Generic Pharmaceuticals and Patents

Byetta (exenatide injection) approved by Health Canada for the treatment of type 2 diabetes

2011-01-22T00:16:00.000-08:00

Jan. 17 - Eli Lilly Canada Inc. is pleased to announce the Health Canada approval of BYETTATM (exenatide injection) for the treatment of adults with type 2 diabetes. BYETTA is indicated for use as a combination therapy with metformin and / or a sulfonylurea to improve blood sugar control in adults with type 2 diabetes who have not achieved adequate glycemic control on maximally tolerated doses of these oral therapies in addition to diet and exercise.

Byetta is peptide with 39 aminoacids and is very effective in controlling the blood glucose levels and is approved in US also.

Novo Nordisk Intends to Appeal Adverse Ruling in Prandin (repaglinide) Patent Case

2011-01-22T00:04:00.000-08:00

Jan. 19, 2011 - Today, Novo Nordisk announced that Judge Avern Cohn of the US District Court for the Eastern District of Michigan issued an adverse ruling in a patent litigation case regarding Novo Nordisk's US Patent No. 6,677,358. The district court ruled that the patent, which covers the combination use of repaglinide and metformin for the treatment of type 2 diabetes, is invalid and unenforceable based on obviousness and inequitable conduct.

The district court ruling is available with me. In case of your interest, you can email me at amit@lifelinehisar.com. I will send you the copy of judgement in a summarised manner.

Novo Nordisk markets repaglinide under the trade name Prandin® and a fixed dose repaglinide/metformin tablet under the trade name PrandiMet®.

Novo Nordisk may appeal this judgement in the federal circuit.

Dr. Reddy's and other four generic players got final approval for Pantoprazole Sodium Delayed-Released Tablets

2011-01-22T00:01:00.000-08:00

Jan 20, 2011 - Dr. Reddy's Laboratories today announced that it has launched Pantoprazole Sodium Delayed-Released tablets (20mg and 40mg strengths), a bioequivalent generic version of Protonix® Tablets in the US market. The Food & Drug Administration (FDA) approved Dr. Reddy's ANDA for Pantoprazole Sodium Delayed-Released tablets on January 19, 2011.

Along with Dr. Reddy's, Mylan, Kudco, torrent and on other player got final approval for Pantoprazole DR tablets. This final approval is due to the expiry of product patent in US. Earlier, Sun pharma and Teva was having final approval for the product.

Pantoprazole Sodium Delayed-Released tablets had total U.S. sales of approximately $1.8 billion for the twelve months ending September 30, 2010 according to IMS Health. Both strengths of Dr. Reddy's Pantoprazole Sodium Delayed-Released tablets are available in 90 count bottles.

Dear Subscribers

2010-12-25T19:09:00.000-08:00

I was not blogging since long time, but now i will update this blog every week.

Sorry for such a long gap.

Regards,
Amit

Watson Says Appeals Court Affirms Concerta Patent Invalid

2010-04-27T20:08:00.000-07:00

Watson Pharmaceuticals, Inc. today confirmed that the U.S. Court of Appeals for the Federal Circuit Court has affirmed a March 31, 2009 District Court decision that the asserted claims of ALZA's United States Patent No. 6,919,373 "the '373 Patent" are invalid.

The details can be read here.

Shire Receives INTUNIV Paragraph IV Notice Letter From Anchen

2010-04-27T20:07:00.000-07:00

Shire plc, the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter from Anchen Pharmaceuticals, Inc. advising of the filing of an Abbreviated New Drug Application for a generic version of Shire's 1 mg, 2 mg, 3 mg, and 4 mg guanfacine hydrochloride extended release tablets, INTUNIV(TM).

The details can be read here.

Actavis Launches Generic Version of Flomax In The U.S.

2010-04-27T20:06:00.001-07:00

Actavis Inc., today began shipping Tamsulosin capsules to its customers in the United States. The generic equivalent to FlomaxÂ®, Tamsulosin is used to treat benign prostatic hyperplasia (BPH).

