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Valdoxan granted marketing authorisation for the treatment of major depressive episodes in Europe

The European Commission has granted marketing authorisation for Servier's Valdoxan/Thymanax (agomelatine), the first melatonergic antidepressant for the treatment of adult patients with major depressive episodes.

24 Feb 2009

Ambrx and Merck Serono expand collaboration through multiple sclerosis drug

Ambrx Inc, and Merck Serono have announced a global strategic collaboration to develop and commercialize Ambrx's ARX424 preclinical product candidate for the treatment of multiple sclerosis.

24 Feb 2009

34 percent of all Medicare Part D enrollees select Medicare Advantage plans for 2009

More than nine million people, or 34 percent of all Medicare Part D enrollees, currently receive their prescription drug benefit through Medicare Advantage plans with prescription drug coverage (MA-PD plans), says new analysis by Avalere Health.

24 Feb 2009

Xencor and CSL Limited establish antibody optimization collaboration

Xencor, Inc., an antibody discovery and development company, announced today that it has entered into an antibody optimization collaboration with CSL, Ltd. The collaboration will provide CSL with access to Xencor's XmAb technology platform to enhance the ADCC effector function of its therapeutic antibodies.

23 Feb 2009

Genentech special committee rejects Roche’s $86.50 offer as inadequate

Genentech, Inc. has announced that a Special Committee of its Board of Directors unanimously recommended that shareholders reject the unilateral tender offer from Roche to acquire all of the outstanding shares of Genentech not owned by Roche for $86.50 cash per share.

23 Feb 2009

Shire to enter European ADHD market with acquisition of EQUASYM IR and XL

Shire plc has announced that it has signed an agreement with UCB to acquire the worldwide rights to EQUASYM IR and XL (methylphenidate hydrochloride) (excluding the USA, Canada and Barbados) used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

22 Feb 2009

Schering-Plough submits response to FDA for SAPHRIS (asenapine) in the acute treatment of schizophrenia and bipolar I disorder

Schering-Plough Corporation has announced that it has responded to the U.S. Food and Drug Administration (FDA) complete response letter for SAPHRIS (asenapine) sublingual tablets, which was received in January 2009.

22 Feb 2009

Endo and Penwest announce settlement of Opana ER litigation

Endo Pharmaceuticals and Penwest Pharmaceuticals announced today that the companies have settled litigation with Actavis South Atlantic LLC regarding the production and sale of generic formulations of Opana(R) ER (oxymorphone hydrochloride) Extended Release Tablets CII.

22 Feb 2009

Biocomposites granted SFDA clearance for geneX in China

Biocomposites announced today that the company's unique bone graft substitute geneX , has been cleared for use by the State Food and Drug Administration (SFDA) of the People's Republic of China.

22 Feb 2009

FDA issues warning on psoriasis drug Raptiva (efalizumab)

The U.S. Food and Drug Administration has issued a public health advisory concerning three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab).

20 Feb 2009

U.S. Court of Federal Claims declares vaccines do not cause autism

The three judges ruled that the measles-mumps-rubella vaccine (MMR), given in combination with thimerosal-containing vaccines, does not cause autism.

17 Feb 2009

Abbott receives FDA clearance for new CELL-DYN Emerald hematology instrument

Abbott has announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new, compact hematology instrument, CELL-DYN Emerald.

11 Feb 2009

Sundia MediTech and Xcovery announce new drug discovery

Sundia MediTech, a CRO company based in Shanghai, China and Xcovery, a company based in Florida, U.S.A. jointly announced their 2 year collaborative success in new drug discovery at IBC's BioProcess International Conference yesterday in San Diego, USA.

10 Feb 2009

Roche commences tender offer for Genentech

Roche announced today that it is commencing a cash tender offer for all outstanding publicly-held shares of Genentech for US$86.50 per share.

10 Feb 2009

New guidelines for prescribing opioid pain drugs

A prestigious panel of pain-management experts representing the American Pain Society (APS) www.ampainsoc.org and the American Academy of Pain Medicine (AAPM) has published the first comprehensive clinical practice guideline to assist clinicians in prescribing potent opioid pain medications for patients with chronic non-cancer pain.

10 Feb 2009