King Pharmaceuticals Provides Update on Embeda NDA Review

Dec 31, 2008 - King Pharmaceuticals, Inc. (NYSE: KG) today announced that the U.S. Food and Drug Administration (FDA) is continuing its review of the New Drug Application (NDA) for EMBEDA™ (morphine sulfate and naltrexone hydrochloride) extended release capsules.

Labopharm Announces FDA Approval of Once-Daily Tramadol HCL Extended Release Tablets for Management of Moderate to Moderately Severe Chronic Pain

December 31, 2008 - Labopharm Inc. today announced that RYZOLT (tramadol HCl extended release tablets), Labopharm's once-daily formulation of the analgesic tramadol, has been approved by the U.S. FDA. RYZOLT is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

The details can be read here.

Nektar Announces Closing of Sale of Specific Pulmonary Delivery Assets to Novartis for $115 Million

Nektar Therapeutics today announced that it has successfully closed the divestiture of specific Nektar pulmonary delivery assets, technology, and intellectual property to Novartis for $115 million in cash. The transaction was completed on December 31, 2008, 2008.

The details can be read here.

FDA Approves for Sterile Vancomycin HCl USP, 500 mg/Vial; 1 g/Vial and Sterile Vancomycin HCl USP, 5 g/Vial Pharmacy Bulk Package

Dec 31, 2008 - Akorn-Strides, LLC today announced that the U.S. Food and Drug Administration has granted approvals for two Abbreviated New Drug Applications (ANDAs) for Sterile Vancomycin HCl USP, 500 mg/vial, 1 g/vial and Sterile Vancomycin HCl USP, 5 g/vial Pharmacy Bulk Package.

The details can be read here.

HAPPY NEW YEAR

Dear Subscribers and Viewers,

WISHING YOU ALL A VERY HAPPY AND PROSPEROUS NEW YEAR 2009.

Thanks for your kind support and overwhelming response.

Amit Bansal

Warner Chilcott, Barr settle Femcon Fe patent challenge

Warner Chilcott Limited announced that its subsidiary Warner Chilcott Company, Inc and Barr Laboratories, Inc, a subsidiary of Barr Pharmaceuticals, Inc, have entered into a settlement and license agreement to resolve the pending patent litigation involving Warner Chilcott's oral contraceptive product, Femcon Fe.

The details can be read here.

Alnylam seeks approval for liver cancer drug, files IND with US FDA

Alnylam Pharmaceuticals, Inc, a leading RNAi therapeutics company, announced that it has submitted an investigational new drug application to the US FDA for ALN-VSP, an RNAi therapeutic for the treatment of liver cancers, including hepatocellular carcinoma and other solid tumours with liver involvement.

The details can be read here.

BLA for PolyHeme Accepted for Filing and Granted Priority Review

Dec 30, 2008 - Northfield Laboratories Inc. announced today that the U.S. FDA has accepted for filing its Biologics License Application (BLA) for PolyHeme, the Company's investigative human hemoglobin-based red cell substitute for the treatment of life-threatening red blood cell loss when an oxygen-carrying fluid is required and red blood cells are not available.

The details can be read here.

GTx Submits New Drug Application for Toremifene 80 mg for the Prevention of Bone Fractures in Men with Prostate Cancer on Androgen Deprivation Therapy

Dec 30, 2008 - GTx, Inc. today announced the submission of a New Drug Application with the U.S. FDA for toremifene 80 mg, an oral selective estrogen receptor modulator (SERM), for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy.

The details can be read here.

FDA Approval of Three Generic Stavudine Formulations

On December 29, 2008 FDA granted approval for three generic fomulations of stavudine. Stavudine is a Nucleoside Reverse Transcriptase Inhibitors (NRTI), which helps keep HIV, the virus that causes AIDS, from reproducing. It is intended to be used in combination with other anti-retroviral agents for the treatment of HIV-1 infection.

The details can be read here.

Mylan's Matrix Receives Final FDA Approval for the Generic Version of the Antiretroviral Zerit Capsules

Mylan Inc. today announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, received final approval from the U.S. FDA on December 29, for its Abbreviated New Drug Application for Stavudine Capsules USP, 15 mg, 20 mg, 30 mg and 40 mg.

The details can be read here.

Watson Pharmaceuticals Receives FDA Final Approval for Generic Mircette

Watson Pharmaceuticals, Inc. , today announced that its subsidiary, Watson Laboratories, Inc., has received final approval from the United States Food and Drug Administration on its Abbreviated New Drug Application for desogestrel/ethinyl estradiol and ethinyl estradiol tablets, 0.15 mg / 0.02 mg and 0.01 mg and placebo tablets (28- day regimen).

The details can be read here.

UK: EWHC Patents Court rules Oxycodone patents valid but not infringed: ratiopharm & Sandoz v Napp Pharmaceuticals

Mr Justice Floyd delivered his judgment in the case of ratiopharm & Sandoz v Napp Pharmaceuticals that Oxycodone patents are valid but not infringed by Ratiopharm and Sandoz. The case related to two of Napp's EP(UK) patents for sustained release formulations for the painkiller drug oxycodone (OxyContin).

Sandoz and ratiopharm had applied to revoke the two patents, EP0722730 and EP1258246 as both the patents are derived from a common priority application and on the grounds that the claimed invention in both was obvious. Napp Pharma counter-claimed for infringement.

Judge Floyd J concluded, after extensive claim construction, that the claims in question required either all the oxycodone to be included in the matrix, and not in the outer layer, or that a spheronising agent was required in the formulation. Neither of these constructions could be used to cover the alleged infringement, since the particle did not have a spheronising agent and a significant proportion of the active ingredient was in the outer layer of the particle.

Judge Floyd finally conclude that the patents related to oxycodone formulation are valid but not infringed by Ratio and Sandoz.

The whole Judgement can be read here.

FDA Sends Abbott Letter About Humira

Dec. 24, 2008--The FDA posted on its web site yesterday a letter it sent to Abbott Laboratories about a review of an American Academy of Dermatology (AAD) Post Meeting News Ad for Humira. According to the FDA, "This AAD Post Meeting News Ad broadens the approved indication......

The details can be read here.

FDA Issues Complete Response Letter to Ipsen for Dysport BLA

Dec 29, 2008 - Ipsen today announced that the US FDA issued a Complete Response Letter for its Biologics License Application (BLA) for its Botulinum toxin Type A, Dysport. The application, submitted by the Group in late 2007, seeks approval to market Dysport for the treatment of cervical dystonia.

The details can be read here.