The European Medicine Agency’s revised guideline on the chemistry of active substances — outlining the information companies must provide the agency about the chemical entities used in a drug product…
The FDA sent an untitled letter to the Avella Specialty Pharmacy in Phoenix, Ariz., for labeling and reporting violations. Source: Drug Industry Daily
More drugmakers have weighed in on the FDA’s draft guidance on biosimilar interchangeability, urging the agency to make clear the designation does not mean a product is superior in terms…
The European Medicines Agency plans to launch an improved version of its adverse event monitoring system, EudraVigilance, in November, with new methods for reporting and analyzing suspected reactions to investigational…
In a March 2017 visit to a compounding facility in Chatsworth, Calif., the FDA found there was no one in charge of quality. Source: Drug Industry Daily
A New Jersey drugmaker was warned by the FDA for failing to submit paperwork on possible adverse drug experiences for their products. Source: Drug Industry Daily
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended 11 medicines for approval, including one new cell therapy, four new drugs and four biosimilars. Source: Drug…
Janssen has filed suit in a New Jersey federal court, hoping to delay a recently approved Remicade biosimilar from entering the market — while the biosimilar’s developer, Samsung Bioepis, bets…
Newly minted FDA Commissioner Scott Gottlieb comes into office immediately faced with many challenges: from hiring issues to budget concerns, drug prices and a nationwide opioid addiction crisis. But those…
The PTO’s Patent Trial and Appeal Board invalidated a patent for AbbVie’s flagship drug Humira, saying its claims were unpatentable following a challenge by Coherus Biosciences. Source: Drug Industry Daily