Archives for October, 2018
UK medicines regulator preparing for no-deal Brexit
Custom Synthesis, Britain’s medicines watchdog is preparing for the possibility of the country leaving the European Union without a deal next March, in which case...
U.S. FDA approves Roche’s bleeding disorder drug
Custom Synthesis, Roche said on Thursday it received approval from regulators for its hemophilia A drug Hemlibra for use in nearly all patients,...
Akcea Therapeutics genetic disease treatment gets FDA approval
Custom Synthesis, Akcea Therapeutics Inc said on Friday its treatment, developed along with Ionis Pharmaceuticals , which targets a rare genetic disease was approved by...
Chinese drugmaker Huahai tumbles after FDA shutout
Custom Synthesis, Shares of China’s Zhejiang Huahai Pharmaceuticals Co Ltd tumbled in early trade on Monday, the first day of trading since the Food...
Novartis strikes deal with Chinese firm to make Kymriah
Custom Synthesis, Novartis has enlisted Chinese manufacturer Cellular Biomedicine (CBMG) to make its $475,000 gene-modifying cancer treatment Kymriah as the Swiss drugmaker intends to...
Insmed’s treatment-resistant lung disease drug gets FDA approval
Custom Synthesis, The Food and Drug Administration on Friday approved Insmed Inc’s lead drug to treat a rare, chronic lung disease, making it...
FDA halts imports from China’s Huahai after heart drug recall
Custom Synthesis, The Food and Drug Administration said on Friday it will no longer allow imports of drug ingredients or medicines made with ingredients...