Two weeks after his confirmation, new U.S. Food and Drug Administration Commissioner Scott Gottlieb was already hard at work looking to hire additional staff and addressing ways to prevent speculator pharma companies from jacking up prices on drugs for which there is no generic equivalent.
A moderate-intensity walking regimen may reduce symptoms of mild cognitive impairment that are linked to poor blood vessel health in the brain, a small study suggests.
Havas Group is expanding its capabilities and footprint in the important and burgeoning Indian market by adding Sorento to its roster of agencies.
The U.S. FDA Oncologic Drugs Advisory Committee recommended approval of Pfizer’s proposed epoetin alfa biosimilar across all indications.
U.S. deaths from Alzheimer’s disease rose by more than 50 percent from 1999 to 2014 – and rates are expected to continue to rise – reflecting the nation’s aging population and increasing life expectancy, American researchers said.
FDA Advisory Committee Recommends Approval of Endari from Emmaus Life Sciences for the Treatment of Sickle Cell Disease
Emmaus Life Sciences Inc. announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration voted 10-to-3 that the overall Benefit-Risk profile of Endari for the treatment of sickle cell disease (SCD) is favorable. The FDA has set a PDUFA target action date for July 7, 2017.
June has the potential to be a make-or-break month for a number of biotech companies. At least 10 are facing critical decisions by the U.S. Food and Drug Administration (FDA).
The number of new drugs approved for sale in United States and Europe has bounced back in 2017, suggesting a marked slowdown in 2016 was an aberration.
Merck Enters Exclusive Worldwide License Agreement with Teijin Pharma for Investigational Antibody Candidate Targeting Tau
Merck announced that it has entered into an exclusive worldwide license agreement with Teijin Pharma for the development, manufacture and commercialization of an investigational preclinical antibody candidate targeting the protein tau. Changes in tau are associated with a number of diseases affecting the nervous system, including Alzheimer’s disease (AD).
Roche is investigating a case of a German patient diagnosed with a deadly brain infection called PML after taking one dose of the company’s new MS drug Ocrevus.
Shares of Aerie Pharmaceuticals were soaring more than 35 percent after the company announced Phase III data for its combination glaucoma drug, Roclatan, met efficacy endpoints.
A bill passed by U.S. House Republicans would cause 23 million people to lose healthcare coverage by 2026 while de-stabilizing health insurance markets in some states and making it hard for sick people to buy insurance, a budget watchdog agency said.
Merck & Co.’s Keytruda became the first cancer drug FDA-approved based on a patients’ specific genetic traits regardless of where in the body the disease originated.
The U.S. FDA accepted a supplemental BLA that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma after prior sorafenib therapy.
Abbott Laboratories is recalling for more than 28,000 of its HeartMate II blood pumps after 26 patients died after attempting to exchange controllers while away from the hospital.
tranSMART Foundation Teams With IBM to Bring Translational Medicine Data to Scientists, Merges With I2B2
Biotech researchers looking to harness the power of big data could have an easier time with the new partnership between IBM and the tranSMART Foundation, a Massachusetts-based nonprofit organization founded in 2012 with a goal of providing a platform to share pre-competitive data for use in designing transformational medicines.
Novartis AG, headquartered in Basel, Switzerland, filed with the state of New Jersey that it plans to lay off more than 200 workers. The company, whose U.S. headquarters are in East Hanover, NJ, is undergoing operational changes.
Shares of Neurocrine Biosciences Inc. were down more than 8 percent after its Phase II Tourette syndrome drug Ingrezza (valbenazine) failed to meet its primary endpoint due to what the company said was inadequate dosing.
Britain’s biotech sector boasts the strongest new drug pipeline in Europe but industry leaders say it needs continued access to global talent, funding and regulatory clarity to thrive in the future – all of which could be jeopardized by Brexit.
President Donald Trump’s 2018 budget proposal takes a machete to the spending plans of nationally funded health programs that fund medical research, disease prevention and insurance plans.