Break from Blogging

Dear Subscribers,

I am taking break from blogging for about a month due to involvement in some other projects.

I am sorry for this break.

enjoy.....

Thanks and Regards,
Amit Bansal

Court Finds J&J Patents Invalid

Boston Scientific Corporation announced today that the U.S. District Court for the District of Delaware has found all four patents in a suit involving Johnson & Johnson to be invalid.

The details can be read here.

Suven receives 2 product patents in China & Russia

Suven Life Sciences Ltd (SUVEN) announces that two product patents were granted in China (100378108 and 100378109) and Russia (2325392 and 2340619) corresponding to two of their new chemical entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases and these patents are valid until 2023 and 2024 respectively.

The details can be read here.

India’s clinical expertise & quality of sites impress CDER, US FDA: Dr Steve Wilson

India’s clinical acumen and quality of healthcare infrastructure designated to conduct human studies are two key parameters which have impressed US FDA officials. The country is an important destination for clinical trials not just for a patient pool but the expertise which it has armed with in terms of personnel and hospital sites, said Dr Steve Wilson, director of Division Biometrics III, Centre for Drug Evaluation and Research, US FDA.

The details can be read here.

Bal Pharma on major export drive, targets regulated markets for APIs, formulations

Bal Pharma, the medium-sized pharma company in Karnataka is on an export over drive mode. The company is looking at expanding its international presence and plans to enter the regulated markets.

The details can be read here.

Patent office begins data compilation on 'working patents' in India

For the first time in the history of patents in the country, the government has started the gargantuan process of compilation of data regarding the status of the valid patents granted during the last over 20 years in the country

The details can be read here.

MAP Pharmaceuticals Announces FDA Will Not Require a Second Pivotal Efficacy Study for Levadex NDA Submission

MAP Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that a second pivotal efficacy study is not required for the Company's LEVADEX(TM) new drug application (NDA) submission for the acute treatment of migraine.

The details can be read here.

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.

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).

the details can be read here.

Cipher secures summary judgment in the company's favour in pending patent litigation involving CIP-TRAMADOL ER

Cipher Pharmaceuticals Inc. today announced a final judgment (the "Cipher Judgment") has been entered in favour of Cipher in relation to pending patent litigation with Purdue Pharma Products L.P. and Napp Pharmaceutical Group Ltd. (together "Purdue") in the United States District Court for the Eastern District of Virginia (the "Court").

the details can be read here.

BioVectra Confirms Partnership to Market Docetaxel in the U.S.A.

Jan 5, 2010 - BioVectra Inc. announced today it has signed agreements with Sandoz Inc. of Princeton, New Jersey, for Sandoz to commercialize and market the Abbreviated New Drug Application (ANDA) for Docetaxel for injection, the generic version of Taxotere®, developed by BioVectra.

The details can be read here.

Actavis (is) - Actavis launches Losartan in Switzerland on day one, achieves record number of launches in 2009

6 January 2010 Actavis Group, the international generic pharmaceuticals company, has launched the antihypertensive drug Losartan on day one, as the patent expired in Switzerland.

The details can be read here.

Pfizer and Strides Arcolab to Collaborate on Generic Products

Jan 6, 2010 - Pfizer and Strides Arcolab today announced a new collaboration, wherein Pfizer will commercialize off-patent sterile injectable and oral products in the United States through its Established Products Business Unit.

The details can be read here.

American Regent announces the availability of Metoprolol Tartrate Injection, USP

(January 6, 2010): American Regent, Inc. announced that its new product, Metoprolol Tartrate Injection, USP, was approved by the FDA and will be available January 6, 2010. It is “AP” rated to Lopressor® (Novartis).

The details can be read here.

Dr. Reddy's type-2 diabetes drug balaglitazone meets primary endpoint in phase III study

Dr Reddy’s Laboratories Ltd and Rheoscience, a subsidiary of Nordic Bioscience A/S, announced the headline results from the first phase-III study for their investigational agent, Balaglitazone. The study (Study 307) was a phase-III, randomized, double blind, parallel-group placebo- and active comparator-controlled clinical study to determine the efficacy and safety of balaglitazone.

