Generics
President Trump’s 10% tariff on active pharmaceutical ingredients and finished dosage forms could push some generic drug makers to exit therapeutic categories if they cannot absorb the new costs, which could lead to shortages.
At a lively AAM Access! conference in Florida, AAM President and CEO John Murphy acknowledged the negative effects of potential tariffs, but also suggested that the second Trump Administration could be an opportunity for the generics and biosimilars sectors to advance market reforms.
“While Vanda developed the brand-name drugs, the trade secret and confidential and proprietary information claimed to have been taken by the government was, in fact, proposed and recommended to Vanda by the FDA,” a US federal court said.
The US FDA wants a smoother transition to newer “low global warming potential” propellants in metered dose inhalers than the prior transition away from CFCs.
As the generic drug industry warily watches another transition process for propellants in metered-dose inhalers, the US FDA is urging companies not to discontinue development because they are afraid of being caught in the switch.
Sandoz announced a $275m settlement to resolve class action antitrust litigation over price-fixing allegations and disclosed that the company made a further provision of $265m linked to the case.
The rush to submit applications before user fees increased may have motivated the sudden drop, a generic industry trend that continues to grow.
The US PTO faces criticism after withdrawing a proposed rule intended to address double-patenting by changing terminal disclaimers.
An increase in complex product submissions may explain median and mean approval time increases for ANDAs, but fewer actions across many categories could be a concern.
Removing the patent-protected indication from the label of Norwich Pharmaceuticals's proposed generic for Xifaxan did not convince the US Supreme Court to hear its petition to review a case from Bausch Health that blocked approval until 2029.
Two more generics manufacturers have settled claims with 50 US attorneys general that they artificially inflated and manipulated the prices of generic drugs for nearly a decade.
Increasing data flow into the agency could improve inspection decision-making.
Sponsors of generic drug applications that miss a goal date, but do not receive an action because of complex scientific or legal questions, would get a notice outlining the lingering issue as part of a new pilot program that might become permanent in the next review cycle.
Generics of the schizophrenia treatment Latuda generated more than $4bn in savings a year after their 2022 approval, according to an FDA study.
US FDA commissioner says the agency plans to look for clinical trial fraud in applications using artificial intelligence, in part to find problems sooner.
Teva resolved two US Department of Justice civil suits accusing the firm of violating the US Anti-Kickback Statute and the False Claims Act by allegedly conspiring to fix the price of three generic drugs and paying Medicare patients’ copays for its multiple sclerosis brand product Copaxone.
The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers.
The proposed CMS innovation center's $2 drug list model will not address the barriers to newer generics getting on Part D formularies and plans may have little incentive to participate in the demo, an industry group said.
As Sandoz publishes a report on US drug shortages, including a call for policy and other improvements, the firm’s North America head and AAM Chair Keren Haruvi discussed potential solutions to ongoing supply-chain failures.
Japan has started to charge patients a portion of the difference between the reimbursement price of the generic and non-generic product if they insist on the latter without a supporting recommendation from the prescribing physician, in a policy designed to further drive generic use.