Momenta Pharmaceuticals Inc. heeded the recommendation of an independent data safety monitoring board (DSMB) and stopped enrollment in the phase II trial of necuparanib (M402) in patients with advanced metastatic pancreatic cancer following the trial's planned interim futility analysis. Read More
A week after Inovio Pharmaceuticals Inc. began testing its Zika vaccine, GLS-5700, in healthy volunteers, the National Institutes of Allergy and Infectious Diseases (NIAID) announced on Tuesday it has dosed the first patient in the phase I VRC 319 trial of its own Zika vaccine. Read More
In a historic move, the CDC has issued a warning for those living in or traveling to a Miami neighborhood after the Zika virus was detected and spreading. Included in that warning is a recommendation that pregnant women be tested for the virus. How have diagnostics players stepped up to protect this – and other – vulnerable populations? Read More
When Congress returns to Washington Sept. 6 following its August recess, lawmakers will face two looming deadlines – for passage of fiscal 2017 spending authorizations and more funding to battle the Zika virus. Read More
LONDON – It's so far, so good for adaptive pathways, with the EMA's final report on its pilot scheme concluding that staggered approval from a small patient subgroup to an increasingly wide patient population can support development in indications where it is hard to generate sufficient data, but that new methodologies are required for gathering data once products are on the market. Read More
Cesca Therapeutics Inc., of Rancho Cordova, Calif., entered subscription agreements with institutional investors for a registered direct offering of 600,000 common shares at $4.10 apiece, a 24 percent discount to the closing price of $5.42 for the company's shares (NASDAQ:KOOL) on Aug. 3. Read More
Trevena Inc., of King of Prussia, Pa., disclosed in its second-quarter earnings that Dublin-based Allergan plc notified the company this month that it does not plan to exercise its exclusive option to license G protein-coupled receptor candidate TRV027. Read More
Adaptimmune Therapeutics plc, of Oxford, U.K., said it received FDA notice of a partial clinical hold on its planned pivotal study of NY-ESO SPEAR T-cell therapy in myxoid round cell liposarcoma. Read More
