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Resverlogix files new patent for dosing combinations of RVX-208, statin therapeutics

Resverlogix Corp. is pleased to announce today that it has filed additional new patent protection based on novel findings derived from its recently completed ASSERT Phase 2 clinical trial.

30 Nov 2010

DTRA presents Outstanding Scientific Achievement award to Aduro BioTech

Aduro BioTech, a clinical-stage immunotherapy company, is pleased to announce the "Outstanding Scientific Achievement" award from the Defense Threat Reduction Agency. The award was presented at the 2010 Chemical and Biological Defense Science and Technology Conference in Orlando, Florida to Dr. Justin Skoble, Associate Director, Biodefense and Process Development at Aduro BioTech.

30 Nov 2010

Dongsheng enters agreement to acquire micro-emulsion alprostadil injection from Wan'Te

Dongsheng Pharmaceutical International Co., Ltd. announced today that it has entered into an agreement with Shanghai Wan'Te Pharmaceutical Co., Ltd. to acquire the intellectual property, exclusive sales and manufacturing rights of micro-emulsion alprostadil injection from Wan'Te for total proceeds of RMB10 million, of which RMB5 million will be paid in cash and RMB5 million will be paid in shares of the Company's common stock.

30 Nov 2010

APP to launch Topotecan for Injection following FDA marketing approval

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Topotecan for Injection, and plans to launch immediately.

30 Nov 2010

University of Adelaide researcher leads collaboration for universal flu vaccine

A University of Adelaide researcher is leading a collaboration between Australia and Indonesia on the production of a universal flu vaccine. The frequent arising of new influenza strains represents the greatest challenge to health authorities as it renders currently available vaccines ineffective, says Dr Mohammed Alsharifi, the Head of the Vaccine Research Group at the School of Molecular and Biomedical Science, University of Adelaide.

30 Nov 2010

Case Western Reserve University grants Thermalin Diabetes exclusive license on portfolio of insulin analogs

Case Western Reserve University has granted an exclusive license on a portfolio of insulin analogs to Thermalin Diabetes, LLC, which has assembled more than $3 million to support the development of these important new drugs.

30 Nov 2010

Alza files patent infringement suit against Impax in connection with Concerta

Impax Laboratories, Inc. today confirms that Alza Corporation has filed suit for patent infringement against Impax in the United States District Court for the District of Delaware in connection with Concerta® (methylphenidate hydrochloride) extended-release 54 mg tablets.

30 Nov 2010

FDA approves Axiron topical solution CIII for testosterone replacement therapy in men

Acrux , a drug delivery company that develops and commercializes patented pharmaceutical products for global markets, and Eli Lilly Company today announced that the United States Food and Drug Administration (FDA) has approved the Axiron® topical solution CIII for testosterone replacement therapy in men. Axiron is the first testosterone topical solution approved for application via an underarm applicator.

29 Nov 2010

WomanCare Global expands product portfolio to include Roselle, Optinor

WomanCare Global is pleased to announce an expansion of their global product portfolio to include Roselle, a combined oral contraceptive (COC) pill containing 150 micrograms of levonorgestrel and 30 micrograms of ethinylestradiol and Optinor, a progesterone-only emergency contraception pill (ECP) containing 750 micrograms of levonorgestrel.

29 Nov 2010

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