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Wyeth's Prevenar vaccine for pneumococcal disease registered in Russia

Wyeth announced today that its 7-valent pneumococcal conjugate vaccine, Prevenar (Pneumococcal saccharide conjugated vaccine, Adsorbed), has been registered by the Russian Ministry of Health and Social Development (Roszdravnadzor) and is expected to be commercially available later this year.

2 Mar 2009

FDA requires boxed warning and risk mitigation strategy for metoclopramide-containing drugs

The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use.

1 Mar 2009

United States files complaint against Forest Labs for allegedly violating the false claims act with Celexa and Lexapro

A Complaint was unsealed today in U.S. District Court in Massachusetts against a New York pharmaceutical company for alleged False Claims Act violations arising from the company's marketing the drugs Celexa and Lexapro for unapproved pediatric use and for paying kickbacks to induce physicians to prescribe the drugs.

25 Feb 2009

Mylan's Matrix receives WHO approval for generic Lopinavir/Ritonavir tablets

Mylan Inc. has announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, received the first and only World Health Organization (WHO) approval for Lopinavir/Ritonavir Tablets, 200 mg/50 mg. Matrix's version of this product is heat-stable and affordable, making it practical for distribution and use in warm climates.

25 Feb 2009

Supermarkets should offer free flu shots rather than free antibiotics

As influenza season shifts into high gear, with 24 states now reporting widespread activity, the nation's infectious diseases experts are urging supermarket pharmacies with free-antibiotics promotions to educate their customers on when antibiotics are the right prescription-and when they can do more harm than good.

25 Feb 2009

Aton Pharma acquires Timoptic product line from Merck & Co

Aton Pharma, Inc., a diversified specialty pharmaceutical company, today announced it has acquired the U.S. marketing rights to the Timoptic product line from Merck & Co., Inc. Timoptic (timolol maleate) is a non-selective beta-adrenergic receptor blocking agent indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

25 Feb 2009

Implicit licenses clinical stage antibody program from Lilly

Implicit Bioscience Ltd has announced the acquisition of the clinical-stage monoclonal antibody IC14 from Eli Lilly and Company. Implicit has paid an undisclosed consideration combining cash and stock to Lilly. Lilly will also receive a royalty on future IC14 sales.

25 Feb 2009

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