The European Medicines Agency seems focused on pharmaceuticals to the near exclusion of medical technology, but the agency recently reported the launch of a pilot program for orphan medical devices.
Samsung Bioepis Co. Ltd., of Incheon, South Korea, is the latest to announce a win in the biosimilar space, gaining MFDS approval of Epyztek (SB-17) as the country’s first biosimilar to Stelara (ustekinumab, Janssen Pharmaceutical Inc.) on April 11.
Samsung Bioepis Co. Ltd., of Incheon, South Korea, is the latest to announce a win in the biosimilar space, gaining MFDS approval of Epyztek (SB-17) as the country’s first biosimilar to Stelara (ustekinumab, Janssen Pharmaceutical Inc.) on April 11.
Putting into jeopardy what was on track to be the first approved therapy in Europe for geographic atrophy (GA), an advanced form of age-related macular degeneration that causes blindness, Apellis Pharmaceuticals Inc. learned of a negative trend vote by the EMA’s Committee for Medicinal Products for Human Use (CHMP) on its MAA for intravitreal pegcetacoplan.
Japanese specialty global pharma Kyowa Kirin Co. Ltd. has agreed to buy out Orchard Therapeutics plc in a $387.4 million cash takeover that could jump $90 million to reach $477.6 million, contingent on the pending U.S. FDA approval of its EU-approved gene therapy, Libmeldy (atidarsagene autotemcel).
Japanese specialty global pharma Kyowa Kirin Co. Ltd. has agreed to buy out Orchard Therapeutics plc in a $387.4 million cash takeover that could jump $90 million to reach $477.6 million, contingent on the pending U.S. FDA approval of its EU-approved gene therapy, Libmeldy (atidarsagene autotemcel).
After 50 years of censorship, there is now growing pressure on EU policymakers to stand up and play a role in promoting the development of psychedelics as medicines and in preparing the ground to ensure equitable access once there are approved products.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Hipra Human Health SLU’s recombinant COVID-19 vaccine, Bimervax, as a booster in people ages 16 and older who have been vaccinated with an mRNA COVID-19 vaccine.
Providing faster and better access to new medicines is the driving force behind a two-year proof-of-concept pilot program the EMA plans to launch in September.
The first gene therapy to treat severe hemophilia A was among the drugs recommended for European approval by regulators from the EMA’s CHMP at its monthly meeting. Manufactured by Biomarin Pharmaceutical Inc., Roctavian (valoctocogene roxaparvovec) was recommended for conditional marketing authorization in the EU for severe hemophilia A in adults who do not have factor VIII inhibitors and no antibodies to adeno-associated virus serotype 5.
