Legal & IP
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.
During a candid and revealing discussion, lobbying experts shared strategies for getting the generics and biosimilars industry’s message heard by lawmakers.
As FDA streamlines regulatory requirements for biosimilars, Robert Foster said during AAM’s annual meeting that if a company brings high-quality data to the agency, ‘sometimes the student ... teaches the tenured professor something new.’
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.
AAM President and CEO John Murphy summarized a year of industry progress in front of generics and biosimilars industry delegates at AAM’s Access! 2026 conference, but also said more efforts were needed to create a sustainable future environment.
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.
Moves to issue a compulsory license for Lilly’s GLP-1tirzepatide products Mounjaro and Zepbound come as Brazil prepares to make its own versions of Novo Nordisk’s semaglutide and liraglutide.
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.
Consistent, AI-verifiable clinical and SEC disclosures are now essential to protect valuation and avoid litigation. Misalignment creates measurable regulatory, financial, and legal risk, while disciplined, synchronized disclosure strengthens credibility and reduces exposure.
DARI is an AI enabled framework that scores how well clinical trial disclosures align across SEC filings, registries, press releases, and presentations, identifying risks in timing, accuracy, consistency, governance, and tone to flag regulatory or litigation exposure.
An India-EU trade deal sets ground for a free trade agreement to lower tariffs on pharma, though an investment protection agreement – likely influencing data exclusivity – will be concluded later. Will the US now reconsider its India tariffs?
Bayer is the latest company seeking compensation from COVID-19 vaccine manufacturers for allegedly infringing patents.
Using artificial intelligence in drug discovery and development could have huge benefits for companies, but a key challenge will be addressing how data is used to train AI tools and managing intellectual property issues, says Clifford Chance’s Stephen Reese.
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.