Amgen’s regulatory ambitions for its non-small cell lung cancer drug Lumakras (sotorasib) ran into headwinds Tuesday, after FDA staff indicated in their briefing document that there might not be sufficient evidence of its efficacy to justify full approval.
Tag Archive for: Amgen
Boehringer Ingelheim on Monday unveiled lower wholesale pricing for its adalimumab-adbm injection, the company’s interchangeable biosimilar to AbbVie’s blockbuster chronic inflammatory therapy Humira (adalimumab).
The U.S. Food and Drug Administration’s staff reviewers said on Tuesday that Amgen’s late-stage study may not provide enough evidence of effectiveness for its lung cancer drug, as the company pursues a traditional approval for the treatment.
Major drugmakers are using artificial intelligence to find patients for clinical trials quickly, or to reduce the number of people needed to test medicines, both accelerating drug development and potentially saving millions of dollars.
In a settlement on September 1, the U.S. Federal Trade Commission cleared Amgen to proceed with its $27.8 billion acquisition of Horizon Therapeutics after several months of scrutiny. Some experts say the agreement is a setback for the agency.
The U.S. Federal Trade Commission on Friday reached a settlement with Amgen Inc. allowing the drugmaker to go ahead with its $27.8 billion acquisition of Horizon Therapeutics, dropping its earlier objections to the deal.
The Biden administration on Tuesday released its list of 10 prescription medicines that will be subject to the first-ever price negotiations by the U.S. Medicare health program that covers 66 million people, with big-selling blood thinner Eliquis from Bristol Myers Squibb and Pfizer among them.
The case will be “withdrawn from adjudication” until Sept. 18, according to the filing, and this will allow the FTC to consider other avenues of resolving the matter, including a settlement.
The Federal Trade Commission seeks to codify its heavier-handed approach, already displayed by its actions regarding Amgen’s acquisition of Horizon, among other deals.
The new guidelines mark a significant shift in the approach to examining mergers in the pharma industry. Previously, the federal government’s antitrust enforcers primarily focused on direct competition, but the updated guidelines now consider how companies leverage their negotiating power.
