|The FDA Gives Oncolytics' Reolysin Ophan Drug Statuc; Anika Submits Regulatory Application For Cingal|
|By Josh Gee|
|Wednesday, 11 February 2015 20:09|
The FDA gave Orphan Drug Status to Oncolytics Biotech, Inc. (USA) (NASDAQ: ONCY) Ovarian Cancer drug, Reolysin, on Wednesday.
Through this designation, Oncolytics Biotech is given tax reductions, along with exclusive rights to any cure within seven years post status designation. This particular status is only given to drugs that help treat rare diseases, which is defined as those afflicting 200,000 people or less.
In 2014, there were 21,980 new cases of the disease with a 44.6 percent survival rate in a five-year period. Year-over-year, Oncolytics Biotech is down 70 percent. On Wednesday, the stock is up 6.4 percent to $0.50.
Anika Therapeutics, Inc. (Nasdaq: ANIK), a leader in products for tissue protection, healing and repair, based on hyaluronic acid (HA) technology, today announced that it has filed regulatory submissions in both the United States and Europe seeking the approval of Cingal, the Company’s novel HA plus steroid single-injection treatment for osteoarthritis of the knee. Anika submitted its application for CE Mark approval to commercialize Cingal in the European Union and also filed its premarket approval application (PMA) with the U.S. Food and Drug Administration to allow for marketing and distribution in the United States.
“After meeting all of the primary and secondary endpoints from our multinational Phase III Cingal clinical trial in a clinically and statistically meaningful fashion, we filed the CE Mark application as planned at the end of 2014 and submitted the PMA a few days ago, ahead of schedule,” said Anika President and CEO Dr. Charles H. Sherwood. “The filing of these submissions is a milestone achievement for Anika and, after approvals, positions us extremely well in the market from a competitive standpoint. In addition to the United States and Europe, we plan to commercialize Cingal in other key markets in the world. We look forward to patients benefiting from Cingal, which provides the convenience and efficacy of our current single-injection treatment, Monovisc®, with the added early symptom relief benefits of a commonly used steroid.”
The Cingal Phase III trial was a 26-week, randomized, double-blind, three-arm, placebo-controlled study designed to evaluate the efficacy and safety of a single injection of Cingal in approximately 368 patients experiencing joint pain from osteoarthritis of the knee who had not responded to conservative treatment. Patients were randomized to receive a Cingal treatment, a placebo treatment or a treatment of Anika’s Monovisc product. After the initial treatment, patients were assessed for 26 weeks at clinical sites in Europe and Canada. The primary clinical effectiveness endpoint data measured the change in the patients’ knee pain over the course of the trial from their baseline level according to the WOMAC Pain Score.
Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, has entered into a clinical trial collaboration agreement with Incyte Corporation (Nasdaq:INCY) to evaluate the combination of Advaxis's Lm-LLO cancer immunotherapy, ADXS-HPV (ADXS11-001), with Incyte's investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360).
Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that it has entered into definitive agreements with affiliates of Sarissa Capital Management LP and an additional accredited investor, in a registered direct offering of 6,043,955 shares of common stock and warrants to purchase up to 3,021,977 shares of common stock.
Applied Genetic Technologies Corporation (Nasdaq:AGTC), a clinical stage biotechnology company developing adeno-associated virus (AAV)-based gene therapies for the treatment of rare eye diseases, today announced financial results for the second quarter ended December 31, 2014.
Auris Medical Holding AG (Nasdaq:EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today announced that it has recently been granted a patent by the Chinese patent office covering the use of its investigational tinnitus treatment AM-101.
Cellular Dynamics International (CDI) (Nasdaq:ICEL) today announced that its iCell® Hepatocytes, or human liver cells manufactured from induced pluripotent stem cells (iPSCs), have been used as a malaria-in-a-dish model to test anti-malarial drug candidates. Sangeeta N. Bhatia, M.D., Ph.D., of the Institute for Medical Engineering and Science, Massachusetts Institute of Technology, infected the iPSC-derived hepatocytes with parasitic Plasmodium species, characterized the cells' drug metabolism capabilities using known antimalarial drugs, and chemically matured the cells to demonstrate higher sensitivity to a different class of drugs.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based cancer diagnostics, announced today the appointment of Randy Goodman, Ph.D., as Director of Reimbursement and Clinical Revenue Cycle Management.
CAS Medical Systems, Inc. (Nasdaq:CASM), a medical technology company that develops, manufactures and markets non-invasive patient monitoring products, today announced that it has priced a firm commitment underwritten public offering of 6,200,000 shares of its common stock at a price to the public of $1.30 per share.
Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company, announced today it will report financial results for the fiscal second quarter ended December 31, 2014, on Thursday, February 12, 2015.
Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company, today announced that the Company has received approval from the India Drug Controller General ("DCGI") for the import and commercialization of its MarrowXpressTM ("MXPTM") System in India.
Dehaier Medical Systems Ltd. (Nasdaq:DHRM), which develops, markets and sells medical devices and wearable sleep respiratory products in China, today announced that it has signed a strategic cooperation agreement with the Clinical Sleep Medicine Center of the Air Force General Hospital (the "Hospital") to fully cooperate on sleep-related clinical research studies, sleep disease diagnosis and treatment, technology and equipment clinical tests, as well as public education and a sleep disorder awareness campaign.
FlexPower Inc. (OTCMKTS:FLXP), a California consumer products corporation that makes and markets innovative pain management products that address the growing needs of the athletic community and baby boomers, is pleased to announce that it had the opportunity to present at the inaugural Innovations Conference,
Gala Global, Inc. (OTCQB:GLAG) today announced it has finalized the initial CBD products.
Heat Biologics, Inc. (Nasdaq:HTBX), a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, announced today the presentation of data demonstrating the incorporation of T-cell costimulatory fusion proteins into Heat's gp96-Ig vaccine platform, at a Keystone Symposia on "Tumor Immunology -- Multidisciplinary Science Driving Combination Therapy," which is being held in Banff, Canada.
Herborium® Group, Inc. (OTC Pink: HBRM), a Botanical Therapeutics® Company's (a provider of unique, all botanical medicines) CEO and Chairwomen Dr. Agnes P. Olszewski issued the following Letter to Shareholders today to respond to rumors of a pending reverse stock split of Herborium's stock.
Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company, today announced the start of a Phase 1 clinical trial of G100 in combination with radiation therapy in patients with metastatic sarcoma. G100 is an investigational immuno-oncology agent designed to generate a robust anti-tumor immune response when administered directly to the tumor micro-environment.
Lion Biotechnologies, Inc. (OTCQB:LBIO), a biotechnology company that is developing novel cancer immunotherapies based on tumor-infiltrating lymphocytes (TIL), today announced that it has obtained an exclusive, worldwide license from the National Institutes of Health (NIH) to intellectual property related for a next-generation TIL technology for the treatment of metastatic melanoma.
Lombard Medical, Inc. (Nasdaq:EVAR), a medical device company focused on endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs), today announced that Michael H. Carrel has been appointed to the Company's Board of Directors.
MedAssets (Nasdaq:MDAS) today announced that HackensackUMC Mountainside, a 365-bed teaching hospital and part of LHP Hospital Group, Inc., has elected to expand and renew its Revenue Cycle Services relationship with the company.
The booming cannabis industry is known to entrepreneurs as the "Green Rush" and, today, Medical Marijuana, Inc. (OTC Pink:MJNA) is announcing a mother lode. In an historic move, Medical Marijuana, Inc., a hemp industry innovator, is relocating from Colorado to California one of the most recognized brands in the cannabis industry and the world: Dixie Botanicals™.