Valneva SE has struggled to get its COVID-19 vaccine on the market, but efforts to get the first Lyme disease vaccine approved in years now appear firmly on track after partner Pfizer Inc. invested €90.5 million (US$94.9 million) in the project. New York-based Pfizer has been working with Saint-Herblain, France based Valneva on the Lyme disease vaccine since April 2020, when the big pharma bought into the development program for the vaccine candidate codenamed VLA-15 for $130 million. Read More
Instead of “Mother, may I” for COVID-19 vaccines for children 6 months through 5 years of age, the U.S. CDC is saying the correct response is “I should.” That was the recommendation June 18 from the CDC’s Advisory Committee on Immunization Practices. CDC Director Rochelle Walensky wasted no time in endorsing the recommendation, which came just a day after the FDA authorized the vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE for babies, toddlers and preschoolers. Read More
While Pfizer Inc. remains active with mergers and acquisitions, Sanofi SA and Bristol Myers Squibb Co. are major players in the top six biopharma deals of 2022. So far this year, the industry has announced 769 deals, including licensings, joint ventures and collaborations, valued at $88.9 billion. Read More
The U.S. FTC isn’t waiting to complete its investigation into potentially anticompetitive practices of pharmacy benefit managers to crack down on some of those schemes. Read More
New data from the phase I study of Ultimovacs ASA’s lead candidate showed positive two-year overall survival data for the cancer vaccine. UV-1, combined with the checkpoint inhibitor Keytruda (pembrolizumab, Merck & Co. Inc.) for treating malignant melanoma, demonstrated a 24-month survival rate of 73% in all 30 patients in the study. Read More
An agreement has been reached in the U.K. to pay a fixed annual fee for two antibiotics, regardless of how often the drugs are prescribed, in a bid to prevent their overuse and slow the development of antimicrobial resistance. Read More
In the last decade, Bayer AG and Novartis AG have shown that radiopharmaceutical technology can produce marketable drugs, with Xofigo (radium-223 dichloride) and Lutathera (lutetium [177Lu] oxodotreotide), respectively approved for prostate cancer and neuroendocrine tumors. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Addex, Myovant, Pfizer, Scholar Rock, Sinomab, Vyne, Zhittya Genesis Medicine. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Basilea, Boehringer Ingelheim, Boundless Bio, Cyclerion, Jatt, Pfizer, Sana, Zura. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Biontech, Cytokinetics, Excellthera, Kazia, LG Chem, Moderna, Mydecine, Novartis, Obseva, Pfizer, Rhythm, Sierra, Theramex. Read More
