The FDA issued a statement Tuesday explaining the causes and progress being made toward resolving critical shortages of I.V. fluids, injectable opioid pain drugs and Mylan NV's Epipen (epinephrine) auto-injector. Read More
Zosano Pharma Corp., of Fremont, Calif., disclosed the publication regarding Adhesive Dermally-Applied Microarray (ADAM) technology for the delivery of the migraine drug zolmitriptan in the Journal of Pharmaceutics. The test evaluated how different in vitro skin models influenced the absorption of zolmitriptan with ADAM. Read More
Intiva Biopharma Inc., of Glendale, Colo., has filed to sell 2.46 million shares of common stock. According to its filing, it is developing drugs containing cannabinoids and/or terpenes for the treatment of various diseases. The company's shares trade on the OTCPink Market under the symbol NTVA. Read More
Politicians, scientists, health officials and advocates working to improve the lots of an estimated 5.7 million Americans living with Alzheimer's disease met in Washington Tuesday for a Senate Special Committee on Aging hearing on legislation promoting better management of the condition. If enacted, The Building Our Largest Dementia (BOLD) Infrastructure for Alzheimer's Act, first introduced late last year, would create a nationwide framework in which to implement Alzheimer's interventions focused on public health issues, such as increasing early detection and diagnosis, reducing risk, and preventing avoidable hospitalizations. With 35 co-sponsors, it's moving through the Senate Health Committee. Read More
Fresh off presentations this month at the American Society of Clinical Oncology in Chicago and the European Hematology Association in Stockholm that confirmed continued progress in its late-stage pipeline, TG Therapeutics Inc. struck a deal to collaborate on the development and commercialization of a preclinical anti-CD47/anti-CD19 bispecific antibody discovered by Novimmune SA. The companies will jointly advance the fully human IgG1, known as TG-1801 (previously NI-1701), on a global basis with a focus on hematologic B-cell malignancies. Read More
LONDON – Immuno-oncology specialist Iteos Therapeutics SA has bounced back from Pfizer Inc.'s rebuff of its lead program, sealing a $75 million series B round that will enable the company to take forward two other compounds that aim to tweak the tumor microenvironment. Read More
Despite wishful predictions in the first years of the regulatory pathway, biosimilars have only lapped at the shoreline of the U.S. biologics market. But the tide is changing. Read More