Dendreon Corporation today announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) is a complete response. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010, by which time it will respond to Dendreon's amended BLA. Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC). [More]

Pfizer announced today that the U.S. Food and Drug Administration (FDA) has approved Revatio® (sildenafil) Injection, an intravenous formulation of Revatio. Revatio is the only FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations. [More]

CombinatoRx, Incorporated and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued Neuromed a letter extending its review of the New Drug Application (NDA) for the product candidate Exalgo™ (hydromorphone HCl) extended-release tablets by three months. [More]

New data released today by Quest Diagnostics Incorporated, the nation's leading provider of employment-related drug testing services, reveal that drug testing of hair specimens from employees and job applicants in the general U.S. workforce has tracked sharp downward trends in cocaine and methamphetamine use from 2005 to the first half of 2009 that mirror similar drops shown by urine testing. [More]

Soligenix, Inc., formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has formed a consortium to develop thermostable technology to advance RiVax(TM) and other rapidly acting vaccines. Soligenix received a $9.4 million grant from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), to support this work. [More]

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today that a combination of its synthetic consensus H1N1, H2N2, H3N2, and H5N1 influenza vaccine candidates achieved protective antibody responses against several different influenza sub-types and strains in ferrets. [More]

Research and Markets (http://www.researchandmarkets.com/research/3e1fb3/analyzing_the_gene) has announced the addition of the "Analyzing the Generic Drugs Sector of the US Pharmaceutical Industry" report to their offering. [More]

The Orlando Dermatology Aesthetic & Clinical (ODAC) conference is proud to welcome two leading executive officers offering their unique perspectives on the state of the industry and future opportunities at its 7th annual program, being held on January 15, 2010 at The Peabody Orlando in Orlando, Florida. [More]

Research and Markets has announced the addition of Decision Resources, Inc.'s new report "Pharmaceutical Market Access, Pricing, and Reimbursement News in the Second Quarter of 2009" to their offering. [More]

Research and Markets has announced the addition of the "CNS Therapeutics - A World Market Review" report to their offering. [More]

Research and Markets (http://www.researchandmarkets.com/research/fae4d4/neurological_disea) has announced the addition of Decision Resources, Inc.'s new report "Neurological Disease: Early-Stage R&D and Dealmaking" to their offering. [More]

Only about 1 in 4 Americans aged 50-64 regularly take advantage of preventive services such as screenings and immunizations, according to a report from the Centers for Disease Control and Prevention in collaboration with AARP and the American Medical Association (AMA). [More]

Increases in deaths from opioid drugs such as OxyContin may be linked to the volume of coverage such deaths receive in the news, according to a study from Children's Hospital Boston and the University of North Carolina (UNC), Chapel Hill. The study compared patterns of opioid deaths and patterns of news coverage between 1999 and 2005, during which time mortality rates from opioid abuse doubled. [More]

Immunization with either live attenuated influenza vaccine (LAIV, also known as FluMist®), or trivalent inactivated influenza vaccine (TIV), appears to offer a protection (~ 45%) against the novel A/H1N1 virus, the cause of the present influenza pandemic. However, the benefit was largely attributed to the youngest age group. The finding emerges from an evaluation of medical encounters and seasonal influenza immunization of U.S. military service members. [More]

Pharmaceutical companies face a fundamental decision about the best way to sell their products. Even if they could find a way to make the current sales model work, pharma companies still face sky-high commercial costs. So, the question is, should pharma companies stick with their traditional sales approach or blow it up and try something new? [More]