Amgen Inc. said the U.S. FDA approved its drug Xgeva to prevent fractures in patients with multiple myeloma.
What are key trends in the transparency compliance landscape? And, how are life sciences manufacturers tackling growing requirements
Swiss drugmaker Roche won approvals for two cancer drugs in Europe and the United States, shoring up its position in new medicines as it braces for falling sales of older products.
Merck KGaA is reviving plans to bring an oral multiple sclerosis (MS) treatment to the U.S. market, hoping for blockbuster sales despite regulatory concerns about side effects having frustrated the German company’s ambitions almost seven years ago.
Daiichi Sankyo Europe GmbH informed Nektar Therapeutics that it was terminating a collaboration and licensing deal, which becomes effective Feb. 4, 2018. All rights and licenses that Daiichi acquired in the deal will revert to Nektar.
Otonomy, which develops innovative therapeutics for diseases and disorders of the ear, is initiating more job cuts as well as planning to divest one of its assets.
The number of people newly diagnosed with HIV in Europe reached its highest level in 2016 since records began, showing the region’s epidemic growing “at an alarming pace,” health officials said.
Trump declares opioid epidemic a public health emergency; crisis could spread to Europe, experts say
As U.S. President Donald Trump declared the opioid crisis a public health emergency, Europe should heed the threat from opioids responsible for America’s deadliest drug epidemic in decades as both regions have seen rises in prescription rates of such medicines, which can be a gateway to dangerous derivatives according to experts.
The science of gene therapy is finally delivering on its potential, and drugmakers are now hoping to produce commercially viable medicines after tiny sales for the first two such treatments in Europe.
The first ever EU antitrust probe into excessive drug pricing is taking the European pharmaceuticals industry into uncharted territory, unnerving some companies and lawyers worried about the reach of market intervention.
Google is betting on the potential of European biotech companies to deliver life-changing drugs by investing alongside Swiss company Novartis in a new $300 million fund run by leading life sciences investment firm Medicxi.
European Commission Approves Pfizer’s Trumenba to Help Prevent Meningococcal Group B Disease in Adolescents and Adults
Pfizer Inc. announced that the European Commission approved Trumenba (Meningococcal Group B Vaccine) for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in individuals 10 years of age and older.
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.
Life expectancy for young HIV-positive adults has risen by 10 years in the United States and Europe.
International groups representing doctors and patients have launched a fresh challenge to the patent on Gilead Sciences’ hepatitis C drug sofosbuvir at the European Patent Office in order to increase access to the treatment.
A study examining genes of more than 120,000 people from Europe, Asia, Africa and the Americas has offered the clearest picture yet of those that drive type 2 diabetes.
France’s Sanofi said two late-stage Phase III clinical trials of its LixiLan diabetes drug had met their targets, readying it for approval in the United States in August and Europe in early 2017.
The Zika virus may spread into Europe as the weather gets warmer, although the risk is low, health officials said.
A $471 million UBS venture fund aims to generate annual returns “north of 10 percent” for its European and Asian investors by financing new cancer drugs.
(Thomson Reuters Foundation) – Europe has become the world’s first region to wipe out malaria, with zero cases reported last year, the World Health Organization (WHO) said on Wednesday. The number of indigenous malaria cases dropped to zero in 2015 from 90,712 in 1995, and the last cases were reported in Tajikistan in 2014, it […]
The EMA said it extended a safety review of chronic hepatitis C treatments after new data showed patients taking the drugs were at risk of their liver cancer returning.