Anticipating FDA approval early next year of its infliximab biosimilar, Celltrion Inc. is trying to clear the patent path so it can launch Remsima in the U.S. as soon as the approval comes down. Read More
Days after the FDA approved Biogen Idec Inc.’s Alprolix (coagulation factor IX [recombinant], Fc fusion protein) as the first recombinant, DNA-derived hemophilia B therapy with prolonged circulation, Baxter International Inc. moved to strengthen its own hemophilia franchise by snapping up the assets of Chatham Therapeutics LLC in a $70 million deal plus potential development, regulatory and commercial milestone payments. Read More
LONDON – The discovery of an enzyme that is vital to the survival of cancer cells, but which normal cells do not seem to need at all, is pointing to entirely new ways of treating cancer. Read More
The once-popular image of disease foundations as “old ladies in tennis shoes” busy mainly with direct patient care is going away, said Annette Bakker, president and chief scientific officer of the Children’s Tumor Foundation (CTF). And that’s good news. Read More
Intercept Pharmaceuticals Inc., of New York, said it commenced an underwritten public offering of 1 million shares of common stock, with 600,000 shares offered by the company and the remaining 400,000 to be sold by certain institutional selling stockholders. Read More
TI Pharma, of Leiden, the Netherlands, reported that five academic institutions, two governmental institutes and two small and medium enterprises from Europe, Africa and Latin America are collaborating to develop drugs against parasites. Read More
Cardiocell LLC, of San Diego, received investigational new drug approval from the FDA for a phase IIa study using its allogeneic stem cell therapy to treat patients with chronic heart failure (CHF). Read More
Daiichi Sankyo Co. Ltd., of Tokyo, said its European subsidiary would add data on 5,000 new patients to a registry it designed to provide insight into the characteristics and management of atrial fibrillation (AF), with a focus on the prevention of thromboembolic events, such as stroke. Read More
Bayer HealthCare Pharmaceuticals Inc., of Whippany, N.J., began enrollment in a trial studying Xofigo (radium Ra 223 dichloride) injection in combination with abiraterone acetate and prednisone/prednisolone for the treatment of asymptomatic or mildly symptomatic chemotherapy-naive patients with bone predominant metastatic castration-resistant prostate cancer. Read More
