Access Pharma Reports Additional MuGard Study Findings; Onyx Submits New Drug Application Print E-mail
By Staff and Wire Reports   
Wednesday, 28 September 2011 20:20

Below is a look at some of the headlines for companies that made news in the healthcare sector on September 28, 2011.

Access Pharmaceuticals, Inc. (OTCBB:ACCP), announced findings of an independent presentation on MuGard clinical experience. The ongoing research study was conducted by the Oncology and Maxillofacial Departments of the Musgrove Park Hospital in Taunton, UK. In the study, 20 head and neck cancer patients were prospectively assessed for MuGard efficacy and tolerability, and compared to a historical comparison group of head and neck cancer patients.

MuGard was effective in prevention, delay and management of radiotherapy (RT) and chemo-radiotherapy (C-RT) induced oral mucositis, as well as reducing the need for opiate pain medicine and gastrostomy (feeding tube) use.  Patients using MuGard noted a reduction of the severity of both clinically assessed and patient perceived symptoms of oral mucositis, resulting in RTOG scoring (the Radiation Therapy Oncology Group assessment score) falling to half of expected value.

Marked reduction in pain experience during and following treatment, required milder pain medication for shorter periods of time, which has a positive impact on cost and other patient side effects such as drowsiness and constipation. MuGard use allowed patients to maintain oral nutrition and hydration for longer than usually seen, with a significant reduction in the use of supplements and gastrostomy feeding tubes. MuGard was generally well tolerated, and clinicians were supportive of MuGard use based on the clearly evident benefits to the patient seen in the study.

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Onyx Pharmaceuticals (NASDAQ:ONXX)
announced it has completed the New Drug Application (NDA) submission to the FDA under the accelerated approval process for carfilzomib, a next generation proteasome inhibitor, for the potential treatment of patients with relapsed and refractory multiple myeloma.

In addition, Onyx has requested priority review of the application, which reduces the time the FDA takes to review a new drug application.

Also Wednesday:

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced the preliminary findings of the Company's randomized, placebo-controlled, Phase 3 clinical study of BEMA Buprenorphine for the treatment of moderate to severe chronic pain in a mixed opioid naive and opioid experienced population.

Discovery Laboratories, Inc. (Nasdaq: DSCO) announced today that the U.S. Food and Drug Administration (FDA) has deemed "complete" the company's Complete Response for SURFAXIN® (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.

EnteroMedics Inc., (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced the closing of its previously announced public offering of 8,800,000 shares of its common stock and warrants to purchase 1,760,000 shares of its common stock.

Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the diabetes, cancer, dermatology and drug delivery markets, today announced the commencement of a Phase 1/2 clinical trial with HTI-501 (rHuCAT-L) in women with moderate to severe edematous fibrosclerotic panniculopathy (also known as cellulite).

Health Discovery Corporation (OTCBB: HDVY) is pleased to announce that the United States Patent and Trademark Office has issued the first of what the Company expects to be several patents covering methods to screen for the presence of prostate cancer using genomic biomarkers that were identified by HDC researchers using the Company's patented RFE-SVM algorithm.

Shares of the tightly held IntelliCell BioSciences, Inc. (OTCQB: SVFC) (PINKSHEETS: SVFC) have been starting to climb since announcing their arrival as a disruptive stem cell harvesting technology firm just a few short weeks ago. Shares rose nearly 16% on Wednesday following a report about the company's early progress and financial revenue projections.

Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that it has completed the New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) under the accelerated approval process for carfilzomib, a next generation proteasome inhibitor, for the potential treatment of patients with relapsed and refractory multiple myeloma.

PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced that it will hold its annual seminar for biopharmaceutical companies and multinational affiliates based in Japan and throughout Asia on October 5, 2011 at the Grand Hyatt Tokyo in Japan.

Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that it has completed enrollment for its Phase II clinical trial of Archexin® in metastatic pancreatic cancer.

As part of its ongoing work in the prevention and control of serious infections in healthcare settings, Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today its sponsorship of the 3rd Annual World MRSA Day.

Spectrum Pharmaceuticals (NasdaqGS:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the appointment of Brian Holzer to the position of Executive Director of Brand Management.

Unilens Vision Inc. (OTCBB: UVIC) (OTCQB: UVIC) (TSX-V: UVI), which develops, licenses, manufactures, distributes and markets specialty contact lenses, today reported its operating results for the fourth quarter and fiscal year ended June 30, 2011.

YM BioSciences Inc. (NYSE Amex: YMI) (TSX: YM) today announced that it has enrolled the first patients in its multi-center Phase II trial of CYT387 administered twice-daily (BID) for the treatment of myelofibrosis.




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