Clover's COVID-19 shot tames delta in pivotal study, delivering boost to global vaccination campaign Facing backlash from scientific community, Cassava drops interim Alzheimer’s data with plenty of caveats Striking deals with Blueprint COO Haviland Sponsored: What’s Driving Record Capital in Genetic Medicine? FDA objects to Summit's midstudy pooling of pivotal trials Sponsored: A New Reference Model for Clinical Trial Recruitment, Enrollment and Retention Success Fungi funding: Hexagon Bio snags $61M to test drugs from fungi for cancer, infectious diseases Luxturna inventor's research helps seal gene therapy biotech Opus Genetics' $19M debut The immune system 'goes rogue' after a stroke, but new research has found a way to block the pathway in mice Pfizer, Moderna, AZ and other COVID vaccine companies face urgent calls to ramp up access around the world ESMO: Owkin's deep learning AI predicts chances of metastatic breast cancer relapse within next 5 years Rural hospitals saw mortality improvements after acquisition deals, study finds Another research group joins the llama-inspired COVID-19 antibody bandwagon Johnson & Johnson trots out two-dose COVID vaccine data as it builds case for boosters Featured Story By Nick Paul Taylor Clover Biopharmaceuticals’ bid to help vaccinate the world against COVID-19 has taken a big step forward. The adjuvanted protein vaccine SCB-2019 held up against a range of variants in a phase 2/3 trial, teeing Clover up to seek approval of the relatively stable jab and deliver it to the COVAX Facility. read more |
| |
---|
| Top Stories By Annalee Armstrong As the scientific community continues to debate the validity of Cassava Sciences’ clinical data for the Alzheimer’s disease candidate simufilam, the biotech is hoping some interim results will soothe worried investors. read more By Amirah Al Idrus Blueprint Medicines’ portfolio of molecularly targeted treatments is the “sweet spot” for a small company, but sometimes a deal is the best way to move forward. Fierce Biotech caught up with the biotech's Chief Operating Officer Kate Haviland to talk about her approach to dealmaking. read more Sponsored By: RBC Capital Markets Gene editing is at the new frontier of biotech innovation, driving capital investments and momentum within the IPO market. Learn more. read more By Nick Paul Taylor Summit Therapeutics’ fix for slow enrollment in its pivotal antibiotic program has created its own problems. Having previously decided to pool subjects in two Clostridium difficile trials, Summit has now revealed the FDA disagrees with its changes. 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 Kyle LaHucik Hexagon Bio has raised $61 million to take small molecules produced by bacteria, fungi and plants and turn them into potential treatments for cancer and infectious diseases. read more By Kyle LaHucik Opus Genetics will take research from the lab of Luxturna inventor Jean Bennett, M.D., Ph.D., into the clinic next year with $19 million in seed financing. read more By Emmy Lucas Strokes are caused by a blocked blood vessel in the brain and researchers believe further complicated when the immune system "goes rogue." What if we could block the immune pathway? Researchers think they've found a way to do just that in mice to improve long-term outcomes after stroke. read more By Eric Sagonowsky As the COVID-19 vaccination gap widens between rich and poor countries, the world's leading vaccine makers are once again under pressure to do more to bridge the divide. Now Amnesty International is accusing the companies of "fueling an unprecedented human rights crisis" by refusing to waive intellectual property rights on their shots. read more By Andrea Park To speed up the race to a 100% survival rate, Owkin has developed a deep learning model that’s able to classify the risk that a patient with early-stage, localized breast cancer will experience metastatic relapse within the next five years. read more By Dave Muoio A new JAMA Network Open study suggests acquired rural hospitals improved quality measures more quickly than their independent peers, adding fuel to the industry's provider consolidation debate. read more By Kyle LaHucik Scientists at the Rosalind Franklin Institute have developed llama-inspired antibodies, or nanobodies, and reported they were effective against COVID-19 in hamster models. The authors of the study are seeking funding to bring the potential treatment into human studies, but they'll face competition from multiple nanobody developers. read more By Kevin Dunleavy Johnson & Johnson showed that a second shot of its COVID-19 vaccine given two months after the first provides 94% protection against symptomatic COVID-19 and 100% protection against severe disease. Additionally, the two doses given two months apart yield a four- to six-fold increase in antibody levels. read more | Download the AppNote to learn about Thermo Fisher Scientific’s GMP-compliant, semiautomated manufacturing platform, which when used with Gibco CTS reagents, protocols, and analytics can result in consistent, efficacious CAR T cell production. Download Now. | Resources Sponsored By: Unlearn AI Read Unlearn’s whitepaper to learn about how novel trial designs with Digital Twins enable more efficient clinical trials, with higher power and smaller required sample sizes. 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 09-10, 2021 | Mercure MOA Berlin & Online Diversity, Equity & Inclusion Week November 9–11, 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 |