Editor’s Note: Fierce Biotech will not be publishing Monday, Jan. 17 in observance of the Martin Luther King Jr. Day holiday. We will return to your inboxes on Tuesday, Jan. 18. Licensing and research tie-ups trump M&A at conference in 'reflection of last year' FDA approval, global partnership on the agenda at Mithra as phase 3 menopause trials hit goals—with one blemish 'Shots on goal' to 'deterministic' drug development: Flagship CEO, Moderna Chair Noubar Afeyan pens first annual letter Decentralized trials, broader service offerings and novel drugs key trends in the CRO space EMA sets out plan to accelerate clinical trials, reduce administrative burden Galapagos execs troll for deals at J.P. Morgan but will hold off on signing for CEO-in-waiting Fending off heart disease by blocking how immune cells 'smell' their surroundings Verana Health lands J&J, Novo backing in $150M round to fund real-world database for drug, device development Idorsia makes friends with Jen Aniston for new sleep campaign, as it preps for insomnia drug launch Fierce Pharma Asia—Takeda, Denali's Alzheimer's hiccup; Daiichi Sankyo's R&D reorg; J&J, Legend's CAR-T supply prep Chutes & Ladders—Galapagos says new CEO expected within weeks, not months Featured Story | By Kyle LaHucik Just like at last year's J.P. Morgan Healthcare Conference, M&A is so 2019. In the third winter of COVID-19, the drug development world hasn’t executive on the type of megamergers we saw in 2019, such as Bristol Myers Squibb’s $74 billion Celgene deal, which dropped in the lead up to the healthcare industry's largest gathering. read more |
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Top Stories By Nick Paul Taylor Mithra has brushed off a missed co-primary endpoint in one of its two phase 3 clinical trials and given a bullish update on the menopause drug, which it expects to gain a global partner this year and go on to win approval on both sides of the Atlantic in 2024. Shares in the Belgian biotech rose 9% to around €22 ($25). read more By Kyle LaHucik Written in the middle of the largest pandemic wave to-date, Flagship Pioneering CEO and Moderna Chairman Noubar Afeyan, Ph.D., penned his first annual letter documenting the sea changes in biotech. He also called on more preemptive measures for future pandemics and tackling the underlying diseases of common illnesses. read more By Gareth Macdonald Resurgent demand was a common theme for CROs presenting at the J.P. Morgan Healthcare Conference with Icon, Syneos and PPD owner Thermo Fisher daring to look beyond the pandemic toward changing industry needs. read more By Nick Paul Taylor The European Medicines Agency (EMA) wants to speed up your clinical trials. Through the Accelerating Clinical Trials in the EU (ACT EU) initiative, the EMA and other bodies have set out 10 actions they plan to prioritize in 2022 and 2023 to transform how studies are initiated, designed and run. read more By Kyle LaHucik After dropping a late-stage asset and hitting an FDA roadblock in the JAK inhibitor class last year, Galapagos is in need of a 2022 rebound. With active discussions underway at the J.P. Morgan Healthcare Conference to find an acquisition target and a new CEO expected within weeks, the biopharma is trying to spark a revival. read more By Angus Liu Scientists at La Jolla Institute for Immunology have discovered that macrophages in arteries could "smell" its surroundings to trigger inflammation in atherosclerosis. Blocking a key protein receptor involved in the process could be a promising target for treating cardiovascular disease, they said. read more By Andrea Park With a new CEO at the helm, the recent launch of an artificial-intelligence-powered data analytics engine and, now, the close of its largest funding round to date, Verana Health appears ready to make good on its promise to revolutionize both drug development and healthcare delivery. read more By Sharon Klahr Coey The average person doesn’t have a lot in common with Jennifer Aniston—her fame, her money, her looks (that hair!) However, there is one thing 25 million Americans do share with the A-lister—insomnia. read more By Angus Liu The FDA has slapped a clinical hold on Takeda and Denali Therapeutics' phase 1-ready Alzheimer's candidate. Daiichi Sankyo is shutting down its Plexxikon R&D facility. Legend Biotech talks manufacturing learnings from Bristol Myers Squibb's CAR-T rival. read more By Kyle LaHucik Galapagos CEO Onno van de Stolpe will likely be replaced in the coming weeks after a 23-year career at the biopharma, and a new chief scientific officer is also on the way. Charles River Labs CFO David Smith will depart the contract research organization this year. And Ogilvy Health named Adam Hessel its chief creative officer. read more Resources Sponsored by: WIRB-Copernicus Group Sites receiving augmentation support enroll more than 30,000 patients in just over three months. See how additional site resources can make a difference. Sponsored by: Thermo Fisher Scientific Learn how a CDMO partnered with Thermo Fisher Scientific to manage high-volume process liquid and buffer preparation scale-up. Download the free case study from Thermo Fisher Scientific Sponsored by: Thermo Fisher Scientific A variety of genetic analysis methods are valuable in ensuring that ex vivo human cells to be used for cell-based therapies are correctly identified, have the correct characteristics, and are free of contaminants. Sponsored by: IQVIA Learn how to elevate your omnichannel marketing strategy with Next Best - a combination of data and analytics, deployed to facilitate decision making. Sponsored by: Catalent Biologics Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Thermo Fisher Scientific Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Immuno-Oncology 360° Summit March 16-18, 2022 | New York Marriott Brooklyn Bridge Fierce JPM Week 2022 January 18-20, 2022 | Virtual Event Fierce Drug Safety Summit February 8-9, 2022 | Arlington, VA | Presented by Fierce Pharma
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