| Solid Bio hopes a shred of positive DMD data will spark a much-needed rally after clinical hold drama AstraZeneca makes RNA play, teaming up with startup to advance twist on red-hot modality GenEdit strikes Eli Lilly gold with $26M for gene therapy delivery system designed to fight side effects Sponsored: What’s Driving Record Capital in Genetic Medicine? Garuda thinks it has cracked the code to off-the-shelf stem cell transplants—and investors are betting $72M to find out Sponsored: A New Reference Model for Clinical Trial Recruitment, Enrollment and Retention Success SAB Biotherapeutics banks $60M more in funding from U.S. officials for COVID-19 antibody Do not enter: Biogen reps banned from D.C.-area neurology clinics over controversial Alzheimer's drug Aduhelm Castor, Trialbee team up for patient enrollment, engagement in clinical trials Summit Clinical Research, PathAI partner on clinical trial services for NASH treatments HealthVerity partners with J&J's Janssen to provide real-world data for clinical trial, R&D work HRSA intends to fine 6 drugmakers over 340B contract pharmacy violations Featured Story | By Annalee Armstrong Solid Bio will present new biopsy results today for three patients who show “durable expression and function of microdystrophin protein” at 1.5 years after dosing at the World Muscle Society 2021 Virtual Congress. read more |
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Top Stories By Nick Paul Taylor AstraZeneca is making a play for the red-hot RNA market. Rather than move directly onto turf fought over by the likes of BioNTech, Moderna and Sanofi, AstraZeneca has teamed up with a new British startup that has put a twist on the idea of using nucleic acids to trigger production of a molecule. read more By Kyle LaHucik GenEdit, developed out of the lab of UC-Berkeley, hopes to deliver gene therapies without the toxic side effects that have hampered current delivery systems. Now, it has $26 million in series A funds from Eli Lilly and venture groups to dig in with its polymer nanoparticles. 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 We know blood stem cell transplants are potential cures for serious diseases. The problem is, patients need cells from immune-compatible donors, creating a supply bottleneck that constrains use in some areas and blocks expansion into new diseases. Garuda Therapeutics thinks it may have come up with a fix for that problem—and has persuaded investors to bet $72 million on its vision. 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 Annalee Armstrong SAB Biotherapeutics has snared another $60.5 million from the U.S. Department of Defense (DOD) to fund an antibody program to treat COVID-19. This brings the total funding SAB's received from the Biomedical Advanced Research Development Authority and the DOD to $200 million. read more By Noah Higgins-Dunn In a stark example of the less-than-friendly reception Biogen's Alzheimer's med Aduhelm has received, the Neurology Center in Washington D.C. has gone so far as to ban Biogen reps from entering their seven office locations. read more By Kyle LaHucik Castor and Trialbee will integrate their platforms to help sponsors meet trial enrollment deadlines and include more diverse patients in clinical studies. read more By Kyle LaHucik Summit Clinical Research is partnering with PathAI to support clinical development programs for treatments of NASH, a nonalcoholic fatty liver disease that causes inflammation and can lead to scarring of the liver. read more By Kyle LaHucik HealthVerity is teaming up with Johnson & Johnson's Janssen Research & Development to provide access to a real-world data ecosystem that includes patient data on 330 million people in the U.S. read more By Robert King HRSA is pushing for six drugmakers to get monetary penalties for restricting sales of 340B discounted products to contract pharmacies. 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 Summit November 9–10, 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 | 