Litigation
Ascent had hoped to join a growing list of US mirabegron competitors, but a Delaware court found its ANDA would infringe valid Astellas patents covering the sustained-release formulation.
As the US Supreme Court prepares to review litigation on generics with carved-out indications, or skinny-labels, Hikma once again won the the US solicitor general's support.
Plaintiffs are likely to succeed on the merits of claims that reconstitution of the Advisory Committee on Immunization Practices violated the Federal Advisory Committee Act and the CDC improperly bypassed ACIP in adopting a new childhood vaccine schedule, a Boston judge said.
An HHS administrative law judge will preside at the formal evidentiary hearing, which stems from a 2019 complete response letter that was followed by administrative and legal appeals, even though Vanda said it would only accept the FDA commissioner as presiding officer.
FDA Principal Deputy Commissioner Sara Brenner and Tracy Beth Høeg, then special assistant to the commissioner, wrote the scientific analyses underlying HHS' May 2025 decision to eliminate the recommendation that healthy children and pregnant women get vaccinated for COVID-19.
The US Supreme Court’s decision to review Hikma and Amarin’s litigation over induced infringement of carved-out patented indications offers a chance to resolve key questions around skinny-label generics, said attorney Chad Landmon.
J&J’s assertion of a 51% reduced risk of death with the prostate cancer treatment apalutamide compared with Bayer’s darolutamide in an observational study is unsubstantiated and the analysis fails to meet the FDA’s rigorous standards, Bayer said in a federal lawsuit.
The Sec. 232 tariffs, which still could be imposed on pharma and other industries, remain a threat despite the US Supreme Court decision striking down President Trump’s International Emergency Economic Powers Act tariffs.
States allege Novartis and its former subsidiary Sandoz colluded with rivals to keep generic drug prices high, then restructured the Sandoz business to limit antitrust liability.
With healthcare at the fore and drug cases in the spotlight, fiscal year 2025 was the largest FCA haul on record.
Bayer is the latest company seeking compensation from COVID-19 vaccine manufacturers for allegedly infringing patents.
The latest step in the long-running saga of Hikma and Amarin’s induced infringement dispute over Vascepa is a US Supreme Court review of the litigation, which could result in changes to generic drug skinny-label policy.
The agency is "reconsidering" manufacturer plans for the 340B rebate model in light of court decisions imposing a temporary stay on implementation.
“Section viii cannot function as Congress intended,” if a Federal Circuit Court ruling stands, the US solicitor general argued in urging the Supreme Court to review and reverse the closely-watched Hikma Vascepa skinny-label case.
A federal judge in Hawaii ruled the FDA failed to consider statutory factors relevant to the REMS and provide a “reasoned explanation” for its restrictive treatment of the drug, but remand could result in an agency determination that more extensive restrictions are needed.
Pink Sheet reporter and editors discuss the FDA’s role in the Astra Zeneca Most Favored Nation drug pricing deal and the Justice Department interpreting the off-label promotion laws differently than the FDA.
Recent Justice Department filings may suggest it is rethinking allowances for drug manufacturers to communicate scientific information on unapproved uses to healthcare providers.
The Trump Administration may differ from the Biden Administration in some areas of health care antitrust enforcement, but experts said some Biden-era priorities may be maintained.
MSN Laboratories wins another case against Novartis and will keep approval for its generic version of Entresto. The decision effectively confirms that US FDA can approve ANDA labels that make limited wording changes to carve around patent-protected indications, reinforcing the agency’s flexibility.
The agreement to resolve or stay numerous legal and administrative disputes resulted from a recent appeals court decision and the new agency leadership's receptiveness to negotiations, said Vanda, which has filed a barrage of challenges against the FDA in recent years.