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FDA accepts Salix's XIFAXAN550 sNDA for Priority Review

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Company's efficacy supplement to the New Drug Application (NDA) for XIFAXAN (rifaximin) 550 mg tablets for the proposed indication of ...

Nabi Biopharmaceuticals completes sale of PentaStaph vaccine candidate to GSK

Nabi Biopharmaceuticals (Nasdaq:NABI) announced today that it has successfully completed the technology transfer of program know-how associated with the sale of the PentaStaphTMvaccine candidate to GlaxoSmithKline Biologicals S.A. (GSK). As a result of successfully completing ...

Sinobiopharma inks agreement with Lianhuan to co-develop, manufacture and commercialize Eplerenone

Sinobiopharma, Inc. (OTCBB:SNBP) ("Sinobiopharma" or the "Company"), an innovative biopharmaceutical products company with primary operations in China, today announced that the Company, through its wholly-owned subsidiary Dong Ying (Jiangsu) Pharmaceutical Co., Ltd., has signed ...

AHF denies BMS sales reprepresentatives access to healthcare centers

Today AIDS Healthcare Foundation (AHF) announced that it has banned pharmaceutical sales representatives from Bristol-Myers Squibb (BMS) from calling on AHF's medical providers and staff in its sixteen U.S. healthcare centers. The decision is based on BMS' refusal to lower the ...

FDA approves Perrigo's OTC Cetirizine Cherry Syrup

Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has received final approval from the U.S. Food and Drug Administration to manufacture and market over-the-counter (OTC) Cetirizine Cherry Syrup, 1mg/ml. Shipments will begin in the Company's fiscal first quarter 2011. ...

Tibotec submits NDA for TMC278 anti-HIV compound to FDA

Tibotec Pharmaceuticals today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TMC278 (rilpivirine), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), being studied for once-daily use with other ...

Simcere subsidiary receives Chinese SFDA approval to manufacture and market Palonosetron

Simcere Pharmaceutical Group ("Simcere" or the "Company") (NYSE: SCR), a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today announced that its subsidiary company Simcere ...

FDA approves Chelsea Therapeutics' Phase II protocol for CH-4051 antifolate in rheumatoid arthritis

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced confirmation by the U.S. Food and Drug Administration (FDA) that its proposed Phase II protocol for CH-4051 in rheumatoid arthritis has been approved by the agency. Chelsea plans to initiate patient screening next ...

FDA notification confirms acyclovir Lauriad for oro-facial herpes labialis

Regulatory News: This notification from the FDA confirms that acyclovir Lauriad represents an innovation in the treatment of oro-facial herpes labialis and strengthens our position to find the adequate partner targeting dermatologists and general practitioners to successfully ...

Commissioner Shao Mingli meets Director of Singapore Health Sciences Authority

On August 17, 2010, Shao Mingli, commissioner of the State Food and Drug Administration, met the visiting Dr John Lim, Director of Singapore Health Sciences Authority and his party. Both parties discussed China s new revised version of GMP, the progresses on information ...

Lamictal can cause aseptic meningitis: FDA

The U.S. Food and Drug Administration today warned that the drug Lamictal (lamotrigine), approved to treat seizures and bipolar disorder, can cause aseptic meningitis, an inflammation of the protective membranes (meninges) that cover the brain and spinal cord not caused by ...

Eli Lilly to appeal against U.S. District Court ruling in Strattera patent litigation

Eli Lilly and Company (NYSE: LLY) today announced that the U.S. District Court for the District of New Jersey has ruled against the company in its patent litigation for Strattera (atomoxetine). In the case of Eli Lilly and Company v. Actavis Elizabeth LLC, et al, the court ruled ...

USFDA approves Sun Pharma's generic Venlafaxine Hydrochloride Extended Release tablets ANDA

Sun Pharma announced that USFDA has granted an approval for an Abbreviated New Drug Application (ANDA) to market a generic version of Venlafaxine Hydrochloride Extended Release tablets. These generic extended release Venlafaxine tablets are therapeutically equivalent to Osmotica...

SFDA issues guides for routine on-site inspection to health food and cosmetics production and distribution enterprises

The State Food and Drug Administration (SFDA) recently issued guides for routine on-site inspection to health food and cosmetics production and distribution enterprises, defining the basic procedures, inspection focuses, inspection methods, and supervision measures for the ...

FDA approves Novartis' Tekamlo for treatment of high blood pressure

The US Food and Drug Administration (FDA) approved Tekamlo (aliskiren and amlodipine) tablets, a single-pill for the treatment of high blood pressure combining the only approved direct renin inhibitor, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine. ...

BASF to build dispersions plant in Huizhou to better serve growing markets in South China

Strengthens BASF s commitment to Asia s fast-growing paper markets, especially China Supports anticipated growth in the region s coatings, construction, printing & packaging and adhesives markets With an annual capacity of 100,000 tons, expands local production network to serve ...

Pfizer's Prevenar 13-valent pneumococcal conjugate vaccine receives WHO prequalification

The World Health Organization (WHO) has granted prequalification to Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed])for active immunization of infants and children from 6 weeks through five years of age against invasive disease, pneumonia and ...

FDA approves Alexion's Rhode Island manufacturing facility as commercila supply source for Soliris

Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that the US Food and Drug Administration (FDA) has approved Alexion's Rhode Island manufacturing facility (ARIMF) in Smithfield, Rhode Island as a second source of commercial supply for Soliris (eculizumab). Earlier ...

FDA to Priority Review Bristol-Myers Squibb Melanoma Drug

Bristol-Myers Squibb has received confirmation that the US Food and Drug Administration (FDA) has accepted its biologics licence application for ipilimumab for filing and review. The company also announced that the application has received a priority review designation, which is ...

Research on clopidogrel reports complexity to FDA black box warning

New findings by McMasterUniversity researchers contradict earlier reports that people with a certain genetic make-up don't benefit from the blood-thinner clopidogrel, also known as Plavix. After researchers from the United States, France and Germany reported clopidogrel is less ...
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