-Zug, Switzerland, Feb. 24, 2017- Auris Medical Holding AG, a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today announced that the US Food and Drug Administration has granted Fast Track designation for AM-111 in the treatment of acute sensorineural hearing loss.
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week- Baebies, a company focused on advancing newborn screening and pediatric testing, announced it has received de novo clearance from the U.S. Food and Drug Administration for SEEKER. "Although these LSDs have FDA approved therapies, this is a significant milestone for the LSD
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week The FDA granted EMFLAZA priority review, which is reserved for investigational medicines that may offer major advances in treatment over existing options. "We are pleased to learn that the FDA has approved EMFLAZA," said Pat Furlong, founding President and CEO of Parent Proj
WASHINGTON, Feb. 25 The Food and Drug Administration published the following rule in the Federal Register for approval of New Animal Drug applications and withdrawal of approval of New Animal Drug Applications:. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for prod
WASHINGTON, Feb. 25 The Food and Drug Administration published the following rule in the Federal Register for withdrawal of Approval of a New Animal Drug Application:. Sujaya Dessai, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, firstname.lastname@example.org. Putney, Inc., One Monu
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week Fulcrum Therapeutics, a company focused on discovering and developing small molecule therapies to unlock gene control and treat serious genetic diseases, announced the appointment of Alan Ezekowitz, MBChB, D.Phil., and James J. Collins, Ph.D., to its Board of Directors. Their
-Idera Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with cancer and rare diseases, today is reporting additional data from the dose-escalation phase of its ongoing Phase 1/ 2 clinical trial of intratumoral IMO-2125, an agonist of TLR9 in combination with ipilimumab
Intellipharmaceutics International Inc., a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs announced that the Company today received final approval from the U.S. Food and Drug Administration for the Company`s abbreviated new drug...
The agent would offer an alternative to PET-based techniques for Alzheimer`s detection, such as Amyvid from Eli Lilly and Vizamyl from GE Healthcare. Most of this was performed by Ananth Annapragada and Jason Eriksen at Texas Children`s Hospital and the University of Houston. Medici is best known in radiology for spending 12 years as CEO of Bracco.
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week Perrigo Company plc announced that it has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration for clindamycin, benzoyl peroxide topical gel, the generic version of Onexton gel. Perrigo has notified Valeant Pharmaceuticals North America LLC
By a News Reporter-Staff News Editor at Investment Weekly News Research and Markets has announced the addition of the "Recombinant Drugs to 2020" report to their offering. This report examines FDA and EMA-approved biological drugs and their position and potential in a dozen major disease segments- markets with important implications for drug deve
NEW YORK, NY/ ACCESSWIRE/ February 24, 2017/ Pomerantz LLP announces that a class action lawsuit has been filed against TG Therapeutics, Inc. and certain of its officers. The class action, filed in United States District Court, Southern District of New York, and docketed under 17- cv-00508, is on behalf of a class consisting of all persons or entit
Feb. 25 Two shareholders of Clovis Oncology are accusing the Boulder company of regulatory violations during clinical trials for its failed lung cancer drug rocilentinib,. Clovis disclosed the most recent allegations in a 10- K filed Thursday with the Securities and Exchange Commission, calling them "unfounded." The 10- K filing also reported tha
The STARR Coalition today announced their partnership with Verified Clinical Trials in an ongoing effort to create meaningful change by increasing communication, partnerships and goodwill among stakeholders in the areas of treatment, advocacy, and pharmaceutical research with emphasis on consumers and patients' mental health well-being.
Cempra Inc shares climbed 35.7 percent to $4.28 after the company disclosed that fusidic acid achieved primary endpoint in Phase 3 study of ABSSSI. IntelliPharmaCeutics Intl Inc shares gained 23.8 percent to $2.66 after the company reported the FDA approval for 500 mg and 750 mg generic Glucophage XR. RH shares jumped 23.2 percent to $31.03 after t
Gainers Cempra Inc rose 52.4 percent to $4.80 in pre-market trading after the company disclosed that fusidic acid achieved primary endpoint in Phase 3 study of ABSSSI. Accelerate Diagnostics Inc shares rose 33.2 percent to $32.95 in pre-market trading after the company disclosed that it has received the FDA marketing authorization for the Accelerat
By a News Reporter-Staff News Editor at Health& Medicine Week Acerus Pharmaceuticals Corporation announces the acceptance of two posters highlighting the clinical benefits of NATESTO for presentation at the Endocrine Society 2017 Annual Meeting to be held on April 1-4, 2017 in Orlando, Florida. Developed by Acerus, NATESTO is the first and
By a News Reporter-Staff News Editor at Drug Week Aeterna Zentaris Inc. announced that it will be presenting at the 2017 BIO CEO& Investor Conference on Monday, February 13 at 8:00 AM EST in New York City. David A. Dodd will be presenting an updated Company overview, as well as meeting with investors. About Aeterna Zentaris Inc. Aeterna Zentaris
By a News Reporter-Staff News Editor at Drug Week Aeterna Zentaris Inc., announced that it will be presenting at the 2nd Annual Disruptive Growth& Healthcare Conference on Thursday, February 16 at 9:30 AM EST. The 2017 Disruptive Growth& Healthcare Conference will offer the exclusive opportunity to discover life science companies focusing on solu
By a News Reporter-Staff News Editor at Drug Week ArQule, Inc. announced that Paolo Pucci, Chief Executive Officer, and Dr. ArQule's lead product, in phase 3 clinical development, is tivantinib, an oral, selective inhibitor of the c-MET receptor tyrosine kinase, for second-line treatment of hepatocellular carcinoma in partnership with Daiichi San
Zug, Switzerland, Feb. 24, 2017- Auris Medical Holding AG, a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today announced that the US Food and Drug Administration has granted Fast Track designation for AM-111 in the treatment of acute sensorineural hearing loss.
The global biomarkers market is estimated to reach USD 53.34 billion by 2021 from USD 27.95 billion in 2016, at a CAGR of 13.8% from 2016 to 2021.. Increasing diagnostic applications of biomarkers, increasing R&D funding for pharma and biotech companies, increasing number of CROs and low cost of clinical trials in developing countries, the high pre
With these two new additional claims, VIDAS B? R? A? H? M? S PCT? becomes the first and only FDA- cleared procalcitonin test available in the U.S. market to assist physicians in antibiotic management for patients with suspected or confirmed LRTI or sepsis. Antimicrobial resistance is considered as a major threat to public health and
Biothera Pharmaceuticals, Inc. will present data today from all cohorts enrolled in a healthy human volunteer study of Imprime PGG, the Company s phase 2 cancer immunotherapy. Before proceeding to further phase 2 studies, we wanted to explore the relationship between pre-treatment ABA levels and response to Imprime PGG, said Jeremy R. Graff
LONDON, UK/ ACCESSWIRE/ February 24, 2017/ Active Wall St. blog coverage looks at the headline from Novartis AG as the Company announced on February 23, 2017, that the US Food and Drug Administration has granted Priority Review for the expanded use of Zykadia as a first-line treatment for patients with metastatic non-small cell lung cancer whose