Pfizer’s COVID vaccine for younger kids meets FDA bar, with CDC panel next week being key to wide rollout Gilead taps brakes on $4.9B bet after rival's failure, pushing blood cancer data out to 2022 Aetna rolls out in-network coverage for Zolgensma, other multimillion-dollar gene therapies Resurgeant Veklury delivers Gilead $1.9 billion in sales and an earnings surprise A COVID-19 vaccine delivered with a patch rivals traditional shots in mice: study DNA Script tallies up $165M to help launch its desktop DNA printer HHS proposes nixing controversial Trump-era 'sunset' rule due to massive resources needed for compliance Daiichi jettisons ADC after flunking early solid tumor test $100M Northwell-backed joint venture will give clinical, commercial guidance to budding AI companies NIH to deal out $75M for health data science research projects across Africa AbbVie’s Vraylar turns in mixed results in depression, but pharma decides to file for approval anyway Magnus Medical debuts with $25M to target drug-resistant depression with personalized therapy Signet Therapeutics gets a $10M top-up for next-gen cancer bets Featured Story | By Kevin Dunleavy Kids ages 5-11 in the United States are now eligible for vaccination against COVID-19. On Friday afternoon, the FDA authorized the Pfizer-BioNTech mRNA vaccine, Comirnaty. The Pfizer shot is the only one approved in the U.S. for those younger than 18. read more |
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Top Stories By Nick Paul Taylor Gilead’s $4.9 billion bet on Forty Seven has run into a delay. Weeks after Takeda’s rival drug flunked a pivotal trial, Gilead has pushed back the release of data from a phase 1b study designed to support accelerated approval. read more By Rebecca Torrence Aetna is launching a new network to cover gene therapies for inherited retinal disease and spinal muscular atrophy. The insurer expects gene therapies to add $45 billion to healthcare costs between 2020 and 2024 if the FDA approves all other therapies currently in the pipeline. read more By Kevin Dunleavy Veklury was thought to be in decline as a treatment for hospitalized COVID-19 patients. But to the surprise of even Gilead, the antiviral staged a comeback in the third quarter, posting $1.9 billion in sales and allowing the company to bump up its projection for annual revenues. read more By Kyle LaHucik Researchers at University of Queensland collaborated with Vaxxas to develop a COVID-19 patch that warded off the virus in mice. They hope to raise funding to bring the patch into clinical testing but are facing competition from existing vaccines and other patch developers. read more By Conor Hale Following the launch of its benchtop DNA printer earlier this year, DNA Script is preparing to take its platform to the masses. Using four specially prepared genetic “inks”—G, A, T and C—the strings of genetic code are assembled letter by letter, before being delivered in a purified, ready-to-use format. read more By Robert King The Department of Health and Human Services proposed getting rid of a controversial Trump-era rule that would spark a massive agency review of all existing regulations, arguing that the previous administration vastly underestimated the cost of compliance. read more By Nick Paul Taylor Daiichi Sankyo’s antibody-drug conjugate team has hit a rare bump in the road, dumping a gastrointestinal stromal tumor candidate after seeing “no clear responses” in a phase 1 trial. read more By Dave Muoio Young AI companies supported by the joint venture will have access to the health system's clinical data and experts as well as the venture firm's commercialization experience. read more By Emmy Lucas The NIH will invest $74.5 million through a new program to establish data science research centers and training across Africa. read more By Angus Liu AbbVie’s antipsychotic Vraylar could get a major boost from a potential expansion into depression. But like some other late-stage contenders, the drug’s clinical results fell short of a home run. read more By Conor Hale The neurostimulation startup Magnus Medical is raising the curtain with $25 million in hand and an FDA breakthrough designation for its personalized treatment for severe cases of depression. read more By Ben Adams Little U.S.-China startup Signet Therapeutics has bagged a second seed round worth around $10 million as plots a path to the clinic. read more | 