The U.S. FDA declined to approve, for a third time, an investigational liver cancer drug regimen comprising HLB Co. Ltd.’s rivoceranib and Jiangsu Hengrui Pharmaceutical Co. Ltd.’s camrelizumab, reportedly citing issues from a drug manufacturing facility inspection.
Astrazeneca plc has added a dual PDE3/4 inhibitor candidate to its chronic obstructive pulmonary disease (COPD) portfolio via a deal worth up to $2.1 billion with Chia Tai Tianqing Pharmaceutical Group Co. Ltd., a Sino Biopharmaceutical Ltd. subsidiary.
The U.S. FDA is proposing a rule to streamline its drug establishment registration regulations for distributed biopharma manufacturing facilities and to strengthen the country’s drug supply chain.
A federal jury was wrong when it determined that Astrazeneca plc should pay Wyeth, a Pfizer Inc. unit, $107.5 million in damages for infringing two cancer patents, the U.S. Court of Appeals for the Federal Circuit said in a recent precedential decision.
Zeta Surgical Inc. received U.S. FDA 510(k) clearance for its transcranial magnetic stimulation (TMS) robotic system which is designed to support precise and repeatable TMS therapy for patients with treatment-resistant depression.
The clinically proven promise of an alopecia drug, without the risks of black box-bearing JAK inhibitors yet with powerful efficacy, led shares of Q32 Bio Inc. (NASDAQ:QTTB) to close July 13 at $21.38, up $10.17, or 90.7%.
Veterans in the U.S. suffering from post-traumatic stress disorder (PTSD) now have access to Neurovalens Ltd.’s Modius Spero, a wearable neuromodulation device, which can reduce their symptoms in as little as four weeks. The treatment, designed for at-home use of 30-minute daily sessions, was approved for use within the Department of Veterans Affairs after the company secured FDA de novo approval.
The U.S. SEC reached a settlement with Weiguo Zhai resolving insider trading charges related to Astrazeneca plc’s $1.1 billion acquisition of Icosavax Inc. in 2023.
The U.S. FDA declined to approve, for a third time, an investigational liver cancer drug regimen comprising HLB Co. Ltd.’s rivoceranib and Jiangsu Hengrui Pharmaceutical Co. Ltd.’s camrelizumab, reportedly citing issues from a drug manufacturing facility inspection.
The synergy – or lack of it – between knockdown drugs and stabilizers in treating transthyretin (TTR)-mediated amyloid cardiomyopathy (ATTR-CM) became one of the topics for debate in the aftermath of the phase III fizzle with gene silencer Wainua (eplontersen), advanced by Astrazeneca plc and Ionis Pharmaceuticals Inc.
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