Cellceutix Corp., of Beverly, Mass., said the FDA’s 30-day waiting period pertaining to the investigational new drug application for Prurisol has passed, and the company is moving toward starting clinical trials of the small-molecule drug in psoriasis. Read More
Novartis AG, of Basel, Switzerland, said the FDA approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria, a form of chronic hives. The new use is for patients 12 years and older who remain symptomatic despite treatment with H1-antihistamine therapy. Read More
Regado Biosciences Inc., of Basking Ridge, N.J. was issued U.S. Patent No. 8,586,524, part of the “Modulators of Pharmacologic Agents” patent family, which identifies the classes of molecules that can be developed as control agents to modulate aptamer activity in the body. Read More
Researchers from the British Flu Watch Group, a multi-university research consortium, have published epidemiological data suggesting that the majority of influenza infections do not lead to symptoms that are severe enough to cause infected individuals to seek medical attention. Read More
Biogen Idec Inc., of Cambridge, Mass., said Health Canada approved Alprolix (coagulation factor IX [recombinant], Fc fusion protein) for the control and prevention of bleeding episodes and routine prophylaxis in adults and in children, ages 12 and older, with hemophilia B. Read More
A vaccine that provided modest protection from contracting HIV in the RV144 “Thai” trial appears to have done so by inducing a broad, “polyfunctional” antibody response, rather than high titers of neutralizing antibodies that are the goal of vaccine development efforts. Read More
Wall Street hailed Endocyte Inc.’s double play – a positive opinion from European regulators on vintafolide in platinum-resistant ovarian cancer (PROC) and good news from a phase IIb trial in non-small-cell lung cancer (NSCLC) with the same compound – by sending its stock through the roof. Read More
Right on time, the FDA approved Celgene Corp.’s phosphodieasterase-4 inhibitor Otezla (apremilast) for adults with active psoriatic arthritis (PsA), a drug that could sell in the range of $1.5 billion to $2 billion by 2017, the company said. Read More
Versartis Inc. turned heads with its Wall Street debut, pricing its initial public offering (IPO) at $21 – the high end of a range expanded just two days earlier – to raise $126 million. But the IPO didn’t whet the appetite of investors. Read More
Shares in Biotie Therapies Oyj dipped 7 percent Friday as partner UCB SA opted not to pursue phase III development of the Parkinson’s disease drug tozadenant, a selective inhibitor of the adenosine 2a (A2A) receptor. Read More
LONDON – Fibrotech Therapeutics Pty has begun dosing in the phase Ib trial of its lead molecule FT011 in treating diabetic nephropathy and is now involved in “intensive discussions” to partner the small-molecule antifibrotic. Read More
