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Synthon receives FDA final approval for generic Xyzal

Perrigo today announced that its licensor and supplier Synthon has received final approval from the U.S. Food and Drug Administration (FDA) for Levocetirizine tablets, a generic version of Xyzal® tablets from UCB/Sepracor, which is marketed in the U.S. by Sanofi-Aventis. Perrigo has the exclusive rights from Synthon to sell and distribute the product in the U.S.

29 Nov 2010

Perrigo launches generic Aleve Liquid Gels

Perrigo today announced that it has launched Naproxen Sodium Soft Gels. The product is the generic equivalent of Bayer HealthCare's Aleve® Liquid Gels, 220mg, an OTC analgesic. Aleve® Liquid Gels had sales of approximately $80 million, as measured by Information Resources, Inc. Perrigo believes it is the first to market a store brand version of this product.

29 Nov 2010

USPTO awards Immunitor key patent for viral vaccine

Immune Network Ltd., advises that its potential acquisition, Immunitor USA Inc., has been issued a key patent by the U.S. Patent and Trademark Office (USPTO).

29 Nov 2010

Common, overprescribed drugs lead to election dopiness and immaturity

As Bill Maher, New York Magazine, the Washington Post and countless cable news and Internet sources have pointed out, the 2010 midterm campaigns and elections seem to have brought to light an American electorate capable of shocking illogic, ignorance and even violence.

29 Nov 2010

Spectrum's FUSILEV sNDA accepted by FDA for review

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the complete response regarding its supplemental New Drug Application (sNDA) for FUSILEV® (levoleucovorin) for Injection for treatment of patients with advanced metastatic colorectal cancer.

29 Nov 2010

3SBio acquires pegsiticase global rights from EnzymeRx for $6.25 million

3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, announced that is has acquired worldwide rights of pegsiticase for all indications from EnzymeRx for a total consideration of US$6.25 million.

29 Nov 2010

AMAG updates product label of Feraheme Injection

AMAG Pharmaceuticals, Inc. today announced that the company has reached agreement with the U.S. Food and Drug Administration (FDA) regarding an update to the product label for Feraheme (ferumoxytol) Injection for intravenous (IV) use.

29 Nov 2010

NovaBay announces meeting with FDA to discuss Aganocide compound for impetigo

NovaBay Pharmaceuticals, Inc., a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, announces a successful meeting with the US Food and Drug Administration (FDA) to discuss the Company's clinical development of its Aganocide compound NVC-422, intended for use in the treatment of impetigo.

29 Nov 2010

Accentia enters strategic agreement with Baxter to purchase Cytoxan drug

Accentia Biopharmaceuticals, Inc. today announced a strategic agreement with Baxter Healthcare Corporation to provide Accentia with the exclusive, worldwide right to purchase Baxter's cyclophosphamide, which is marketed under the brand name Cytoxan, for the treatment of designated autoimmune diseases including multiple sclerosis.

29 Nov 2010

Affymax, Takeda to regulate peginesatide drug for treating anemia in CRF patients

Affymax, Inc. and Takeda Pharmaceutical Company Limited , today announced that following pre-New Drug Application (NDA) discussions with the U.S. Food and Drug Administration (FDA), the companies will move forward with their regulatory strategy for the investigational drug, peginesatide, for the treatment of anemia in chronic renal failure (CRF) patients on dialysis in the United States.

29 Nov 2010

HAL Allergy files MAA for PURETHAL Mites and SUBLIVAC FIX products at Paul-Ehrlich-Institute

HAL Allergy today announced that it has filed marketing authorization applications (MAA) for PURETHAL(R) Mites and SUBLIVAC(R) FIX Grasses, Trees, and Mites (incl. homologous group products) at the Paul-Ehrlich-Institute, the regulatory authority in Germany.

29 Nov 2010

Marcus evans Summit highlights potential growth, innovation in drug discovery

Drug discovery scientists need to broaden their approaches to pharmaceutical research and development (R&D) and Medicinal Chemistry, to take advantage of untapped opportunities, says Torsten Hoffmann, Head Discovery Chemistry at F. Hoffmann La Roche, Basel, Switzerland. Chemical Biology allows room for innovation, but is often overlooked by scientists in the industry.

29 Nov 2010

Selcia announces drug discovery collaboration agreement with Gilead Sciences

Selcia Limited, a leading contract research organisation, today announced a drug discovery collaboration agreement with Gilead Sciences, Inc. (Foster City, California).

29 Nov 2010

Pfizer, Protalix announce marketing authorization submission in Europe for taliglucerase alfa

Pfizer Inc. and Protalix BioTherapeutics, Inc. today announced the submission of a Marketing Authorization Application to the European Medicines Agency for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD)for the treatment of Gaucher disease. Taliglucerase alfa was granted Orphan Designation by the European Commission for the treatment of Gaucher disease on March 23, 2010.

29 Nov 2010

New irreversible covalent approach to inhibit viral protease

Avila Therapeutics, Inc., a biotechnology company developing novel targeted covalent drugs, has published research in Nature Chemical Biology demonstrating the first-ever selective irreversible inhibition of a viral protease using a targeted covalent drug.

28 Nov 2010

GFS solution to Cholera

GFS BioProtect™ Effluent Remediator kills Vibrio cholerae O: 1, serotype Ogawa to Log 3 immediately, and the kill rate for this and several other pathogens continues to improve over time. The product breaks down B Class biomass (latrine and septic tank waste) into A class biomass suitable for reuse.

28 Nov 2010

Pharma enhances its focus on Asia-Pacific partnerships

While the Japanese market still dominates deal activities in the Asia-Pacific (APAC) region, companies and research institutes in emerging APAC countries have recently been attracting high calibre collaborators, according to the latest analysis by Datamonitor.

28 Nov 2010

Impax initiates patent challenge in connection with SIMCOR

Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed in connection with SIMCOR® (niacin/simvastatin) extended-release tablets, 1000/20 mg.

26 Nov 2010

Researchers synthesize iron compounds that inhibit growth of Mycobacterium tuberculosis

A team of researchers from Spain and Latin America have synthesized two iron compounds that inhibit the in vitro growth of Mycobacterium tuberculosis, the bacteria that causes tuberculosis. Due their low level of toxicity in mammel cells, the compounds could be used in the future as therapeutic agents and hospital disinfectants.

26 Nov 2010

FDA extends review period of Cladribine Tablets for MS therapy

EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, announced today that the U.S. Food and Drug Administration (FDA) has extended its review period for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS) by three months to February 28, 2011.

26 Nov 2010