Another knock back for amyloid: Roche's approach to presymptomatic Alzheimer's ends in failure BIO: 'Diversity candidates' and knowledge 'shortfalls': Women in biotech say 'I'm here to do my job' despite toxic tropes Delimiting and delivering: Promontory co-founder 'can't hire fast enough' as small biotech expands vision Sponsored: An Integrated Approach to Developing Next-Generation Genomic Medicines Biogen takes nuclear option, terminating Karyopharm ALS pact after getting a look at phase 1 data Bavarian Nordic sets up COVID booster for battle against Pfizer-BioNTech's shot Exelixis signs on $25M to check out 3 drug targets from BioInvent's antibody library Despite efficacy doubts, FDA advisors endorse Pfizer, Moderna COVID shots for preschoolers CAR-T countdown: NeoImmuneTech drug could reduce number of cells needed for cancer therapy five-fold Boston Scientific offers $230M for Korean maker of gastrointestinal and airway stents Sanofi taps AI firm Yseop to automate trial report writing FDA's drug manufacturing oversight lags as pandemic wears on Pharmacy retail giant Walgreens looks to disrupt the clinical trials business Featured Story | By Nick Paul Taylor Roche's long-running attempt to show its anti-amyloid-beta antibody works very early in the Alzheimer's disease pathway has ended in defeat. The AC Immune-discovered candidate failed to improve outcomes in cognitively unimpaired individuals at high imminent risk for developing Alzheimer's symptoms. read more |
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Top Stories By Max Bayer Discussions and dialogues addressing efforts to increase diversity in biotech permeated this year's BIO, with new data indicating slight gains across the industry. Yet toxic tropes persist both in and out of the conference, underscoring how much room for improvement remains. read more By Gabrielle Masson Promontory Therapeutics has ditched its old name in an effort to “delimit” itself and is now doing what many others can’t—expanding. read more Sponsored by: Danaher Corporation The life sciences companies at Danaher enable gene editing, gene therapy and mRNA medicines with integrated solutions that improve research, development and manufacturing. read more By Nick Paul Taylor Biogen is jettisoning one of its three clinical-phase amyotrophic lateral sclerosis candidates, kicking an oral nuclear export inhibitor back to Karyopharm Therapeutics. read more By Annalee Armstrong Bavarian Nordic plans to put its COVID booster, called ABNCoV2, up against Pfizer and BioNTech’s Comirnaty in a phase 3 trial slated to start in August. read more By Gabrielle Masson Exelixis will pay $25 million upfront for the right to check out three drug targets from BioInvent's library, all in the name of bringing new antibody-based immuno-oncology therapies to market. read more By Kevin Dunleavy An FDA advisory committee has recommended by a unanimous vote that the Pfizer and Moderna COVID-19 vaccines be sanctioned for preschoolers. While the blessing sets up the Comirnaty and Spikevax vaccines for long-awaited authorizations, questions remain about how effective the shots will be given the rapidly evolving virus. read more By James Waldron NeoImmuneTech’s drug NT-I7 has shown potential to reduce the number of cells needed in a CAR-T therapy infusion five-fold, as well as boosting survival rates in mice. read more By Andrea Park Boston Scientific is adding a familiar face to its family of medical devices. read more By Gareth Macdonald Sanofi will use artificial intelligence to automate aspects of clinical trial report writing in a bid to speed up its drug development efforts. read more By Fraiser Kansteiner In fiscal year 2021, the FDA sent out 70% of follow-up letters to manufacturing facilities within 90 days of an inspection. Over that same stretch, the regulator completed 48% of regulatory actions for facilities in need of follow-up within six months of inspection closing, the agency said in a new report. Both represented declines from the prior year. read more By Heather Landi Walgreens' healthcare ambitions continue to grow as the pharmacy retail giant expands its reach into clinical trials, leveraging its vast trove of patient data, its technology assets and its retail locations. Industry CRO veteran Ramita Tandon, who is leading the new business line, spoke with Fierce Healthcare to lay out Walgreens' clinical trials strategy. read more Resources Sponsored by: PwC Don’t miss these critical considerations when evaluating your HCP interactions management program. Sponsored By: Thermo Fisher Scientific Sponsored by Thermo Fisher Scientific The journey for starting or expanding a lab can be exhilarating, while also being challenging--learn how this free program provides savings and solutions to support your goals. Sponsored By: CG Life Explore the new cell therapy handbook from Thermo Fisher Scientific. Sponsored by: Merit Solutions Quality operations guide your organization through regulatory compliance processes and safeguard your products, processes, and reputation. But your team is capable of so much more. Quality incident data and processes can be a driver of significant business value if shared with other stakeholders. Sponsored by: Blue Matter, strategic consultants in the life sciences Recent trends are driving big changes in Medical Affairs. This paper explores why, and what MA teams can do to stay ahead of the curve. Sponsored by: Catalent Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Fierce Digital Pharma Engage June 14-15, 2022 | Huntington Beach, CA Fierce Digital Pharma Innovation Week June 21-23, 2022 | Virtual Event Fierce Biotech Summit September 19-20, 2022 | Boston, MA Fierce New Product Planning Summit September 20-22, 2022 | Boston, MA Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ Fierce European Trial Master File Summit November 14-16, 2022 | London, UK Fierce Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Virtual Event Fierce JPM Week 2023 January 2023 | San Francisco, CA & Virtual | 