Lilly, swinging at the king, shows Dupixent rival works in phase 3, but wait for key figures goes on The 7-year itch? Boehringer culls $600M cancer pact with CureVac, heaping more woe to the biotech Investors are tripping on psychedelics startups despite a murky path to commercial success Sponsored: Artificial Intelligence in Drug Discovery Requires Validated Data Zombie biotech Sesen Bio's resurrection plans limping again as FDA rejects bladder cancer drug FDA lifts clinical hold on Rocket gene therapy trial, creating launchpad for start of pediatric dosing Beckley Psytech bags $80M to fuel psychedelics for depression, debilitating headaches Exelixis fuels $15M into the Invenra research engine, firing up a 20-target cancer collab BrainQ reels in $40M to trial AI-powered electromagnetic field therapy device for stroke recovery After FibroGen's FDA rejection in anemia, Akebia CEO aims to seize first-in-class opening with vadadustat Here are 3 major policy areas that health industry groups are closely watching in $3.5T infrastructure bill Featured Story | By Nick Paul Taylor Eli Lilly is gunning for Regeneron and Sanofi’s blockbuster Dupixent. Having paid $1.1 billion to enter the IL-13 space last year, Lilly has now revealed the success of its challenger in two pivotal trials—but is yet to share the numbers that will show whether lebrikizumab is a true contender for the throne. read more |
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Top Stories By Ben Adams Back in 2014, a German pharma and a then largely unknown fellow German biotech in CureVac penned a $600 million mRNA cancer pact. Buried in financials posted Monday morning, CureVac quietly reported that Boehringer Ingelheim has walked away from the deal, which was penned in 2014 and included $45 million upfront plus $556 million in biobucks. read more By Arlene Weintraub Eighteen venture capital firms have poured more than $79 million into biopharma companies developing psychedelic compounds into therapies for depression, post-traumatic stress disorder, and more. Two IPOs in the field have outperformed expectations. But all that cash is flowing into an industry that’s facing its fair share of risks. read more Sponsored By: BioIVT Machine-learning-based techniques in drug and diagnostic discovery require copious amounts of biomedical data, and that data needs to be validated to ensure success. read more By Ben Adams The stroke of 4 p.m. on a Friday is witching hour for biotechs, and it proved to be a scary night for Sesen Bio. The once zombie, now resurrected biotech was hoping for an approval for its bladder cancer asset Vicineum (oportuzumab monatox-qqrs), but data and manufacturing issues have scuppered those plans. read more By Nick Paul Taylor Rocket Pharmaceuticals’ gene therapy trial is back on track. With the FDA lifting the clinical hold after Rocket changed the study protocol, the biotech is now on course to start dosing children in the third quarter. read more By Amirah Al Idrus With the funding, Beckley Psytech will complete a phase 1b study of psilocybin in a rare, debilitating headache condition and start a phase 1 study of a new formulation of 5-MeO-DMT, a psychedelic found in the venom of the Sonoran Desert toad, before kicking off a phase 2 study in depression. read more By Kyle LaHucik Exelixis and Invenra are expanding their oncology collaboration for the second time, with Exelixis doling out $15 million upfront this time. The partnership and licensing agreement comes with an additional 20 oncology targets. read more By Andrea Park The new investment will help cover the costs of a clinical trial that BrainQ is planning to launch in several U.S. hospitals. read more By Angus Liu In the race for novel oral drugs to treat anemia of chronic kidney disease, AstraZeneca and FibroGen’s roxadustat held the front-runner position for quite some time. But as that program has now stumbled, rival Akebia Therapeutics sees a first-in-class opportunity for its underdog vadadustat. read more By Robert King As the Senate starts to develop the contents of a $3.5 trillion reconciliation package, industry groups are keeping a close eye on what healthcare policies could eventually be included and what could not. read more Resources Sponsored by: Patheon by Thermo Fisher Scientific Learn how to build a robust packaging strategy and the key technical considerations in packaging design and operational planning to enable rapid commercialization of pharmaceuticals. 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. Sponsored by: Patheon by Thermo Fisher Scientific Learn how regulations are changing and key considerations for commercializing cell and gene therapies without sacrificing quality. Sponsored By: LabVantage Solutions, Inc. Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem. 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. Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Medical Affairs Strategic Summit (MASS) September 13-15, 2021 | New Brunswick, NJ Clinical Quality Oversight Forum September 27-29, 2021 | Philadelphia, PA Diversity, Equity & Inclusion Week November 9–11, 2021 | Virtual Event Fierce Biotech Forum Boston, MA | November 16-17, 2021 | 