Litigation

The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.

Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.

Glenmark Pharmaceuticals agreed to pay $25m in the US to resolve its alleged liability under the False Claims Act linked to price-fixing allegations.

Finding the right way to measure outcomes is just one of the difficulties involved in conducting clinical trials of potential new therapies for loss of hearing, which can have a number of different causes.

Johnson & Johnson plans to shift 340B price concessions on Stelara and Xarelto to rebates for some hospitals beginning in October, allowing for more company oversight of claims.

The European Medicines Agency has started reviewing new marketing applications for 10 products, including Blenrep, GSK’s previously approved multiple myeloma drug that was withdrawn from the market, and vimseltinib, which could become the EU’s first oral treatment approved for TGCT.

The European Medicines Agency has started reviewing new marketing applications for 10 products, including Blenrep, GSK’s previously approved multiple myeloma drug that was withdrawn from the market, and vimseltinib, which could become the EU’s first oral treatment approved for TGCT.

A Japanese approval for Lilly's Alzheimer's drug donanemab is expected soon following a positive recommendation from the MHLW. The ministry has also announced reimbursement prices for 12 new products including Fabhalta, along with price cuts for Tezspire, Dupixent and competitors following a review.

Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.

But the overall impact of the Supreme Court decision may not seem as “immediate” in 340B compared to other federal programs.

Experts expect litigation challenging Medicare’s definitions of single-source drug and bona fide marketing to get a boost from recent Supreme Court rulings, but overall, the IRA is likely better positioned in a post-Chevron world than older Medicare statutes.

The US Federal Trade Commission’s focus on potential anti-competitive behavior by pharmacy benefit managers picks up steam as Chair Lina Khan approaches the end of her term.

Reading Hikma’s press releases and other public documents made it “at least plausible” that a physician would look to prescribe Hikma’s generic Vascepa product for any of its indications, including the highly-valued, patent-protected cardiovascular indication, the US Federal Circuit decided, reopening a lawsuit against the generics firm.

This is Julia's test article to check workflow steps

The unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits.

Rahul Rao, the deputy director of the FTC Bureau of Competition, discussed the agency’s thinking on recent pharma deals that it viewed as anti-competitive.

The US Court of Appeals for the Second Circuit afirmed a US district court decision to dismiss purchaser and payer claims linked to so-called “pay-for-delay” agreements with generics firms over nebivolol rivals to Bystolic.

The fourth court loss for pharma in industry's attempts to kill Medicare’s drug price negotiation program adds to the list of reasons courts have rejected legal challenges to the Inflation Reduction Act.

Leaders from Novartis, Bayer, Sun Pharma, the Indian Pharmaceutical Alliance, Médecins Sans Frontières and Anand and Anand discuss India’s evolving intellectual property rights landscape, including pre-grant oppositions, enforcement action and other realities. Concerns around evergreening, restrictions on patent-eligible subject matter and compulsory licensing were also key talking points at a recent conference in Hyderabad.

Changes to inhaler pricing may be more ‘business as usual’ for the drug industry than the Vermont senator wants to let on. FTC, meanwhile, is keeping the patent pressure on Teva, the only inhaler manufacturer to not act following Sanders’ investigation.