The details can be read here.

Heartburn for Sun Pharma and Teva in the US

2010-04-26T20:28:00.000-07:00

Mumbai: Sun Pharmaceuticals and Teva received a blow after a US federal jury ruled that Pfizer Inc and Altana AG have valid patents for acidity medicine Protonix (pantoprazole).

The details can be read here.

Break from Blogging

2010-01-27T19:05:00.000-08:00

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

2010-01-20T18:36:00.001-08:00

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

2010-01-12T18:58:00.000-08:00

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

2010-01-12T18:57:00.001-08:00

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

2010-01-12T18:49:00.000-08:00

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

2010-01-12T18:48:00.000-08:00

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

2010-01-11T18:50:00.000-08:00

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

2010-01-11T18:49:00.000-08:00

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

2010-01-10T18:35:00.000-08:00

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

2010-01-10T18:34:00.000-08:00

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

2010-01-08T18:46:00.000-08:00

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

2010-01-08T18:45:00.000-08:00

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

2010-01-08T18:43:00.001-08:00

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

2010-01-08T18:41:00.000-08:00

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

2010-01-07T18:50:00.000-08:00

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

2010-01-07T18:47:00.000-08:00

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

2010-01-07T18:46:00.000-08:00

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

2010-01-07T18:44:00.000-08:00

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'

2010-01-06T19:08:00.000-08:00

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

2010-01-06T19:07:00.001-08:00

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

2010-01-06T19:00:00.000-08:00

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

2010-01-06T18:59:00.000-08:00

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

2010-01-06T18:51:00.000-08:00

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

2010-01-06T18:50:00.000-08:00

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.

2010-01-06T18:47:00.000-08:00

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

2010-01-06T18:46:00.000-08:00

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

2010-01-06T18:45:00.000-08:00

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

2010-01-06T18:44:00.000-08:00

(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

2010-01-05T18:48:00.000-08:00

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

2010-01-05T18:47:00.000-08:00

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

2010-01-05T18:45:00.000-08:00

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

2010-01-05T18:39:00.000-08:00

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

2010-01-05T18:32:00.000-08:00

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

2010-01-04T19:03:00.000-08:00

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

2010-01-04T19:02:00.000-08:00

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

2010-01-04T18:59:00.000-08:00

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

2010-01-04T18:58:00.000-08:00

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

2010-01-04T18:57:00.000-08:00

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

2010-01-04T18:56:00.001-08:00

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

2010-01-04T18:54:00.000-08:00

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

2010-01-04T18:53:00.000-08:00

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.

DCGI slaps show cause notice on GSK for running HPV ad in media

2009-12-25T19:03:00.000-08:00

The Drug Controller General of India (DCGI) has eventually issued a show-cause notice to the GlaxoSmithKline (GSK) for launching an advertisement campaign in the national media on cervical cancer vaccine without taking prior approval from his office.

The details can be read here.

Glenmark Pharma's US subsidiary receives two tentative approvals from US FDA

2009-12-25T19:02:00.001-08:00

Glenmark Generics Inc., USA (GGI), a subsidiary of Glenmark Generics, has received tentative approval from US FDA for pramipexole dihydrochloride tablets, the generic version of Boehringer Ingelheim’s Mirapex tablets and Atomoxetine hydrochloride capsules, the generic version of Lilly’s Strattera.

the details can be read here.

Ranbaxy subsidiary Ohm receives Warning Letter from US FDA for cGMP violations

2009-12-25T19:01:00.001-08:00

Ohm Laboratories Inc (Ohm), a wholly owned subsidiary of Ranbaxy Laboratories Limited, has received a Warning Letter, dated December 21, 2009, from the USFDA, for its liquid manufacturing facility located in Gloversville, New York, USA.

The details can be read here.

