With the FDA’s required safety milestone notched in their phase III study of COVID-19 vaccine candidate BNT-162b2, Pfizer Inc. and Biontech SE said they will request emergency use authorization “within days.” They plan to produce up to 50 million doses before the year ends and as many as 1.3 billion doses before 2021 ends. The phase III study of their mRNA candidate met all the primary efficacy endpoints with a “p” value of <0.0001 for those without a prior SARS-CoV-2 infection, which was the first primary objective, and also for patients with and without a prior SARS-CoV-2 infection, the second primary objective.
As COVID-19 vaccine efforts heat up, so will cyberattacks: Bluevoyant report
Cybersecurity firm Bluevoyant LLC said attacks on biotech and pharmaceutical firms jumped by 50% between this year and last. For Bluevoyant’s annual report on the industry, analysts looked at open-source records of 25 publicly reported attacks that have taken place in the last four years. With more people working from home, nation-states are focusing more on companies developing COVID-19 vaccines, a phenomenon likely to increase as products get closer to market, the firm said.
The new dealmaking normal: What the industry thinks
In a world where the traditional way of conducting business has been disrupted for most of the year, companies for the most part appear to have adapted well to the prevailing environment. In terms of the volume and value of financing transactions and partnership deals, records have been set, far outpacing what had been previously established during a normal 12-month period. BioWorld provides the results of its short poll examining readers’ own experiences during these challenging times and how they might reshape their approach to doing business going forward.
Taiho acquires Japan rights for LTI-01, Lung Tx’s therapeutic for LPE
HONG KONG – Taiho Pharmaceutical Co. Ltd. has signed an exclusive license agreement with Lung Therapeutics Inc., picking up the Japanese rights to Lung Tx’s LTI-01, a recombinant human single-chain urokinase plasminogen activator for loculated pleural effusion (LPE). Lung Tx, of Austin, Texas, will receive an up-front payment and will be eligible for milestone and royalty payments based on product sales through the agreement, the companies said. Tokyo-based Taiho will meet with Japan’s Pharmaceuticals and Medical Devices Agency as the first step toward starting clinical trials.
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