Coronado Bio Presents Interim Data from Autism Study; FDA Advisory Committee Unanimously Recommends GRASTEK Print E-mail
By Staff and Wire Reports   
Thursday, 12 December 2013 19:50
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 12, 2013.

Coronado Biosciences, Inc. (Nasdaq: CNDO)
, a biopharmaceutical company developing novel immunotherapy agents for the treatment of autoimmune diseases and cancer, today announced that Dr. Eric Hollander, Clinical Professor of Psychiatry and Behavioral Sciences at Albert Einstein College of Medicine of Yeshiva University and Director of the Autism and Obsessive Compulsive Spectrum Program at Montefiore Medical Center and Einstein, presented interim data from his pilot study of oral TSO (Trichuris suis ova or CNDO-201) to treat autism at the American College of Neuropsychopharmacology Annual Meeting in Hollywood, Florida.

The study is a double-blind, randomized, placebo-controlled, cross-over study and enrolled 10 high-functioning adult autism spectrum disorder patients who were able to give informed consent to participate in the study and who had a history of allergies and/or a family history of immune-inflammatory illness. They were treated for 12 weeks with either TSO or placebo, followed by a 4-week washout phase and then 12 weeks of placebo or TSO. The TSO dosage used in the study was 2,500 ova once every two weeks.

In the first 5 patients that completed the study, there was a statistically significant separation from placebo in favor of TSO on three measures of disease: the Montefiore-Einstein Rigidity Scale (MERS), the Repetitive Behavior Scale-Revised (RBS-R) Sameness Scale, and the Social Responsiveness Scale (SRS)-Repetitive Behaviors Scale. The treatment was well tolerated.

The study is still ongoing and final results are expected in the middle of 2014.

"There is increasing evidence that immune dysregulation plays an important role in this developmental disorder and we are encouraged by the interim data from this pilot study with TSO," said Dr. Harlan F. Weisman, Coronado's Chairman and CEO. "We believe autism is an area of unmet medical need where a natural immune system regulator like TSO may help a part of the autism population."



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ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF)
today announced that the Allergenic Products Advisory Committee of the US Food and Drug Administration has voted unanimously that the available data support the efficacy and safety of Merck's GRASTEKTM in patients aged five to 65 years. The committee further recommended that adrenaline auto-injectors should be made available for patients at home.

GRASTEKTM is the proposed US trade name of the grass sublingual allergy immunotherapy tablet, licensed to Merck (known as MSD outside the USA and Canada) for North America by ALK, and marketed in Europe under the brand name GRAZAX(R).  

The FDA is currently reviewing Merck's Biologic License Application (BLA) for GRASTEKTM for the treatment of grass pollen induced allergic rhinitis, with or without conjunctivitis, in adults and children of five years and older.

Jens Bager, ALK's President and CEO, said: "ALK welcomes the FDA Advisory Committee's conclusion, which represents another important step towards bringing this innovative new treatment to US patients."  

Although not binding, the FDA will consider the committee's recommendation as it completes its review of the BLA for GRASTEKTM, a process that is expected to be concluded during the first half of 2014.



Also Thursday:




ACETO Corporation (Nasdaq:ACET)
, a global leader in the marketing, sale and distribution of products for Human Health, Pharmaceutical Ingredients and Performance Chemicals, today announced that its wholly-owned French subsidiary, Aceto France SAS, acquired Inter'actifs, a distributor of ingredients to the cosmetics and personal care industries.

AngioDynamics (Nasdaq:ANGO)
, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced it will report its fiscal 2014 second quarter financial results for the period ended November 30, 2013, on Thursday, January 9, 2014, after the close of the U.S. financial markets.

Baxano Surgical, Inc. (Nasdaq:BAXS),
a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the spine affecting the lumbar region, today announced the 2014 Medicare Final Physician Fee Schedule Rule released in late November revises upward the Practice Expense Relative Value Units (PERVUs) for Current Procedural Terminology (CPT) Code 22586 for pre-sacral interbody fusion.

Biodel Inc. (Nasdaq:BIOD)
will issue its fourth quarter fiscal year 2013 financial results on December 18, 2013.

BioReference Laboratories, Inc. (Nasdaq:BRLI)
announced today it plans to issue earnings results for the fourth quarter and year end for 2013 before the open of market trading on Thursday, December 19, 2013.

BioSpecifics Technologies Corp. (NASDAQ: BSTC)
, a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX (collagenase clostridium histolyticum or CCH) in the U.S and XIAPEX® in the EU, today announced that its Board of Directors has reauthorized the stock repurchase program under which BioSpecifics is authorized to repurchase up to $2 million of its outstanding common stock.

BioTelemetry, Inc. (Nasdaq:BEAT)
, the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, announced that recently published research from an observational study of more than 200,000 patients demonstrates significant in-hospital cost savings in the twelve months following diagnosis using mobile cardiac telemetry.

B.O.S. Better Online Solutions Ltd. (Nasdaq:BOSC)
, today announced that its Supply Chain Division received orders in the amount of $800,000 from medical equipment manufacturers in Israel and Europe.

