Novo Nordisk A/S, of Bagsværd, Denmark, submitted a supplemental application to the FDA for including data from the two SWITCH phase IIIb trials in the label for diabetes drug Tresiba (insulin degludec), first approved about a year ago. The studies compared the efficacy of Tresiba vs. insulin glargine, and Tresiba turned up noninferior in reducing HbA1c. Read More
Medivir AB, of Stockholm, said the independent data monitoring committee recommended continuation of the ongoing randomized, double-blind phase IIa study (MIV-711-201) of MIV-711 in patients with moderate knee osteoarthritis (OA), based on a review of unblinded safety data. Read More
Bioinformatics-based methods to estimate how sensitive non-small-cell lung cancer (NSCLC) would be to different chemotherapy combinations have been reported by scientists from the Greek National Technical University of Athens. Read More
Aquinox Pharmaceuticals Inc., of Vancouver, British Columbia, said it closed its public offering of 6.2 million shares of common stock, including 802,500 shares in the underwriters' full exercise of their overallotment option. Gross proceeds totaled $75.4 million. Read More
HONG KONG – With an eye firmly set on the double-digit growth of the pharmaceutical market in Vietnam and the rest of Asia-Pacific, French drugmaker Sanofi SA recently signed a strategic cooperation agreement with Vietnam's state-run giant Vinapharm Corp. Read More
WASHINGTON – For FDA commissioner Robert Califf, combination products are "definitely on my mind right now," but he noted that various centers at the agency will have to rewire their thinking in order to accommodate what is expected to be a growing volume of combination product applications. Read More
HONG KONG – Retinal cells derived from the reprogrammed stem cells of one monkey have been transplanted into the eyes of others, without immune rejection and need for immunosuppressants, said researchers from the RIKEN Center for Developmental Biology (CDB) in Kobe, Japan. Read More
TOKYO – India's Sun Pharmaceutical Industries Ltd. will be heading to Japan to sell generics and biosimilars in partnership with Mitsubishi Tanabe Pharma Corp., beginning in November. Read More
LONDON – The biosimilar version of infliximab has overtaken the originator product Remicade in the U.K., but in spite of lower prices, patient access to the anti-TNF-alpha antibody has not increased, according to the British Biosimilars Association (BBA). Read More
Prescription Opioid and Heroin Epidemic Awareness Week closed Friday, but intense talks around the topic and related drug development haven't stopped – and probably won't anytime soon. Read More
