Bad regulatory news didn’t quash hopes for Travere Therapeutics Inc. with sparsentan, its dual-acting antagonist of the endothelin type A and angiotensin II type 1 receptors for focal segmental glomerulosclerosis (FSGS), a disease of kidney scarring.
The brakes have now been pumped twice at Larimar Therapeutics Inc. as the FDA placed a clinical hold on its CTI-1601 Friedreich’s ataxia (FA) clinical program, and the company won’t close on a planned $95 million private placement financing. Larimar’s stock (NASDAQ:LRMR) took a battering May 26 as shares slumped 33.46% to close at $8.99.
With the global COVID-19 pandemic and variants raising expectations about the need for booster shots, more companies are jumping into the vaccine space. But unless those sponsors have been engaging “in an ongoing manner” with the U.S. FDA on developing the manufacturing process and clinical trial program for their vaccine candidates, their emergency use authorization (EUA) requests may be denied, according to a new FDA guidance on EUAs for COVID-19 vaccines.
LONDON – New guidelines for stem cell research open the door to extending the legal limit on human embryo research beyond the current 14-day maximum set down 40 years ago. In revised guidelines, the International Society for Stem Cell Research (ISSCR) has moved research on human embryos from category 3, which explicitly bans their study in culture post 14 days in any circumstances, to category 2B, in which research post 14 days would be permissible if there is a clear scientific rationale – and after a thorough specialized review.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Immunitybio, Larimar, Mezzion, PTC, Revance, Travere.
New three-year safety and efficacy data on Takeda Pharmaceutical Co. Ltd.'s dengue vaccine candidate, TAK-003, showed it to be 62% more effective than placebo in preventing virologically confirmed infections with the virus and 83.6% more effective than placebo in preventing hospitalizations caused by the mosquito-borne viral disease and due to any of the four dengue virus serotypes in patients ages 4 to 16.
The European Commission's (EC) Medical Device Coordination Group (MDCG) has provided a set of templates to fulfill European Medical Device Regulation (MDR) requirements on submitting clinical investigation application and notification documents in the absence of the European database on medical devices (EUDAMED).
With $41 billion in sales, the medical technology market in Germany leads Europe, followed by France and Italy, which each manage only half the sales of Germany each month. The U.K., in fourth place, barely sees one-fifth of Germany's revenues, according to a report from BVMed, the German association of medical device manufacturers. German firms also reported a 4.9% reduction in business in 2020 due principally to the COVID-19 pandemic.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Biological Laboratories, Amg International, Choicespine, Guard Medical, Ihealthscreen, Jenavalve, Quidel, Unity HA, Uroviu.
The Institute for Clinical and Economic Review (ICER) will turn its magnifying glass on insurance companies as it evaluates how 15 of the largest U.S. payers cover 28 cost-effective prescription drugs.
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