Things are getting hairy for New Jersey-based pharma Shiongi and its head lice treatment Ulesfia. The FDA is chastising the company for putting out a copay coupon that talks up the lotion's benefits without warning patients about its risks.
Gilead Sciences has notched up yet another HIV therapy approval as touted blockbuster Descovy gains the nod from the U.S. regulator.
In a frantic effort to curb the Zika outbreak--which has now reportedly spread in more than 50 countries and territories--world vaccines experts are pooling knowledge to hopefully inform vaccine development.
GlaxoSmithKline and its Italian research partners are plotting major new European research hubs with future growth in gene therapies and beyond after the CHMP recommended its new "bubble boy" drug for approval in Europe on Friday.
Drugmakers had high hopes for the FDA's biosimilars labeling guidance; both reference-product drugmakers and copycats figured they might be able to use biosimilar labeling to their marketing advantage, depending on the language. But no dice, the FDA said late last week.
Over the past few years, regulators have frequently found fault with data integrity at manufacturers and CROs, which have been accused of everything from logging discrepancies in uncontrolled Excel files to the duplicating of electrocardiogram results. In response, PricewaterhouseCoopers is calling for adoption of technologies to identify and prevent fraudulent activities.
The FDA has released further draft guidelines on how biopharma should name their new copycat biologics in what has been described as a "positive for the biosimilars industry," but problems over interchangeability remain.
In 2008, contaminated raw heparin from China was tied to the deaths of dozens of U.S. dialysis patients, leading the FDA to realize it needed inspectors in China to oversee manufacturers. But a House investigation, launched that year and still ongoing, is questioning whether the FDA has done enough and whether the tainted heparin may still be getting into the U.S.
The French drugmaker Genfit will start a Phase II study in the coming months for its experimental liver damage drug elafibranor as it also hopes for a lull in the financial headwinds to get its IPO off this year.
Five years after defibrotide was first rejected by the FDA, its new rights owner, Jazz Pharmaceuticals, has finally gained the nod in the U.S. in what will likely prove a highly lucrative approval for the biotech.