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Acting FDA Commissioner Janet Woodcock is calling for a wide-ranging federal investigation into her own agency’s actions during the drug approval process with Biogen over its newly approved Alzheimer’s disease drug Aduhelm (aducanumab). Read More
The FDA shot down each of the requests in the petition, except a requested revision to draft guidance to clarify the definition of what are known as “free” and “bound” paclitaxel or albumin. Read More
The findings showed that the risk of mortality for patients treated with an interleukin-6 receptor antagonist plus a corticosteroid was reduced by 13 percent vs. standard of care. Read More
The European Parliament has voted to expand the European Medicines Agency’s (EMA) authority to monitor the supply chain for drugs and medical devices. Read More
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