|ViroPharma gets EU recommendation. Lilly receives CRL for Alzheimer's test|
|By Mary Davila|
|Friday, 18 March 2011 18:20|
ViroPharma Incorporated (Nasdaq:VPHM) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of a Centralized Marketing Authorization for Cinryze in adults and adolescents with hereditary angioedema (HAE) for routine prevention, pre-procedure prevention and acute treatment of angioedema attacks.
"This would be the first C1-inhibitor therapy to be approved in Europe for prevention of HAE attacks in patients with hereditary angioedema," commented Dr. Emel Aygoren-Pursun, University Hospital, Frankfurt. "Prophylactic therapy with C1-inhibitor concentrate is an important step forward in the management of severely affected HAE patients. It is also beneficial that this C1-inhibitor therapy is also to be approved for therapy of acute attacks and pre-procedure prevention."
Shares gained 66 cents to $19.08.
Eli Lilly and Company (NYSE:LLY) and its wholly owned subsidiary, Avid Radiopharmaceuticals, Inc., have received a complete response letter from the FDA for their New Drug Application for Amyvid, a Positron Emission Tomography (PET) imaging agent under investigation for the detection of beta-amyloid plaque in the brains of living patientssuspected of having Alzeimer's disease. The FDA cited the need to establish a reader training program for market implementation that helps to ensure reader accuracy and consistency of interpretations of existing Amyvid scans.
"Lilly and Avid have been engaged in an active and ongoing dialogue with the FDA," said Wei-Li Shao, Lilly brand director for Amyvid. "We remain confident in the data submission package for Amyvid."
Shares of Lilly rose 35 cents to $34.48
Affymax, Inc. (Nasdaq:AFFY), today announced the pricing of an underwritten public offering of 8,474,576 shares of its common stock at a price to the public of $5.90 per share.
Protalix BioTherapeutics, Inc. (NYSE-AMEX: PLX, TASE: PLX), announced today the pricing of its previously announced underwritten public offering of 4,000,000 shares of its common stock at a price to the public of $5.50 per share.
Allezoe Medical Holdings (OTCBB:ALZM) today announces that Organ Transport Systems is preparing for clinical trials of its LifeCradle® and that the company plans to begin with applications of its technology to donor heart preservation.
Astro-Med, Inc. (NASDAQ: ALOT) today announced that Erik J. Mancyak was appointed as Vice President and Corporate Controller by the Board of Directors, effective April 1, 2011.
Axia Group (PINK SHEETS:AGIJ) Collagenna Skin Care Products/Melem Secret is pleased to announce that two of its products are under evaluation by a major national American retail chain.