After months of speculation, Sarepta Therapeutics Inc. hit pay dirt, gaining accelerated approval – and a rare pediatric disease priority review voucher (PRV) – from the FDA for its Duchenne muscular dystrophy (DMD) drug, eteplirsen, branded Exondys 51. Read More
Sutro Biopharma Inc., of San Francisco, presented findings from two studies of investigational antibody drug conjugates (ADC) that it developed to target CD74, a protein highly expressed in hematologic malignancies. Read More
Seattle Genetics Inc., of Bothell, Wash., said it enrolled the first patient in a multicenter phase I trial of SGN-CD123A to treat relapsed or refractory acute myeloid leukemia. Read More
Vical Inc. and partner Astellas Pharma Inc. remain hopeful for positive data from an ongoing phase III study testing cytomegalovirus (CMV) vaccine ASP0113 in hematopoietic stem cell transplant (HCT) recipients, set to read out late next year, despite the product's phase II miss in solid organ transplant patients. Read More
LONDON – The threat of antimicrobial resistance (AMR) reaches the top of the international agenda tomorrow, when the United Nations (UN) general assembly is due to hold a high level meeting to discuss the issue and approve a resolution to tackle the problem on a broad front. Read More
SHANGHAI – Asia's contender in the CRISPR patent battle is now a step closer to seeing global IP claims validated. Toolgen Inc., of Seoul, South Korea had two patent applications granted by the Korea Intellectual Property Office covering genome editing using the CRISPR platform. Read More
Two years and more than 900 comments to the docket later, the NIH has published the final rule for clinical trial registration at clinicaltrials.gov, declaring the rule will go into force on Jan. 18, 2017. Read More
Teva Pharmaceutical Industries Ltd. reported on Monday that a phase II trial of its experimental Huntington's disease (HD) drug pridopidine showed a statistically significant impact on disease progression at 52 weeks vs. placebo. Read More
FDA commitments in the BsUFA II goals letter to improve communication, transparency and staffing are getting high marks from industry, which sees those steps as essential to bettering the review of biosimilars for the U.S. market. Read More
