Bethesda, Md. ? The National Human Genome Research Institute (NHGRI), part of the National Institutes of Health (NIH), today announced the latest round of grant awards totaling more than $13.3 million to speed the development of innovative sequencing technologies that reduce the cost of DNA sequencing and expand the use of genomics in medical research and health care.
Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) for bifeprunox, an investigational atypical antipsychotic for the treatment of schizophrenia.
Anesiva, Inc. (Nasdaq: ANSV) announced today that the U.S. Food and Drug Administration (FDA) granted orphan drug status to product candidate 4975 for the treatment of a painful condition in the foot known as interdigital neuroma in patients who fail conservative treatments, such as foot pads, NSAID’s (non-steroidal anti-inflammatory drugs) and injections of corticosteroids, that would otherwise require removing or chemically destroying the nerve that causes the pain. Orphan drug designation is granted by the FDA to encourage companies to develop products that treat rare diseases and conditions and includes incentives such as market exclusivity for seven years, tax credits on qualified clinical trial expenses and a waiver of the FDA prescription drug user fees.
Innocoll, Inc. announced that its wholly-owned subsidiary, Innocoll Pharmaceuticals, has received US 510k approval for CollaGUARD(TM), an advanced wound care product based on Innocoll’s proprietary CollaRx(TM) membrane technology. CollaGUARD is indicated for the management of superficial and deep wounds, including coverage of skin ulcers and temporary dermatoplasty in the case of lesion and burns. CollaGUARD has already received CE-mark approval for marketing in Europe.
TriPath Imaging Inc. (Nasdaq: TPTH) and Ventana Medical Systems, Inc. (Nasdaq: VMSI), announced today that TriPath Imaging has received 510(k) clearance from the U.S. Food and Drug Administration for the Ventana Image Analysis System (VIAS(TM)) when used with tissues stained for p53. In 2005 and 2006, the Companies announced 510(k) clearances for VIAS when used with the Ventana Estrogen Receptor (ER), Progesterone Receptor (PR), Ki-67 and HER- 2/neu assays.
Agennix today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the Company’s oral formulation of Talactoferrin Alfa (talactoferrin or TLF) for the treatment of renal cell carcinoma (RCC). Oral TLF is currently in Phase II clinical development for RCC. Results from a multi-center Phase 2 RCC trial that included six leading U.S. cancer centers were presented at the 2006 Annual meeting of the American Society of Clinical Oncology (ASCO).
Nabi Biopharmaceuticals (Nasdaq: NABI) today announced it has completed enrollment for its Phase IIB “proof-of-concept” study for NicVAX(R) (Nicotine Conjugate Vaccine), the company’s novel, innovative and proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse. Enrollment for the trial was completed three months earlier than anticipated, paving the way for the release of trial results early in the second quarter of 2007.
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a biopharmaceutical company with a portfolio of innovative, clinical stage products for the treatment of cancer and hepatitis C virus infection, today announced that it has received regulatory approval in India for a new clinical trial of its lead tumor necrosis therapy (TNT) agent Cotara(R). The trial is designed to test the safety and efficacy of Cotara in patients with glioblastoma multiforme, a deadly form of brain cancer. Cotara is currently being studied in a multi-center U.S. glioblastoma trial. Previous studies using Cotara to treat brain cancer have produced encouraging results, and Peregrine expects that positive data from this trial in combination with data from the ongoing U.S. clinical trial should provide the foundation for planning the future development and commercialization of Cotara.
Manhattan Pharmaceuticals, Inc. (Amex: MHA) today announced expansion of its oral Oleoyl-estrone (OE) clinical obesity program to include the morbidly obese. A new US Phase 2a clinical trial evaluating oral OE in morbidly obese male subjects will be initiated in October 2006. The morbidly obese population in the US is estimated to be 14 million people. OE is the Company’s orally administered product candidate in development for the treatment of obesity.
Chikungunya is turning out to be a national epidemic & a major calamity. There are horror stories of whole villages in Rajasthan being affected & old people who are so debilitated that they are not able to feed themselves.