Alkermes plc is ramping up a phase I study of ALKS-8700, a small-molecule prodrug of monomethyl fumarate (MMF) for the treatment of multiple sclerosis. Read More
For the time being, the promise of biomarkers has, by and large, not been realized. Although it has been recognized for decades that good biomarkers could greatly improve both resource allocation and patient outcomes, very few biomarkers have sufficient clinical utility to be in widespread use. Read More
BOGOTA, Colombia – A shortage of pentavalent and hexavalent vaccines that left children in Latin America and Europe exposed to a series of preventable diseases for months may have been resolved, but countries are still trying to fill in the gaps. Read More
Myos Corp., which is taking a bifurcated approach in developing products to improve muscle mass, increase mobility and reduce frailty, is going to the "cloud" through a research and development agreement with newco Cloud Pharmaceuticals Inc. Although terms were not disclosed, the partners will focus on identifying and advancing candidates that inhibit targets in the myostatin regulatory pathway and inflammatory mediators associated with sarcopenia and cachexia. Read More
The infectious disease field is in crisis, according to Eszter Nagy, president and CEO of Arsanis Biosciences Inc., an Austro-American biotech that is offering an approach that differs from the typical antibiotic regimen. Read More
In a push for more corporate accountability, Sens. Bob Casey (D-Pa.), Richard Blumenthal (D-Conn.) and Tom Harkin (D-Iowa) introduced the Hide No Harm Act in the Senate this week. The bill would make it a federal crime, punishable by up to five years in prison, for a corporate officer to knowingly allow a dangerous product or service into the market. Read More
Dipexium Pharmaceuticals Inc., of New York, reported that a phase I study testing Locilex (pexiganan acetate cream 1 percent), an antibiotic peptide formulated as a topical cream, in mild infections of diabetic foot ulcers showed the cream was not an irritant. Read More
Intermune Inc., of Brisbane, Calif., said pirfenidone was granted breakthrough therapy designation by the FDA in idiopathic pulmonary fibrosis (IPF). Read More
Helsinn Group, of Lugano, Switzerland, and Chugai Pharma Marketing Ltd., a wholly owned subsidiary of Chugai Pharmaceutical Co. Ltd., of Tokyo, said they inked an agreement for the marketing rights of netupitant-palonosetron fixed-dose combination (NEPA), being evaluated for the prevention of chemotherapy-induced nausea and vomiting. Read More
Ipsen SA, of Paris, said the New England Journal of Medicine published clinical results showing that Somatuline Autogel/Somatuline Depot (lanreotide) achieved statistically significant prolongation and progression-free survival (PFS) over placebo in patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Read More
Critical Outcome Technologies Inc. (COTI), of London, Ontario, amended the expiry date of its approximately 3.6 million common share purchase warrants, which were issued as part of a nonbrokered private placement on Jan. 30, 2013, and scheduled to expire July 29. Read More
