DUBLIN – Shares in Santhera Pharmaceuticals Holding AG surged by as much as 71% June 1 on news that the high-dose arm of a phase IIb pivotal trial of vamorolone hit the primary endpoint of an improvement vs. placebo in the time-to-stand velocity attained by ambulatory boys with Duchenne muscular dystrophy (DMD). Read More
Alkermes plc worked its way through a complete response letter (CRL) issued in late 2020 as the FDA has approved Lybalvi (olanzapine and samidorphan) for treating adults with schizophrenia and bipolar I disorder. The once-daily, oral antipsychotic treatment, the company’s first, is for maintenance monotherapy or acute treatment of manic or mixed episodes and as a monotherapy or adjunct to lithium or valproate. The therapy had a June 1 PDUFA date. Read More
Amgen Inc.’s Merdo Gordon, head of commercial global operations, said just-approved Lumakras (sotorasib) is “priced very well compared to other targeted medicines available in the market” for cancers driven by specific mutations. “Just characterizing the launch broadly, look, it’s really hard to tell because of the variability of our reach to customers right now” – a result of the COVID-19 pandemic. Read More
Interim findings that Sanofi SA's venglustat is unlikely to provide a meaningful benefit to people with autosomal dominant polycystic kidney disease (ADPKD) have caused the company to halt a phase II/III study of the candidate. Testing continues in other rare diseases, but the exit could be a boon for Otsuka Pharmaceutical Co. Ltd.'s Jynarque (tolvaptan), its generic competitors and ascendant novel ADPKD programs still underway. Read More
Trading in shares in AB Science SA was suspended Tuesday after a safety signal prompted a voluntary hold on two late-stage clinical studies of its masitinib, in mastocytosis and amyotrophic lateral sclerosis, respectively. Read More
Data on the prevalence of diabetes in the U.S. show that non-Hispanic white people are least likely to suffer from the disease. Yet to date most genetic studies of the glycemic traits that are used to diagnose and monitor type 2 diabetes and cardiometabolic health have focused on individuals of European ancestry. Read More
Jam-packed with efforts to address COVID-19 variants and next-step booster shots, as well as safety concerns over vaccine co-administrations and the expansion of emergency use authorizations (EUAs) into younger populations, May was another busy pandemic-fighting month for the world, despite higher numbers of those vaccinated and declining death and hospitalization rates. Read More
The Biden administration is reviving the U.S. FDA’s Unapproved Drugs Initiative, which was terminated late last year by the Trump administration. Read More
With 10 cases of serious shock and anaphylaxis, including one death, in the month since Seikagaku Corp.’s osteoarthritis drug, Joyclu (diclofenac etalhyaluronate sodium), launched in Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) issued a blue letter to health care professionals and is adding a warning section to the drug’s Japanese label. Read More
Drug regulators throughout China cracked down last year on companies manufacturing and selling counterfeit and substandard drugs and active pharmaceutical ingredients. Read More
