Merck & Co. Inc. CEO Robert Davis said the pneumococcal vaccines (PCVs) space is “an area where there is still a high unmet need, and what we have is a new vaccine specifically targeted to the adult population that addresses 83% of the residual disease. That's about 30% higher than anyone else that's out there.” Speaking Jan. 9 at the J.P. Morgan Healthcare Conference (JPM), Davis predicted that his firm “will take a majority share” of the market if approved. The Merck candidate, V-116, bears a PDUFA date with the U.S. FDA of June 17.
An FDA culture that discourages scientific disagreement with U.S. administration policies may be a perennial problem regardless of the party in power. That’s one of the between-the-lines takeaways from a Jan. 3 letter the Republican leadership of the House Energy and Commerce Committee sent to FDA Commissioner Robert Califf – along with a stern warning that the agency had better respond in a timely manner.
Sail Biomedicines Inc. has received two grants from the Bill & Melinda Gates Foundation to advance the company's Endless RNA (eRNA) platform to develop secreted monoclonal antibodies and vaccines for malaria.
It is not the first malaria vaccine, but R21, recommended for use by the World Health Organization in October, is the first that can be manufactured at modest cost and the sort of scale needed for widespread prevention of the killer disease in Africa.
A safe and effective vaccine for preventing respiratory syncytial virus (RSV), a common and sometimes serious respiratory infection, had eluded biopharma for decades. But in 2023, the world saw the first – and second – vaccine hit the market.
Limmatech Biologics AG and Abvacc Inc. have entered into a license agreement that grants Limmatech the exclusive rights to further develop Abvacc’s multivalent toxoid vaccine candidate, LBT-SA7 (formerly IBT-V02), designed to prevent infections caused by Staphylococcus aureus.
Sirnaomics Ltd.'s subsidiary Rnaimmune Inc. has received IND clearance from the FDA to begin trials of RV-1770, an mRNA vaccine targeting the human respiratory syncytial virus (RSV) to prevent RSV infection in adults. Rnaimmune will conduct a phase I study of RV-1770 administered intramuscularly in healthy adults.
Invivyd Inc.’s VYD-222 produced positive initial top-line results in the ongoing pivotal phase III Canopy study for preventing symptomatic COVID-19. The results could reach a vulnerable population of patients who are immunocompromised and don’t get the same protection as other patients, the company’s CEO, Dave Hering, told BioWorld.
The Novo Nordisk Foundation is committing up to DKK1.8 billion (US$260 million) to establish a research and vaccine development initiative that aims to create new or improved vaccines for respiratory diseases, including tuberculosis (TB) and influenza.
Astrazeneca plc, which seemed to have backed away from vaccine development after the COVID-19 pandemic, clearly took a shine to Icosavax Inc.’s virus-like particle technology and signed a deal to take over the firm for as much as $1.1 billion.
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