Engene Holdings Inc.’s protocol amendment to its phase II trial with detalimogene voraplasmid in bladder cancer worked out in a big way, and shares of the firm closed Nov. 11 at $8.82, up $2.81, or 47%. Engene rolled out additional preliminary data from the pivotal cohort of the ongoing Legend study testing the nonviral gene therapy in high-risk, Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without concomitant papillary disease. Read More
The industry has been complaining about the drug pricing and reimbursement policies of European governments for years, but only now with the Trump administration’s moves to enforce most favored nation (MFN) pricing and reduce the U.S./EU price gap are governments facing up to the reality that they will have to pay more for new drugs. Read More
Bluejay Therapeutics Inc.’s lead compound, the fully human monoclonal antibody brelovitug (BJT-778), produced positive virologic response data in the company’s phase II study of chronic hepatitis D virus, a condition with no approved treatment in the U.S. Read More
Drug developer stocks strengthened further through September and October, with the BioWorld Drug Developers Index (BDDI) rising from a 7.69% gain at the end of August, to 24.91% through the third quarter and 28.96% at October’s close. The BDDI outperformed both the Nasdaq Biotechnology Index and the Dow Jones Industrial Average, which finished October up 24.49% and 11.8%, respectively. Read More
The U.K. government has published a road map for phasing out animal testing in life sciences research and announced £75 million (US$98.6 million) for work to develop nonanimal models, leaving scientists concerned because they say, in many cases, there can never be meaningful alternatives to using live animals. Read More
Editor Annette Boyle discusses the challenges med-tech companies face in bringing innovation to market and how the industry can overcome them. Read More
Clinical updates, including data readouts and publications: Adarx, Amgen, Anaptysbio, Apogee, Astrazeneca, Atai Beckley, Bioinvent, Bluejay, Camurus, Cogent, Inflarx, Ionis, Mannkind, Merck, Mineralys, Neurogastrx, Novo Nordisk, Organon, Roche, Swedish Orphan Biovitrum, Vor. Read More
Biopharma happenings, including deals and partnerships, and other news in brief: AN2, Damora, Eli Lilly, Galecto, Genfit, GSK, Meiragtx, Teva, Transition, Voyager. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Avenzo, Boehringer, City, Tenaya, UCB, Vera. Read More
