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This week, the FDA could approve the first CRISPR-edited therapy in the U.S., while two other companies await decisions on topical drugs.
CEO Emma Walmsley projects that the British biopharma’s Arexvy sales will exceed £1 billion in its first year on the market, leaving Pfizer’s Abrysvo respiratory syncytial virus vaccine far behind in the race.
Patients treated with Altimmune’s investigational GLP-1/glucagon dual receptor agonist saw up to 15.6% weight loss, and nearly a third of those taking the highest dose lost at least 20% of their body weight.
The company is hoping the topline results for Veozah, which won FDA approval in May, will support health technology assessments for reimbursement negotiations in Europe.
The two companies have settled all pending U.S. patent litigation, clearing the way for commercialization of Samsung Bioepis’ SB17, a proposed biosimilar of Stelara.
Despite a recent Phase II miss, Xenon Pharmaceuticals is forging ahead with its candidate for major depressive disorder, offering 8.4 million common shares for sale.
Facing the loss of Humira revenues from biosimilar competition, AbbVie is looking to grow its pipeline by acquiring ImmunoGen and its antibody-drug conjugate Elahere, which was granted FDA accelerated approval last year.
Listen to this in-depth discussion on how AI can help identify end-to-end data weaknesses, as well as broader implications regarding the inevitability of human interaction, with guests from GSK, IQVIA, Exelixis and DataHow.
For forms of Alzheimer’s, frontotemporal dementia and Parkinson’s caused by genetic defects, gene therapy could change the treatment landscape.
The regulator accepted Karuna Therapeutics’ NDA and set a PDUFA date of September 26, 2024. If approved, it would be the first new mechanism of action to treat schizophrenia in decades, the company contends.
The troubled Indian pharma company received its second FDA warning letter in months, which this time cited quality control and data integrity lapses at its manufacturing facility in Gujarat, India.
After Verve Therapeutics recently announced gene editing therapy results, the company is offering up its stock to the public and Eli Lilly. However, the stock was down 13% Wednesday on the news.