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

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

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

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

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

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

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.

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

The details can be read here.

Heartburn for Sun Pharma and Teva in the US

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

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.