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Under a new program, described in a draft guidance issued Tuesday, the FDA will expedite development and assessment of applications, including supplements, for drugs that are manufactured using a designated advanced manufacturing technology (AMT). Read More
Actions and future plans by the Biden administration to impose drug price controls could prove disastrous for U.S. clinical trials and medical innovation overall, the U.S. Chamber of Commerce (CoC) claims in a new report. Read More
Comments from AstraZeneca, Pfizer, Johnson & Johnson and Certara on the FDA’s draft guidance on developing peptide drugs focused on ways to categorize peptides and the potential for the drugs to cause an immune response. Read More
The FTC announced on Monday its intention to block Sanofi’s proposed acquisition of an exclusive license to Maze Therapeutics’ therapy in development for treatment of Pompe disease and hours later Sanofi announced that it was cancelling the deal. Read More
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fall unified agenda of proposed rules for the FDA includes a new rule that revokes two old rules that have either been superseded or do not reflect current agency practice, the agenda says.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