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FDA assigns priority review to ATryn from GTC Biotherapeutics

The US Food and Drug Administration, or FDA, has assigned Priority Review to GTC Biotherapeutics, Inc.'s Biologic License Application, or BLA, for ATryn.

4 Sep 2008

Celgene receives FDA 'fast track' for Amrubicin in small cell lung cancer after first-line chemotherapy

Celgene Corporation today announced that Amrubicin has been granted Fast Track product designation by the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer after first-line chemotherapy.

4 Sep 2008

Anadis to commercialise "BioGard" adjunctive therapy for HIV/AIDS

Anadis announced today its commercialization of a new product, BioGard, intended to maintain gastrointestinal and immune system health. The specific formulation may be of particular clinical benefit in persons undergoing antiretroviral therapy for HIV/AIDS.

4 Sep 2008

Merck Serono and Ablynx to jointly develop nanobodies

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that it has entered into an agreement with Ablynx, to co-discover and co-develop Nanobodies against two targets in oncology and immunology. The agreement includes an upfront cash payment to Ablynx of EUR10 million.

4 Sep 2008

Vimpat (lacosamide) approved in Europe

UCB announced today that the European Commission (EC) has approved Vimpat (lacosamide) as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. Vimpat is the first new antiepileptic drug (AED) for partial-onset seizures in three years and offers a new treatment option for European patients living with uncontrolled partial-onset epilepsy.

3 Sep 2008

Biovail files abbreviated new drug application for Fenofibrate tablets

Biovail Corporation today announced that the United States Food and Drug Administration (FDA) has accepted the Company's abbreviated new drug application (ANDA) for a generic formulation of 145mg and 48mg strengths of fenofibrate tablets (sold under the brand name Tricor by Abbott Laboratories).

3 Sep 2008

Concern raised again about heart drugs Zetia and Vytorin

The editors of the New England Journal of Medicine have raised concern regarding the cholesterol-lowering drugs Zetia and Vytorin.

3 Sep 2008

Spinifex secures major investment to develop pain drug

Spinifex Pharmaceuticals, an Australian pain drug development company, today announced it has secured venture capital investment of A$12 million from GBS Venture Partners Limited, Brandon Capital Partners and Uniseed to fund the development of its pain management drug, EMA401.

2 Sep 2008

Economic pressures lead some uninsured to stop medications, cut doses

The Jackson Clarion-Ledger on Wednesday examined how some U.S. residents who cannot afford health insurance are reducing the amount of medications they take or cutting doses, as well as seeing the doctor less frequently, to save money.

1 Sep 2008

WSJ examines drugmakers' use of 'unbranded product advertising' to promote disease awareness, treatment options

The Wall Street Journal on Friday examined "unbranded product advertising" for brand-name drugs, which allow drugmakers to drive television viewers to Web sites promoting drugs without the requirement of listing the products' side effects in the TV advertisement.

1 Sep 2008

Antiangiogenic and anti-inflammatory drugs: are they safe?

Since Rofecoxib (Vioxx) was withdrawn from the worldwide market based on the safety findings of the Adenomatous Polyp Prevention on Vioxx (APPROVe) study, the uncertainty around the cardiovascular safety of NSAIDs and COX-2 inhibitors remains and leaves practitioners with difficult management decisions for the hundreds of millions of patients worldwide who continue to require pain-relieving therapy to maintain an acceptable quality of life.

1 Sep 2008

Medicare overpaid for prescription drugs with new generic versions because of delay in incorporating new prices into payment calculations

Medicare overpaid for irinotecan, a cancer drug sold by Pfizer under the name Campostar, by $6.5 million in March because of a delay in updating its pricing formula, according to a report released on Tuesday by the HHS Office of Inspector General, Bloomberg/Los Angeles Times reports.

29 Aug 2008

Infectious Disease Research Institute receives $6.3 million NIAID grant to study TB vaccine

Seattle's Infectious Disease Research Institute on Tuesday announced it has received a $6.3 million grant from NIH's National Institute of Allergy and Infectious Diseases to study a new tuberculosis vaccine, the Puget Sound Business Journal reports (Puget Sound Business Journal, 8/27).

29 Aug 2008

Barr receives U.S. approval for generic Razadyne tablets

Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., received final approval from the U.S. Food & Drug Administration (FDA) to manufacture and market a generic version of Ortho McNeil Janssen's Razadyne (galantamine hydrobromide), 4 mg, 8 mg and 12 mg tablets. Barr intends to launch its generic Razadyne tablets product immediately.

28 Aug 2008

New beta-blocker for heart disease and angina

Researchers at The University of Nottingham have been awarded £2.8 million by the Wellcome Trust to develop a new drug that could ease the suffering of hundreds of thousands of heart disease patients who are unable to take beta-blockers.

28 Aug 2008

FDA grants IND for Davanat to treat breast cancer patient

Pro-Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) application for use of Davanat in combination with 5-FU to treat a breast cancer patient at the Brown Cancer Center in Louisville, Kentucky. Davanat also is being administered in Phase II clinical trials for first-line treatment of colorectal and biliary cancer patients.

28 Aug 2008

Thiazolidinediones - diabetes drugs carry significant cardiovascular risks

A class of oral drugs used to treat type 2 diabetes may significantly increase the risk of serious cardiovascular events, according to an editorial published online in Heart Wednesday by two Wake Forest University School of Medicine faculty members.

28 Aug 2008

Gleevec receives FDA priority review for gastrointestinal stromal tumors after surgery

Novartis has announced that Gleevec (imatinib mesylate) tablets, (known as Glivec (imatinib) outside the US, Canada and Israel), has been granted priority review status by the US Food and Drug Administration (FDA) as the first therapy to be reviewed for use after surgery in kit-positive gastrointestinal stromal tumors (GIST).

27 Aug 2008

FDA grants CLIA waiver to American Bio Medica for drug test

American Bio Medica Corporation has announced today that the US Food and Drug Administration (FDA) has granted CLIA waived status to the Company's Rapid TOX point of collection drug test product line.

From Medica Corporation 27 Aug 2008