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Soliris (Eculizumab) granted orphan drug designation in Europe and U.S. for atypical hemolytic uremic syndrome

Alexion Pharmaceuticals, Inc. has announced today that Soliris® (eculizumab), its first-in-class complement inhibitor, has been granted Orphan Medicinal Product Designation by the European Commission for the treatment of patients with atypical Hemolytic Uremic Syndrome (aHUS). AHUS is an ultra-rare, inherited, and life-threatening complement-inhibitor deficiency disease that often progresses to end-stage kidney disease or failure. The U.S. Food and Drug Administration granted orphan drug designation to Soliris for the same indication in May 2009. Soliris is not approved for the treatment of patients with aHUS.

6 Aug 2009

Obama to drug industry: We still have a deal

"Pressed by industry lobbyists, White House officials on Wednesday assured drug makers that the administration stood by a behind-the-scenes deal to block any Congressional effort to extract cost savings from them beyond an agreed-upon $80 billion," The New York Times reports.

6 Aug 2009

Celera and Aurora to collaborate on cardiovascular genetics

Aurora Health Care, Wisconsin's largest health care provider, and Celera Corporation announced today that they have entered into an agreement to collaborate on the integration of genetic testing aimed at optimizing heart care for Aurora patients

6 Aug 2009

Bill Clinton, Pfizer, and Mylan announce new agreements to lower prices of antiretrovirals for HIV/AIDS in the developing world

President Bill Clinton announced two important and complementary agreements today to enable better, more affordable treatments for patients on second-line antiretroviral (ARV) therapy for HIV/AIDS in the developing world.

6 Aug 2009

Fast-tracked H1N1 vaccines will not compromise safety, WHO says

Efforts to fast-track the approval of H1N1 (swine) flu vaccines will not compromise the safety or quality controls of vaccine production, the WHO said in a written statement Thursday, the Mail & Guardian reports.

6 Aug 2009

Spectrum Pharmaceuticals acquires rights and IP for Renazorb

Spectrum Pharmaceuticals today announced that it has acquired 100% rights to RenaZorb (a family of compounds represented by SPI-014, also known as RZB-014), a lanthanum-based nanotechnology compound with potent and selective phosphate binding properties, for all human and non-human indications.

6 Aug 2009

Research details role of galectin-3 in heart failure

BG Medicine today announced the publication of a peer-reviewed article on the role of galectin-3 in heart failure development and progression.

6 Aug 2009

Alnylam and Tekmira to collaborate on RNAi therapeutics

Alnylam Pharmaceuticals, Inc. and Tekmira Pharmaceuticals Corporation announced today that they will jointly participate in a new research collaboration focused on the discovery of novel cationic lipids and lipid nanoparticles for the systemic delivery of RNAi therapeutics.

6 Aug 2009

Phytomedical partners with LATITUDE Pharmaceuticals on lead anti cancer compound for glioblastoma

PhytoMedical Technologies, Inc. has announced their partnership with LATITUDE Pharmaceuticals, Inc. to develop an IV Formulation for its lead anti cancer compound for glioblastoma. LATITUDE Pharmaceuticals, Inc. is a widely recognized expert in the area of drug formulations and delivery systems.

6 Aug 2009

Innexus Biotechnology announces business development initiative on lead preclinical candidate

InNexus Biotechnology Inc. announced today that the Company will embark on a business development initiative for DXL625™ (CD20), the Company’s lead preclinical candidate for the prospective treatment of Non-Hodgkin’s Lymphoma and/or Chronic Lymphocytic Leukemia.

6 Aug 2009

Orexo: Abstral NDA submitted to U.S. FDA

Orexo AB has announced that its partner, UK-based international specialty pharmaceutical company ProStrakan Group plc, has submitted the New Drug Application (NDA) for Abstral™ (for the treatment of breakthrough cancer pain in opioid-tolerant patients) to the US Food and Drug Administration (FDA).

6 Aug 2009

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