Novavax's latest COVID-19 vaccine delay sends shares tumbling nearly 20% Moderna is ready to spend billions in COVID-19 cash, and the famed biotech has sights set on gene editing Sierra raids the bargain bin again, picking up AstraZeneca cancer drug to pair with Gilead castoff Dicerna’s stock sinks after its Alnylam rival shows mixed data, stymieing approval filing Aprea's myeloid program iced by FDA while tricky adverse event profile is sorted out No discounts here: Biotech EQRx to raise $1.8B in SPAC deal for lofty discount drug goal Former Merck exec joins Kallyope as president, soon-to-be CEO AstraZeneca chief Soriot lends GlaxoSmithKline's Walmsley CEO wisdom, support as activist investors press for change Moderna, citing variants and waning immunity, expects COVID-19 boosters to become a fact of life Cigna anticipates elevated claims costs for rest of 2021, execs say Medtronic boosts ear, nose and throat portfolio with $1.1B bid for sinus implant maker Intersect ENT Chutes & Ladders—Scholar Rock founding CEO returns to top spot as Kingsley swiftly exits Fierce Pharma Asia—BeiGene's flagship U.S. hub, Brukinsa win; Takeda's tax bill, regulatory delays Featured Story By Kyle LaHucik Novavax hit another roadblock in its COVID-19 vaccine journey in the U.S., with the company pushing back an FDA filing from May to July to now the fourth quarter. The company filed in India, Indonesia and the Philippines this week, and expects more submissions later this year with WHO, UK, EU, Australia, Canada and New Zealand. read more |
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| Top Stories By Annalee Armstrong Moderna has found a direction to volley its mountain of COVID-19 vaccine cash: gene editing. Executives revealed during a second-quarter earnings call Thursday that Moderna is ready to “expand our horizons” with external technologies or products. Read: They’re ready to start buying. read more By Nick Paul Taylor AstraZeneca has offloaded its BRD4 BET inhibitor AZD5153 to Sierra Oncology. Sierra plans to start a phase 2 trial testing the drug in combination with the JAK inhibitor it picked up from Gilead in 2018. read more By Nick Paul Taylor After finding success with one RNAi candidate for a rare metabolic disorder that impacts the kidneys called primary hyperoxaluria 1, Dicerna Pharmaceuticals was hopeful that a second RNAi candidate would be able to tackle other types of PH. However, the company released mixed results from what was meant to be a pivotal study for nedosiran, sending its shares down some 13% when the markets opened today. read more By Annalee Armstrong The FDA slapped a hold on Aprea Therapeutics’ myeloid malignancy programs for eprenetapopt after serious side effects cropped up in trial patients. The high-risk nature of the patients’ disease and prior treatment means the biotech is not quite sure whether its drug caused the problems. But the FDA decided to pause the entire program while the safety risks are sorted out. read more By Kyle LaHucik After raising $750 million in private financing since January 2020 on its towering mission to rewrite the life sciences pricing model, EQRx has now tapped the public markets for another $1.8 billion in a SPAC deal. read more By Kyle LaHucik Kallyope has been relatively quiet since securing a $112 million raise in March 2020, but now the gut-brain biotech will have a former Merck leader at the helm to ramp up clinical work. Jay Galeota joins the New York City biotech as president and will become CEO by October 1. read more By Angus Liu As GlaxoSmithKline CEO Emma Walmsley faces a high-profile challenge from activist investor Elliott Management, she has won backing from an unexpected source: AstraZeneca chief Pascal Soriot. read more By Eric Sagonowsky For anyone thinking aggressive COVID-19 vaccine rollouts would bring a quick end to the pandemic, Moderna has a word of caution. While U.S. authorities aren’t yet ready to recommend vaccine boosters, the company believes that add-on shots will become a fact of life for some as the virus sticks around and continues to put up a fight. read more By Paige Minemyer Cigna posted $1.5 billion in profit in the second quarter of 2021, echoing its industry peers in seeing its earnings decline from Q2 2020. read more By Andrea Park Medtronic’s latest acquisition is nothing to sneeze at, with an offer of more than $1 billion for a handful of devices already cleared in the U.S. and Europe. read more By Kyle LaHucik It's another swift exit for Tony Kingsley as he leaves Scholar Rock's CEO spot to founding CEO Nagesh Mahanthappa, Ph.D. IGM Biosciences snagged Gilead's oncology chief as chief medical officer. And Arch Oncology hired a trio of leaders from AbbVie, Bristol Myers Squibb and Xencor. read more By Angus Liu BeiGene is building an R&D and manufacturing center in New Jersey as its Brukinsa posted a win in chronic lymphocytic leukemia. Takeda sees delays for two drug candidates in the U.S. and EU and it will have to keep fighting a €398 million Irish tax bill. And more. read more | With the expansion of its DNA services, Cobra Biologics, a Charles River company, has capacity to offer rapid 6-week delivery of HQ plasmids as starting material for clinical evaluation of viral vector mediated immunotherapies. 2021 slots available. | Resources Sponsored by: Patheon by Thermo Fisher Scientific Learn how a decentralized clinical trial strategy improves patient recruitment, reduces drop-out rates, and ultimately streamlines the path to the next trial phase. 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