Another biotech SPAC bites the dust as Blade Therapeutics’ planned merger is cancelled After $750M bet, AbbVie lays down marker in fiercely competitive bispecific niche Daiichi Sankyo’s survival data means it may finally be ready to compete with Novartis’, Astellas’ marketed AML meds Sponsored: An Integrated Approach to Developing Next-Generation Genomic Medicines A new day for pediatric cancer patients: Day One's share price doubles on initial data for brain tumor drug With stacked to-do list, ImCheck checks off next funding round, refueling with about $101M Beta vaccine, alpha player? Sanofi, GSK post next-gen COVID-19 jab data to unlock booster market Amid FDA delay, Amylyx scores conditional ALS drug nod in Canada Regeneron's Eylea could lose 30% of its patients to Roche's Vabysmo over the next year: analyst survey FDA rebukes small biotech Althera for promotional claims on its cholesterol combo drug Bluebird scores 2nd straight win at high-stakes FDA gene therapy meeting Featured Story | By James Waldron Blade Therapeutics set out plans for a blank-check deal in November 2021 that would have given Blade about $255 million to bankroll trials in fibrosis and neurodegenerative conditions. But the move to join the NASDAQ by merging with SPRIM Global Investments' special purpose acquisition company have hit a dead end. read more |
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Top Stories By Nick Paul Taylor AbbVie and Genmab have posted more clinical data on their potential blockbuster rival to Roche’s newly approved Lunsumio, linking the CD20xCD3 bispecific epcoritamab to a 39% complete response rate that fell away somewhat in patients previously treated with CAR-T. read more By James Waldron Daiichi Sankyo’s challenger to Novartis’ Rydapt looks like it may get another shot at FDA approval, with quizartinib posting positive survival data from a phase 3 trial. 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 Gabrielle Masson Day One Biopharmaceuticals appears to be living up to its namesake, unveiling positive initial data for its oral drug tovorafenib, which aims to treat a brain tumor in children that currently has no approved treatment. read more By Annalee Armstrong A phase 2 trial ready to expand? Check. Plans for combination studies? Check. More pipeline assets to move into the clinic? Check. With all that on the to-do list, ImCheck Therapeutics has refueled with a €96 million ($101 million) funding round that featured existing investors Pfizer, Gimv and more. read more By Nick Paul Taylor Sanofi and GSK have shared a glimpse at the data they plan to use to bring a next-generation COVID-19 booster vaccine to market this year. The data drop covers two clinical trials that suggest the beta-specific vaccine can induce a stronger response against omicron than first-generation products. read more By Eric Sagonowsky After some skepticism from the U.S. FDA and its expert advisers, Amylyx Pharmaceuticals has scored the first worldwide approval for its ALS drug, AMX0035. The conditional nod requires the company to deliver phase 3 data from its PHOENIX trial, which is underway. read more By Kevin Dunleavy A survey of 20 retina specialists conducted by Evercore ISI indicates that Vabysmo could soon become the first choice of macular degeneration patients, eventually supplanting Regeneron and Bayer’s powerhouse Eylea. As a result, Evercore is projecting more sales erosion for Eylea than the Wall Street consensus. read more By Ben Adams,Karl Greenberg Althera Pharmaceuticals, a maker of cardiovascular medications, is in the FDA crosshairs for its flagship cholesterol oral delivery drug Roszet. read more By Eric Sagonowsky Going into a two-day FDA advisory committee meeting this week, bluebird bio faced uncertainty over the viability of its gene therapy prospects. But the drugmaker has impressed an FDA panel and come away with a pair of expert endorsements for its lead drugs. 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 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 | 