LONDON – The EU is taking concerted action to detect new variants of SARS-CoV-2, investing €225 million (US$270 million) to increase viral genome sequencing to 5% of positive cases across Europe, and to carry out research on their evolution and transmissibility.
The U.S. House Energy and Commerce Committee needed two days of hearings to get through a spending measure that provided the FDA with $500 million for its part in the government response. The CDC would receive $7.5 billion for vaccine distribution and tracking, all developments that ran parallel to an announcement that another 200 million doses of vaccine will be delivered by the end of July at a cost of $3.7 billion.
LONDON – The EMA has requested all COVID-19 vaccine developers to investigate if their products offer protection against new variants of SARS-CoV-2 and to submit the relevant data.
Under threat of emerging variants, the EU is taking to heart lessons learned so far in the global COVID-19 pandemic to accelerate the review of vaccines, improve data sharing from clinical trials and address the difficulties inherent in the mass production of vaccines that may contain up to 400 components.
LONDON – The U.K has started the world’s first trial alternating an adenoviral vectored COVID-19 vaccine with one that delivers the virus spike protein instructions encoded in messenger RNA. The heterologous prime boost trial will recruit 820 participants into an eight-arm study comparing different combinations of the Astrazeneca plc/Oxford University and Pfizer Inc./Biontech SE vaccines, administered in a different order and at different intervals.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA weighing Xeljanz safety results; EMA initiates OPEN collaboration; NICE evaluating guidance processes; TGA seeking comments; USPTO extends program with Japan’s, Korea’s patent offices; NICE recommends Keytruda in NSCLC; Florida researcher indicted.
Pfizer Inc. reported solid earnings for 2020 and said it expects even bigger things this year as the company projects approximately $15 billion in earnings from the COVID-19 vaccine it co-developed with Biontech SE.
LONDON – Two new U.K. studies point to long-term persistence of COVID-19 antibodies after both natural infection and vaccination, conferring protection against subsequent infection for at least three months.
DUBLIN – Imcyse SA has successfully parlayed a research collaboration it entered with Pfizer Inc. in 2017 into a license agreement, under which it will finalize preclinical development of a drug candidate for rheumatoid arthritis (RA) based on its Imotope technology in return for an undisclosed up-front payment, equity investment and up to $180 million in milestones, as well as tiered royalties on product sales.
LONDON –The Russian COVID-19 vaccine Sputnik V now has validation from the Western science establishment, after The Lancet published full interim results of the phase III trial on Feb 2. The peer-reviewed paper confirms the 91%-plus efficacy that the vaccine’s developer, Gamaleya National Center of Epidemiology and Microbiology, claimed in its own announcement of the results in December.
