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Today's Rundown

    

Thank you to Janssen Oncology for sponsoring Fierce Biotech's ASCO coverage.

 

 

Featured Story

FDA's 'intellectually insulting' aducanumab decision opens up a regulatory foothold for leading competitors

The FDA seems to have set a new regulatory standard with its approval of Biogen’s aducanumab, now known as Aduhelm, in Alzheimer’s disease under an accelerated review pathway. So now what? Pharmaceutical companies and biotechs are surely asking this question in the aftermath of the controversial approval.

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Top Stories

Indivior enters sparse cannabis use disorder pipeline with $30M upfront for Aelis rights deal

French biotech Aelis Farma and Virginia-based pharmaceutical Indivior are joining forces on a phase 2 cannabis use disorder treatment.

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FDA approval for aducanumab? Check. Soaring stocks for Biogen competitors? Yes, indeed.

The FDA's approval of aducanumab set in motion a positive ripple effect for Biogen's publicly traded Alzheimer's treatment competitors, including Eli Lilly, which recently posted data on its own candidate, donanemab.

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Sponsored: In a Year of Crisis, Maryland Biotech Responds with Leadership

Prior to the pandemic, nearly a quarter of Maryland’s biopharm and medical tech companies focused on infectious diseases. As COVID-19 spread, dozens of Maryland companies joined the global response.

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Bayer's billon-dollar Parkinson's disease bets land in the clinic

Bayer’s Parkinson’s disease stem cell therapy has officially landed in the clinic while another treatment for the neurodegenerative movement disorder is seeking patients. The first dose of DA01was administered in a phase 1 clinical trial through Bayer subsidiary BlueRock Therapeutics. Bayer has also kicked off a gene therapy trial in Parkinson’s disease through Asklepios BioPharmaceutical.

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Sponsored: Innovative POC MATLOC Digital Device for CKD

Health Logic Interactive is working on advanced technology called MATLOC that has the potential to revolutionize the Chronic Kidney Disease treatment space from the ground up.

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Seagen joins SpringWorks' long list of BCMA combo partners

Seagen has teamed up with SpringWorks Therapeutics to test its anti-BCMA antibody in combination with a gamma secretase inhibitor. The planned phase 1 builds on evidence that inhibiting gamma secretase prevents the cleavage and shedding of BCMA from the surface of myeloma cells.

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Graphite files for $100M IPO to fund push to cure sickle cell

Graphite Bio has filed to raise up to $100 million in an IPO. The money will support the development of gene editing drugs for sickle cell disease, X-linked severe combined immunodeficiency syndrome and Gaucher disease.

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Biogen's aducanumab crosses FDA finish line just in time to save its business

The verdict is in: The FDA has approved Biogen’s controversial Alzheimer’s treatment aducanumab. What's next? A ripple effect across Alzheimer's research, more controversy for the FDA and an all-out launch effort at Biogen, which really needs the sales boost.

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Resources

Whitepaper: How to Launch a Successful BYOD Strategy in Any Phase

For faster deployment, improved patient engagement, and better-quality data — go where your patients are. GO BYOD with Lunexis™ from Clinical Ink.

Paid Marketplace: Story of Success: Ashfield Healthcare Empowers Field Sales to Grow Market Share based on Data

Discover how Ashfield Healthcare uses the power of data and analytics to enable pre-call planning, inform sales rep actions and drive higher market share for its target pharmaceutical products.

eBook: Improving Diversity and Inclusion in Clinical Trials

Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning the barriers to participation and the strategies to overcome them.

Whitepaper: Closed Cell Processing System Benefits for Cell & Gene Therapy

Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Optimized automation of certain steps of the workflow may decrease hands-on time and the cost of the cell manufacturing process.

Guide: Your Guide to Overcome Inconsistent Clinical Data Standards

Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials.

eBook: The New Standard: Virtual Study Training in Clinical Trials

The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster – learn more today.

Report: New research indicates an accelerated shift to decentralized clinical trials

New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19.

Content Hub: Process Intensification Resource Center

A one-stop hub for Cytiva resources to support process intesification

Whitepaper: COVID-19 Survey report: The Lasting Impact on Outsourcing Decisions

How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond?

Content Hub: Emerging Biotech Resource Center

A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule

Content Hub: Remarque Systems Resource Hub

Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. 

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