Pharmaceutical and biotech news covering drug approvals, clinical trials, FDA decisions, and pharmaceutical industry developments.
The FDA granted accelerated approval for Johnson & Johnson's Rybrevant Faspro for specific head and neck cancers, marking the first use of the amivantamab-based drug outside lung cancer treatment. The decision relied on tumor response data from the Phase 1b/2 OrigAMI-4 trial.
Shares of Hims & Hers Health increased in premarket trading Friday following an announcement of a partnership with Eli Lilly. As part of the agreement, Hims said it will not compound GLP-1 medications like Zepbound in the future, shifting delivery to Lilly's telehealth platform for cash-paying patients.
GSK and Moderna have settled their patent litigation concerning COVID-19 and RSV vaccines through cross-licenses with no financial exchange. The agreement resolves GSK's 2024 claims regarding lipid nanoparticle technology, while a separate suit against Pfizer and BioNTech continues.
Moderna reported a third-quarter profit of $162 million, reversing a year-ago loss of $200 million. Revenue reached $1.31 billion, surpassing estimates, as international demand for Covid-19 vaccines stabilized. The company lifted its full-year growth outlook.
The FDA Law Blog argues that drug repurposing should be integrated into the FDA's Rare Disease Framework Initiative as a fit-for-purpose development pathway. It contends that leveraging existing clinical data for approved drugs can streamline regulatory review for new rare disease indications without requiring redundant trials.
Novo Nordisk CEO Mike Doustdar announced that CagriSema is moving into production for a direct-to-consumer launch. The combination drug showed significant weight loss in Phase 3 trials, though specific pricing details were withheld by the executive.
Novartis revealed seven previously unknown tumor cases in children treated with its spinal muscular atrophy therapy, Zolgensma. While only two of nine total reports show evidence linking tumors to the treatment, regulatory authorities are examining the data as a potential safety signal following public disclosure regarding more than 6,000 patients treated.
This preview outlines Quanterix's upcoming Q3 earnings report, highlighting consensus estimates of a -$0.42 EPS and $33.85M in revenue, representing a 15.9% year-over-year decline. It notes the company's recent history of beating earnings expectations despite projected losses.
Financial commentary outlines Veracyte's 2027 outlook, projecting volume growth and improved profitability while noting strategic adjustments to Decipher Prostate test volumes following strong Q3 performance.
Kimberly-Corp reported a 30% increase in Rogaine sales this year, driven by an unexpected boost in demand from consumers using GLP-1 weight-loss medications like Ozempic. The surge highlights the unintended side effects of popular diet drugs on hair loss.