Schering, MSP Singapore sue Mylan for cholesterol drug Vytorin

2009-12-25T18:54:00.000-08:00

Mylan Inc confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc have been sued by Schering Corporation and MSP Singapore Company in connection with the filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for Ezetimibe and Simvastatin tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg.

The details can be read here.

WHO grants prequalification to Novaritis' 3 influenza A vaccines

2009-12-23T19:16:00.001-08:00

Novartis announced that the World Health Organization (WHO) has granted prequalification for all three of its influenza A (H1N1) 2009 monovalent vaccines for supply to United Nations (UN) agencies: the cell culture-based and MF59 adjuvanted vaccine Celtura, the egg-based and MF59 adjuvanted vaccine Focetria as well as the egg-based A(H1N1) vaccine manufactured using the seasonal Fluvirin platform.

The details can be read here.

GSK undertakes to withdraw ad on cervical cancer vaccine to DCGI

2009-12-23T19:14:00.000-08:00

After almost a month of advertisement blitzkrieg in several national newspapers on cervical cancer vaccine, in gross violation of Drugs & Cosmetics Act, 1940 and Drugs and Magical Remedies Act 1954, the GlaxoSmithKline (GSK) has given an assurance to the Drug Controller General of India (DCGI) that it is unilaterally withdrawing the ads, it is learnt.

The details can be read here.

Lupin settles Alzheimer drug litigation with Forest Laboratories

2009-12-22T19:19:00.000-08:00

Lupin has settled all ongoing Hatch-Waxman litigation relating to Memantine tablets with Forest Laboratories, Inc. Memantine tablets are Lupin's generic version of Forest's Alzheimer disease treatment Namenda tablets.

The details can be read here.

Ligand Announces Positive Regulatory Opinion in Europe for Revolade for Chronic Immune Thrombocytopenic Purpura

2009-12-21T19:01:00.000-08:00

Dec 18, 2009 - Ligand Pharmaceuticals Incorporated today announced that its partner GlaxoSmithKline has received a positive opinion for Revolade® (eltrombopag/Promacta®) from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP).

The details can be read here.

Prophylaxis of Influenza in Infants and Children Approved as an Additional Indication of Anti-influenza Drug Tamiflu

2009-12-21T18:59:00.000-08:00

December 18, 2009 - Chugai Pharmaceutical Co., Ltd. [Head Office: Chuo-ku, Tokyo; President: Osamu Nagayama (hereafter, "Chugai")] announced today that on December 18, 2009, the Ministry of Health, Labour and Welfare granted approval for the anti-influenza drug oseltamivir phosphate [product name: Tamiflu®] in an additional indication of "prophylaxis of influenza in adults, infants and children" in the formulation as Tamiflu® Dry Syrup, and it granted approval for a change in the dosage and administration for Tamiflu® Capsules in the pediatric prophylaxis indication. Chugai markets Tamiflu® in Japan.

The details can be read here.

Sepracor Granted Patent Term Extension for Lunesta and Provides Update On Lunesta Pediatric Studies

2009-12-21T18:57:00.002-08:00

Dec. 17, 2009 -- Sepracor Inc. today announced that the United States Patent and Trademark Office has determined that U.S. Patent No. 6,444,673, which is a composition of matter patent that covers the human drug product LUNESTA® (eszopiclone), received patent term extension under 35 U.S.C. § 156.

The details can be read here.

Teva Launches Co-Beneldopa (Levodopa/Benserazide)

2009-12-21T18:57:00.001-08:00

Teva UK Limited has launched generic co-beneldopa capsules in a variety of strengths. The company says that they are the first generic to reach the market.

"We're delighted to be launching co-beneldopa capsules," said Kim Innes, Commercial Director, Teva UK Limited. "This product fits well with our range and strengthens our position as the UK's leading generics supplier.

The details can be read here.

