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Senate urged to pass strong prescription drug safety provisions

Consumers Union is urging the Senate to approve strong prescription drug-safety provisions this week in a major Food and Drug Administration bill, and resist attempts to weaken the bill when it comes to triggering quick safety action or moderating mass advertising of a new drug when there are signs of danger.

1 May 2007

Health advocates, drug industry reps lobby lawmakers for support in Thailand drug licensing dispute

International health advocates and drug industry representatives are lobbying U.S. lawmakers and the Bush administration for their support in the dispute over Thailand's decision to issue compulsory licenses for medications, including some antiretroviral drugs, CongressDaily reports (Vaughan, CongressDaily , 4/26).

30 Apr 2007

Brazilian Health Minister says country will purchase generic version of Merck antiretroviral if price not lowered

Brazilian Health Minister Jose Gomes Temporao on Wednesday signed a decree declaring that the country would purchase from an India-based drug maker a generic version of Merck 's antiretroviral Efavirenz if the company does not offer the drug at a lower price, the AP/Forbes reports.

30 Apr 2007

Web site to list medications of natural disaster evacuees

SureScripts on Tuesday unveiled a Web site that will allow health care workers to access the prescription information of people who live in areas impacted by natural disasters, the AP/Jackson Clarion-Ledger reports.

30 Apr 2007

Submission of NDA for Istradefylline(KW-6002), an investigational anti-Parkinson's disease drug

Kyowa Hakko Kogyo Co. has announced that Kyowa Pharmaceutical, Inc., its wholly owned U.S subsidiary, submitted on April 25, 2007 a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Istradefylline(KW-6002), its investigational drug for Parkinson's disease.

30 Apr 2007

Schering-Plough announces European approval of new formulations of AERIUS (Desloratadine)

European Commission approves AERIUS Tablets (2.5 mg and 5 mg) and AERIUS Oral Solution (0.5 mg per 1ml).

30 Apr 2007

INVEGA granted positive opinion recommending approval in Europe

Janssen-Cilag International NV has announced that the Committee for Human Medicinal Products (CHMP) in the European Union, has granted a positive opinion recommending approval of INVEGA (paliperidone prolonged release tablets).

30 Apr 2007

FDA approves INVEGA treatment for schizophrenia

The U.S. Food and Drug Administration (FDA) has approved INVEGA (paliperidone) Extended-Release Tablets, a new once-daily, atypical antipsychotic, for the long-term maintenance treatment of schizophrenia.

30 Apr 2007

FDA approves new treatment for von Willebrand disease

The U.S. Food and Drug Administration (FDA) has approved Humate-P (Antihemophilic Factor/von Willebrand Factor Complex) for the prevention of excessive bleeding during and after surgery in certain patients with mild to moderate and severe von Willebrand disease (vWD).

30 Apr 2007

Caraco Pharmaceuticals to market generic Nimotop

Caraco Pharmaceutical Laboratories has announced that it will market Nimodipine Capsules, 30mg (Nimotop) on behalf of Sun Pharmaceutical Industries, Inc. (Sun), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd.

30 Apr 2007

Ranbaxy receives approval to manufacture Pravastatin Sodium tablets in U.S.

Ranbaxy Pharmaceuticals has announced that RLL has received approval from the U.S. Food and Drug Administration to manufacture and market Pravastatin Sodium Tablets (Pravastatin), 10 mg, 20 mg, 40 mg and 80 mg, with 180-day market exclusivity in the U.S. healthcare system for the 80 mg strength.

27 Apr 2007

Ranbaxy receives approval to manufacture Zolpidem tablets for insomnia

Ranbaxy Laboratories Limited (RLL), has announced that the Company has received final approval from the U.S. Food and Drug Administration to manufacture and market Zolpidem Tartrate Tablets, 5mg and 10mg.

27 Apr 2007

Novagali Pharma announces FDA clearance of trial for treatment of dry eye syndrome

Novagali Pharma has announced that the Company's Investigational New Drug Application (IND) to conduct a pivotal Phase III clinical trial of its Cyclosporine A ocular product, Nova22007, has been granted by the U.S. Food and Drug Administration (FDA).

27 Apr 2007

Inex Pharmaceuticals announces expected completion date for Tekmira Pharmaceuticals Corporation

Inex Pharmaceuticals Corporation has announced that it expects the closing of the spin-out of Tekmira Pharmaceuticals Corporation ("Tekmira") to occur at the close of business on April 30, 2007.

27 Apr 2007

Under the microscope...doctors' relationships with drug companies

According to a recent survey almost all doctors in the U.S. have some form of relationship with drug companies.

26 Apr 2007

Physician ties to drug industry stronger than ever

Despite the potential for conflict of interest, virtually all practicing physicians in the U.S. have some form of relationship with pharmaceutical manufacturers but the nature and extent of those relationships vary, depending on the kind of practice, medical specialty, patient mix, and professional activities, reports a study in the April 26 issue of the New England Journal of Medicine.

26 Apr 2007

Wyeth Pharmaceuticals receives FDA approvable for Bazedoxifene for the prevention of postmenopausal osteoporosis

Wyeth Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for bazedoxifene, a selective estrogen receptor modulator (SERM) for the prevention of postmenopausal osteoporosis.

26 Apr 2007

Psychotherapeutic drug spending surges

Spending on prescription drugs to treat depression, anxiety, pain, schizophrenia and other conditions climbed from $7.9 billion in 1997 to $20 billion in 2004 - over a 150 percent increase, according to the latest News and Numbers from the Agency for Healthcare Research and Quality.

25 Apr 2007

Neuromed licenses chronic pain product from ALZA Corporation

Neuromed Pharmaceuticals has announced that it has licensed from ALZA Corporation the exclusive U.S. rights to develop and commercialize OROS(R) Hydromorphone, an extended release formulation of a potent opioid analgesic in Phase 3 clinical development.

25 Apr 2007

Time for FDA to set the record straight on common painkillers

The U.S. Food and Drug Administration (FDA) has caused an unnecessary scare about some pain relievers by adding a warning to drugs that are safe, says Curt Furberg, M.D., Ph.D., from Wake Forest University School of Medicine.

25 Apr 2007