Helsinn Birex Pharmaceuticals Ltd.
Division of Helsinn Group
Latest From Helsinn Birex Pharmaceuticals Ltd.
Helsinn and AB Science plan to conduct additional studies with their products the CHMP turned down this month, in an effort to secure eventual EU approval in the rejected indications. A third company, XBiotech, hasn’t ruled out similar action. New MAAs would be required.
Two orphan medicines have been withdrawn from the evaluation process at the European Medicines Agency, one of them for recurrent nephrotic syndrome, the other for mesothelioma. Three products are undergoing a re-evaluation after an initial negative opinion from the CHMP.
Other medicines receiving positive opinions from the EU’s top scientific advisory panel after its March meeting include Helsinn’s Akynzeo for chemotherapy associated nausea and vomiting, the first 9-valent HPV vaccine, Sanofi Pasteur MSD’s Gardasil 9, and Boehringer Ingelheim’s Synjardy combination of empagliflozin and metformin.
The market for supplements sold by health care providers heats up, with firms offering practitioner-focused labeling, custom brands and products targeted to specific patient needs. As supplement use grows, more practitioners are interested in guiding patients’ choices in vitamins and other nutritionals.
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