Pfizer's pH1N1 vaccine for swine made available

2009-12-16T19:04:00.001-08:00

Swine producers have a new conditionally-licensed vaccine from Pfizer Animal Health to help protect their herds from the pandemic H1N1 (pH1N1) strain of Swine Influenza Virus (SIV). Pfizer Animal Health announced that its Swine Influenza Vaccine, pH1N1 – Killed Virus, has been approved by the US Department of Agriculture (USDA) for vaccination of healthy swine, including pregnant sows and gilts, three weeks of age or older against SIV subtype H1N1.

The details can be read here.

New Indication for Procoralan: Use in Combination With Beta Blockers for Chronic Stable Angina Patients

2009-12-16T18:58:00.000-08:00

The European Medicines Agency (EMEA) has recently approved a new indication for Procoralan*(ivabradine). Procoralan can now be administered to chronic stable angina patients, who remain inadequately controlled despite an optimal dose of beta blockers, and whose heart rate is above 60 beats per minute.

The details can be read here.

Govt to introduce Bivalent Oral Polio Vaccine as trials prove its efficacy in India

2009-12-13T18:49:00.000-08:00

The Union Health Ministry will soon introduce the Bivalent Oral Polio Vaccine (bOPV) in specific areas of the country in its polio eradication drive as trials in India have shown that the bOPV vaccine is more efficacious than the traditionally used trivalent oral polio vaccine (tOPV).

The details can be read here.

Study shows oral insulin spray acts faster than insulin delivered subcutaneously

2009-12-11T19:10:00.000-08:00

Published in the journal Diabetes, Obesity and Metabolism, an independent review of clinical trials of Generex Oral-lyn shows that the oral insulin spray has a faster onset of action and shorter duration of action than insulin delivered subcutaneously.

The details can be read here.

Wanbury launches anti-anaemia drug Cpink IIC

2009-12-11T19:07:00.000-08:00

Wanbury Ltd, country’s fastest growing pharmaceutical company as per the latest ORG IMS, has launched an advanced form of its anti-anaemia drug Cpink (Ferrous Ascorbate). The product is called Cpink IIC and will be used in the treatment of anaemia in pregnant women and children.

The details can be read here.

Abbott Seeks FDA Approval of New Dosage Strengths of Simcor (niacin extended-release/simvastatin)

2009-12-11T19:06:00.000-08:00

Abbott has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for two new dosage strengths of SIMCOR®, a cholesterol medication. SIMCOR is a fixed-dose combination of niacin extended-release and simvastatin.

The details can be read here.

Protalix Completes NDA Submission for taliglucerase alfa for the Treatment of Gaucher's Disease

2009-12-11T19:04:00.000-08:00

Dec 9, 2009 - Protalix Biotherapeutics, Inc. (NYSE-Amex: PLX) today announced the completion of its New Drug Application (NDA) submission with the U.S. Food and Drug Administration (FDA) for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD) for the potential treatment of Gaucher's disease.

The details can be read here.

Eurand Granted FDA Approval for ZENPEP First and Only FDA-Approved Pancreatic Enzyme Product Clinically Tested in Patients Under 12 Years Old

2009-12-11T18:54:00.000-08:00

August 28, 2009) - Eurand N.V., a specialty pharmaceutical company, today announced U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for ZENPEP™ (pancrelipase) Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions.

The details can be read here.

Trial Date Set for Cubicin Patent Litigation

2009-12-11T18:52:00.000-08:00

Dec 11, 2009 - Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that a trial date has been set for patent litigation in the U.S. District Court for the District of Delaware against Teva Parenteral Medicines, Inc. (TPM), Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. alleging infringement of Cubist's US Patent Nos. 6,468,967 and 6,852,689, which expire on September 24, 2019, and US Patent No. RE39,071, which expires on June 15, 2016.

The details can be read here.

Mylan Receives Approval for Generic Version of Antiepileptic Keppra 1000 mg

2009-12-11T18:50:00.000-08:00

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 1000 mg. Levetiracetam Tablets are the generic version of UCB Pharma's antiepileptic Keppra®.

