Pharmaceutical News

RSS

Sagent Pharmaceuticals recalls metronidazole injection

Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of all lots of metronidazole injection, USP 500mg / 100mL (NDC number 25021-131-82) manufactured by Claris Lifesciences and distributed by Sagent.

18 May 2010

MorphoSys AG (DE) - AbD Serotec enters new growth area

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that its research and diagnostic antibody unit AbD Serotec is active in a new growth area.

18 May 2010

FDA issues complete response letter for roflumilast NDA

Forest Laboratories, Inc. and Nycomed today announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for roflumilast. Roflumilast was reviewed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations.

18 May 2010

FDA approves ROXRO PHARMA's SPRIX Nasal Spray

ROXRO PHARMA, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SPRIX™ (ketorolac tromethamine) Nasal Spray, for the short-term (up to 5 days) management of acute moderate to moderately severe pain that requires analgesia at the opioid level.

17 May 2010

Halozyme announces voluntary HYLENEX product recall

Halozyme Therapeutics, Inc. today announced that Halozyme and Baxter have confirmed the presence of small flake-like glass particles in a limited number of vials of HYLENEX® (hyaluronidase human injection) product at the Baxter manufacturing facility. Earlier today, Halozyme notified the U.S. Food and Drug Administration that it is voluntarily recalling affected lots of 150U HYLENEX product from distribution.

17 May 2010

NanoViricides signs Research Agreement with UCSF for testing anti-HIV drug candidates

NanoViricides, Inc., announced that it has signed a Research Agreement with the University of California, San Francisco for testing of its anti-HIV drug candidates. Cheryl Stoddart, PhD, Assistant Professor in the UCSF Division of Experimental Medicine, will be the Principal Investigator.

17 May 2010

Aeterna Zentaris' AEZS-108 receives orphan medicinal product designation for ovarian cancer in Europe

Aeterna Zentaris Inc. a late-stage drug development company specialized in oncology and endocrinology, today announced that it has received a positive opinion for orphan medicinal product designation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency, for its compound AEZS-108 for the treatment of ovarian cancer. AEZS-108, the Company's doxorubicin targeted conjugate compound, is currently in a Phase 2 trial in advanced ovarian and advanced endometrial cancer in Europe.

17 May 2010

Polypill to be tested in new heart disease trial

Researchers will be exploring whether a new, very low cost, one-a-day combined 'polypill' could reduce the risk of heart attacks, strokes and other cardiovascular problems across the world, in a major new international trial that launches today.

17 May 2010

Halozyme Therapeutics announces delivery of notice of breach to Baxter Healthcare

Halozyme Therapeutics, Inc. today announced the delivery of a notice of breach to Baxter Healthcare Corporation due to Baxter's failure to provide HYLENEX (hyaluronidase human injection) in accordance with the terms of the parties' existing development and supply contracts.

17 May 2010

Statins may play role in lowering risk of clot-related diseases: Study

Individuals at risk for clot-related diseases may benefit from taking common cholesterol-lowering drugs known as statins, according to a study conducted by researchers at the University of Connecticut.

17 May 2010

Long-term, regular use of vitamin E in women may help decrease risk of COPD: Study

Long-term, regular use of vitamin E in women 45 years of age and older may help decrease the risk of chronic obstructive pulmonary disease by about 10 percent in both smokers and non-smokers, according to a study conducted by researchers at Cornell University and Brigham and Women's Hospital.

17 May 2010

Amended class action complaint against Pfizer

Robbins Geller Rudman & Dowd LLP ("Robbins Geller") today announced that an amended class action complaint will be filed in the United States District Court for the Southern District of New York. The amended complaint will be on behalf of purchasers of Pfizer Inc. publicly traded securities during the period between January 19, 2006 and January 23, 2009.

15 May 2010

Protox announces positive top-line results from the TRIUMPH study in first quarter 2010

Protox Therapeutics Inc. a leader in the development of receptor targeted fusion proteins, today released financial results for the first quarter 2010, ended March 31, 2010. "The first quarter of 2010 marked significant achievements for the company, namely the announcement of positive top-line results from the TRIUMPH study and the subsequent completion of a five million dollar financing," said Dr. Fahar Merchant, President and CEO of Protox.

15 May 2010

Biovest International announces filing of proposed Plan of Reorganization

Biovest International, Inc. today announced that the Company filed its proposed Plan of Reorganization with the U.S. Bankruptcy Court for the Middle District of Florida, Tampa Division. With this filing, Biovest is positioned to emerge from Chapter 11 protection this summer as a fully restructured company.

15 May 2010

Intellipharmaceutics announces dismissal of patent litigation settlement on Focalin XR drug

Intellipharmaceutics International Inc. and its wholly owned subsidiary Intellipharmaceutics Corp. today announced that it and its licensee and development partner Par Pharmaceutical, Inc. ("Par") have received confirmation that the previously announced stays of the patent litigation concerning a generic version of Novartis' Attention Deficit Hyperactivity Disorder drug, Focalin XR®, (dexmethylphenidate hydrochloride), have expired without regulatory intervention, and that the parties have stipulated to a dismissal of the litigation.

15 May 2010

Dyadic International reports $1.1 million net loss for first-quarter 2010

Dyadic International, Inc., a leading-edge biotechnology company focused on the discovery, development, manufacture and sale of specialty enzyme products and solutions for the bioenergy, industrial enzyme and biopharmaceutical industries, today announced financial results for the quarter ended March 31, 2010.

15 May 2010

Small anti-abortion advocacy group flexes muscle in midterm elections

The Washington Post reports on the increasingly important role of a small antiabortion advocacy group, the Susan B. Anthony List, which is targeting Senate Majority Leader Harry Reid in his bid for re-election.

15 May 2010

Lotus Pharmaceuticals first-quarter net income up 38%

Lotus Pharmaceuticals, Inc., a growing developer, manufacturer and seller of medicine and drugs in the People's Republic of China today reported its financial results for the first quarter ended March 31, 2010.

15 May 2010

Amgen submits BLA for denosumab subcutaneous RANK Ligand inhibitor

Amgen Inc. today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for denosumab, a subcutaneous RANK Ligand inhibitor. The BLA submission summarizes clinical experience from nearly 6,900 patients across 18 clinical studies, including approximately 5,700 patients with advanced cancer in the three, pivotal, Phase 3, head-to-head trials versus Zometa® (zoledronic acid).

15 May 2010

U.S. healthcare practitioners can resume use of Rotarix, says FDA

GlaxoSmithKline announced that the Food and Drug Administration has determined that U.S. healthcare practitioners can resume the use of Rotarix (Rotavirus Vaccine, Live, Oral), effective immediately. This action supersedes the FDA's recommendation from March 22, 2010 and reflects the agency's assessment that the presence of porcine circovirus type 1 in the vaccine poses no safety risk.

15 May 2010