Citing the lack of clear evidence that vaccine protection against severe COVID-19 disease is substantially waning in the EU in people younger than 80, the European Centre for Disease Prevention and Control and the EMA’s COVID-19 task force concluded that it’s too early to consider using a fourth dose, or second booster, of mRNA COVID-19 vaccines in the general population.
Pfizer Inc., with pockets bulging from COVID-19 vaccine money, is taking another step in respiratory syncytial virus (RSV) development with its acquisition of Reviral Ltd.
One of Pfizer Inc.’s last decisions of 2021 was to shell out $6.7 billion for San Diego’s Arena Pharmaceuticals Inc., a deal centered around the pipeline inflammatory disease pill etrasimod. A potential successor to Xeljanz (tofacitinib), the price New York-based Pfizer paid suggests blockbuster potential for etrasimod. Phase III results announced March 23 suggest Pfizer’s big acquisition, the fifth largest in biopharma in 2021, was money well spent.
With the World Health Organization’s COVAX facility having more COVID-19 vaccine doses available than have been requested by the countries it was designed to help, industry groups are pushing back against the proposed TRIPS waiver for COVID-19 vaccines.
"Now is the time to discuss the need for future boosters as we aim to move forward safely, with COVID-19 becoming a virus like others such as influenza that we prepare for, protect against and treat,” the FDA’s Peter Marks said in announcing an April 6 virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC).
Alnylam Pharmaceuticals Inc. has filed suits against both Pfizer Inc. and Moderna Inc. over alleged infringements of its patent on biodegradable cationic lipids that it said "are foundational to the success of the mRNA COVID-19 vaccines."
With the World Health Organization’s COVAX facility having more COVID-19 vaccine doses available than have been requested by the countries it was designed to help, industry groups are pushing back against the proposed TRIPS (Trade-Related Aspects of Intellectual Property Rights) waiver for COVID-19 vaccines that has been agreed to by the EU, India, South Africa and the U.S.
With global COVID-19 cases on the rise once again, the World Trade Organization (WTO) said it reached consensus among four WTO members – the U.S., European Union, India and South Africa – for an IP waiver regarding vaccines, a proposal to which biopharma reiterated its objections. Meanwhile, in the U.S., the White House appealed to Congress to provide adequate funding to continue the country’s pandemic response, and Pfizer Inc. and Biontech SE submitted an application to the FDA seeking emergency use authorization for a fourth shot of its COVID-19 vaccine.
Chinese state-owned enterprise China Meheco Group Co. Ltd. has signed a deal with Pfizer Inc. to be its mainland China partner for the commercialization of the COVID-19 pill Paxlovid (nirmatrelvir and ritonavir), which won conditional approval from China’s NMPA earlier this year.
Big pharma sponsors of clinical trials in Ukraine are putting studies on hold in Russia, Ukraine and Belarus as the conflict continues into its third week. As revealed by BioWorld last week, hundreds of clinical trials were being conducted in the two countries at the time Russian President Vladimir Putin gave orders to invade Ukraine on Feb. 20.
