Under a deal that depends on Novartis AG's big, pending asset swap with Glaxosmithkline plc (GSK), the BRAF inhibitor encorafenib (also known as LGX818) – stranded with Novartis since December, when the pharma giant returned MEK blocker binimetinib rights to Array Biopharma Inc. – is joining its sister at Array, and the phase III combination trial called COLUMBUS in BRAF-positive melanoma (encorafenib's fate in which had been unsure), will go on. Read More
After a delay of nearly five years, Progenics Pharmaceuticals Inc. dosed the first patient in a resumed phase II registration study of the radiotherapeutic Azedra (Ultratrace iobenguane I 131). Read More
Zafgen Inc.'s shares (NASDAQ:ZFGN) rose 5 percent to $38.97 Friday as the company priced a public offering of about 3.9 million shares at $35 each. Read More
DUBLIN – Italian gene therapy pioneer Luigi Naldini is one of the co-founders of a new start-up, Genenta Science SpA, a spinout from the San Raffaele Hospital in Milan, which aims to exploit his deep experience in lentiviral vectors in the development of ex vivo engineered autologous cell therapies for cancer. Read More
Riding high on new interim data suggesting plasma-derived alpha-1 antitrypsin (AAT) might help patients with graft-vs.-host disease (GvHD) recover when steroids fail, Omni Bio Pharmaceutical Inc. is angling to produce an irresistible proof-of-concept package showing its preclinical recombinant AAT (rAAT) could do the same and more. Read More
A number of politicians, including President Obama, have jumped on the personalized medicine bandwagon, which a skeptic might say is a sure sign the idea will soon find itself mired in turf wars and ideological scrums. Read More
The EMA's Committee for Medicinal Products for Human Use (CHMP) is recommending the suspension of hundreds of drugs being marketed in the EU that were approved based primarily on clinical studies conducted at GVK Biosciences in Hyderabad, India. Read More
Otonomy Inc., of San Diego, priced its follow-on public offering of 2.55 million common shares at $29.25 apiece for gross proceeds of approximately $75 million. Read More
Incyte Corp., of Wilmington, Del., said it earned a $25 million milestone from Novartis AG, of Basel, Switzerland, triggered by the EMA's positive opinion of Jakavi (ruxolitinib) for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea. Read More
Eisai Co., Ltd., of Tokyo, said the German Federal Joint Committee (G-BA) has confirmed that the largest defined patient group has "considerable" additional benefit of Halaven (eribulin) vs. certain comparator therapies as determined by the G-BA. Read More
Lixte Biotechnology Holdings Inc., of East Setauket, N.Y., said the number of clinical sites where its phase I trial of lead compound, phosphatase inhibitor LB-100 for use in combination with docetaxel, is being conducted has been expanded from one to five institutions. Read More
Researchers from the U.S. Army Medical Research Institute of Infectious Diseases have reported that the Ebola virus behind the current outbreak may be mutating in a way that makes it less susceptible to several experimental drugs that are currently in development. Read More
