Glenmark scrip plunges on suspension of pain drug trials

Glenmark Pharmaceuticals on Friday said the clinical trials for its experimental pain treatment molecule has been suspended, following which its scrips plunged 20 per cent on the bourse.

The details can be read here.
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GSK to acquire Laclede's dry mouth brand Biotene for $170 mn

GlaxoSmithKline (GSK) Consumer Healthcare announced that it has reached an agreement with Laclede, a privately held company, to purchase the leading Dry Mouth brand Biotene for $170 million. The transaction is subject to regulatory review by competition authorities in the United States and Europe, and is expected to complete by early 2009.

The details can be read here.

Lilly, Amylin enter into supply agreement for exenatide

Amylin Pharmaceuticals, Inc and Eli Lilly and Company have entered into a product supply agreement for exenatide once weekly, a development compound that, if approved, would become the first once weekly therapy to treat type-2 diabetes.

The details can be read here.

Marketing Authorization Application for Lipsovir submitted to European regulatory authorities

Oct. 23, 2008-Medivir has now submitted an application for marketing authorization to the European regulatory authorities for Lipsovir®, a topical product for prevention and treatment of cold sores.
Lipsovir® is a patented combination of hydrocortisone (an anti-inflammatory agent) and acyclovir (an antiviral agent) in a proprietary cream base developed by Medivir.

The details can be read here.

Teva Introduces Fentanyl Transdermal System, CII

October 23, 2008 – Teva Pharmaceuticals is pleased to announce the FDA approval of Fentanyl Transdermal System, CII, 25 mcg, 50 mcg, 75 mcg and 100 mcg. This product is AB rated and bioequivalent to Duragesic®* Transdermal System. Fentanyl Transdermal System is available in cartons containing 5 patches each.

The details can be read here.

New data shows liraglutide is more effective than exenatide in treatment of type-2 diabetes

Canadian Diabetes Association and Canadian Society of Endocrinology and Metabolism Professional Conference and Annual Meetings, physicians will get a first-time look at more detailed results from a phase-3b clinical study Liraglutide Effect and Action in Diabetes (LEAD) 6 comparing the investigational new drug liraglutide to exenatide. The study showed that liraglutide, a human GLP-1 analog administered once daily was significantly more effective at improving blood glucose control (as measured by HbA1c) than exenatide, a GLP-1 mimetic administered twice daily.

The details can be read here.

Valeant Pharma, GSK close worldwide pact for retigabine

Valeant Pharmaceuticals International announced that it has closed on its exclusive worldwide collaboration agreement with GlaxoSmithKline (GSK) for the investigational drug retigabine, a first-in-class neuronal potassium channel opener for the treatment of adult epilepsy patients with refractory partial onset seizures. Under the terms of the agreement, Valeant received an upfront payment of $125 million from GSK.

NeurogesX Submits NDA for NGX-4010 Dermal Capsaicin Patch for Treatment of Postherpetic Neuralgia (PHN)

NeurogesX, Inc. , a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that it has submitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for approval to market its investigational product candidate, NGX-4010, for the management of pain due to postherpetic neuralgia (PHN). NeurogesX anticipates that the application, which is subject to acceptance by the FDA, will be subject to a standard review with a Prescription Drug User Fee Act (PDUFA) date in the second half of 2009.

The details can be read here.

Antigenics Submits Oncophage Application for European Approval

Oct. 22, 2008 - Antigenics Inc. today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) requesting approval for Oncophage(R) in earlier-stage, localized renal cell carcinoma (kidney cancer) under the conditional authorization provision. Currently, there are no EMEA-approved drug therapies for this patient population.

The details can be read here.

U.S. FDA Approves Prezista Once-Daily as Part of Combination Therapy for Treatment-Naive Adults with HIV-1

The FDA has granted PREZISTA (darunavir) tablets, a protease inhibitor, approval for an expanded indication for once-daily dosing as part of HIV combination therapy in treatment-naive adults (those who have never taken HIV medication before). The FDA also granted traditional (full) approval to PREZISTA as twice-daily for use in treatment-experienced adult patients.

The details can be read here.

FDA Approves Astellas' Vaprisol (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia

October 22, 2008 -- Astellas Pharma US, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new premixed formulation of Vaprisol: Vaprisol(R) (conivaptan hydrochloride injection) Premixed in 5% Dextrose. Discovered and developed by Astellas, Vaprisol, an arginine vasopressin (AVP) receptor antagonist, is the first and only approved drug indicated for the treatment of both euvolemic and hypervolemic hyponatremia in hospitalized patients.

The details can be read here.

Mylan Confirms First-to-File Patent Challenge Relating to Lescol

Mylan Inc. today confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Novartis in connection with Fluvastatin Capsules USP, 20 mg (base) and 40 mg (base), the generic version of Novartis' Lescol(R) Capsules.

The details can be read here.

Mylan Receives Tentative FDA Approval for First-to-File Generic Version of Blood Pressure Drug Benicar HCT

October 22, 2008 -- Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg.

The details can be read here.

US FDA seeks approval for setting up offices in India for better monitoring of exports

The US Food and Drug Administration (FDA) has sent a proposal to India to set up its first liaison office in Delhi for better coordination with the regulatory authorities and the industry on ensuring safety of food and medicinal products being exported from here.

The details can be read here.

Eisai of Japan setting up manufacturing, R&D facilities at Vizag, to be operational by March 2011

Eisai Co of Japan is entering India by setting up a manufacturing and R&D base at Vizag in south India. The company is setting up a pharmaceutical manufacturing plant for producing API and drug and formulation research facility.

The details can be read here.