Pharmaceutical News

RSS

Eli Lilly withdraws application for additional U.S. indication for Cymbalta for chronic pain

Eli Lilly and Company has withdrawn its supplemental New Drug Application (sNDA) from the U.S. Food and Drug Administration (FDA) for Cymbalta (duloxetine HCl) for the management of chronic pain.

30 Nov 2008

Watson Pharmaceuticals receives FDA approval for generic Wellbutrin XL

Watson Pharmaceuticals, Inc. has announced that its subsidiary, Watson Laboratories, Inc., has received final approval today from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets (XL) in the 150 mg strength.

26 Nov 2008

Sun Pharma acquires Chattem Chemicals, Inc

Sun Pharmaceutical Industries Ltd. has announced that its fully owned US subsidiary, Sun Pharmaceutical Industries, Inc., has acquired 100% ownership of Chattem Chemicals, Inc. (Chattem) from Elcat, Inc,.

26 Nov 2008

Generic drug competition benefits Ontarians

Following yesterday's release of the Competition Bureau's report, "Benefiting from Generic Drug Competition in Canada: The Way Forward," the Ontario Pharmacists' Association (OPA) is emphasizing that competition in the generic drugs industry is already benefiting Ontarians through accessible, high quality, cost-effective professional pharmacy care.

26 Nov 2008

FDA issues complete response letter for Ceftobiprole for treatment of complicated skin infections

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections.

26 Nov 2008

MorphoSys and Galapagos enter alliance to co-develop novel therapeutic antibodies in bone and joint disease

MorphoSys AG and Galapagos NV announced today the launch of a long term co-development alliance aimed at discovering and developing antibody therapies based on novel modes of action in bone and joint disease, including rheumatoid arthritis, osteoporosis and osteoarthritis.

26 Nov 2008

Scientists create synthetic Heparin in more varieties

Scientists at the University of North Carolina at Chapel Hill have learned to customize a key human enzyme responsible for producing heparin, opening the door to a more effective synthetic anticoagulant as well as treatments for other conditions.

25 Nov 2008

Roche to acquire Memory Pharmaceuticals

Roche and Memory Pharmaceuticals has announced that the two companies have signed a definitive merger agreement for Roche to acquire all the outstanding shares of Memory Pharmaceuticals in an all-cash transaction for an aggregate price of approximately USD 50 million.

25 Nov 2008

Selzentry (maraviroc) becomes fully approved HIV antiretrovial

The U.S. Food and Drug Administration (FDA) has granted Selzentry (maraviroc) full (traditional) approval for use in treatment-experienced adults with CCR5-tropic HIV-1 in combination with other antiretrovirals.

25 Nov 2008

Caraco Pharmaceutical Labs responds to FDA warning

Caraco Pharmaceutical Laboratories, Ltd. announced today that it has timely submitted its response to the FDA warning letter that was received on October 31, 2008.

25 Nov 2008

Febuxostat recommended by panel for treatment of hyperuricemia in patients with gout

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) recommended that the FDA approve febuxostat for the treatment of hyperuricemia in patients with gout.

25 Nov 2008

Live oral Shigella vaccine licensed to PATH

The University of Maryland, Baltimore (UMB) has licensed a pediatric vaccine against Shigella bacteria to PATH, an international nonprofit group, to support clinical trials, with the goal of developing a vaccine suitable for children in resource-poor countries.

24 Nov 2008

Ustekinumab receives positive opinion in Europe for treatment of plaque psoriasis

Janssen-Cilag announced today that ustekinumab, the first in a new class of biologics, has received a positive opinion for the treatment of moderate to severe plaque psoriasis from the European Committee for Medical Products for Human Use (CHMP).

24 Nov 2008

FDA accepts Labopharm's NDA for formulation of trazodone

Labopharm Inc. has announced that its New Drug Application (NDA) for the Company's novel once-daily formulation of trazodone (DDS-04A), a serotonin antagonist reuptake inhibitor (SARI), for the treatment of major depressive disorder, has been accepted for review and filed by the U.S. Food and Drug Administration (FDA).

24 Nov 2008

King Pharmaceuticals and Alpharma sign definitive merger agreement

King Pharmaceuticals, Inc. and Alpharma Inc. have 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.

24 Nov 2008

Tapentadol hydrochloride approved for pain relief

The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain.

24 Nov 2008

New plan to tackle off-label prescribing

Physicians and policy-makers know that drugs are frequently prescribed to treat certain diseases despite a lack of FDA approval - a practice known as off-label prescribing.

24 Nov 2008

Valdoxan - a melatonergic antidepressant - receives positive European opinion for major depressive disorder

The first melatonergic antidepressant - Valdoxan/Thymanax (agomelatine) - has received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) for its use in the treatment of adult patients with major depressive disorder (MDD).

21 Nov 2008

Nplate receives positive opinion for marketing authorisation in Europe

Amgen has announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Nplate (romiplostim) in the European Union (EU).

21 Nov 2008

Eli Lilly completes tender offer for ImClone Systems

Eli Lilly and Company and ImClone Systems Incorporated have announced the successful completion of the previously announced tender offer by Lilly's wholly-owned subsidiary, Alaska Acquisition Corporation, for all outstanding shares of ImClone at a price of $70.00 per share in cash.

21 Nov 2008