Hopes that MEK inhibitor selumetinib might rise above an earlier failure to improve a rare eye cancer were dashed as the Astrazeneca plc-backed candidate fell short of improving progression-free survival during SELECT-1, a phase III trial targeting NSCLC. Read More
LONDON – Ablynx NV improved the prospect of triggering a phase III opt-in and €75 million (US$83.1 million) option payment from Abbvie Inc., turning in positive top-line results in a phase IIb combination study of its anti-interleukin-6R (IL-6R) nanobody, vobarilizumab (ALX-0061), in the treatment of rheumatoid arthritis. Read More
HONG KONG – Two research teams have independently identified a specialized cytotoxic killer T-cell population and shown that boosting the number and killing ability of those cells may lead to an effective treatment for currently incurable lifelong viral infections, notably HIV. Read More
With just a few months to go, the FDA’s drug center is still hoping to push out more than 100 new and revised draft guidances before the year ends and a new administration comes on board. Read More
NEW DELHI – India’s drug pricing regulator, the National Pharmaceutical Pricing Authority (NPPA), has fixed price caps on 24 essential drugs used for the treatment of cancer, HIV, bacterial infections, anxiety and cardiac conditions, a move that is expected to cut the government’s costs by a quarter. Read More
Arrowhead Pharmaceuticals Inc., of Pasadena, Calif., priced a private offering of approximately 7.63 million common shares at $5.90 apiece, even with the stock’s (NASDAQ:ARWR) closing price on Monday, Aug. 8. Read More
Amag Pharmaceuticals Inc., of Waltham, Mass., reported record second-quarter sales of $78.4 million for Makena (hydroxyprogesterone caproate injection), approved to lower the risk of pre-term birth, and $24.3 million for Feraheme (ferumoxytol), the iron deficiency anemia drug indicated to treat patients with chronic kidney disease, leading to product and service revenues of $127.4 million on a GAAP basis compared with $123.9 million in the second quarter of 2015 – a period that included $39.2 million of collaboration revenue. Read More
Prometic Life Sciences Inc., of Laval, Quebec, said it completed enrollment of the adult population (50 adults) in its pivotal intravenous immunoglobulin (IVIG) phase III trial in primary immunodeficiency disease. Read More
