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Teva Pharmaceuticals has asked a Colorado federal judge to keep alive its lawsuit challenging the state’s epinephrine auto-injector (epi-pen) affordability program as unconstitutional, arguing that suing in state court for compensation is not reasonable under the circumstances. Read More
HHS’s fall unified agenda of proposed rules for the FDA includes a new rule that revokes two old rules that have either been superseded or do not reflect current agency practice, the agenda says. Read More
Angering drugmakers, the Biden Administration announced Thursday that it’s supporting a previously unused, obscure and controversial regulatory authority called “march-in” rights to achieve lower prices on taxpayer-funded drugs deemed too expensive for consumers. Read More
The FDA has released two draft guidances with interim policies addressing the FDA’s efforts to finalize bulk drug lists for compounders subject to 503A regulations and for compounders using bulk substances under 503B regulations. Read More
After agreeing to a voluntary plan to help lower drug prices in the UK, the Association of the British Pharmaceutical Industry (ABPI) has issued a statement today accusing the UK government and England’s National Health Service (NHS) of sending mixed messages to life science companies. Read More
After agreeing this fall to participate in the Inflation Reduction Act (IRA) drug price negotiation program, AstraZeneca — whose type 2 diabetes therapy Farxiga (dapagliflozin) was among the first 10 drugs singled out for the new cost-cutting measure — is still fighting the government over the program. Read More
The House Subcommittee on Health Care and Financial Services has asked the FDA to schedule a briefing with Committee staff no later than Dec. 11 to help with an investigation of the efficacy of OTC drugs after an advisory committee concluded that a commonly used decongestant, phenylephrine, is ineffective. Read More
Aggressively using all the FDA’s regulatory flexibility to advance burgeoning treatments for rare diseases, particularly gene therapy, was a theme highlighted Monday by CBER Director Peter Marks. Read More
As the public comment period closes Monday on the FDA’s rule to regulate laboratory-developed tests (LDT), the FDA has received more than 2,100 remarks — including hundreds in opposition that are identical — that strongly diverge on whether the proposed rule will ensure test reliability or will burden labs with red tape and reduce the availability of tests for infectious diseases. Read More
Recalled glucose capsules marketed as a health supplement for blood glucose control were found to contain glyburide and metformin — drugs that treat type 2 diabetes by lowering blood sugar — were deemed a Class I recall by the FDA, the most serious type of recall as use may cause serious injuries or death. Read More