The details can be read here.

Perrigo Confirms Filing for Generic Version of Clobex(R) Spray and Announcement of Lawsuit by Galderma and Dermalogix

2009-12-11T18:48:00.000-08:00

Perrigo Company today announced that it has filed an Abbreviated New Drug Application for Clobetasol Propionate Topical Spray, 0.05%, a generic form of Clobex® Spray.

The details can be read here.

Lannett Receives FDA Approvals for Hydromorphone Hydrochloride Tablets USP, 2 mg, 4 mg and 8 mg Strengths

2009-12-11T18:46:00.000-08:00

Dec 10, 2009 - Lannett Company, Inc. today announced that it has received approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Hydromorphone Hydrochloride Tablets USP, 2 mg, 4 mg and 8 mg, the generic equivalent of Purdue Pharmaceuticals' (formerly Abbott's) Dilaudid® Tablets 2 mg, 4 mg and 8 mg.

The details can be read here.

Alkermes licenses long-acting fusion proteins, Medifusion technology from Acceleron Pharma

2009-12-08T19:02:00.000-08:00

Alkermes, Inc and Acceleron Pharma, Inc announced that Alkermes has licensed a proprietary long-acting Fc fusion technology platform, called the Medifusion technology, which is designed to extend the circulating half-life of proteins and peptides. The first drug candidate being developed with this technology is a long-acting form of a TNF receptor-Fc fusion protein for the treatment of rheumatoid arthritis (RA) and related autoimmune diseases.

The details can be read here.

St. John's selected for GSK's H1N1 vaccine ‘Pandemrix’ trial on 50 volunteers

2009-12-08T19:00:00.000-08:00

GlaxoSmithKline (GSK) has selected St John’s National Academy of Health Sciences as one of the five locations to conduct the trial for the H1N1 vaccine ‘Pandemrix’ in the country. The trial is expected to commence by the month-end.

The details can be read here.

BHR Pharma Files Investigational New Drug Application, Receives Orphan Drug Designation, for Traumatic Brain Injury Treatment

2009-12-08T18:53:00.000-08:00

BHR Pharma, LLC (BHR) announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its proprietary BHR-100 intravenous progesterone infusion product.

The details can be read here.

Mylan Announces Settlement Agreement Related to Antidepressant Effexor XR

2009-12-08T18:51:00.000-08:00

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has entered into settlement and license agreements with Wyeth, now part of Pfizer, relating to Venlafaxine Hydrochloride (HCl) Extended Release (ER) Capsules, 37.5 mg, 75 mg and 150 mg, the generic version of Wyeth's Effexor XR® Capsules, a treatment for major depressive disorder.

The details can be read here.

Biovel Lifesciences up for sale, looking for potential bio-pharma buyers

2009-12-07T18:52:00.000-08:00

Bangalore-based biopharmaceutical start-up Biovel Lifesciences is looking to exit from the life sciences space and is keen for an early outright buyout. Biovel has been in dialogue with several companies including Ranbaxy, Avesthagen, Shantha Biotechnics Ltd and Orchid Chemicals, it is learnt.

The details can be read here.

NanoBio says new intranasal nanoemulsion vaccine adjuvant also effective by subcutaneous & intramuscular injection

2009-12-07T18:49:00.002-08:00

NanoBio Corporation announced positive results from studies in mice in which immune responses were evaluated following administration of 5µg doses of recombinant H5N1 pandemic flu antigen combined with the company’s novel nanoemulsion vaccine.

The details can be read here.

Voltaren Gel (diclofenac sodium topical gel) - Hepatic Effects Labeling Change: Cases of drug-induced hepatotoxicity reported

2009-12-07T18:49:00.001-08:00

Dec. 5, 2009-Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the Prescribing Information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.

The details can be read here.

Somaxon Receives Complete Response Letter from the FDA for Silenor NDA

2009-12-07T18:46:00.000-08:00

Dec 7, 2009 - Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced that the company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia.

