Merged business will operate under the Cytel brand and employ 1,000 statisticians and data scientists across the U.S., India, and Europe. Cytel Inc., a global provider of analytical software and services, and Axio Research, a Seattle-based provider of biostatistics to…
Australian biotech Clinuvel gets approval in US for rare skin disorder drug Scenesse
Australian biotech Clinuvel has claimed a US approval for Scenesse, a treatment for a rare skin disorder that causes extreme sensitivity to light. The under-the-skin implant has been cleared by the FDA to treat erythropoietic protoporphyria (EPP), a genetic disorder…
US court tells J&J to pay $8bn damages to man over breast growth
A court has told Johnson & Johnson to pay $8 billion in punitive damages to a man who said he was not warned that an antipsychotic drug could lead to breast growth. A jury in Philadelphia awarded the damages to…
Novo Nordisk and bluebird bio Enter 3-Year Gene Therapy Collaboration Pact
Cambridge, Massachusetts-based bluebird bio and Bagsvaerd, Denmark-based Novo Nordiskannounced they have agreed to collaborate to develop next-generation genome editing therapies for genetic diseases, including hemophilia. The deal will last three years, with a top priority to develop a gene therapy…
FDA Boosts Rare Disease Research with $15 Million in Grants
The U.S. Food and Drug Administration (FDA) awarded $15 million in grants to fund 12 new clinical trials over the next four years to foster the development of rare disease treatments. The grants were awarded through the FDA’s Orphan Products…
Owning Research Integrity: Make It Everyone’s Obligation
Defending against research misconduct is the responsibility of everyone involved in a trial, from the principal investigator down to the lowest lab technician. Red flags can appear in any aspect of a trial, ranging from missing or altered data, significant…
1,000th Patient Treated with Impella (heart pumps) in Japan
TOKYO–(BUSINESS WIRE)– Abiomed (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, announces the 1,000th patient has been treated with the Impella heart pump in Japan. The Impella 2.5 and Impella 5.0 heart pumps are approved for the treatment…
Merck and Co’s cancer drug Keytruda to smash sales records by 2023 – forecast
Merck & Co’s Keytruda cancer immunotherapy is set to become the world’s top-selling drug by annual revenue in 2023, smashing sales records set by AbbVie’s inflammatory disease drug Humira, according to a new forecast. According to the forecast from GlobalData,…
Flawed trials supported half of recent approvals of cancer drugs in Europe, study says
As drug makers race to bring cancer treatments to market, a new study finds about half of the supporting clinical trials for cancer medicines recently approved in Europe had a high risk of bias, underscoring concerns about approval standards and…
