The accelerated FDA approval of Bayer's Hyrnuo covers treatment of advanced cases of non-small cell lung cancer with HER2 mutations. It will compete against an HER2-targeting Boehringer Ingelheim pill approved in August.
Arrowhead Pharmaceuticals’ RNAi drug plozasiran, brand name Redemplo, is now the second FDA-approved therapy for familial chylomicronemia syndrome, an inherited lipid disorder. Beyond its claims of safety and dosing advantages, Arrowhead set a dramatically lower price for its first commercial product, which will compete against an Ionis Pharmaceuticals drug.
AI-native tax firm Gelt combines top human tax experts with AI to help physicians and healthcare practices use data-driven tax strategies to lower liabilities, improve profitability, and future-proof their finances.
Johnson & Johnson is acquiring Halda Therapeutics for its lead program, a drug that recently posted encouraging Phase 1 data in advanced prostate cancer. This drug comes from a proprietary Halda platform technology that yields oral small molecules offering a novel mechanism for killing cancer cells.
Iambic’s latest financing follows the presentation of data for its breast cancer drug during the recent European Society of Medical Oncology conference. Our financing roundup includes capital raised by startups developing novel therapies immunology, metabolic disorders, genetic diseases, and more.
Merck’s Cidara Therapeutics acquisition brings a lead program with potential to become a first-in-class drug for preventing influenza infection. A Phase 3 study is already underway, timed to coincide with the start of the flu season in the Northern Hemisphere.
Phase 3 results for the Novartis malaria drug “GanLum” show it was comparable to the standard of care and led to cure rates that top the threshold recommended by the World Health Organization. If approved, this new combination drug would become the first novel malaria therapy in more than 25 years.
Alan Murray on improving access for medical transportation.
The Phase 2 failure in major depressive disorder marks the second time in a little more than a year that Neurocrine Biosciences has reported a drug licensed from Takeda Pharmaceutical fell short in the clinic. Last year, a different drug from this partnership failed a mid-stage test in schizophrenia.
Eli Lilly is paying $75 million up front for global rights to AAV-AIPL1, a gene therapy on track for U.S. and European regulatory submissions in the rare, inherited eye disorder Leber congenital amaurosis 4, or LCA4. The deal brings to Lilly another late-stage gene therapy for the eyes following the pharma giant’s October acquisition of Adverum Biotechnologies and its lead program for wet AMD.
Pfizer’s offer of up to $86.25 in cash for each share of obesity drugs developer Metsera share tops the up to $86.20 Novo Nordisk was willing to pay. The financial consideration and the greater certainly of a deal close tipped the balance in Pfizer’s favor, ending a bidding war for Metsera and its next-generation obesity medications.
The six new drugs awarded FDA Commissioner’s National Priority Vouchers brings to 15 the total number of therapies selected for the new pilot program. Under this program, the FDA says the standard 10- to 12-month review time could be shaved down to “within months.”
Greenway Health blends smart technology with human expertise to elevate revenue cycle.
Braveheart Bio is preparing to advance to Phase 3 testing in obstructive hypertrophic cardiomyopathy, or oHCM. The startup says its small molecule could have safety advantages over Camzyos, a Bristol Myers Squibb capsule projected to become a blockbuster seller in this indication.
The FDA has approved UCB’s Kygevvi for treating children and adults with thymidine kinase 2 deficiency, an inherited mitochondrial disorder. It’s the drugmaker’s first ultra-rare disease product.
Sarepta Therapeutics attributed the Phase 3 failure to the Covid-19 pandemic, during which many patients missed multiple doses of its Duchenne muscular dystrophy therapies. The company plans to discuss with the FDA traditional regulatory approvals based on the totality of data that includes real world evidence from the years these drugs have been commercially available under accelerated approvals.
Pfizer claims Metsera breached their merger agreement, adding that a tie-up of the biotech with GLP-1 drug giant Novo Nordisk would violate U.S. antitrust law. Metsera called the arguments “nonsense” and said Pfizer is trying to buy the obesity drug developer for less than what Novo is willing to pay.
Private equity-backed Clario brings to Thermo Fisher Scientific software that collects, manages, and analyzes clinical trial endpoint data. Analysts see Clario’s offerings as highly complementary to PPD, the contract research organization that Thermo Fisher acquired in 2021.