Strategy
Chief Medical Officer Samit Hirawat will step down to pursue new career opportunities, the company said.
Plus deals involving Lilly/Gate Bioscience, Concentra/iTeos, Nicox/Kowa, Ajax/Schrodinger, I-Mab/Bridge Health, Otsuka/Cantargia, JCR/Acumen and more.
In its Q2 update, Viking reported that Phase III trials of subcutaneous VK2735 are under way, and that it expects Phase II data for an oral formulation before year’s end.
Gefurulimab will give AstraZeneca a new option to compete against Argenx’s Vyvgart Hytrulo, which is available subcutaneously.
The Swiss giant has been talking to the US government about selling medicines directly to patients.
The Danish medical dermatology specialist doubles boosts its sales force ahead of the launch of Anzupgo.
Natco to buy out Adcock Ingram’s minority shareholders in what’s possibly its biggest M&A investment, opening up substantial opportunities in South Africa and the region. If the offer goes through, it will result in the delisting of Adcock, with Bidvest and Natco co-owning the firm.
Roche paused shipments of the Duchenne muscular dystrophy gene therapy in countries that reference US FDA approval of Elevidys after the agency asked Sarepta to pause US shipments; it remains available in Japan and Brazil.
Stock shoots up over 460% on positive results in two ulcerative colitis trials of the oral first-in-class candidate.
Scrip discusses the latest M&A activity and trends with CEO Shawn Titcomb of Allele Capital and Cheryl Reicin, a partner focused on international life sciences activity at Mintz.
Looking to improve on the efficacy and safety of Roche’s Esbriet and BI’s Ofev, Avalyn has inhalable formulations of those drugs in Phase IIb and Phase I, respectively.
FDA issued a complete response letter to Replimune’s BLA for a novel oncolytic immunotherapy for melanoma in a surprise to management and investors.
The French major is paying $1.15bn For the UK biotech and its bivalent candidate, VXB-241.
The Austrian firm is delisting from the NASDAQ and closing down.
Seeking to move Columvi into second-line DLBCL, Genentech got an FDA letter saying the Phase III STARGLO study’s benefits may have been driven by results in Asian enrollees.
Reimbursement rules are disincentivizing innovation, according to Vas Narasimhan.
As AI-driven firms including Insilico, big pharmas J&J, Amgen, GSK and AstraZeneca and Chinese and Indian firms like BeOne and Dr. Reddy’s advance PRMT5 inhibitor candidates, what’s driving interest, what could lead to the first global approval and what are the challenges ahead?
Swiss major confident that new oncology drugs will fill revenue gap.
After a second quarter of declining Elevidys sales following two deaths of DMD patients treated with the gene therapy, Sarepta is cutting costs to fund remaining programs and meet debt requirements.
Plus deals involving Novartis/Sironax, Neuraxpharm/Dizlin, Recursion/RallyBio, MaaT/Clinigen, Future Pak/Theratechnologies, BerGenBio/Oncoinvent, Xoma/Turnstone and more.