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Genzyme’s Mozobil approved in Europe

Genzyme Corporation announced today that the European Commission has granted marketing authorization for Mozobil ® (plerixafor injection), providing a significant new option for patients with the blood cancers lymphoma and multiple myeloma who require an autologous stem cell transplant.

6 Aug 2009

Biochemics and Pacific Pharmaceutical to collaborate on skin products

BioChemics, Inc. (BCI) has announced the signing of a research collaboration agreement with Pacific Pharmaceutical Co., Ltd, a publicly held Company in South Korea to evaluate the use of BCI's VALE® based compositions in cosmetic applications.

6 Aug 2009

Appeals court affirms invalidation of Yasmin patent

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Court of Appeals for the Federal Circuit has affirmed a ruling by the U.S. District Court for the District of New Jersey finding Bayer Schering's U.S. Patent No. 6,787,531 invalid. The patent is listed in the Orange Book for Bayer's oral contraception Yasmin®.

5 Aug 2009

Innovative diabetes drug discovery partnership

The Juvenile Diabetes Research Foundation said today that it has entered into a novel collaborative research agreement with the Genomics Institute of the Novartis Research Foundation (GNF) to create a diabetes drug discovery and development platform.

5 Aug 2009

Baxter completes production of batches of CELVAPAN A/H1N1 pandemic vaccine

Baxter International Inc. (NYSE: BAX) today announced that it completed production of its first commercial batches of CELVAPAN A/H1N1 pandemic vaccine in late July and is discussing plans for distribution with national health authorities, subject to obtaining appropriate authorizations. CELVAPAN, the brand name for the company’s A/H1N1 pandemic influenza vaccine, is made using Baxter’s proprietary Vero cell culture technology.

From Baxter International Inc. 5 Aug 2009

Impax Labs receives FDA approval for generic version of Depakote

Impax Laboratories has confirmed that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company’s Abbreviated New Drug Application (ANDA) for generic version of Depakote® (divalproex ER) 500mg Extended-release Tablets.

5 Aug 2009

Epicept files NDA for Ceplene in Canada

EpiCept Corporation has announced that it has filed a New Drug Submission (NDS) with Health Canada for Ceplene® (histamine dihydrochloride) for the treatment of acute myeloid leukemia (AML) patients in first complete remission. Health Canada typically accepts or refuses an NDS and designates review status within forty-five days of filing. If accepted, the customary timeframe for completion of review and an approval decision is within one year.

5 Aug 2009

New understanding on Gleevec's limitations

University of Michigan researchers have developed an animal model that provides strong evidence why imatinib, marketed as Gleevec, helps patients with chronic myeloid leukemia survive longer, but does not keep the disease from returning if treatment ends.

4 Aug 2009

Evidence of Malaria origins, could lead to vaccine development

"Malaria may have jumped to humans from chimpanzees much as AIDS did, U.S. researchers reported on Monday in a [Proceedings of the National Academy of Sciences] study they hope could help in developing a vaccine against the infection," Reuters reports.

4 Aug 2009

Tuberculosis drugs under development could have large impact on the disease

The latest drug regimens, vaccines and diagnostic tools under development to combat tuberculosis could have a potentially large impact on the disease once they become available, according to research findings published in the Aug. 3 early edition online of the Proceedings of the National Academy of Sciences.

4 Aug 2009

FDA approves Livalo (pitavastatin), a new cholesterol-lowering drug

The U.S. Food and Drug Administration today approved the 4 milligram maximum dose of Livalo (pitavastatin), a drug intended to improve blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels.

3 Aug 2009

Dysport, an anti-wrinkle alternative to Botox

The new anti-wrinkle facial filler Dysport, which could be used as an alternative to Botox, noticeably reduced frown lines between the eyes, according to users and independent reviewers in a study involving plastic surgeons at UT Southwestern Medical Center.

3 Aug 2009

Comp. effectiveness promises better, cheaper health care but cricits link it to rationing

"Federal health agencies, seeking to hand out stimulus funds to research the effectiveness of various medical treatments, said they will include projects that look in part at the cost of drugs and other treatments.

3 Aug 2009

House panel passes protection for drug makers

The House Energy and Commerce Committee passed an amendment to their broad health reform bill giving drug makers 12 years of exclusive rights to market new biologic drugs, "a setback" to the administration and consumer advocates who hoped to make generic drugs more widely available, the Wall Street Journal reports.

3 Aug 2009

FDA approves Avastin plus interferon-alfa for people with metastatic renal cell carcinoma

Genentech, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Avastin (bevacizumab) plus interferon-alfa for people with metastatic renal cell carcinoma, the most common type of kidney cancer. According to the American Cancer Society, kidney cancer is the eighth most commonly diagnosed cancer in the United States. In 2009, approximately 13,000 Americans will die from the disease.

3 Aug 2009

US FDA approves Lipsovir for cold sores

The US Food and Drug Administration (FDA) has now approved Lipsovir, i.e. granted Medivir's New Drug Application (NDA) for the use of acyclovir and hydrocortisone for early treatment of recurrent cold sores to decreases the risk of cold sores, and to shorten the healing time for those cold sores which are not prevented.

3 Aug 2009

FDA approves Invega Sustenna for schizophrenia

The U.S. Food and Drug Administration today approved Invega Sustenna (paliperidone palmitate) extended-release injectable suspension for the acute and maintenance treatment of schizophrenia in adults.

2 Aug 2009

FDA approves Onglyza (saxagliptin) for type 2 diabetes

The U.S. Food and Drug Administration has approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels.

2 Aug 2009

U.S. decision on use of adjuvants could reduce world supply of H1N1 vaccine, says Lancet editorial

"A U.S. plan to rely on swine flu vaccines without ingredients to stretch the supply [known as adjuvants] would reduce the number of available shots just when other countries need them most, the British journal Lancet said in an editorial," Bloomberg writes.

31 Jul 2009

Industry lobby wars heighten as reform efforts progress

"Healthcare companies are spending millions of dollars and marshaling armies of lobbyists to influence a landmark debate in the U.S. Congress that could dramatically change the way they do business," Reuters reports.

31 Jul 2009