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.
The FDA has finalized a rule that will require pharmaceutical companies to electronically submit, list and register information on finished drug products and active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. Read More
To shed light on the regulatory requirements for production of co-crystals, the FDA is offering drugmakers submitting ANDAs and NDAs a clearer definition of co-crystals that no longer denotes them as an in-process material. Read More
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has effectively banned products from a Pfizer plant in India after a joint inspection by the FDA, MHRA, Australia’s Therapeutic Goods Administration and Health Canada, the first joint investigation by the four agencies. Read More
A federal judge ruled that Apotex’s biosimilars of Amgen’s Neulasta and Neupogen do not infringe on a patent that covers a protein refolding process. Read More
Sen. Chuck Grassley (R-Iowa) has deemed Mylan’s response to his inquiry on the cost of the company’s allergy drug EpiPen “incomplete,” asking for further detail on its price-setting analyses and the product features. Read More
Product claims on three companies’ websites led the FDA to issue warning letters declaring that the products have not been tested in human trials and cannot be advertised as bestowing health benefits. Read More
Clinical trials to prove biosimilar interchangeability with reference products will likely involve multiple switches between the products, an industry expert said. Read More