EMA reports big wins for small pharma
The success rate for marketing authorisation applications for small and medium-sized enterprises (SMEs) has doubled between 2016 and 2020, according to the European Medicines Agency (EMA). In 2016,… read more.
The success rate for marketing authorisation applications for small and medium-sized enterprises (SMEs) has doubled between 2016 and 2020, according to the European Medicines Agency (EMA). In 2016,… read more.
Diurnal Group plc announces that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a Marketing Authorisation for Efmody (hydrocortisone modified-release hard capsules – development name… read more.
European Society of Clinical Microbiology and Infectious Diseases Research presented by Dr Ana R. Freitas, and colleagues from UCIBIO, Faculty of Pharmacy, University of Porto, Portugal, showed that… read more.
Advicenne announces that the Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Sibnayal (ADV 7103) in the UK, for the treatment of distal renal… read more.
European Society of Clinical Microbiology and Infectious Diseases Research presented at this year’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) taking place online (9-12 July) shows… read more.
Hansa Biopharma, announced three-year follow-up data in crossmatch positive patients who received imlifidase prior to kidney transplantation. As reported in an article, which has been accepted for publication… read more.
Mountain Valley MD, Ontario, Canada The results of the first study to evaluate the stability of Trivalent Inactivated Poliovirus Vaccine (tIPV) formulated in desiccated liposomes (QuIcksometm) has yielded… read more.
Merck has announced that the FDA has approved an expanded label for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with locally advanced cutaneous squamous… read more.
The development and testing of personalised, multidrug tablets will be one of the outputs of a new research collaboration between Gustave Roussy and FabRx Ltd, a biotechnology start-up… read more.
Merck announced that the company plans to voluntarily withdraw the U.S. accelerated approval indication for Keytruda for the treatment of patients with recurrent locally advanced or metastatic gastric… read more.
The Bone and Joint Journal Early mobilisation after hip fracture surgery has become standard care on the basis of national guidance. The evidence for this is based on… read more.
Lupin Pharmaceuticals announced that the FDA has approved the company’s supplemental New Drug Application (sNDA) to expand the use of Solosec (secnidazole) to include the treatment of trichomoniasis… read more.