The US Food and Drug Administration has approved Teva Pharmaceutical Industries Ltd. s generic version of Mylan NV s life-saving allergy injection, EpiPen, at a time when regulators are looking to lower healthcare costs. There has also been a shortage of EpiPen in North America, Europe and Canada since earlier this year due to manufacturing d
Guided by the novel endpoint development framework released by the Clinical Trials Transformation Initiative in 2017, ActiGraphs Scientific Affairs and Data Management division, headed by Director Tyler Guthrie, will facilitate joint research and development projects involving corporate partners and subject matter experts from within the...
Albany, NY 08/18/2018 Global Albumin Market Snapshots. The global albumin market was valued at US$ 750 Mn in 2017 and is anticipated to reach US$ 1200 Mn by 2026 at a CAGR of over 5.0% from 2018 to 2026. For instance, in May 2017, China's Food and Drug Administration granted approval to clinical trials of human blood albumin produced from
The U.S. Army Medical Research Acquisition Activity has issued a sources sought notice for the development of tick-borne encephalitis vaccine for use by U.S. service members. Excerpts of the notice state: The vaccine must be European Medicines Agency approved, and shall achieve U.S. Food and Drug Administration licensure. For more information about
Mario Polywka, COO of the preclinical contract research organization Evotec, said in a press release, Our INDiGO platform reduces time and cost while consistently producing a quality data package for clinical trial agreements and investigational new drug filings. Mark Bamberger, CSO of Stealth stated, Our team at Stealth evaluated all options to he
Rep. Faso had written to FDA Commissioner Dr. At the time, the FDA had just added epinephrine auto-injectors to the FDA' s list of existing drug shortages. I'm glad to see the FDA approve additional effective and safe devices that will lower costs for consumers and expand access. "
SPR Therapeutics, Inc., a leader in neurostimulation technology for pain, today announced that the U.S. Food and Drug Administration has cleared its SPRINTendura and extensa Peripheral Nerve Stimulation Systems. With the ease of use and dual lead capabilities weve built into the SPRINT System we look forward to advancing the early use of neurostimu
Sirnaomics, Inc., a biopharmaceutical company in discovery and development of RNAi therapeutics, announces that the U.S. Food and Drug Administration has approved the companys first oncology IND application. Although it is more common in Asia, its incidence in Europe and North America has increased significantly in recent decades. In 2017, STP705 w
Mateon Therapeutics, Inc., a biopharmaceutical company developing investigational drugs for the treatment of orphan oncology indications, today announced that the U.S. Food and Drug Administration placed a partial clinical hold on Study OX1222 during a telephone conversation held with the Company on August 16, 2018. OX1222 is the Companys clinical
-Motif Bio plc, a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced that iclaprim data will be presented at the upcoming European Society of Clinical Microbiology and Infectious Diseases/ American Society For Microbiology Conference on Drug Development to Meet the Challenge of Antimicrobial...
Neurocrine Biosciences, Inc. today announced it will present data from its movement disorders programs, including additional long-term results for INGREZZA capsules, the first U.S. Food and Drug Administration approved treatment for adults with tardive dyskinesia, and data analyses from a Phase III study on opicapone, an investigational treatment f
Collaboration research agreements can go a long way to expedite clinical trials which, in turn, could reduce research and development costs, or share them. Novocure and US Oncology Research said in a joint press release on Wednesday a collaboration for Panova-3, a Phase 3 trial. Daniel D. Von Hoff, principal investigator for Panova-3 and chief scie
Two pharmaceutical companies have announced positive results from a Phase 3 study of an experimental non-opioid pain reliever that has a history of safety concerns. Teva and Regeneron are jointly developing fasinumab as a treatment for chronic pain from osteoarthritis of the knee and hip. "We are encouraged by these data and look forward to advanc
After publishing its second quarter results, Canadian biotech company Promis Neurosciences got a target price reduction from Andr Uddin of Mackie Research Capital, who now sees a longer timeline for the potential licensing of the companys Alzheimer treatment drug, which PMN expects still have its first clinical trial by the second half of 2019..
The US FDA has approved Regenerons latest indication for eye drug Eylea, just four days after rejecting the sBLA in a complete response letter. Regeneron Pharmaceuticals announced approval of its supplemental biologics license application for Eylea injection, with a 12- week dosing schedule, earlier today. The approval comes just days after the fir
Sirnaomics founder and CEO Patrick Lu, Ph.D., said the patisiran approval validates the RNAi class of therapeutics and it is our belief that the industry will see great enthusiasm and expanded discovery and development of novel RNAi therapeutics for many disease applications. The Gaithersburg, Maryland- based biotech has been working on RNAi therap
ViiV Healthcare announced positive headline results from its global, phase III ATLAS study of a long-acting, injectable two-drug regimen for the treatment of HIV. ATLAS was designed to establish if HIV-1-infected adult participants who had maintained viral suppression for at least six months, on a daily oral regimen comprised of two nucleoside reve
Global law firm White& Case LLP has advised SYNLAB on the acquisition of Yhtyneet Medix Laboratoriot Oy, Finland's leading private laboratory company, from Medix Laboratoriot Oy and Yhtyneet Laboratoriot Oy. SYNLAB Group, the European market leader in medical diagnostic services, offers the full range of innovative and reliable medical diagnostics
Visiongain, a independent media company, issued the following news release:. Visiongain's new report Biosimulation World Market 2017-2027: Revenue Prospects by Product, Services, Application (Drug Development, Preclinical Testing, ADME/Tox, PK/PD, Clinical Trials, Drug Discovery, End User (Pharmaceutical and Biotechnology Companies, CROs, Academic&
A1M Pharma announces that the company's drug candidate ROSgard shows strong protection against acute renal injury in a pre-clinical study conducted in the United States together with Indiana University. The pre-clinical AKI study in the United States was conducted with a different animal species, and with a partially different methodology compared
Agency: " Food and Drug Administration, HHS." SUMMARY: The Food and Drug Administration is announcing that a proposed collection of information has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995.. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Dr
Akari Therapeutics, a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases, today announced its financial results for the first quarter ended March 31, 2018 and highlights its pipeline of Phase II and Phase III clinical trials.
CAMBRIDGE- Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, today announced it has agreed on the structure and key terms of value-based agreements with leading health insurers for ONPATTRO lipid complex injection, a first-of-its-kind RNA interference therapeutic for the treatment of the polyneuropathy of hereditary...
CAMBRIDGE- Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced today that the United States Food and Drug Administration approved ONPATTRO lipid complex injection, a first-of-its-kind RNA interference therapeutic, for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.