Crushing the hopes of drug and device companies, the U.S. Supreme Court’s March 23 orders list showed it denied cert in Takeda Pharmaceutical v. Painters & Allied Trades, which sought to rein in the expansion of class action lawsuits.
Eli Lilly and Co. got a breather when the U.S. Ninth Circuit Court of Appeals agreed that the company doesn’t owe Research Corporation Technologies Inc. (RCT) royalties on its diabetes drugs under a licensing agreement Lilly had made with Phillips Petroleum Co. in 1990 and that Phillips later sold to RCT.
In a lawsuit that’s been bouncing through the courts for years, the U.S. Court of Appeals for the District of Columbia once again cleared the way for several biopharma and medical device companies to potentially be held liable, under the Anti-Terrorism Act, for terrorist attacks against hundreds of Americans in Iraq.
Unless the U.S. Supreme Court steps in to reverse the decision, the NIH’s attempt to cap indirect costs at 15% in all its grants is dead. The U.S. Court of Appeals for the First Circuit upheld a permanent injunction Jan. 5 that was issued by a lower court, vacating an NIH supplemental guidance imposing the across-the-board cap both retroactively and prospectively.
Unless the U.S. Supreme Court steps in to reverse the decision, the NIH’s attempt to cap indirect costs at 15% in all its grants is dead. The U.S. Court of Appeals for the First Circuit upheld a permanent injunction Jan. 5 that was issued by a lower court, vacating an NIH supplemental guidance imposing the across-the-board cap both retroactively and prospectively.
A U.S. appeals court schooled the FDA as it handed Vanda Pharmaceuticals Inc. a “technical knockout” of sorts in yet another regulatory bout with the agency – this one over the FDA’s refusal to grant the company’s request for a hearing after it had received a complete response letter (CRL) for a jet lag supplemental indication for Hetlioz (tasimelteon).
Planting seed money and “wishing” is not enough to claim “irreparable harm” to secure a preliminary injunction or to establish the standing required to appeal a patent board decision, the U.S. Court of Appeals for the Federal Circuit ruled May 7 in two decisions involving Incyte Corp. and Sun Pharmaceutical Industries Ltd.
Planting seed money and “wishing” is not enough to claim “irreparable harm” to secure a preliminary injunction or to establish the standing required to appeal a patent board decision, the U.S. Court of Appeals for the Federal Circuit ruled May 7 in two decisions involving Incyte Corp. and Sun Pharmaceutical Industries Ltd.
The Trump administration dashed hopes that it would temper the Medicare price negotiations mandated by the Inflation Reduction Act when it filed the government’s brief in response to Novartis AG’s appeal to the U.S. Court of Appeals for the Third Circuit.
Now that Novo Nordisk A/S’ blockbuster semaglutide franchise has been selected as one drug for the next round of the CMS price negotiation, the Bagsværd, Denmark-based company is asking a U.S. appellate court to expedite its consideration of Novo’s challenge to the negotiations and the way CMS is implementing the program.
