Chinese biosimilar maker Shanghai Henlius Biotech Inc. won EMA approval for its Zercepac, a biosimilar to Roche Holding AG’s Herceptin (trastuzumab) on July 28. Henlius CEO Scott Liu told BioWorld that Zercepac will be the first Chinese monoclonal antibody biosimilar to enter the EU market, setting a precedent for Chinese drugmakers seeking to join the global race in biosimilars.
DUBLIN – Although Europe has moved first to approve Blenrep (belantamab mafodotin), Glaxosmithkline plc’s antibody-drug conjugate (ADC) as a fifth-line therapy in relapsed or refractory multiple myeloma, U.S. patients may well be first to gain access to the new drug.
DUBLIN – Emer Cooke, named this week as the next executive director of the EMA, is the first woman to lead the organization since its creation in 1994. She is due to take up the post in November, but her appointment must first be ratified by the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI). She is due to present a statement to the group on July 13.
DUBLIN – Johnson & Johnson’s Janssen Biotech arm is on the brink of a historic first vaccine approval, having secured a positive vote May 29 from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for its prime-boost Ebola virus vaccine combo, Zabdeno (Ad26.Zebov) plus MVABEA (MVA-BN-Filo).
LONDON - EMA Director General Guido Rasi has hit out at the lack of coordination in COVID-19 clinical trials, questioning if the huge number of small studies that are running will support regulatory decision-making.
LONDON – Geopolitical tensions over the issue of access to COVID-19 vaccines intensified this week, after the CEO of French pharmaceutical company Sanofi SA said the U.S. government would get first access to its product because it was first to fund the research.
The EMA's Committee for Medicinal Products for Human Use said Friday it has started a rolling review of Gilead Sciences Inc.'s antiviral, remdesivir, for the potential treatment of COVID-19. The move put into play one of multiple regulatory tools it has deployed "to speed up the assessment of a promising investigational medicine during a public health emergency."
DUBLIN – The EMA has activated a COVID-19 task force to coordinate and accelerate the European regulatory response to the pandemic. The task force is intended to take a lead role in shaping the development, authorization and post-approval surveillance of drugs and vaccines for treating or preventing COVID-19 infection.
The jury is still out on how much hydroxychloroquine and chloroquine actually help in the treatment or prevention of COVID-19, but desperate times have led desperate health care providers to use the antimalarial drugs to treat patients in desperate need of coronavirus cures.
DUBLIN – Novartis AG, Bristol Myers Squibb Co. and Sanofi SA were among firms that secured positive opinions from EMA’s Committee for Medicinal Products for Human Use (CHMP) on marketing authorization applications for new therapies, which will progress to formal approvals 67 days from now. Because of the COVID-19 pandemic, the committee’s March meeting was held virtually.
RSS
