Taking advantage of new technologies to eliminate the lag time in reporting trial data to the U.S. FDA, the agency is moving toward a real-time clinical trial pilot program that will build on two proof-of-concept trials initiated by Amgen Inc. and Astrazeneca plc.
Alleging “untrue statements” included in the approval application for vasculitis drug Tavneos (avacopan), the U.S. FDA’s Center for Drug Evaluation and Research is proposing to withdraw the NDA for small-molecule C5aR antagonist at the center of Amgen Inc.’s 2022 buyout of Chemocentryx Inc. for $3.7 billion.
Abstracts released ahead of the American College of Cardiology meeting held in late March in New Orleans, along with the start of dosing near the end of January in Novartis AG’s phase IIb trial with siRNA therapy DII-235, also known as BW-20829, perked up the already-lively lipids/heart space.
Amgen Inc. has patented new GTPase KRAS (mutant) inhibitors, particularly, GTPase KRAS (G12D mutant) inhibitors that are potentially useful for the treatment of cancer.
Once again, Amgen Inc.’s Tavneos (avacopan) is under U.S. FDA scrutiny, as the agency alerted patients and doctors March 31 about 76 cases of drug-induced liver injury, including eight deaths, with “reasonable evidence of a causal association” with the drug.
As expected, the EMA is recommending withdrawal of the mpox indication for Siga Technologies Inc.’s tecovirimat, whilst maintaining its approval as a treatment for smallpox, cowpox and adverse reactions to vaccinia vaccines.
Repeated promotional claims Patrick Soon-Shiong made about Immunitybio Inc.’s Anktiva – such as “We have now discovered and developed this drug … approved for bladder cancer, but it actually can treat all cancers” – landed the Culver City, Calif., company a strongly worded warning letter from the U.S. FDA.
The disjointed health care system that patients face today blocks a significant proportion of them from accessing life-changing, innovative drugs, prompting many in the biopharma industry to explore more direct-to-consumer (DTC) pathways. During Pharma USA, a Reuters Events meeting held in Philadelphia March 16-17, executives from Eli Lilly and Co., Roche Holding AG’s Genentech unit, Amgen Inc. and consulting firm ZS Associates, among others, offered glimpses into a future where R&D is no longer enough.
Shortly after Amgen Inc. walked away from its partnership with Kyowa Kirin Co. Ltd., the Tokyo-based company said it is discontinuing all ongoing clinical trials for rocatinlimab due to safety concerns.
Shortly after Amgen Inc. walked away from its partnership with Kyowa Kirin Co. Ltd., the Tokyo-based company said it is discontinuing all ongoing clinical trials for rocatinlimab due to safety concerns.