Celator Pharmaceuticals, Inc. (Nasdaq:CPXX)
, a pharmaceutical company developing new and more effective therapies to treat cancer, today announced that the independent Data and Safety Monitoring Board (DSMB) for the Company's Phase 3 clinical study comparing CPX-351 (cytarabine:daunorubicin) Liposome Injection versus the conventional cytarabine and daunorubicin treatment regimen (commonly referred to as 7+3 ) as first-line therapy in older patients with high-risk (secondary) acute myeloid leukemia (AML) should continue as planned without any modifications.

Champions Oncology, Inc. (OTC:CSBR)
, engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs, announced today its financial results for the fiscal quarter ended October 31, 2013.

The Cooper Companies, Inc. (NYSE:COO)
today announced that its Board of Directors has authorized the repurchase of up to an additional $200.0 million of common stock under the existing share repurchase program.

Coronado Biosciences, Inc. (Nasdaq:CNDO),
a biopharmaceutical company developing novel immunotherapy agents for the treatment of autoimmune diseases and cancer, today announced that Dr. Eric Hollander, Clinical Professor of Psychiatry and Behavioral Sciences at Albert Einstein College of Medicine of Yeshiva University and Director of the Autism and Obsessive Compulsive Spectrum Program at Montefiore Medical Center and Einstein, presented interim data from his pilot study of oral TSO (Trichuris suis ova or CNDO-201) to treat autism at the American College of Neuropsychopharmacology Annual Meeting in Hollywood, Florida.

Endocyte, Inc. (Nasdaq:ECYT)
, a biopharmaceutical company and leader in targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases, today announced that it has dosed the first patient in its Phase 1 clinical trial in advanced solid tumors for its SMDC EC1456, a folate receptor (FR)-targeting folate-tubulysin conjugate.

Eternity Healthcare / GMEA (OTCBB:ETAH)
, a Medical Device and Services Provider company, today announced that it has obtained market approval for a gel-based vest that could reduce body temperature by over 10 degrees in the hottest temperatures of year. The vest, once activated, will remain effective for days, depending on the environment.

Integra LifeSciences Holdings Corporation (Nasdaq:IART)
today announced the publication of the clinical study, Collagen Conduit Versus Microsurgical Neurorraphy: 2-Year Follow Up of a Prospective, Blinded Clinical and Electrophysiological Multicenter Randomized, Controlled Trial, in the December issue of The Journal of Hand Surgery.

IntelGenx Technologies Corp. (OTCQX:IGXT) (TSX-V:IGX)
, a drug delivery company focused on the development of novel oral rapidly disintegrating delivery systems including its proprietary VersaFilm™ technology, as well as oral controlled-release products, announced today that it has entered into definitive agreements with institutional investors to purchase approximately $3.5 million of securities in a registered public offering.

IPC The Hospitalist Company, Inc. (Nasdaq:IPCM)
, a leading national hospitalist physician practice company, announced today that it has completed the previously announced agreements to acquire the assets of four affiliated entities: Park Avenue Health Care Management, LLC; Park Avenue Medical Associates, PC; Park Avenue Medical Associates, LLC; and Geriatric Services, PC.

Landec Corporation (Nasdaq:LNDC)
will hold a conference call on Friday, January 3, 2014 at 8 a.m. Pacific time to discuss its results for the second quarter 2014.

Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA)
announced today that it has named Michael Franken, M.D. as President, Biosimilars Business.

Myriad Genetics, Inc. (Nasdaq:MYGN)
today presented clinical data at the 2013 San Antonio Breast Cancer Symposium that showed the myRisk Hereditary Cancer test found 51 percent more patients with a higher risk of hereditary breast and ovarian cancer than did testing for the BRCA1 and BRCA2 genes alone.

Dr. Ron Najafi, Chairman and Chief Executive Officer of NovaBay® Pharmaceuticals, Inc. (NYSE MKT:NBY) acknowledged as a first step the U.S. Food & Drug Administration for asking pharmaceutical companies to voluntarily reduce the use of antibiotics in animal feed and drinking water.

Nuvilex, Inc. (OTCQB:NVLX)
, an international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, commented today that ongoing preparations for its planned late-phase clinical trials appear to be timely as recent reports in the scientific literature point to an ever-increasing incidence of pancreatic cancer.

Oculus Innovative Sciences, Inc. (Nasdaq:OCLS)
a global healthcare company that designs, manufactures and markets prescription and non-prescription products 27 countries, today announced a regulatory approval in Mexico for the company's new Microcyn®-based scar management hydrogel, under the brand name Epicyn™.

Over the first 18 months of the Partnership for Patients initiative, Premier, Inc.'s (Nasdaq:PINC) Hospital Engagement Network (HEN) worked with nearly 450 organizations in 37 states to reduce readmission rates by 4.9 percent and hospital-acquired conditions (HACs) by 12 percent.

Response Genetics, Inc. (Nasdaq:RGDX)
, a company focused on the development and sale of molecular diagnostic tests that help determine a patient's response to cancer therapy, announced today it intends to offer and sell registered shares of its common stock in an underwritten public offering.

VIVUS, Inc. (Nasdaq:VVUS)
today announced that it has entered into a License and Commercialization Agreement with Sanofi to commercialize avanafil on an exclusive basis in Africa, the Middle East, Turkey, and the Commonwealth of Independent States (CIS) including Russia.

XOMA Corporation (Nasdaq:XOMA)
announced today it is offering to sell, subject to market and other conditions, shares of its common stock pursuant to an effective shelf registration statement in an underwritten public offering.



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