LONDON – The EU is to set up an equivalent to the U.S. Biomedical Advanced Research and Development Authority (BARDA), after coming under criticism from pharma companies about Europe’s inability to swiftly seal advance purchase agreements for COVID-19 vaccines. The plan was announced on Sept. 16 by European Commission President Ursula von der Leyen, in her first state of the union address since coming into office at the start of 2020. The new agency will support capacity and readiness to respond to cross-border health threats and emergencies, “whether of natural or deliberate origin,” she said.
LONDON – The U.K. government has signed a €1.4 billion (US$1.7 billion) advance purchase agreement with French biotech Valneva SE, for the supply of up to 190 million doses of its attenuated COVID-19 vaccine, VLA-2001.
LONDON – The U.K. is funding a national program of research to investigate the major unanswered questions related to the immune response to COVID-19. The aim of the research, involving teams of immunologists in 17 research institutions, is to unpick the immunological backdrop of one of the most notable aspects of COVID-19 infection, which is the huge spectrum of severity of symptoms.
Advanced talks between the European Commission and Curevac AG have positioned the company to potentially supply up to 405 million doses of its investigational mRNA-based COVID-19 vaccine to the bloc. News of the progress, following similar EU-level talks with an alliance of Sanofi SA and Glaxosmithkline plc, Johnson & Johnson and Astrazeneca plc, sent Curevac's recently-listed U.S. shares (NASDAQ:CVAC) climbing 16% to $66 on Aug. 20.
LONDON – A pan-European consortium backed by 11 pharma companies is pooling resources in a €77.7 million (US$92.5 million) five-year plan to advance development of therapeutics for COVID-19 and other coronaviruses.
Reports out of Russia that the country approved a COVID-19 vaccine came with more questions than answers, as some in the rest of the world fretted over the apparently paltry degree of testing. Though the product has not completed phase III trials – human research thus far has involved only two groups of volunteers of 38 people each – Russia President Vladimir Putin is said to have declared Gam-COVID-Vac adequately studied.
LONDON – Research and health emerged as the biggest losers following a marathon four days of negotiations by EU leaders on the bloc’s €1.1 trillion (US$1.3 trillion) 2021 - 2027 budget and the formation of a €750 billion (US$872 billion) pandemic recovery fund. Rather than €94.4 billion over the next seven years as proposed, the R&D program Horizon Europe, will get €80.9 billion.
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.
LONDON – While the pandemic raged, Brexit was simmering on the back burner, but now as infections wane, the industry is turning its attention back to being ready for the U.K. cutting ties with the EU at the end of December.
LONDON – An independent U.K. inquiry has found that failure to take seriously concerns raised by patients has resulted in life-threatening problems caused by medical devices and drugs being ignored for decades.