Facing erosion of its mighty Eylea (aflibercept) franchise and near-term loss of exclusivity with Dupixent (dupilumab), Regeneron Pharmaceuticals Inc. took a blow as one of two phase III trials with IL-33-blocking monoclonal antibody itepekimab failed in chronic obstructive pulmonary disease (COPD). The Tarrytown, N.Y.-based firm’s shares (NASDAQ:REGN) closed May 30 at $490.28, down $115.11, or 19%. Partner Sanofi SA, of Paris, saw its stock (NASDAQ:SNY) dip somewhat, too, and ended at $49.37, down $2.98. Cantor analyst Carter Gould opined that the latest news “all but [ruled] out a path forward short of a new study” with the compound. Read More
For the second time in as many months, the lack of statistically significant overall survival data sent shares of Summit Therapeutics Inc. sliding, despite otherwise positive findings for PD-1/VEGF bispecific candidate ivonescimab in non-small-cell lung cancer. But analysts noted the stock reaction overlooks the consistency of the efficacy data to date, as well as the fact that the phase III Harmoni study marks the first pivotal trial testing ivonescimab in a global population. Read More
In yet another China antibody-drug conjugate (ADC) deal, Astellas Pharma Inc. is inlicensing a phase I/II ADC targeting Claudin 18.2 from Evopoint Biosciences Co. Ltd. for up to $1.34 billion. Read More
The EU is having another go at improving access to capital for biotechs and science-based startups, in a bid to enable them to remain anchored in Europe. The Startup and Scaleup strategy, announced on May 28, is a response to the long-running problem that although Europe has strong foundations in its academic research, the innovative companies this science spawns often end up being acquired by U.S. companies, or moving to the U.S. to list on Nasdaq or the New York Stock Exchange. Read More
CSPC Pharmaceutical Group Ltd. on May 30 disclosed that the company was engaged in ongoing negotiations with unnamed, independent third parties regarding three license deals and collaborations that could total up to $5 billion combined. Read More
Despite the advancement of AI and machine learning technologies and their incorporation into cancer treatment and drug development, a lack of trust and understanding of these new approaches is impeding care and treatment. Read More
A dynamic chart of the latest executive orders (EOs) from the Trump administration that have been published in the Federal Register and that directly impact the biopharmaceutical and medical technology sectors. Read More
More and more, artificial intelligence is becoming inseparable from drug development. But it needs to be well integrated with the right people and support technologies in order to be successful, according to Josep Bassaganya-Riera, the founder and CEO of Nimmune Biopharma Inc. With more than 20 years in the industry, he shared his insights and experience about the crucial importance of getting technology and people in balance. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biohaven, Corestemchemon, Keros, Moderna, Neurocrine, Oric, Pepgen, Taysha, Uniqure. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accuredit, Alcon, Bayer, Capsida, Daiichi, Eton, Jiangsu Hengrui, Merck, Stealth. Read More
