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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
Diamond Wipes International, a manufacturer of medicated wipes, drew a Form 483 with six observations following an FDA inspection at its Chino, Calif., manufacturing facility. 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
AstraZeneca’s planned acquisition of Alexion Pharmaceuticals, a prominent developer of drugs for rare diseases, has received a green light from the European Commission. 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
Over-the-counter drugmaker Sanit Technologies, which does business as Durisan, drew the FDA’s attention for water quality and other deficiencies observed during a March 1-5 inspection of its plant in Sarasota, Florida. Read More