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Biogen and FDA have narrowed the treatment indications for Aduhelm (aducanumab), now recommending the antiamyloid antibody only for patients with mild cognitive impairment (MCI) and early Alzheimer’s disease (AD). Read More
OxyContin maker Purdue Pharma filed a restructuring plan that includes its owners, the Sackler family, paying $4.2 billion toward the settlement of opioids lawsuits, dissolves Purdue following its bankruptcy, and has the Sackler family and Purdue agreeing to disclose about 30 million internal documents related to the company and the family’s roles in igniting and fueling the opioid crisis over the past 20 years. Read More
The FDA sent a warning letter to Round Rock, Texas-based Davati Medical Supply instructing it to stop marketing an unapproved quadrivalent influenza vaccine. Read More
The World Health Organization (WHO) has recommended the use of interleukin-6 receptor blockers — including Roche’s Actemra (tocilizumab) and Sanofi’s Kevzara (sarilumab) — plus corticosteroids for the treatment of severe COVID-19. Read More
Colorado has become the second state — after Minnesota — to pass a law capping the price of insulin for both insured and uninsured diabetic patients, continuing a trend of states passing legislation to rein in the cost of the life-saving medicine — so far, mostly for people with health insurance — in response to what they see as inaction by Congress and the federal government. Read More
The FDA has mostly — but not entirely — rejected the Celgene/Bristol Myers Squibb (BMS) petition to delay generic versions of its blockbuster chemotherapy drug Abraxane (paclitaxel) from hitting the market. Read More
Another lawmaker has joined the ranks of those calling for a federal investigation into an allegedly improper collaboration between FDA officials and Biogen to ensure approval of Aduhelm (aducanumab), the first new Alzheimer’s treatment in nearly 20 years. Read More
She has held several prominent positions within the agency, including lead negotiator with industry for the FDA’s commitments under the Generic Drug User Fee Act (GDUFA) III. Read More
Teva Pharmaceuticals has filed federal lawsuits against Aurobindo and Lupin over their planned generics of its Huntington’s disease drug Austedo (deutetrabenazine). Read More
On its long slog toward FDA approval, teplizumab, a monoclonal antibody being developed for delaying or preventing type 1 diabetes, has stumbled over bioequivalency concerns. Read More