Applied DNA Sciences Announces SigNature DNA Compliance With FDA Guidelines; Myriad and BioMarin Expand Collaboration to Evaluate Talazoparib Print E-mail
By William Kent   
Tuesday, 17 March 2015 18:50
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 17, 2015. 
Applied DNA Sciences, Inc. (NASDAQ: APDN) announced Covington & Burling, considered the best law firm in the US for FDA law (source: U.S. News and World Report), considers SigNature DNA to be immediately suitable for inclusion in prescription drugs in order to authenticate their originality and thereby exclude counterfeit drugs from the supply chain.
FDA has been deeply concerned about the rapid growth and increased sophistication of illegal counterfeiting of FDA-regulated products. In October 2011, FDA published a Final Guidance document on the use of so called "Physico-Chemical Identifiers" (PCIDs). SigNature DNA is used in drugs at levels of approximately 1 part per trillion (1 in 1012); this level of SigNature DNA is less than 1/100,000ththe level of DNA considered permissible as a contaminant in oral doses. Any PCID that satisfies the general principals established in the FDA Guidance is highly likely to be acceptable for any FDA-regulated product, except for those subject to an FDA-approved New Drug Application.
The extremely low levels of SigNature DNA required to authenticate a single dose are so small that they cannot adversely affect drug product integrity.
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Myriad Genetics, Inc. (Nasdaq:MYGN) announced an expansion of the Company's collaboration with BioMarin Pharmaceutical Inc. Under the expanded collaboration, BioMarin will use Myriad's myChoice HRD™ companion diagnostic test to prospectively identify patients with metastatic breast, ovarian and potentially other tumor types that may be sensitive to talazoparib. Financial terms were not disclosed.
Talazoparib is an investigational poly-ADP ribose polymerase (PARP) inhibitor being developed by BioMarin.  In the expanded relationship, the companies also will collaborate under FDA regulations and guidelines for the development and potential regulatory approval requirements for both talazoparib and myChoice HRD.
"Myriad is a pioneer in personalized medicine. Our companion diagnostics are providing clinicians with valuable biological data to accelerate and improve healthcare for their patients," said Mark Capone, president of Myriad Genetic Laboratories. "With cancer treatments, there is no one-size-fits-all approach for patients. We are excited to be working with BioMarin to help identify the patients who are most likely to benefit from talazoparib based on their own genetic makeup and biology."
The expansion adds to an ongoing collaboration that began in September 2013, when BioMarin began using Myriad's BRACAnalysis CDx companion diagnostic test in its pivotal Phase 3 EMBRACA and Phase 2 ABRAZO clinical studies of talazoparib for advanced or metastatic breast cancer patients carrying BRCA mutations. 
 
Also Tuesday:  
 
Aldeyra Therapeutics, Inc. (Nasdaq:ALDX), a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced that it has opened enrollment for its Phase II clinical trial of NS2 for patients with Sjögren-Larsson Syndrome.
Anavex Life Sciences Corp. (OTCQX: AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer's and other central nervous system (CNS) diseases, pain and various types of cancer, today announces that Christopher U. Missling, PhD, president and chief executive officer, will participate in a clinical trials podium discussion titled, "Is there a way to increase the chance of success in Phase 3?" at the 12th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD 2015). 
MedAssets, Inc. (Nasdaq:MDAS) today announced that Charles O. Garner was promoted to serve as executive vice president and chief strategy and transformation officer. 
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 reported financial results for the three months and full year ended December 31, 2014.
Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today that it has entered into a clinical trial collaboration with Roche to evaluate the safety, tolerability and preliminary efficacy of varlilumab, Celldex's CD27 targeting investigational antibody, and MPDL3280A (anti-PDL1), Roche's investigational cancer immunotherapy in a Phase 1/2 study in renal cell carcinoma.
Cellectar Biosciences, Inc. (Nasdaq:CLRB), a clinical stage biopharmaceutical company developing innovative agents for the detection and treatment of cancer, announced that management will host a conference call and live webcast to discuss fourth quarter and full year 2014 financial results and provide an update on each of its development programs on Tuesday, March 24th at 5:00 PM ET.
Coherus BioSciences, Inc. (Nasdaq:CHRS), a leading pure-play, global biosimilars company with late-stage clinical products, today announced that it has finalized the Biologics License Application (BLA) enabling clinical program for CHS-1701, a pegfilgrastim biosimilar candidate, and initiated a pivotal pharmacokinetics and pharmacodynamics (PK/PD) study pursuant to feedback received from the U.S. Food and Drug Administration (FDA) on the CHS-1701 development plan. 
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today that it plans to release financial results for the fourth quarter and year ended December 31, 2014 on Thursday, April 2, 2015, during pre-market hours.
Entellus Medical, Inc. (Nasdaq:ENTL), a medical technology company focused on the design, development and commercialization of products for the minimally invasive treatment of chronic and recurrent sinusitis patients in the physician office setting or operating room, today reported its financial results for the three months and year ended December 31, 2014.
Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company, today reported financial results for the quarter and year ended December 31, 2014, as well as recent highlights.
Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today provided a corporate update and reported financial results for the fourth quarter and full year ending December 31, 2014.
Histogenics Corporation (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced that Adam Gridley, President and Chief Executive Officer of Histogenics, will present at the 2015 Canaccord Genuity Musculoskeletal Conference on March 24, 2015 at 3:30 pm Pacific time at the MGM Grand in Las Vegas.
Kite Pharma, Inc., (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products based on CAR and TCR gene therapy platforms for the treatment of cancer, today announced that it has further strengthened its TCR product platform and established a European presence through the acquisition of T-Cell Factory B.V. (TCF™), a privately held Dutch company, which has been renamed Kite Pharma EU.
Macrocure Ltd. (Nasdaq:MCUR), a clinical-stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2014.
MedAssets, Inc. (Nasdaq:MDAS) today announced that Charles O. Garner was promoted to serve as executive vice president and chief strategy and transformation officer. 
MRI Interventions, Inc. (OTCQB:MRIC) is pleased to announce that seasoned medical device financial executive Harold A. (Hal) Hurwitz has been appointed the company's next Chief Financial Officer. 
Oxford Immunotec Global PLC (Nasdaq:OXFD), a global commercial-stage diagnostics company focused on developing and commercializing proprietary tests for the management of immune-regulated conditions, today announced that Stephen M. Gansler has joined the Company as Senior Vice President and Global Head of Human Resources. 
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, reported financial results for the year ended December 31, 2014.
Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, is providing an update of its three clinical development programs and financial results for the year ending December 31, 2014.



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