Featured Story | By Annalee Armstrong Small Alzheimer’s biotech Cassava Sciences is defending its work after a citizen petition filed with the FDA questioned the scientific integrity of the biotech’s clinical trials for simufilam and asked the agency to put them on hold. The whistleblower petition posted aftermarket Tuesday details “grave concerns about the quality and integrity" of the studies supporting the drug candidate. read more |
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Top Stories By Amirah Al Idrus Eli Lilly is signing another protein degradation partner, signaling a growing commitment to the space, which seeks to tackle “undruggable” targets. The company is handing over $35 million and promising more than $1.6 billion in milestone payments to work with Lycia Therapeutics on up to five of these tricky targets in areas including immunology and pain. read more By Kyle LaHucik If you're going to call one state home, make it Massachusetts, says a host of biopharma startups that raised an eye-popping $4.3 billion in venture capital cash in just one quarter. The first quarter haul for the New England state is close to the $5.8 billion record set for all of 2020 and makes the first three months of this year the third-highest funding total on record, surpassing the bronze spot notched in 2017. read more By Nick Paul Taylor Add Brii Biosciences to the list of biotechs that have surged forward because of the COVID-19 pandemic. Brii, which only launched in 2018, now has phase 2/3 clinical trial data showing its antibody cocktail slashes the chances of hospitalization and death in high-risk outpatients with COVID-19 infections. read more By Kyle LaHucik Atavistik Bio came out of stealth with $60 million in series A funding to tackle metabolic diseases and cancers on Tuesday. The financing should support three or four years of operations as the preclinical biotech works to figure out which indications to go after first. read more By Kyle LaHucik William Ludlam, M.D., Ph.D., is leaving Chiasma to take on the chief medical officer role at Recordati Rare Diseases. The executive was previously senior vice president of clinical development and medical affairs at Chiasma and prior to that was a Novartis senior medical director for the pituitary disorders unit. read more By Nick Paul Taylor The heart failure field has finally started to see progress in recent years, as drugs such as Novartis’ Entresto have bucked the history of failure. Yet, the focus remains largely on the symptoms. Heart failure is a disease that is controlled, not cured. Cardior Pharmaceuticals has a bigger goal—and has persuaded investors to commit €64 million ($75 million) to support its ambitions. read more By Arlene Weintraub University of Arizona researchers led a study that found that levels of the inflammatory enzyme sPLA2-IIA could predict severe COVID-19. With further research, the enzyme, which is similar to a paralyzing enzyme in rattlesnake venom, could be a viable therapeutic target, they suggested. read more By Angus Liu Many cancer patients may progress or relapse after being treated with CAR-T cell therapies, because tumor cells expressing low levels of the target antigen could survive and escape detection. Scientists at the Fred Hutchinson Cancer Research Center have designed new CARs with better antigen sensitivity, and they have shown promise in mouse studies. read more By Fraiser Kansteiner Shortly after the U.S. telegraphed its booster plan for Pfizer and Moderna’s mRNA-based COVID-19 vaccines, Johnson & Johnson has rolled out trial results showing a follow-up dose of its vaccine boosts recipients' antibody responses. read more By Andrea Park Two years after the FDA first issued a safety notice outlining the lack of clinical evidence to support the use of robotic-assisted surgery systems in mastectomies, the agency is doubling down. read more By Heather Landi Marking the first mental health megamerger, teletherapy startup Ginger plans to merge with meditation app Headspace that will expand their combined reach to 100 million consumers. read more Resources 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 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 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. | 
