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An extended-release (ER) generic lamotrigine, used to treat epilepsy, is bioequivalent to GSK’s Lamictal, the FDA has determined — a finding that opens the way for pharmacy-level substitution of any generic ER lamotrigine product for the brand name. Read More
Seven major pharmaceutical companies — AbbVie, Amgen, Gilead, Johnson & Johnson, Novartis, Roche and Takeda — have formed the INTREPID (International Readiness for Preventing Infectious Viral Disease) Alliance to accelerate progress in discovery and development of new antivirals for future pandemics. Read More
A vaccine for a common — but deadly — infection of newborns, a new cancer treatment, and more promising data on an Alzheimer’s drug are among the stories we cover this month. Read More
The Institute for Clinical and Economic Review (ICER) will assess the comparative clinical effectiveness and economic value of Novartis’s drug iptacopan for treating paroxysmal nocturnal hemoglobinuria (PNH), a rare genetic blood disease. Read More
Illumina and Pfizer are each heading up collaborations starring pharmaceutical heavy hitters who will work together to accelerate drug development, although in different ways. Read More
Regenerative medicine development faces challenges in standardization, regulation and manufacturing the Government Accountability Office (GAO) determined in a recently released report. Read More
WHO and the International Council for Harmonisation (ICH) plan to establish a unified language that streamlines global regulatory decision making on the safety and efficacy of drugs, while offering insights into the scope, causes and consequences of diseases. Read More
Multiple clinical trial results from two manufacturers posted in the past several days in The Lancet show high levels of success of both weight loss in obese adults and in control of type 2 diabetes through weight loss. Read More
Addressing growing interest in the therapeutic potential of psychedelic drugs, the FDA has published a draft guidance noting multiple unique considerations for psychedelic drug development programs and challenges in designing trials. Read More
This month, our review of recent clinical trial results features Rinvoq’s sustained remission in almost half of Crohn’s disease patients, Novo Nordisk’s semaglutide showing significant patient weight loss, and improved insulin and fasting glucose levels in a phase 2B study of Akero Therapeutics’ human fusion protein efruxifermin.Read More