WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Hope springs, for the second week in a row: Moderna’s COVID-19 vaccine hit its phase 3 primary endpoint, posting 94.5% efficacy with no severe cases of the disease. That news joins Pfizer and BioNTech’s similarly mRNA-based shot, which has delivered similar levels of effectiveness—and now both teams have their eyes on obtaining the FDA’s blessing, before racing to produce tens of millions of doses. Still, the agency’s review may take weeks, as it pursues a thorough and transparent process that aims to not only validate the injections, but to also ensure the public has trust in any vaccine, with the stakes being so high. | |
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Featured Story | By Nick Paul Taylor Moderna’s phase 3 COVID-19 vaccine has hit its primary endpoint with efficacy of 94.5%. Ninety cases of COVID-19, including all 11 severe cases seen so far, happened in the placebo cohort, versus five cases among people who received mRNA-1273. read more |
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Top Stories Of The Week By Angus Liu Scientists are continuing to try to repurpose existing medicines as a fast approach to containing COVID-19. After analyzing a large patient registry, researchers at the Cleveland Clinic suggested that a popular over-the-counter sleep aid melatonin may be a possible option for the disease. read more By Eric Sagonowsky Gilead’s remdesivir, now known as Veklury, is perhaps the most successful COVID-19 drug so far. It scored a full FDA nod in October after months of emergency use and brought in $873 million last quarter. But an influential European medical association now says it shouldn't be used in intensive care patients. read more By Eric Sagonowsky A week after Pfizer posted impressive early coronavirus vaccine efficacy numbers, Moderna took the spotlight early Monday with impressive findings of its own. But separate from its big announcement, the mRNA biotech said its vaccine can be kept at refrigerated temperatures for 30 days, reducing hurdles for a potential large-scale rollout. read more By Nick Paul Taylor Pfizer is preparing to file its COVID-19 vaccine for emergency use authorization (EUA) after passing a key safety milestone. CEO Albert Bourla, Ph.D., said Pfizer now has the median two-month follow-up data needed to secure EUA from the FDA, putting it a step closer to bringing its vaccine to market in the U.S. read more By Eric Sagonowsky As leading COVID-19 vaccines post positive phase 3 data and near FDA submissions, the agency official in charge of reviewing vaccines is emphasizing transparency and patience during the high-stakes process. Americans should expect reviews to take weeks rather than days, according to Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research. read more By Conor Hale The FDA has authorized its first all-in-one COVID-19 diagnostic that allows people to test themselves within their own home, from a swab to a result in about 30 minutes. read more By Ben Adams Johnson & Johnson is confident that it has a one-dose knockout vaccine that can protect against COVID-19, but it’s now starting a late-stage two-dose test just in case. read more By Kyle Blankenship With a range of COVID-19 vaccine candidates nearing the finish line, more eyes are turning to the strength of drugmakers' supply chains to meet global demand. One of the drugmakers leading the pack—Johnson & Johnson—can tout a supply chain that's the best in its field, a new report finds. read more By Angus Liu Roche’s Tecentriq has some company in triple-negative breast cancer. Merck’s Keytruda, used in tandem with chemo, has won FDA accelerated approval to treat triple-negative breast cancer patients whose tumors express high levels of PD-L1 at a combined positive score of at least 10. read more By Nick Paul Taylor D3 Bio has emerged with $200 million from a syndicate of heavy hitters and an ex-AstraZeneca leader in the CEO role. George Chen, M.D., set up D3 Bio after seven years at AstraZeneca and persuaded investors including Sequoia Capital China and Temasek to bankroll his plans. read more Resources Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored By: Veeva New industry-wide research reveals that the quality and breadth of HCP data is imperative as commercial teams adjust to remote engagement and execute a tailored approach. Read the full report to see all findings and benchmark your organization’s progress. 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