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Pharmaceutical companies say new approach by FDA has led to decrease approvals of new medications

An "intensifying focus on safety and a diminished tolerance for side effects" by FDA have "dramatically lowered" the chances that experimental medications will reach the market and have led to a recent decrease in approvals of new treatments, according to pharmaceutical companies, the Wall Street Journal reports.

2 Jul 2008

SureScripts, RxHub merge, create single e-prescription network

Officials from SureScripts and RxHub, two electronic prescription networks, on Tuesday will announce their merger in an effort to promote greater adoption of electronic prescribing by physicians, the Washington Post reports (Goldfarb, Washington Post, 7/1).

2 Jul 2008

FDA approves generic Risperidone for the treatment of schizophrenia, bipolar disorder

The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions.

1 Jul 2008

Watson Pharmaceuticals launches generic version of dronabinol

Watson Pharmaceuticals, Inc. has announced that, under a supply agreement with Solvay Pharmaceuticals, Inc., Watson has launched the authorized generic version of dronabinol in the 2.5, 5 and 10 mg once daily dosage strengths.

30 Jun 2008

Report finds 32% increase in drug industry lobbying spending in 2007

The pharmaceutical industry spent $168 million on lobbying in 2007, a 32% increase over the previous year, according to a report released Tuesday by the Center for Public Integrity, the Wall Street Journal reports.

26 Jun 2008

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

Pharmaceutical News

Pharmaceutical companies say new approach by FDA has led to decrease approvals of new medications

SureScripts, RxHub merge, create single e-prescription network

FDA approves generic Risperidone for the treatment of schizophrenia, bipolar disorder

Watson Pharmaceuticals launches generic version of dronabinol

Report finds 32% increase in drug industry lobbying spending in 2007

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

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