We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
In preparation for a September 2017 expiration, the FDA has scheduled a Dec. 18 public meeting to kick off reauthorizing the Biosimilar User Fee Act. Read More
Starting Oct. 1, pharma companies seeking to cash in on a rare pediatric disease priority review voucher must pay the FDA $2.727 million — $165,000 more than in the fiscal year ending Wednesday. Read More
Novartis Thursday launched a program to provide 15 drugs in Kenya, Ethiopia and Vietnam, with plans to eventually expand to 30 low- and middle-income countries. Read More
GlaxoSmithKline’s Aiken, S.C., plant received a four-observation Form 483 from the FDA for failing to follow quality control procedures and other GMP violations. Read More
Two new studies point to concerns over the FDA’s increasing use of expedited development and approval pathways — programs that rely on early-stage trials that produce less robust data. Read More
A qui tam lawsuit, unsealed Tuesday, alleges that Takeda used a sham clinical trial to obtain FDA approval for a new version of its gout drug Colcrys — raking in hundreds of millions of dollars as a result and delaying generic competition. Read More
A federal appeals court has affirmed Shire Pharmaceuticals’ patents for Vyvanse, blocking efforts by five drugmakers to market generic versions of the attention deficit hyperactivity disorder drug. Read More
The owner of Turing Pharmaceuticals says he will reverse course after raising a public outcry this week by upping the price by 5,000 percent. Read More
Amgen and Allergan claim their biosimilar candidate is clinically equivalent to Roche’s blockbuster Avastin in adult patients with advanced non-small cell lung cancer. Read More
Amgen is hoping a Delaware judge will be more agreeable than a California court as it sues Hospira to slow the biosimilar maker from marketing its challenger to Epogen. Read More