|Momenta Spikes Up Following FDA News On Copaxone; StemCells Completes Enrollment of First Cohort in Phase II Pathway Study|
|By Marilyn Mullen|
|Thursday, 16 April 2015 18:55|
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 16, 2015.
Teva Pharmaceutical Industries Ltd (ADR) (NYSE: TEVA) fell nearly 4 percent Thursday to $63.34 following news that the FDA denied its petition to block generic versions of its Copaxone drug.
Mylan NV (NASDAQ: MYL) surged amid the news to $67.76, up 1.48 percent, while Momenta Pharmaceuticals, Inc. (NADDAQ: MNTA) spiked from $16.36 to $20.04 Thursday after the FDA approved its generic version of Copaxone, called Glatopa.
"We are proud to be able to offer patients with multiple sclerosis the first generic version of daily COPAXONE and the first generic product in this space," said Craig Wheeler, President and CEO, Momenta Pharmaceuticals. "The FDA approval of the ANDA for once daily Glatopa further validates Momenta's approach of using innovative physicochemical and biologic characterization to gain approval of complex generics, biosimilars and novel drugs, and advances Momenta's goal of expanding access to high quality, more affordable medicines."
Momenta Pharmaceuticals gave back some of its earlier gains and recently traded at $17.26, up 7.2 percent.
StemCells, Inc. (NASDAQ: STEM), announced today that it has completed transplanting the six patients comprising the first cohort of its Phase II Pathway® Study. The first cohort is an open-label dose escalation arm to determine the cell dose to be used for the second cohort of the study. The second cohort of the study is a single-blind arm in 40 patients that will assess efficacy of the Company's proprietary HuCNS-SC® (purified human neural stem cells) platform technology for the treatment of cervical spinal cord injury (SCI).
"We are breaking new ground with this study," said Stephen Huhn, M.D., FACS, FAAP, vice president, CNS clinical research and CMO at StemCells, Inc. "This is the first controlled study to use neural stem cells with the intent to demonstrate improvement in motor function following spinal cord injury. In this first cohort, we have achieved the highest number of neural stem cells administered into the injured human spinal cord in medical history. We expect to release six month interim data on the first cohort later this year.
"Interest in this study from both physicians and patients has been very encouraging, resulting in the rapid enrollment of this cohort. The Company is using web-based recruitment and, in the first six months, we have seen over 1,500 inquiries and 500 completed questionnaires and over 100 subjects have been reviewed for possible eligibility. Our experience with the first cohort reflects great clinical momentum, as well as the excitement within the spinal cord injury community for potential novel treatments. Detecting evidence of motor improvement in this Phase II study would provide proof-of-concept for this approach in spinal cord injury and would ultimately lead to a therapy that dramatically enhances the quality of life for those afflicted with spinal cord injuries."
3D Systems (NYSE:DDD) announced today that a 20-month-old toddler is breathing and swallowing easier thanks to a team of cardiologists and cardiothoracic surgeons at Washington University School of Medicine in St. Louis, MO, who used a full-color 3D printed replica of his heart to prepare for a delicate, 2.5 hour procedure at St. Louis Children's Hospital.
Amyris, Inc. (Nasdaq:AMRS) will report financial results for the first quarter ended March 31, 2015 after market close on Tuesday, May 5, 2015.
CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the development and commercialization of clinically differentiated, high value, non-invasive surveillance solutions for transplant recipients, today announced new evidence that the proportion of cell-free DNA (cfDNA) derived from the transplanted organ and found in the bloodstream of the recipient is correlated to the rejection status of the organ.
ExamWorks Group, Inc. (NYSE:EXAM) announced today that it has closed its previously announced offering of $500.0 million in aggregate principal amount of 5.625% senior notes due 2023 (the "Notes") pursuant to an effective shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC") on April 7, 2015.
Hemp, Inc. (OTC:HEMP), a leader in the industrial hemp industry, announced today the Kush Cakes re-launch, with Dewmar International BMC, Inc. (OTC:DEWM) was a huge success at the Big Industry Show in Denver, CO April 14 and 15, 2015.
Herborium® Group, Inc. (OTC Pink: HBRM), a Botanical Therapeutics® Company providing unique, all botanical medicines (Botanical Therapeutics®), announced today its 2015 First Quarter financial results. The company filed the Quarterly Financial Report with OTC, on Wednesday April 15th, 2015.
iCAD, Inc. (Nasdaq:ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced that the Company will release financial results for the first quarter ended March 31, 2015 before market open on Thursday, April 30, 2015.
INC Research Holdings, Inc. (Nasdaq:INCR), a leading global Phase I to IV contract research organization, today announced the formation of a new Site Advocacy Group (SAG) focused on streamlining and enhancing the payment process for clinical research sites.
MacroGenics, Inc. (Nasdaq:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, today announced that pre-clinical data from programs based on its Dual-Affinity Re-Targeting (DART®) bi-specific technology will be presented at the 2015 American Association for Cancer Research (AACR) Annual Meeting in Philadelphia, PA by the Company and Pfizer, Inc., one of MacroGenics' collaboration partners.
No stranger to providing security for the quickly growing cannabis industry, Medical Marijuana, Inc.'s (OTC Pink:MJNA) subsidiary, Wellness Managed Services' MPS International (MPSI), has secured exclusive security contracts for historic events including Seattle Hempfest.
Medigus Ltd. (TASE:MDGS), a medical device company developing minimally invasive endosurgical tools and a leader in direct visualization technology, announced that results of an ex-vivo study are being revealed today at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Annual Meeting, currently taking place through April 17th at the Gaylord Opryland Hotel and Convention Center in Nashville, Tennessee.
MedAssets (Nasdaq:MDAS) today announced that it recently held its 15th annual Healthcare Business Summit in Las Vegas, which brought together nearly 4,000 healthcare providers, suppliers and business partners to network and exchange lessons learned for workable ways to create a more consumer-driven, value-based and data-centric healthcare system.
MediciNova, Inc. (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), announced that the Tokyo Stock Exchange (TSE) has announced a new rule affecting the trading of dual-listed stocks on the Tokyo Stock Exchange, including the stock of MediciNova.
Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy, announced today that the Company will release its financial results for the first quarter ended March 31, 2015, after the close of the stock market on Thursday, April 23rd, 2015.
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), today announced that the U.S. Food and Drug Administration has granted marketing approval of Sandoz's Abbreviated New Drug Application for once daily Glatopa™ (glatiramer acetate injection, formerly M356) 20 mg/mL, a generic equivalent of daily COPAXONE® 20 mg.
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that it will conduct a conference call to discuss the approval of Glatopa™ (glatiramer acetate injection, formerly M356) 20mg/mL, the first substitutable generic for COPAXONE®.
NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced the expansion of its rapidly growing product portfolio focused on cutting edge genomic—and now proteomic—cancer research with the introduction of three new products for the nCounter® Analysis System.
Sysco Corporation (NYSE:SYY) and its specialty produce company FreshPoint were recently recognized with the Produce for Better Health (PBH) Foundation's prestigious Role Model Award.
Trillium Therapeutics Inc. (Nasdaq:TRIL) (TSX:TR) an immuno-oncology company developing innovative therapies for the treatment of cancer, today announced it will be providing an update on its SIRPaFc immune checkpoint inhibitor program, targeting the CD47 protein, at the 106th Annual Meeting of the American Association for Cancer Research.