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Johnson & Johnson on Wednesday reported late-stage trial data showing its first-in-class orexin receptor antagonist reduced major depressive disorder symptoms as an adjunctive treatment in patients with insomnia.
In this second episode of our collaboration with DIA, we discuss the challenging, collaborative process of regulating advanced therapy product development with guests James Wabby, AbbVie and Rob Schulz, Suttons Creek, Inc.
AstraZeneca on Wednesday unveiled Phase I results for its PCSK9 inhibitor, acquired from Dogma Therapeutics in 2020, which when combined with a statin reduced LDL-C levels in patients with high “bad” cholesterol.
Merck on Wednesday announced a deal worth $3 billion to buy EyeBio and its first-in-class trispecific antibody Restoret, marking the pharma’s return to the ophthalmology space after nearly a decade.
In a late-stage trial, Insmed’s small molecule DPP1 inhibitor cut yearly exacerbation rates by around 20% in bronchiectasis patients, according to topline data.
Driven by growing market demand and an improving supply chain, the global weight-loss drug market is expected to hit $150 billion in value by the early 2030s, according to analysts cited by Reuters.
Amgen on Tuesday secured the FDA’s green light for the first interchangeable biosimilar to AstraZeneca’s Soliris to treat two rare diseases: paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Transitioning from team member to manager has its challenges, including managing ex-peers. There are a few ways you can make the change easier.
AstraZeneca last week set another ambitious goal, this time with plans to nearly double its total revenue by the end of the decade. However, it’s easier said than done, according to analysts.
The FDA currently does not recommend using changes in lean mass as an endpoint in clinical trials for weight loss drugs. Should it?
AstraZeneca targets $80 billion in revenue by 2030, layoffs at Bayer, BMS and Pfizer continue to generate attention across the biopharma industry, Takeda takes a deep dive into the molecular glue space and conference season is in full swing.
Johnson & Johnson’s deal for Numab Therapeutics’ bispecific antibody NM26, slated to enter Phase II studies, comes on the heels of J&J’s $850 million Proteologix bispecific antibody acquisition.
The potential purchase by the Japanese conglomerate could secure access to Calliditas’ IgA nephropathy therapy Tarpeyo, which won the FDA’s full approval in December 2023.
NS Pharma, a subsidiary of Nippon Shinyaku, announced Monday that its Duchenne muscular dystrophy candidate Viltepso failed a late-stage confirmatory trial, showing no significant motor function improvements over placebo.
Flagging a risk of hypoglycemia, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Friday did not recommend the approval of Novo Nordisk’s once-weekly insulin icodec for type 1 diabetes.
With back-to-back victories in IgA nephropathy and C3 glomerulopathy, Novartis on Saturday said it is planning to make regulatory submissions for the rare kidney diseases this year.
AstraZeneca and Daiichi Sankyo’s investigational antibody-drug conjugate Dato-DXd failed to significantly improve overall survival in non-small cell lung cancer patients versus docetaxel.
While NK cell therapies can potentially avoid the serious side effects sometimes seen with CAR T cell therapies, experts say durability may stall their path to the market.
As AstraZeneca looks to climb toward the top of biopharma companies by revenue by the end of the decade, smaller companies are looking to join the ranks of the unofficial Big Pharma club.
Recent M&A activity indicates a potential resurgence in the appetites of larger companies for psychiatric drug development, but experts say the space may not offer a sufficient risk-reward proposition for R&D.