The details can be read here.

FDA Approves Lilly's Zyprexa for Two Adolescent Indications

2009-12-07T18:44:00.002-08:00

The U.S. Food and Drug Administration (FDA) today approved Zyprexa® (olanzapine) in tablet form as an option for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents aged 13-17 years old.

The details can be read here.

Santarus Receives FDA Approval for Immediate-Release Omeprazole Tablet with Dual Buffers

2009-12-07T18:44:00.001-08:00

Dec 5, 2009 - Santarus, Inc., a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for immediate-release omeprazole/sodium bicarbonate/ magnesium hydroxide tablets in 40 mg and 20 mg dosage strengths of omeprazole.

The details can be read here.

FDA Grants First Approval for a Product Derived from Pichia pastoris

2009-12-07T18:42:00.000-08:00

Dec 7, 2009 - RCT licensee Dyax Corp. has received approval from the U.S. Food and Drug Administration for KALBITOR® (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.

The details can be read here.

Tris Pharma Announces Two NDA Approvals from FDA including a Pioneering, First-Ever 24 hour Liquid Sustained Release Product

2009-12-07T18:41:00.000-08:00

Tris Pharma, a specialty pharmaceutical company that develops innovative drug delivery technologies, announced that the US Food and Drug Administration (FDA) has approved its first two New Drug Applications (NDAs) based on its proprietary OralXR+TM platform technology including the first-ever 24 hour liquid sustained release product.

the details can be read here.

Higher studies of 50,000 pharmacy graduates in trouble as no decision yet on GATE exams

2009-12-06T18:57:00.001-08:00

The higher studies of around 50,000 pharmacy graduates in the country are still hanging in balance, with no decision on conducting the graduate aptitude test for engineering (GATE) exams for pharmacy which would have brought them both recognition and the necessary funds.

The details can be read here.

Impax Labs acquires ANDAs from Watson & Cobalt

2009-12-06T18:56:00.001-08:00

Impax Laboratories, Inc announced it acquired Abbreviated New Drug Applications (ANDA) from Watson Pharmaceuticals and Cobalt Laboratories, a subsidiary of Arrow Group.

The details can be read here.

ICON Receives Warning Letter Relating to Two Studies

2009-12-06T18:53:00.000-08:00

Dec 4, 2009 - ICON plc, today announced it has received a warning letter from the U.S. Food and Drug Administration (FDA) regarding clinical study management services provided by the company to one of its clients in relation to two studies conducted between 2004 and 2006.

The details can be read here.

Janssen-Cilag Submits Marketing Authorisation Application in Europe for Paliperidone Palmitate for the Treatment of Schizophrenia

2009-12-06T18:52:00.000-08:00

(December 4, 2009) -- Janssen-Cilag International NV, has submitted a Marketing Authorisation Application to the European Medicines Agency for paliperidone palmitate, an investigational once-monthly atypical antipsychotic intramuscular injection for the treatment of schizophrenia.

The details can be read here.

US FDA Approves SEROQUEL XR For Add-On Treatment of Major Depressive Disorder

2009-12-06T18:48:00.000-08:00

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR® (quetiapine fumarate) Extended Release Tablets as adjunctive (add-on) treatment to antidepressants in adults with Major Depressive Disorder (MDD).

The details can be read here.

Watson Files FDA Application for Generic Rozerem

2009-12-06T18:46:00.000-08:00

Watson Pharmaceuticals, Inc., a leading global specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc.-Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 8mg ramelteon tablets prior to the expiration of a patent owned by Takeda Pharmaceutical Company Limited.

The details can be read here.

Cadila Healthcare may approach SC on Sec 3(d) of Patent Act on clopidogrel case

2009-12-03T19:26:00.000-08:00

The Ahmedabad-based Cadila Healthcare may approach the Supreme Court seeking interpretation of the controversial Section 3(d) of the Indian Patent Act. The company has lost its case against the Hyderabad-based Glochem Industries Ltd to retain patent protection for its antiplatelet drug, clopidogrel besylate, it is learnt.

