Sandoz Inc. came out the big winner Nov. 18 when the U.S. Court of Appeals for the Federal Circuit wiped out $39 million in infringement damages a jury had awarded to Allergan plc. Sandoz overcame “the doubly high burden of persuading us to overturn a jury verdict of no invalidity,” the appellate court said in its precedential opinion.
Taking aim at big pharma’s current penchant for acquisition over in-house innovation, Sen. Elizabeth Warren (D-Mass.) is asking the Federal Trade Commission (FTC) to consider the impact a biopharma merger, whether it’s proposed or a done deal, may have on future innovation.
Gate Neurosciences Inc. was first founded in 2019, but officially launched last week with two clinical-stage assets and a bold goal: to develop better drugs for CNS disorders and identify better-suited patients for those drugs. The company’s first molecular target is the NMDA receptor. Gate has acquired the rights to two NMDA receptor modulators, zelquistinel and apimostinel.
A lengthy trial over two generic drug manufacturers’ alleged role in fueling the opioid epidemic in West Virginia came to an end this week when the U.S. affiliate of Teva Pharmaceuticals Ltd. and Allergan, now part of Abbvie Inc., agreed to a settlement totaling more than $161.5 million.
Deciding not to roll the dice this time, Johnson & Johnson (J&J) and its U.S.-based Janssen Pharmaceutical Cos. removed themselves April 18 from an ongoing opioid trial in West Virginia by agreeing to a $99 million settlement with the state.
Abbvie Inc.’s FDA clearance of Vuity (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia in adults, could bring relief to about 128 million Americans: almost half of the U.S. population, the company said. It’s the first and only eye drop given U.S. regulators’ go-ahead for what’s known as age-related blurry near vision – but plenty more have generated clinical data.
The FDA has undertaken several new actions in connection with breast implants, including a new restriction on distribution to implant centers that review a pre-implant checklist with patients receiving implants. However, the agency has also mandated that manufacturers add a black-box warning of potential adverse events, such as the risk of developing anaplastic large cell lymphoma (ALCL).
LONDON – Sosei Heptares has attracted a third pharma partner to its G protein-coupled receptor (GPCR) discovery platform, signing a potential $1 billion-plus deal with Abbvie Inc. in inflammatory and autoimmune diseases.
An experimental gene editing therapy for an inherited form of blindness has become the first in vivo CRISPR medicine to be administered to patients, according to Editas Medicine Inc. and its partner, Allergan plc, which licensed the candidate in 2018.
No matter how effective it is, a drug is worthless if the people who need it can’t afford it. That’s been almost an anthem for patients and policy wonks testifying before U.S. Congress on drug prices.
