Valneva SE’s share price plummeted May 16 after the European Commission decided to terminate an advance purchase agreement for millions of doses of its COVID-19 vaccine candidate VLA-2001 because of delays in development. The company’s shares (Paris:VLA) fell more 19% to €9.65 (US$10.07) after it said it would reconsider its financial guidance for 2022.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Checkpoint, Clearmind, Editas, Hansa, Mitsubishi Tanabe, Neurocrine, Polarityte, UCB, Yiling.
News that the U.S. Trade Representative (USTR) had signed off on a compromise World Trade Organization (WTO) proposal to waive IP rights for COVID-19 vaccines caught Congress by surprise earlier in early May. Now, some members, both Democrats and Republicans, are reminding USTR Katherine Tai that she has an obligation to consult with Congress on such trade issues.
As the COVID-19 pandemic slowly starts to ease globally, efforts are already gearing up to predict the next potential pandemic. One institute researching the increasing number of diseases transmitted from animals to humans is Canada’s Vaccine and Infectious Disease Organization, part of the University of Saskatchewan. Now, together with collaborators including the Canadian government, it’s sponsoring a phase II trial of COVAC-2, a squalene-in-water adjuvanted microsphere peptide-based protein subunit vaccine that contains a portion of the SARS-CoV-2 spike protein.
The commercial success of COVID-19 mRNA vaccines has other companies in the space “looking in the attic, so to speak,” to see if they have any patents they can assert against components of the vaccines so they can get a percentage of the sales, Aziz Burgy, a patent attorney, told BioWorld. Given the global spread of the pandemic and how quickly it came on, the vaccines have generated billions of dollars in sales in a short period of time, and other companies want a share, he said. He compared today’s patent infringement cases against the vaccine producers to the litigation seen in the early days of the smartphone revolution when other high-tech companies scrambled for a piece of Apple’s and Samsung’s profits.
In an effort to increase global access to COVID-19 technologies, the World Health Organization’s COVID-19 Technology Access Pool and the Medicines Patent Pool finalized a licensing agreement May 12 with the U.S. NIH for research tools, early stage vaccines and diagnostics.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amicus, Ascletis, Cue, Eli Lilly, Immuron, Incyte, Iterum, Kiromic, Regulus, Spine, Veru.