The details can be read here.

Lexiva (fosamprenavir calcium) - Dear Healthcare Professional Letter: Association between Lexiva and myocardial infarction in HIV infected adults

2009-12-03T19:07:00.000-08:00

Dec. 3, 2009-GlaxoSmithKline and FDA notified healthcare professionals of a potential association between Lexiva and myocardial infarction and dyslipidemia in HIV infected adults. GSK has modified the existing Warnings and Precautions section of the Prescribing Information to note that increases in cholesterol have occurred with treatment, the importance of lipids management, and a recommendation that triglyceride and cholesterol testing be performed prior to initiating therapy with LEXIVA and at periodic intervals during therapy.

The details can be read here.

Endo Pharmaceuticals Provides Regulatory Update on AVEED (Testosterone Undecanoate) Injection

2009-12-03T19:06:00.000-08:00

Endo Pharmaceuticals today announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for its extended-duration testosterone undecanoate injection, AVEED(TM), for men diagnosed with low testosterone. Low testosterone is also known as hypogonadism.

The details can be read here.

Novartis Receives Approval In The European Union For Onbrez Breezhaler, A New Once-Daily Bronchodilator For Patients With COPD

2009-12-03T19:03:00.000-08:00

December 3, 2009 - Novartis announced today that the European Commission (EC) has approved Onbrez Breezhaler (QAB149 or indacaterol) in both 150 mcg and 300 mcg doses as a new once-daily maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).

The details can be read here.

Cephalon Files Patent Infringement Lawsuit Against Teva Pharmaceuticals

2009-12-03T19:02:00.000-08:00

Cephalon, Inc. today announced that it has filed a lawsuit in U.S. District Court in Delaware against Teva Pharmaceuticals USA, Inc. for infringement of U.S. Patent Nos. 7,132,570, 7,297,346 (the "'346 Patent") and RE37,516 (for the Cephalon product NUVIGIL® (armodafinil) Tablets [C-IV].

The details can be read here.

Shire and Teva Settle Litigation Concerning Supply of ADDERALL XR Authorized Generic

2009-12-03T19:01:00.000-08:00

Shire plc, the global specialty biopharmaceutical company, announces that it has settled the litigation with Teva Pharmaceuticals USA, Inc. ("Teva") over Shire's supply to Teva of an authorized generic version of ADDERALL XR. Shire has been supplying Teva with authorized generic ADDERALL XR since April 1, 2009.

The details can be read here.

Stallergenes gets European nod to market Oralair

2009-12-02T19:03:00.000-08:00

Stallergenes has been granted European approval to market Oralair in both adults and children through a Mutual Recognition Procedure. Germany, the first country where Oralair has been marketed, was the reference Member state.

The details can be read here.

Keryx Receives FDA Fast Track Designation for KRX-0401 (Perifosine) for the Treatment of Relapsed/Refractory Multiple Myeloma

2009-12-02T19:01:00.000-08:00

Keryx Biopharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, for the treatment of relapsed/refractory multiple myeloma.

The details can be read here.

Javelin Pharmaceuticals Submits Dyloject New Drug Application to FDA for Management of Acute Moderate-to-Severe Pain in Adults

2009-12-02T19:00:00.000-08:00

Dec 2, 2009 - Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, for the management of acute moderate-to-severe pain in adults.

The details can be read here.

Teva Announces the Submission of a Biologics License Application (BLA) for XM02 for the Treatment of Chemotherapy-Induced Neutropenia

2009-12-02T18:59:00.000-08:00

Dec 1, 2009 - Teva Pharmaceutical Industries Ltd., today announced the submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for XM02, a granulocyte colony-stimulating factor (G-CSF) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.

The details can be read here.