The details can be read here.

Novartis to acquire majority control of eye-care major Alcon

Novartis intends to gain full ownership of Alcon Inc by first completing the April 2008 agreement with Nestlé SA to acquire a 77 per cent majority stake in a global leader in eye care and subsequently entering into an all-share direct merger with Alcon for the remaining 23 per cent minority stake.

The details can be read here.

Keryx Biopharmaceuticals Announces Special Protocol Assessment Agreement with FDA for Phase 3 Registration Program of Zerenex

Jan. 5 --Keryx Biopharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 clinical program for Zerenex(TM) (ferric citrate), its iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD).

The details can be read here.

FDA Approves Addition of Sustained Overall Survival Benefit to Label for Velcade (Bortezomib) for Injection

Jan 4, 2010 - The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE, which expands the label to include long-term (median follow-up 36.7 months) overall survival (OS) data from the landmark VISTA1 trial and provides specific dosing recommendations for patients with hepatic impairment. The VISTA trial examined the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

the details can be read here.

European Commission Approves New Intravenous Formulation Of Pfizer’s Revatio (Sildenafil) For The Treatment Of Pulmonary Arterial Hypertension

Pfizer Inc. announced today that the European Commission has approved Revatio® (sildenafil) solution for injection for patients who are currently prescribed oral Revatio and who are temporarily unable to take oral medicine, but are otherwise clinically and haemodynamically stable.

The details can be read here.

Ranbaxy launches dermatology product Lulifin in India

Ranbaxy Laboratories Limited (Ranbaxy) has launched a New Chemical Entity (NCE), Lulifin (Luliconazole), in the Indian dermatology market. This follows a strategic in-licensing agreement with Summit Pharmaceuticals International Corporation, Japan (SPI) allowing Ranbaxy, exclusive marketing rights, for India.

The details can be read here.

Zydus Cadila receives DCGI nod to conduct H1N1 vaccine trial

The Ahmedabad-based pharma major, Zydus Cadila has received approval from the Drug Controller General of India (DCGI) to conduct clinical trials for the H1N1 (swine flu) vaccine.

The details can be read here.

Zota Healthcare to launch anti-oxidant combo for alcoholism

The Zota Healthcare Ltd, a pharma manufacturing, marketing and exports firm based in Surat, Gujarat, is planning to launch an anti-oxidant targeting liver psoriasis caused by alcoholism within a couple of months. The company claims that this is the first of its kind product available to address alcoholism in India.

The product, a combination of two amino acids – taurine and racemethionine, is to be promoted as a food supplement in the initial stage though the company is also planning to conduct clinical trials on limited volunteers to collect scientific details for its future operations.

the details can be read here.

FDA Issues Complete Response Letter for Ceftobiprole

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) today announced it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for ceftobiprole.

The details can be read here.

FDA Accepts NDA Filing for Retigabine

Valeant Pharmaceuticals International today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) seeking marketing approval for the investigational drug retigabine, a neuronal potassium channel opener for the adjunctive treatment for adult epilepsy patients with partial-onset seizures.

The details can be read here.

FDA Approves a High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older

Dec. 23 -- The U.S. Food and Drug Administration today approved Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B.

The details can be read here.

Mylan Receives Tentative FDA Approval Under PEPFAR for Matrix Laboratories' New Drug Application (NDA) for Efavirenz Tablets

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Efavirenz Tablets, 50 mg, 100 mg and 200 mg.

The details can be read here.

U.S. Patent and Trademark Office Grants Reissued Patent Replacing OSI Pharmaceuticals’ Tarceva Composition of Matter Patent

OSI Pharmaceuticals, Inc. today announced that the U.S. Patent & Trademark Office (PTO) has granted reissue patent RE41,065, replacing Tarceva’s® (erlotinib) composition of matter patent (formerly No.5,747,498).

The details can be read here.