After the US Food and Drug Administration (FDA) discovered an abbreviated new drug application (ANDA) relied on data from a disreputable contract researcher, and after repeated attempts over five years to get the company to resubmit new data, the agency…
Alexion Pharma to acquire clinical-stage biopharmaceutical firm Achillion
BOSTON & BLUE BELL, Pa.–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) today announced that they have entered into a definitive agreement for Alexion to acquire Achillion, a clinical-stage biopharmaceutical company focused on the development of oral small…
Allergan gets FDA okay for paediatric Botox use
The FDA has approved Allergan’s Botox to treat lower-limb spasticity in children, further extending the use of the drug – widely used as a wrinkle treatment – in therapeutic indications. The US regulator has given the botulinum toxin-based drug a…
Spark Therapeutics Wins Prix Galien USA Award for LUXTURNA® (voretigene neparvovec-rzyl) as Best Biotechnology Product
PHILADELPHIA, Oct. 25, 2019 (GLOBE NEWSWIRE) — Spark Therapeutics (NASDAQ:ONCE), a fully integrated, commercial gene therapy company dedicated to challenging the inevitability of genetic disease, today announced that the Galien Foundation has awarded the prestigious 2019 Prix Galien USA Award…
Building a Site of Choice: Advice from the Field
What does a site need to do to trim its study start-up timeline from several weeks down to just a few days? Panelists from various site organizations shared their secrets to rapid start-up and other best practices at MAGI’s “Be…
CDSCO Invites Suggestions To Improve Sugam Portal
In order to promote digital India and ease of doing business, the Central Drugs Standard Control Organisation (CDSCO) has asked for suggestions from the stakeholders to improve Sugam portal for effective online processing of applications. CDSCO under its e-Governance initiative…
CDSCO Received approval to Increase ManPower
Meanwhile, the health ministry’s proposal to the department of expenditure seeking recruitment of manpower to form a vertical in the CDSCO has been approved. “We need human resource to set up laboratories, to test devices. The finance department is agreeable…
Single regulatory framework likely for all medical devices
All imported and locally-made medical devices will have to meet certain standards of quality and efficacy to enter the Indian market. The government has begun framing the rules and a draft notification to this effect is likely to be put…
FDA approves new Eli Lilly drug to ‘resolve’ migraine pain in two hours
FDA approves Eli Lilly’d new migraine drug Reyvow. Reyvow was proven to be “significantly” more effective than a placebo in resolving the pain and “most bothersome” migraine symptoms. Migraines are three times more common in women than in men and…
Still too little progress on antibiotic resistance, says O’Neill report update
The O’Neill report on antimicrobial resistance in 2016 generated headlines around the world warning that once-trivial infections may become death sentences without drastic action. Now, three years on, an update on progress has been published and concludes that there has…
