 million upfront, which is slightly below its market capitalization. It could get up to another $92.4 million under the financing deal to support a Phase 1b in Alzheimer’s. Its stock $PMN was down about 25% on Friday morning. Confo raises €60M Series B: The Belgian GPCR biot ..read more

The European Medicines Agency on Friday held its ground against anti-amyloid treatments, saying it will not recommend Eisai and Biogen’s Alzheimer’s drug Leqembi for approval. The decision, according to the EMA’s medicines committee (CHMP), is due to only a slight advantage of Leqembi over placebo on a clinical dementia rating scale, and the potential for serious side effects. CHMP previously rejected Biogen’s other Alzheimer’s drug Aduhelm, and is still reviewing Eli Lilly’s donanemab. Leqembi, Aduhelm and donanemab are now approved in the US. CHMP said that it “considered that the observed e ..read more

Calliditas Therapeutics’ NOX enzyme inhibitor succeeded in a Phase 2b trial in people with a rare liver disease that features inflammation and injury in the bile ducts. In the placebo-controlled 76-participant TRANSFORM trial in patients with primary biliary cholangitis and liver stiffness, patients dosed with 1,600 mg setanaxib achieved a 19% reduction in alkaline phosphatase (ALP) levels from baseline at 24 weeks. Those enrolled in the lower 1,200 mg dose attained a 14% improvement in ALP. Both doses were statistically significant, according to a Friday release, but the company did not share ..read more

Sun Pharma’s $576 million acquisition of Concert Pharmaceuticals is paying off with an FDA approval of the alopecia drug that came with the 2023 deal. The agency approved the tablet Leqselvi (deuruxolitinib) for the treatment of adults with severe alopecia areata, an autoimmune disease that causes hair loss. According to Sun Pharma, around 700,000 people in the US have alopecia and about 300,000 have the severe form of the disease. Approval of Leqselvi, a JAK inhibitor, was based on data from two Phase 3 clinical trials that enrolled patients with at least 50% hair loss. The studies met the pr ..read more

Nima Farzan Nima Farzan has joined pain company Latigo Biotherapeutics after leaving Kinnate Biopharma, which was sold to XOMA Corporation in April. Latigo emerged earlier this year with $135 million from Westlake Village BioPartners and others to develop new, non-opioid pain treatments. It currently has a candidate in early-stage studies, as well as other preclinical compounds lined up behind it. It’s an interesting time for pain drug development — the first novel, non-opioid pain treatment in many years is heading toward a potential FDA approval. Vertex Pharmaceuticals said in April it’s wor ..read more