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Today's Rundown

 

    

Thank you to Catalent for sponsoring Fierce Biotech's ESMO 2021 news coverage.

 

Featured Story

Solid Bio hopes a shred of positive DMD data will spark a much-needed rally after clinical hold drama

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.

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Top Stories

AstraZeneca makes RNA play, teaming up with startup to advance twist on red-hot modality

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.

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GenEdit strikes Eli Lilly gold with $26M for gene therapy delivery system designed to fight side effects

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.

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Sponsored: What’s Driving Record Capital in Genetic Medicine?

Gene editing is at the new frontier of biotech innovation, driving capital investments and momentum within the IPO market. Learn more.

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Garuda thinks it has cracked the code to off-the-shelf stem cell transplants—and investors are betting $72M to find out

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.

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Sponsored: A New Reference Model for Clinical Trial Recruitment, Enrollment and Retention Success

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.

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SAB Biotherapeutics banks $60M more in funding from U.S. officials for COVID-19 antibody

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.

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Do not enter: Biogen reps banned from D.C.-area neurology clinics over controversial Alzheimer's drug Aduhelm

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.

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Castor, Trialbee team up for patient enrollment, engagement in clinical trials

Castor and Trialbee will integrate their platforms to help sponsors meet trial enrollment deadlines and include more diverse patients in clinical studies.

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Summit Clinical Research, PathAI partner on clinical trial services for NASH treatments

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.

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HealthVerity partners with J&J's Janssen to provide real-world data for clinical trial, R&D work

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.

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HRSA intends to fine 6 drugmakers over 340B contract pharmacy violations

HRSA is pushing for six drugmakers to get monetary penalties for restricting sales of 340B discounted products to contract pharmacies.

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Resources

Whitepaper: Applications of Digital Twins in Clinical Trials for Alzheimer’s Disease

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.

Whitepaper: Evaluating current manufacturing platforms for recombinant AAV production

Choose the right AAV platform for your viral vector-based therapy

Whitepaper: The Value of Precision Medicine Informatics Initiatives Research Findings

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.

Whitepaper: Challenging Tradition: The Argument for Integrated Commercialization to Improve Operational Agility

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.

Whitepaper: High-yield NK cell culture for allogeneic cell therapy applications

Thermo Fisher Scientific introduces a new NK cell culture medium designed to support feeder-free, high-yield growth for cell therapy applications.

Whitepaper: Going from Process R&D to Clinical APIs Quickly and Effectively

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.

eBook: Get solutions to market faster

Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization.

eBrief: Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

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.

Whitepaper: Achieving a Successful Drug Product Technology Transfer

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.

Events