| After $3.2B deal, Sanofi dumps Translate's mRNA COVID vaccine but hits the gas on switch to modified molecules Here we go again: Eisai starts rolling FDA approval submission for Biogen-partnered Alzheimer's drug Ziopharm's new CEO cuts 50% of workforce amid trial delays for T-cell receptor therapy Sponsored: Navigating the complexities of oncology clinical trials in an increasingly competitive landscape Valneva, hit by COVID contract chaos, sees Lyme disease vaccine drop-off in phase 2, but boosters helping Sponsored: A New Reference Model for Clinical Trial Recruitment, Enrollment and Retention Success Shionogi licenses out 3rd-gen HIV asset to ViiV, notches a flop in chronic cough Innovent to pay Union up to $267M for rights to midstage psoriasis, eczema asset in China Anji Pharma nabs $70M for late-stage diabetes treatment, ex-Novartis asset Fierce Biotech's 2021 Fierce 15 Merck's reported $11B Acceleron buy could help it diversify beyond Keytruda, but antitrust hurdles loom: analysts Hospital finances 'not out of the woods yet' as delta fuels high-acuity stays in August Roche's Genentech will communicate with patients, trial participants using Lifelink Systems' chatbot Featured Story | By Nick Paul Taylor The ink on Sanofi’s $3.2 billion takeover of Translate Bio is barely dry, but the French big pharma is already tweaking its plans, dumping a COVID-19 vaccine prospect after seeing interim phase 1/2 data and accelerating its switch to modified mRNA. read more |
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Top Stories By Nick Paul Taylor Biogen and Eisai are once again trying to get accelerated FDA approval for an Alzheimer’s disease drug candidate. Having reset the bar to U.S. market access with Aduhelm, the partners have begun a rolling submission for another anti-amyloid beta antibody in early Alzheimer’s patients. read more By Kyle LaHucik After 28 days in the CEO post, Kevin Boyle is eliminating more than half of his staff, about 60 people, to extend Ziopharm Oncology's runway. The biotech has run into multiple clinical trial delays for its T-cell receptor program after slashing its glioblastoma asset in the beginning of the year. read more Sponsored by: Premier Research With the shift from traditional chemotherapy agents to innovative immuno-oncology drugs and cell and gene therapies, oncology clinical trials have increased in complexity. read more By Ben Adams Valneva and partner Pfizer say their experimental Lyme disease vaccine has seen a drop-off in protection after 18 months and will need a booster, though early data suggest that later shot can help. read more Sponsored by: IPM.ai Rare diseases demand a modern recruitment approach grounded in uncovering the ideal, medically-eligible patient population with the highest propensity for study enrollment and retention. read more By Ben Adams Japanese pharma Shionogi is looking to build on the success of its GSK- and Pfizer-partnered infectious disease joint venture ViiV as it pens a new licensing deal for a long-acting HIV asset. read more By Kyle LaHucik Innovent Biologics will pay Danish biotech Union Therapeutics up to $267 million to license a potential psoriasis and atopic dermatitis drug in China. The drug, acquired from Leo Pharma last year, will enter phase 2b studies in those indications soon and could set Union up for a global licensing deal. read more By Kyle LaHucik Anji Pharma will deploy its $70 million series B on a phase 3 type 2 diabetes asset that it acquired from Elcelyx Therapeutics in 2019 and a mid-stage constipation drug hopeful. Anji also acquired an oncology program from the Broad Institute earlier this year. read more By Ben Adams COVID-19 was inevitably the focus of Fierce 15 last year. This year, it’s pretty much more of the same as we see how the sector has and continues to navigate the pandemic while raising cash, running trials, hiring staff, keeping them safe, and making deals during an incredibly difficult 18 months. read more By Angus Liu Merck has emerged as a finalist to acquire Acceleron for around $11 billion. The deal dovetails with the Big Pharma company’s plan to diversify beyond Keytruda, but overlapping businesses could attract antitrust scrutiny, analysts say. read more By Dave Muoio Kaufman Hall's latest monthly report suggests that hospitals' margins and volumes have improved over 2020 but still fall short of 2019's performances. read more By Kyle LaHucik Roche's Genentech will start communicating personalized information to patients, clinical trial participants and providers via a digital chatbot. The goal is to be able to provide information on a smartphone to more people. read more Resources Sponsored by: WCG Every biopharma sponsor faces the challenge of initiating, running and closing trials on time, but oncology studies pose several unique hurdles. Sponsored by: Patheon by Thermo Fisher Scientific Choose the right AAV platform for your viral vector-based therapy Sponsored by: XIFIN inc. Download the Value of Precision Medicine Informatics (PMI) Initiatives report to learn about the technology, data types, and the value derived from more than 100 PMI initiatives. Sponsored by: EVERSANA Today’s economics do not allow manufactures to keep making decisions in an antiquated way. They need to challenge tradition & deliver faster, cheaper, successful launches. Learn how. Sponsored by: Thermo Fisher Scientific Thermo Fisher Scientific introduces a new NK cell culture medium designed to support feeder-free, high-yield growth for cell therapy applications. Sponsored by: Cascade Chemistry by Aceto Read four customer success stories and four success factors that helped move pharmaceutical customers of Cascade Chemistry by Aceto quickly and effectively to clinic with trial-ready APIs. 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. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Let A Digital Sherpa Uncomplicate The Path for Patients Recorded on September 15, 2021 Sea-dumped chemical weapons: environmental risk, occupational hazard September 22, 2021 Clinical Quality Oversight Forum September 27-29, 2021 | Philadelphia, PA The MedTech Conference 2021 September 27 - 30, 2021 Introduction to Structure Elucidation in Drug Development Sep 29, 2021 Pharma PR & Communications Summit October 4-5, 2021 | Jersey City, NJ Virtual U.S. Healthcare Compliance Certificate Program October 11 – 14, 2021 Fierce Biotech Cell & Gene Therapy October 19, 2021 | Virtual Event Fierce Health Payer Summit October 26, 2021 | Virtual Event Announcing the 9th International mRNA Health Conference November 9-10, 2021 Diversity, Equity & Inclusion Summit November 9–10, 2021 | Virtual Event Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Fierce Biotech Forum 2022 | Virtual Event | 