Pharmacy News EU

Catheter Connections, Inc., a manufacturer of innovative vascular access and infection control products, announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its DualCap? product. DualCap is the only device that nests two disinfecting caps together – for both IV access points, the needleless injection site (NIS) [...]

July 29In the wake of health reform’s passage into law, Hospira Inc. will begin testing a cheaper version of a popular anemia biotech treatment in the first phase of a U.S. clinical trial.Lake Forest-based Hospira said it will begin the first phase of trials for a "biosimilar," or a biogeneric, version of brand-name Epogen in [...]

July 29WILMINGTON PPD Inc. and Microsoft Corp. have agreed to jointly develop technology to improve efficiency in managing risk evaluation and mitigation strategy programs mandated by the U.S. Food and Drug Administration.The technology will be based on the Microsoft Amalga Unified Intelligence System, a data aggregation platform that gives health care professionals access to [...]

FLORHAM PARK, N.J., July 29 /PRNewswire/ Shionogi Inc., a U.S.-based group company of Shionogi & Co., Ltd., today announced the U.S. Food and Drug Administration approval of CUVPOSA? (glycopyrrolate), the first liquid treatment for patients ages 3-16 who suffer from chronic severe drooling associated with neurologic conditions such as cerebral palsy. CUVPOSA? was designated [...]

LONDON – AstraZeneca PLC has reported a 22 per cent rise in second quarter net profit and has also revealed that a key new drug – its blood thinner Brilinta – has been given a thumbs up by an advisory committee of the U.S. Food and Drug Administration.The Anglo-Swedish drugmaker on Thursday posted net profit [...]

PARIS Sanofi-Aventis SA warned Thursday that its core earnings may fall up to 4 percent this year as a result of the U.S. Food and Drug Administration’s approval of a generic version of its Lovenox, an injected drug for preventing life-threatening blood clots.In a statement, the Paris-based drug maker says its so-called business net [...]

SAN DIEGO, July 29 /PRNewswire-FirstCall/ Orexigen Therapeutics, Inc. (Nasdaq: OREX) announced that results from its COR-I trial of Contrave were published online today in the journal Lancet. COR-I was the largest of the four, 56-week, Phase 3 trials supporting the New Drug Application for Contrave, currently under review by the U.S. Food and Drug [...]

The U.S. Food and Drug Administration today required Baxter Healthcare Corp. to take specific steps to carry out the April 2010 recall of all Colleague Volumetric Infusion Pumps (CVIP) and to provide customers with a refund, a replacement pump, or lease termination (see also Infusion Pumps).Baxter is responsible for recalling as many as 200,000 CVIP [...]

GENEVA, Switzerland, July 28, 2010 /PRNewswire/ Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announcedtoday that the U.S. Food and Drug Administration (FDA) has accepted forfiling the New Drug Application (NDA) for Cladribine Tablets as a therapy forrelapsing forms of multiple sclerosis (MS).
The application also has been granted a [...]

SILVER SPRING, Md., July 28 /PRNewswire-USNewswire/ The U.S. Food and Drug Administration today approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years.(Logo: (Logo: Drooling is normal in infants. But a significant proportion of the developmentally disabled population experiences drooling caused primarily by [...]