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.
Manufacturers developing biosimilars in Europe want regulators to go back to comparing their therapies with the reference product, based on the actual amount of active ingredient in a dose, rather than a proposed standard that compares dosages and routes of administration. Read More
European regulators have granted Astellas’ oncology drug Xtandi a new indication for men with pre-chemotherapy prostate cancer who have failed androgen deprivation therapy, putting it in direct competition with Johnson & Johnson’s Zytiga. Read More
The FDA’s quality metrics collection program is facing delays as the agency expands it to include biologics manufacturers in addition to drugmakers. Read More
The FDA is expected to start training investigators next year on how to tell whether a facility’s quality culture is good or poor, a development that lays the groundwork for eventual scrutiny of this new indicator during inspections. Read More
India’s Central Drugs Standard Control Organization is seeking industry feedback on a draft of accreditation and ethics standards that it expects from clinical trial sites, investigators and ethics committees. Read More
The FDA has approved a new indication for Sanofi’s tuberculosis drug Priftin in combination with isoniazid to treat latent tuberculosis infection (LTBI). Read More
The UK’s healthcare cost watchdog is recommending coverage of Roche’s cancer drug Gazyvaro with chlorambucil for some chronic lymphocytic leukemia patients, reversing its earlier rejection of the combo therapy over concerns with the manufacturer’s clinical- and cost-effectiveness models. Read More
The UK lags far behind other industrialized countries in providing patients access to the latest medicines, a situation that is caused by overly zealous national and local healthcare funding schemes, asserts a new report from a British pharmaceutical trade group. Read More
The FDA yesterday finalized the first of four guidances that govern how drugmakers scale up production of a drug once it’s approved, the first revision to the guidances since the late 1990s. Read More
Manufacturers of fixed dose combination products that are less than four years old should confirm with India’s drug pricing authority that the products have been approved and are not deemed prohibited under Indian drug law. Read More