Shares of Zalicus Inc., the company that will soon give Epirus Pharmaceuticals Inc. entrée to the public market through a reverse merger, shot up 39.8 percent Thursday as Epirus promoted trial results showing that BOW015, its biosimilar to the anti-tumor necrosis factor therapy Remicade (infliximab, Johnson & Johnson) compared favorably to the branded drug in a phase III equivalence trial. Read More
Drug developers and analysts seeking to handicap the outcome of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee (adcom) meeting might have left scratching their heads after a day and a half of sponsor and agency presentations. Read More
SHANGHAI – China's distribution sector took a big step toward consolidation with the announcement that Sinopharm Group Co. Ltd and Shanghai Fosun Group Co. Ltd. would form a joint venture (JV) to create what promises to be the first nationwide drug and medical device network. Read More
The decision by the European Federation of Pharmaceutical Industries Association (EFPIA) to go public this week on Italy's and France's embrace of off-label use of medicines represents a further escalation of an issue it has previously campaigned on behind closed doors. Read More
LONDON – A strategy of boosting the immune response against cancer, using a drug which has already delivered highly encouraging results for patients with leukemias and other hematological malignancies, may be equally successful when applied to solid tumors such as those of the breast and lung, new animal studies suggest. Read More
HONG KONG – Looking to reach out to more users and drug companies and riding the wave of growth of online information and platforms to facilitate the sharing of information between governments and users, China's drug regulator is now using mobile technology as part of its communications strategy. Read More
Novavax Inc., of Gaithersburg, Md., said it closed its public offering, issuing about 28.8 million shares of common stock, including 3.8 million shares covering overallotments, at $4 apiece. Read More
Morphosys AG, of Martinsried, Germany, and Merck & Co. Inc., of Whitehouse Station, N.J., said they signed an agreement to discover and develop therapeutic antibodies against undisclosed immune checkpoints. Read More
Amgen Inc., of Thousand Oaks, Calif., and Astrazeneca plc, of London, reported phase II results in The New England Journal of Medicine, with data from the 168-patient study showing that brodalumab, a drug that targets the interleukin-17 receptor, significantly improved signs and clinical symptoms associated with psoriatic arthritis, including tender and swollen joints, at 12 weeks, as measured by a 20 percent improvement in the American College of Rheumatology (ACR20) response criteria. Read More
Parion Sciences Inc., of Durham, N.C., and Osaka, Japan-based Santen Pharmaceutical Co. Ltd. agreed to jointly develop and commercialize Parion's experimental treatment for dry eye disease, P-321, in parts of Asia. Under the deal's terms, Santen will make an undisclosed option payment to secure certain rights to P-321 and to support the upcoming combination phase I/IIa trial of the drug. Read More
Pfizer Inc., of New York, presented two abstracts on phase I studies evaluating the bioequivalence of its potential biosimilars to rituximab and infliximab at the European League Against Rheumatism congress in Paris. Read More
