FDA Approves Actemra for the Treatment of Moderately to Severely Active Rheumatoid Arthritis

Jan. 11, 2010 - Roche today announced that the United States (US) Food and Drug Administration (FDA) approved ACTEMRA (tocilizumab, RoACTEMRA in the European Union) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

The details can be read here.

Centre introduces bivalent vaccine to eradicate polio

The bivalent vaccine (bOPV) is being introduced in the country for the first time in Bihar from tomorrow which is National Immunization Day (NID) for pulse polio campaign. President Pratibha Devisingh Patil launched the NID by administering polio drops to ten babies at Rashtrapati Bhawan in Delhi today.

The details can be read here.

Biovel Lifesciences may be bought over by Ranbaxy for about Rs.50 cr

Biovel Lifesciences, a bio pharmaceutical start-up venture, is all set to be acquired by Ranbaxy. The final deal is yet to be inked and is expected to be over by this weekend.

The details can be read here.

BioCryst's Partner Green Cross Files for Peramivir Regulatory Approval in South Korea

BioCryst Pharmaceuticals, Inc. today announced that it has been informed by its partner, Green Cross Corp., that Green Cross has filed a New Drug Application (NDA) in South Korea to seek regulatory approval for intravenous (i.v.) peramivir to treat patients with influenza.

The details can be read here.

Boston Scientific Announces Japanese Approval for PROMUS Everolimus-Eluting Coronary Stent System

Boston Scientific Corporation announced today that it has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its PROMUS® Everolimus-Eluting Coronary Stent System for the treatment of coronary artery disease.

The details can be read here.

LTKfarma pursues development of proprietary TK therapy

January 8, 2010 LTKfarma announces that in the patent litigation initiated against Molmed S.p.A. by Université Pierre et Marie Curie (UPMC) and LTKfarma on June 8, 2007, and based on the Italian part of European patent EP 0 564 646, the Court of Milan ruled on October 21, 2009, that the plaintiffs had the standing to bring the suit.

The details can be read here.

Watson Files FDA Application for Generic LoSeasonique

Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its levonorgestrel and ethinyl estradiol (0.10 mg/0.02 mg) oral contraceptive product prior to the expiration of U.S. Patent No. 7,615,545, which is owned by Duramed Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceutical Industries, Ltd. Watson's levonorgestrel and ethinyl estradiol product is a generic version of Teva's LoSeasonique®.

The details can be read here.

FDA Grants Orphan Drug Status for Personalized Lymphoma Vaccine

Jan 7, 2010 - Biovest International, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BiovaxID®, Biovest's personalized lymphoma vaccine. BiovaxID represents a new class of active immunotherapy and is one of the few select late-stage patient-specific cancer vaccines vying to be among the first to reach market.

The details can be read here.

Amifampridine Phosphate Receives Marketing Approval in the EU for LEMS

BioMarin Pharmaceutical Inc. announced today that the European Commission has granted marketing approval for 3,4-diaminopyridine (amifampridine phosphate), for the rare autoimmune disease Lambert Eaton Myasthenic Syndrome (LEMS). Amifampridine phosphate, developed by the pharmaceutical unit (AGEPS) of the Paris Public Hospital Authority (AP-HP) and licensed from EUSA Pharma SAS, is the first approved treatment for LEMS, thereby conferring orphan drug protection and providing ten years of market exclusivity in Europe. It has also received orphan drug designation in the U.S.

The details can be read here.

Teva Announces Settlement Agreements with AstraZeneca Regarding Generic Prilosec and Nexium

Jan 7, 2010 - Teva Pharmaceutical Industries Ltd. announced today that it has entered into two definitive agreements with AstraZeneca to settle patent litigation regarding Teva's U.S. generic versions of AstraZeneca's Prilosec® (omeprazole) and Nexium® (esomeprazole), including all claims for patent infringement and damages.

The details can be read here.

Watson Files ANDA Application for Generic Nuvigil

Watson Pharmaceuticals, Inc., a leading global specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., a Nevada Corporation, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 50 mg, 100 mg, 150mg, 200 mg, and 250mg strength armodafinil tablets prior to the expiration of patents owned by Cephalon France.

the details can be read here.

Pharma industry urges govt to withdraw WHO study on 'data exclusivity'

The domestic pharmaceutical industry has urged the government to withdraw a study launched by the World Health Organization (WHO) in consultation with the Union ministry of health on implementing 'Data Exclusivity' in India.

the details can be read here.

Jubilant to expand its animal facility, to open nude mice centre for pre-clinical research

Jubilant Biosys, the subsidiary of Jubilant Organosys is in the process of expanding its preclinical capabilities. The company is in the process of expanding its animal facilities, which includes a nude mice facility for research efforts across oncology, metabolic diseases and CNS therapeutic areas.

The details can be read here.

Wockhardt gets tentative US FDA nod for Alzheimer’s drug memantine

Wockhardt has received tentative approval from the US FDA for marketing the 5mg and 10mg tablets of memantine HCl, which is used for treatment of moderate to severe Alzheimer’s disease and dementia. Memantine is the generic name for the brand Namenda, marketed in the United States by Forest Laboratories. The patent covering this product is under litigation in the US courts.

The details can be read here.

Ark files for re-examination of Cerepro

5 January 2010 - Ark Therapeutics Group plc, announces that it has filed the formal request to the European Medicines Agency (EMEA) for re-examination of its marketing authorization application (MAA) for Cerepro®, Ark's novel gene-based therapy for operable malignant glioma (brain cancer).

the details can be read here.