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. Read More
Springworks Therapeutics Inc. plans to file an NDA for its lead drug candidate, nirogacestat, for treating desmoid tumors later this year, as top-line data from a pivotal phase III trial indicate that it provided patients with a substantial progression-free survival benefit. Read More
The recent online publication of findings from the University of Southern California ataxia working group called Enigma served to fuel more interest in the simmering drug development space of Friederichs’s ataxia (FRDA), where a handful of gene therapies and other approaches, plus one promising small-molecule treatment, are in the works. Read More
As the COVID-19 pandemic continues to wind down, the value of biopharma company deals with nonprofit and government entities, as well as grants, are down nearly 64%. Through mid-May 2022, BioWorld has tracked 309 bio/nonprofit deals worth $1.12 billion, and a total of 129 grants valued at $505.85 million. Read More
Now is a good time to be involved with type 1 diabetes (T1D) research, according to a U.K. biotech that hopes to reduce or cut the need for insulin injections to treat the condition. Read More
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. Read More
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. Read More
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. Read More
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. Read More
