Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alpine, Antios, Assembly, Blue Lake, Ceruvia, CSL, Dermavant, ENB, Immune, Merck & Co., Neuronascent, Noveome, Ocugen, Roche, Synlogic, United, Xcovery.
An executive compensation consultant is facing both civil and criminal charges related to insider trading in advance of an acquisition announcement by one of his clients, Kadmon Holding Inc.
With drug shortages becoming a fact of life during the pandemic, the U.K.’s Medicines & Healthcare Products Regulatory Agency (MHRA) is issuing two guidances to help ensure access to essential medicines in Great Britain and Northern Ireland, especially during shortages and public health emergencies.
Dermavant Sciences Inc. has received its first FDA approval with the agency’s blessing of Vtama (tapinarof) for treating plaque psoriasis in adults. The treatment is also the first FDA-approved, steroid-free topical medication in its class in addition to being the first psoriasis novel topical chemical entity introduced to the market in the past 25 years.
The U.S. FDA’s approval, in recent years, of new medicines that can fight certain drug-resistant bugs makes it possible to conduct noninferiority trials of potential antibacterial therapies in patients with infections caused by those bugs since active controls are now available.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altamira, Astrazeneca, Bharat, Biohaven, Depymed, Eiger, Greenwich, Immunitybio, Immunogen, Nymox, Ocugen, Regeneron, Salubris, Sanofi, Therapeuticsmd.
Although it was recently overturned in a legal challenge, a short-lived California state law mandating gender quotas for corporate boards may have made a few drug and device companies based in the state think twice about the makeup of their boards.
Just in case the U.S. FDA didn’t get the message from its advisory committee about drug applications based solely on clinical trial data from China, a trio of U.S. lawmakers wrote to FDA Commissioner Robert Califf to voice their concerns about the “current ‘East to West’ movement of clinical data” to support the approval of me-too drugs.
The U.S. FDA sent a refuse to file letter to Nymox Pharmaceutical Corp. regarding its NDA for fexapotide triflutate, a pro-apoptotic protein intended for treating benign prostatic hyperplasia. The letter noted that more long-term safety data was needed for the application, the company said.
Zhejiang Acea Pharmaceutical Co. Ltd. failed to obtain marketing approval from China’s NMPA for its third-generation EGFR tyrosine kinase inhibitor, abivertinib. The NDA was based on a phase II trial of abivertinib in patients with EGFR Thr790Met point mutation-positive non-small-cell lung cancer with disease progression from prior EGFR inhibitors.
RSS
