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FDA approves sBLA for Influenza A (H1N1) 2009 Monovalent Vaccine

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental biologics license application (sBLA) for licensure of its Influenza A (H1N1) 2009 Monovalent Vaccine.

16 Sep 2009

BioMedReports.Com issues special investigative report on CEL-SCI

BioMedReports.Com, the news portal which covers Wall Street's biomedical sector and delivers financial and investment intelligence to a community of highly informed investors, has issued a special investigative report on CEL-SCI Corporation.

16 Sep 2009

Clinical trial data of Lipsovir presented at ICAAC

Medivir presented Lipsovir (ME-609) at a poster session on 14th September at the ongoing ICAAC (Interscience Conference on Antimicrobial Agents and Chemotherapy) meeting.

16 Sep 2009

AMRI files two new patent infringement lawsuits

AMRI announced today that it has filed two new patent infringement lawsuits in U.S. District Court in New Jersey against Dr. Reddy’s Laboratories, Ltd., Dr. Reddy’s Laboratories, Inc. and Sandoz, Inc. (“the defendants”) for infringement of AMRI’s U.S. Patent Number 7,390,906. The recently issued patent relates to the manufacturing process for the active ingredient in sanofi-aventis’s Allegra and AllegraD drug products.

16 Sep 2009

Study reveals ineffectiveness of insulin and metformin against inflammatory biomarkers

In patients with recent onset type-2 diabetes, treatment with insulin or the diabetes drug metformin did not reduce inflammatory biomarkers, such as high-sensitivity C-reactive protein, although the treatment did improve glucose control, according to a study in the September 16 issue of JAMA.

16 Sep 2009

Urgent vaccine requirements for treating epidemic diseases voiced at ECI 2009

As a result of dominant media coverage of new epidemic threats such as swine influenza, other infection risks receive less public attention than they deserve. "We would like to bring to everybody's attention that the infectious diseases with the most severe consequences continue to be old acquaintances such as tuberculosis, HIV/AIDS, malaria and hepatitis C. About six million people worldwide die of these diseases every year," says Professor Dr. Dr. h. c. Stefan H. E. Kaufmann, Director of the Max Planck Institute for Infection Biology in Berlin, at the 2nd European Congress of Immunology ECI 2009.

16 Sep 2009

Ganeden Biotech unveils the first quick dissolving, thin strip probiotic product

Ganeden Biotech Inc., makers of the patented probiotic strain GanedenBC30(R), today announced the launch of the first quick dissolving, thin strip probiotic product. The new thin strip product is the latest in a number of innovative probiotic-enhanced products introduced by Ganeden Biotech over the past year.

16 Sep 2009

GENova Biotherapeutics and Prime BioResearch sign collaboration agreement

GENova Biotherapeutics Inc. ("GENova") today announced that it has signed a collaboration agreement with Prime BioResearch, Ltd. ("Prime BioResearch") the agreement is focused on how personalized medicine can be applied to cure cancer.

16 Sep 2009

FDA grants orphan drug status to Advanced Life Sciences' Restanza

Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS) today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to Restanza(TM) (cethromycin), its novel, once daily oral antibiotic, for the prophylactic treatment of plague and tularemia. Both tularemia and plague are classified by the Centers for Disease Control as Category A Bioterrorism Agents, which is the highest priority classification.

16 Sep 2009

New book on pharmacology launched

Academic Press, a division of Elsevier, would like to announce the new book, Pharmacology: Principles and Practice, authored by Miles Hacker, William S. Messer, II and Kenneth A. Bachmann.

16 Sep 2009

Bavarian Nordic to deliver IMVAMUNE(R) vaccines

Bavarian Nordic A/S (OMX: BAVA) announced today that it has signed a contract with the military of an undisclosed EU country for the delivery of a small order for IMVAMUNE(R). The vaccines will be delivered in 2009. The size and value of the contract is undisclosed.

16 Sep 2009

Four H1N1 vaccines approved by FDA

The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.

16 Sep 2009

Pre-clinical studies of ID-12 orally-bioavailable inhibitor completes

ChemDiv Inc. of San Diego, and iDialog (Intellektualniy Dialog) of Yaroslavl, Russia, announced today the successful completion of a pre-clinical development and the subsequent nomination of ID-12 as lead clinical development candidate for the treatment of chronic hepatitis C. This novel small molecule orally-bioavailable inhibitor of hepatitis C virus (HCV) blocks early stage of viral infection.

16 Sep 2009

New peptide-based cancer vaccine tested in genital cancer patients

Preventive vaccination against infectious diseases has been a major milestone for the health of modern society. The development of therapeutic vaccination against established diseases is much more difficult. For more than 100 years researchers have already tried to develop cancer vaccines and now first promising clinical results raise hopes. A summary of the most attractive new approaches gave Professor Carmen Scheibenbogen, Institut für Medizinische Immunologie, Charité-Universitätsmedizin, at a press conference in Berlin.

16 Sep 2009

Phase 3 clinical study results of bazedoxifene released

Wyeth Pharmaceuticals, a division of Wyeth, announces findings from a placebo-controlled Phase 3 study of bazedoxifene 20 mg extended to five years, which indicated a significant reduction versus placebo in new vertebral fractures in postmenopausal women with osteoporosis.

15 Sep 2009

Idera Pharmaceuticals to discuss TLR-targeted drug discovery and development programs

Idera Pharmaceuticals, Inc., a biotechnology company engaged in the discovery and development of DNA- and RNA-based drug candidates targeted to Toll-like Receptors (TLR), today announced that it will discuss its TLR-targeted drug discovery and development programs and provide a general corporate overview at the UBS Global Life Sciences Conference on Monday, September 21, 2009, at 10:30 a.m. EDT at the Grand Hyatt New York Hotel in New York City.

15 Sep 2009

Biocryst signs agreement with three partners to represent its anti-viral peramivir outside U.S.

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has signed binding letters of intent with three partners who will exclusively represent BioCryst and its anti-viral peramivir for influenza stockpiling opportunities, as well as for marketing and distribution of peramivir for seasonal influenza upon local regulatory approval, within their territories outside the U.S.

15 Sep 2009

Halozyme Therapeutics to present its product development pipeline

Halozyme Therapeutics, Inc., a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced its participation in the UBS Global Life Sciences Conference to be held on September 21-23, 2009 in New York City.

15 Sep 2009

Neuroskin Psoriasis Relief DRTV test results announced by avVaa World Health Care

avVaa World Health Care Products Inc. (Pink Sheets: AVVH), a global biotechnology company, manufacturer and distributor of nationally branded therapeutic, natural skin and health care products, announced the results of its first DRTV test week.

15 Sep 2009

CPEX Pharmaceuticals to discuss the clinical aspects of nasal insulin therapy

CPEX Pharmaceuticals, Inc. (“CPEX”) today announced that it will participate in the Ninth Annual Diabetes Technology Meeting to be held November 5–7, 2009, at the Hyatt Regency Airport in San Francisco, California. Dr. Lance Berman, Senior Vice President and Chief Medical Officer, is scheduled to present an oral presentation titled “The Technology and Clinical Aspects of Nasal Insulin Therapy” at 9:30 a.m. PST on Saturday, November 7, 2009.

15 Sep 2009