Last week s news was varied: from Roche reporting patient death in the phase 3 trial of the company s hemophilia blockbuster emicizumab, to Novartis cancer drug Zykadia being granted priority review by the US FDA. Bellerophon Therapeutics Vermillion, Inc. Galectin Therapeutics Jaguar Animal Health Alphatec Holdings Bellerophon Therapeutics
As America s opioid crisis reaches epidemic levels, Kaleo has jacked up the list price for its Evzio auto-injector by 600 percent, soaring from $690 several years ago to $4,500, according to lawmakers. And that, in a nutshell, illustrates the lunacy of the U.S. health care system. Our system of health care financing is the most cynical such s
Merck& Co., Inc., known as MSD outside the United States and Canada, today announced results of the pivotal Phase 3 clinical study of letermovir, an investigational antiviral medicine for the prevention of clinically-significant cytomegalovirus infection in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant, also.
by Syed Haitham Rohit Shelatkar, director at Vitabiotics, believes that vitamin supplements can reduce susceptibility to common health problems like cardiovascular diseases. Muscat: Use of micronutrients on a routine basis can help prevent or cure diseases, according to a health expert. Rohit Shelatkar, director at Vitabiotics, believes that vitami
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA Research findings on FDA Actions are discussed in a new report. We characterized the pivotal studies supporting FDA approval of otolaryngologic prescription drug indications. " Between 2005 and 2014, the FDA approved 48 otolaryngologic prescription drug indications based on 64
By a News Reporter-Staff News Editor at Heart Disease Weekly- Janssen Research& Development, LLC announced that the Phase 3 COMPASS trial, evaluating the efficacy and safety of XARELTO for the prevention of major adverse cardiac events, including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease or
McCarthy said she's frustrated that the Food and Drug Administration is approving cancer drugs without proof that they cure patients or help them live longer. Pushed by patient advocates who want earlier access to medications, the- FDA has approved a flurry of oncology drugs in recent years, giving some people with cancer a renewed sense of hope an
-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
Dr Reddys Laboratories has been issued with a Form483 after an inspection at its active pharmaceutical ingredient plant in Miryalaguda in Telangana, India. The site was one of several Dr Reddys facilities criticized in a US FDA warning letter published in 2015.. In addition, the FDA said Dr. Reddys had failed to prevent unauthorized access to quali
HUNTINGTON- Like they have done in other lawsuits against them, wholesale drug distributors accused by Huntington officials of flooding the city with an excess of prescription drugs are requesting the case be tried in federal court rather than a local court. Gregory Donald Chaney, AmerisourceBergen Drug Co., Cardinal Health Inc. and McKesson Corp.
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
Findings from University of Pennsylvania Hospital in the Area of Drug Delivery Systems Described. According to news reporting out of Philadelphia, Pennsylvania, by NewsRx editors, research stated, "Red blood cells are innate carriers that can also be engineered to improve the pharmacokinetics and pharmacodynamics of many drugs, particularly...
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
Global Weight Loss and Obesity Management Market, by Fitness Equipment (Cardiovascular Training Equipment, Strength Training Equipment, Body Composition Analyzers, Fitness Monitoring Equipment), by Surgical Equipment (Minimally Invasive Surgical Equipment, Non-Invasive Surgical Equipment), by Dietary Supplements, by Services, by Geography Indus
-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
LOS ANGELES, CA/ ACCESSWIRE/ February 25, 2017/ Lundin Law PC, a shareholder rights firm, announces a class action lawsuit against TG Therapeutics, Inc.. Investors, who purchased or otherwise acquired TG Therapeutics shares between September 15, 2014 and October 12, 2016 inclusive, are encouraged to contact the firm 60 days within this notice, also
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...
-Natural Subsistence, a dietary supplement manufacturer that designs a variety of products to improve peoples health and nutrition, announced its product Leyzene now available on StackedNutrition.com, a popular website for nutritional products. Natural Subsistence develops supplements formulated to complement every aspect of health to allow...
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
Directors from Pharma To Market Pty Ltd and Ador Consulting Pte Ltd announce that the two companies have joined forces, resulting in the founding of Pharma To Market Pte Ltd, based in Singapore. Pharma To Market are pleased to announce their expansion into Asia with the opening of an office in Singapore. Joelle and her team will provide support for
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