Avesthagen gets licence to manufacture bioactives for ayurvedic drugs

Avesthagen Limited, India's leading life sciences company that focuses on pharma and population genetics leading to predictive, preventive, personalized healthcare has been granted a licence to manufacture bioactives for ayurvedic drugs by the Drugs Licensing Authority, under the Department of Ayush, Ministry of Health & Family Welfare, Government of India. This licence will help Avesthagen to tap into the huge Indian ayurvedic market and the growing global market of ayruvedic products.

The details can be read here.

ScinoPharm gets US patent for novel crystal forms of Irinotecan Hydrochloride

ScinoPharm, an active pharmaceutical ingredient (API) specialist, has been granted US Patent No. 7,435,818 entitled "Novel Crystal Forms of Irinotecan Hydrochloride." The new patent provides for novel crystalline forms of irinotecan hydrochloride and processes for their preparation as well as pharmaceutical compositions containing the new forms and methods of treating metastatic carcinoma of the colon or rectum using these new forms.

The details can be read here.

Sun Pharma acquires Chattem Chemicals from Elcat

Sun Pharmaceutical Industries Ltd announced that its fully-owned US subsidiary, Sun Pharmaceutical Industries, Inc, has acquired cent per cent ownership of Chattem Chemicals, Inc (Chattem) from Elcat, Inc. The terms of the transaction were not disclosed.

The details can be read here.

Johnson & Johnson to acquire Omrix

Johnson & Johnson and Omrix Biopharmaceuticals, Inc, a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced a definitive agreement whereby Omrix will be acquired for approximately $438 million in a cash tender offer. Omrix is expected to operate as a stand-alone entity reporting through Ethicon, Inc, a Johnson & Johnson company and leading provider of suture, mesh, hemostats and other products for a wide range of surgical procedures.

The details can be read here.

Basilea Pharmaceutica Ltd. (CH) - FDA issues Complete Response Letter for ceftobiprole

November 26, 2008 - Basilea Pharmaceutica Ltd. announces that the U.S. Food and Drug Administration (FDA) issued to the sponsor, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD), a Complete Response Letter for ceftobiprole for the treatment of complicated skin and skin structure infections including diabetic foot infections.

The details can be read here.

Pfizer's Novel HIV/AIDS Treatment Selzentry Becomes the Latest Fully Approved Antiretrovial for Treatment-Experienced HIV Patients

Nov 25, 2008 - The U.S. FDA has granted SELZENTRY (maraviroc) approval for use in treatment-experienced adults with CCR5-tropic HIV-1 in combination with other antiretrovirals. SELZENTRY was originally granted accelerated conditional approval in August 2007 based on 24-week data from pivotal Phase 3 studies. SELZENTRY now becomes the latest fully approved treatment for HIV.

The details can be read here.

Québec is the First Province to Cover New, Topical Once-Daily Rosacea Medication

Québec leads the way by being the first province to list MetroGel(R) 1% (metronidazole topical gel, 1%) on its provincial formulary for the treatment of rosacea - a facial skin disease thataffects an estimated two million Canadians(1). MetroGel is the most commonly prescribed topical medication for rosacea(2). The new 1% formulation provides a convenient once-daily dosing for individuals who suffer from this skin condition.

The details can be read here.

California Court's Decision Could Be Deathblow to Pharma Innovation

Legal history was made earlier this month when an intermediate appeals court in San Francisco became the first appellate court in the nation to let a civil case go forward against a product manufacturer by a consumer who used the generic equivalent of that product.

The details can be read here.

Cephalon and Eurand File Patent Infringement Lawsuit Against Mylan Pharmaceuticals and Barr Pharmaceuticals

Cephalon, Inc. and Eurand, Inc. today announced that they have filed a lawsuit in U.S. District Court in Delaware against Mylan Pharmaceuticals, Inc. and its subsidiary, Mylan, Inc., and Barr Pharmaceuticals, Inc. and its subsidiary, Barr Laboratories, Inc., for infringement of Eurand's U.S. Patent Number 7,387,793.

The details can be read here.

Barr Confirms Patent Challenge of Amrix Extended-Release Capsules, 15mg & 30mg

Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Anesta in connection with its Amrix (cyclobenzaprine hydrochloride) extended-release capsules, 15mg and 30mg.

the details can be read here.

King Pharma to acquire Alpharma for around $1.6 bn

King Pharmaceuticals, Inc and Alpharma Inc announced that the two companies have signed a definitive merger agreement under which King will acquire all of the outstanding shares of Class A Common Stock of Alpharma for $37.00 per share in cash for a total equity value of approximately $1.6 billion. The Boards of Directors of both companies have unanimously approved the transaction.

The details can be read here.

DOR BioPharma's orBec Receives Orphan Drug Designation in Australia for the Treatment of GI GVHD

November 25, 2008 - DOR BioPharma, Inc, a late-stage biopharmaceutical company developing products to treat the life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines against certain bioterrorism agents, announced today that the TGA of Australia has designated orBec as an Orphan Drug for the treatment of patients with gastrointestinal Graft-Versus-Host-Disease following allogeneic hematopoietic cell transplantation.

the details can be read here.

U.S. FDA Grants Pralatrexate Orphan Drug Designation for the Treatment of Patients with Diffuse Large B-Cell Lymphoma

Allos Therapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of small molecule therapeutics for the treatment of cancer, today announced that the U.S. FDA granted orphan drug designation to the Company's novel antifolate, pralatrexate, for the treatment of patients with diffuse large B-cell lymphoma.

The details can be read here.

Arthritis Advisory Committee Recommends FDA Approval of Febuxostat for the Treatment of Hyperuricemia in Patients With Gout

Takeda Global Research & Development Center, Inc., U.S., announced today that the Arthritis Advisory Committee of the U.S. FDA recommended that the FDA approve febuxostatfor the treatment of hyperuricemia in patients with gout.

The details can be read here.

AstraZeneca Provides Update on Agreement With Abraxis Biosciences for Co-Promotion of Abraxane in the US

On 19 November 2008, AstraZeneca entered into an agreement with Abraxis BioScience, LLC, under which, subject to the satisfaction of terms and conditions thereof, Abraxis would re-acquire exclusive rights to market ABRAXANE in the United States.

The details can be read here.