A day of anticipation ended in disappointment as Salix Pharmaceuticals Ltd. and Progenics Pharmaceuticals Inc. received a complete response letter late Friday from the FDA for injectable Relistor (methylnaltrexone bromide) for opioid-induced constipation in adult patients with chronic, noncancer pain, which has not responded to treatment with laxatives.
Four months after passing on an opportunity to pursue Phase III trials of its hepatitis C drug GS-7977 in combination with Bristol-Myers Squibb Co.'s daclatasvir, Gilead Sciences Inc. has confirmed that it will go it alone instead, pressing ahead with its in-house NS5A inhibitor GS-5885.
Celgene Corp., of Summit, N.J., exceeded analysts' estimates modestly in its second-quarter earnings report, turning in total revenues of $1.367 billion, a 16 percent increase over the second quarter of 2011. Those revenue increases were led by growing sales of multiple myeloma blockbuster Revlimid (lenolidomide).
A strong launch of Eylea (aflibercept injection) for age-related macular degeneration led Regeneron Pharmaceuticals Inc.'s revenues for the second quarter, with $194 million in sales.
The FDA released briefing documents for two products on the slate for consideration at Thursday's meeting of the dermatologic and ophthalmologic drugs advisory committee.
Following encouraging results from a Phase III trial, PTC Therapeutics Inc., of South Plainfield, N.J., completed a $30 million financing to support late-stage development of ataluren. The drug has showed clinically meaningful trends in Duchenne's and Becker muscular dystrophy and cystic fibrosis.
Sanofi SA and Regeneron Pharmaceuticals Inc. began enrolling patients for several trials within its Phase III program for REGN727, an antibody for lowering LDL cholesterol.
Acucela Inc., of Seattle, began a Phase III trial of 2 percent rebamipide ophthalmic suspension for dry eye syndrome. The trial will support eventual U.S. regulatory submission for the product, already launched in Japan as Mucosta by Otsuka Pharmaceutical Co. Ltd.
Juventas Therapeutics Inc., of Cleveland, is funded through the end Phase II trials for its biologic product, JVS-100, now that it has closed a $22.2 million Series B financing round co-led by Triathlon Medical Venture Partners and New Science Ventures.
Some investors were puzzled when shares of Quest Diagnostics Inc. surged nearly 5 percent Thursday morning for apparently no reason. They could hardly be blamed for not knowing that Madison, N.J.-based Quest is entitled to a rather large payday upon commercialization of Merck & Co. Inc.'s odanacatib, which just blasted through its Phase III study goals upon interim analysis.
