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Ranbaxy receives tentative approval to manufacture Valganciclovir hydrochloride tablets

Ranbaxy Laboratories Limited (RLL), announced today that the company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Valganciclovir Hydrochloride Tablets, 450 mg. Total annual market sales for Valganciclovir HCl Tablets were $239 million (IMS - MAT: March 2008).

25 Jun 2008

Sanofi Pasteur inaugurates high-tech vaccine production facility in France

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today the inauguration of a high-tech vaccine production facility in France to respond to soaring demand worldwide.

25 Jun 2008

FDA advisory committee recommends approval of Tolvaptan for hyponatremia

The U.S. Food and Drug Administration (FDA) Advisory Committee on Cardiovascular and Renal Drugs voted to recommend the approval of tolvaptan, Otsuka Pharmaceutical Development & Commercialization, Inc.'s (OPDC) investigational treatment for patients with hyponatremia.

25 Jun 2008

Pennsylvania Gov. Rendell says state could save $95 million annually by purchasing Medicaid drugs

Pennsylvania Gov. Ed Rendell (D) says the state could save $95 million annually under a plan to centralize Medicaid prescription drug purchasing within the state Department of Public Welfare, but state Republicans say those savings would be offset by hidden expenses in the plan, the Philadelphia Inquirer reports.

25 Jun 2008

Controversial diet drug Rimonabant now available on the NHS in Britain

A controversial diet drug has been approved for use on the National Health Service (NHS) in Britain.

24 Jun 2008

Drug assistance programs help the medicine go down

A new study of state-subsidized pharmacy assistance programs showed that providing prescription drug coverage for low-income seniors reduces Medicaid and Medicare costs. Moreover, needy seniors enrolled in the programs were able to cut their dose skimping and nursing home admissions in half, according to the Brandeis University research.

24 Jun 2008

FDA approves Kinrix - combination vaccine for diphtheria, tetanus, pertussis and polio diseases in one shot

GlaxoSmithKline has announced that the U.S. Food and Drug Administration (FDA) has approved Kinrix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine], the first combination vaccine to offer protection against diphtheria, tetanus, pertussis and polio diseases in one shot.

24 Jun 2008

Melior Discovery signs option agreement with Pfizer

Melior Discovery, Inc. announced today that it has signed an option agreement that provides Pfizer Inc the exclusive right to negotiate a license to MLR-1023, Melior's drug candidate for Type II diabetes.

24 Jun 2008

Barr and Bayer sign agreements for launch of generic Yasmin and Yaz oral contraceptives

Barr Laboratories, Inc. has entered into supply and licensing agreements with Bayer for generic versions of Bayer's Yasmin (drospirenone and ethinyl estradiol) and Yaz (drospirenone and ethinyl estradiol) oral contraceptive products.

24 Jun 2008

Apollo acquisition boosts NZ biotech Symansis

New Zealand biotech Symansis has purchased Australian company Apollo Cytokine Research for A$500,000 (NZ$627,000) to build on its unique cell signaling science and fast track expansion into new international markets.

24 Jun 2008

FDA lifts clinical hold on Genta's Tesetaxel

Genta Incorporated announced that the Company has received notification from the U.S. Food and Drug Administration (FDA) that Genta may resume clinical trials with tesetaxel, a leading oral taxane in Genta's oncology product portfolio.

23 Jun 2008

Study shows generics now own 63% of Medicare Part D market

Wolters Kluwer Health, a division of Wolters Kluwer, has released the results of a study that looks at key statistical outcomes of the Medicare Part D (MPD) prescription drug program.

23 Jun 2008

Bionomics and Merck Serono to collaborate to discover and develop novel, oral treatment for MS

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that a Development and Licensing Agreement with Bionomics was signed, under which Merck Serono would develop new treatments for multiple sclerosis (MS) and other autoimmune conditions based on compounds from Bionomics Kv1.3 program.

19 Jun 2008

Pharmaceutical companies lobbying States to restrict use of lower-cost generic alternatives

Pharmaceutical companies, which "have been waging war against inexpensive generic drugs for years at the national level," are now "taking their fights to the states, promoting proposals that would" bar pharmacists from automatically replacing prescriptions for brand-name drugs with generics, the Baltimore Sun reports.

17 Jun 2008

Warning about use of psychiatric drugs with the elderly

Health officials in the U.S. are warning doctors that prescribing certain psychiatric drugs to elderly people suffering from dementia can increase their risk of death.

17 Jun 2008

Death rate linked to comtaminated heparin almost doubles

The drug watchdog in the U.S., the Food and Drug Administration (FDA) have updated the number of deaths in patients who took the drug heparin.

17 Jun 2008

ExpIND process speeds Alzheimer's drug research

Researchers are actively cutting the time and cost it normally takes to develop radiopharmaceuticals by taking advantage of "Exploratory Investigational New Drug" (ExpIND), an FDA-sanctioned procedure that enhances post-discovery drug development while observing scientific and patient safety standards.

16 Jun 2008

Bionovo discovers new estrogen regulatory elements for breast cancer and osteoporosis drugs

Bionovo Inc. today announced results on the role of estrogen regulatory elements important in developing drugs for breast cancer and osteoporosis.

16 Jun 2008

Cymbalta approved for fibromyalgia

The U.S. Food and Drug Administration (FDA) has approved Cymbalta (duloxetine HCl) for the management of fibromyalgia, a chronic widespread pain disorder, Eli Lilly and Company announced.

16 Jun 2008

Mylan announces FDA approval for generic Effexor and tentative approval for generic antihypertensive Avalide

Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Venlafaxine Hydrochloride (HCl) Tablets 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base) and 100 mg (base).

16 Jun 2008

Pharmaceutical News

Ranbaxy receives tentative approval to manufacture Valganciclovir hydrochloride tablets

Sanofi Pasteur inaugurates high-tech vaccine production facility in France

FDA advisory committee recommends approval of Tolvaptan for hyponatremia

Pennsylvania Gov. Rendell says state could save $95 million annually by purchasing Medicaid drugs

Controversial diet drug Rimonabant now available on the NHS in Britain

Drug assistance programs help the medicine go down

FDA approves Kinrix - combination vaccine for diphtheria, tetanus, pertussis and polio diseases in one shot

Melior Discovery signs option agreement with Pfizer

Barr and Bayer sign agreements for launch of generic Yasmin and Yaz oral contraceptives

Apollo acquisition boosts NZ biotech Symansis

FDA lifts clinical hold on Genta's Tesetaxel

Study shows generics now own 63% of Medicare Part D market

Bionomics and Merck Serono to collaborate to discover and develop novel, oral treatment for MS

Pharmaceutical companies lobbying States to restrict use of lower-cost generic alternatives

Warning about use of psychiatric drugs with the elderly

Death rate linked to comtaminated heparin almost doubles

ExpIND process speeds Alzheimer's drug research

Bionovo discovers new estrogen regulatory elements for breast cancer and osteoporosis drugs

Cymbalta approved for fibromyalgia

Mylan announces FDA approval for generic Effexor and tentative approval for generic antihypertensive Avalide

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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