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Today's Rundown

Featured Story

‘Let the games begin’: Reinvigorated Alzheimer’s pipeline breaches the levee with planned Lilly filing, Bristol Myers opt-in

The floodgates are now open on new Alzheimer’s treatments, thanks to the FDA’s approval of Biogen’s Aduhelm. Bristol Myers Squibb will pay Prothena $80 million to opt in on an anti-tau therapy, Biogen and Eisai won a breakthrough therapy designation for an anti-amyloid antibody and Eli Lilly will file its med for accelerated approval later this year.

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Top Stories

With J&J, GSK leading the pack, AbbVie jumps in the multiple myeloma fight with TeneoOne buy

AbbVie's rivals Bristol Myers Squibb, Johnson & Johnson and Seagen are staring down multiple myeloma, so the maker of Humira is snapping up TeneoOne after seeing some promising early data that piqued the pharma's interest. The Illinois-based Big Pharma is buying the TeneoBio affiliate for an undisclosed sum nearly two and a half years after shelling out $90 million to help develop a bispecific antibody that targets BCMA and CD3. 

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Monte Rosa sticks its Nasdaq landing, banking $222M for 'molecular glues'

Monte Rosa Therapeutics is capping off a fundraising spree with a $222.3 million IPO to get two of its “molecular glue” treatments into the clinic and advance its other discovery-stage programs. The company raised $96 million in September 2020 and followed up with another $95 million six months later.

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Sponsored: Addressing Roadblocks in Decentralized Clinical Trials

In a recent virtual roundtable discussion, industry experts shared their insight on the challenges faced in implementing decentralized trials and how to address them.

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Lilly to file for accelerated FDA approval of Alzheimer's drug after Aduhelm OK opens the floodgates

Eli Lilly plans to file for accelerated approval of its Alzheimer’s disease prospect donanemab later this year. The planned filing on the strength of phase 2 data comes hot on the heels of the FDA’s decision to grant accelerated approval to Biogen’s Aduhelm.

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Sponsored: Culture Drives Employee Engagement, Supports Business Growth

By refocusing company culture around the connection between employees and the rare disease community, Alexion has increased employee engagement and charted a new path for business success. Read more.

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Arcus shares scant analysis of phase 2 data on Gilead-partnered TIGIT drug

Arcus Biosciences has reported “encouraging clinical activity” in a phase 2 clinical trial of anti-TIGIT drug domvanalimab but held off on releasing any numbers from the study.

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Belldegrun's VC firm nabs a major $825M funding well for next-gen biotechs

After an illustrious career in biotech, including navigating Kite Pharma and then Allogene to become major players in the cell therapy space, Arie Belldegrun, M.D., and his new venture firm are looking to make a series of bets on the next big thing in biotech.

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Lyndra banks $60.5M to bring ultralong-acting pill into pivotal schizophrenia trial

As Lyndra Therapeutics mulls partnerships to build out its pipeline of central nervous system disorder treatments, it’s raised $60.5 million to move its lead program, a once-weekly pill for schizophrenia, into a pivotal trial. The company plans to start that trial later this year and—if all goes to plan—is gearing up for a commercial launch in the U.S. "a few years later."

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A $57B drug? Medicare faces a massive bill for Biogen’s Aduhelm—even if it limits coverage

Rather than cheers, furor broke out when Biogen's Alzheimer's drug Aduhelm crossed the FDA's finish line, partly because of the company's whopping $56,000 list price for a year of treatment. Now, Washington is left to decide whether to limit access or take on tens of billions in Part B drug spending—or both.

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EQRx puts Exscientia's AI on drug discovery duty to develop low-cost cancer drugs

What do you get when you cross an artificial-intelligence-powered platform for drug discovery with a corporate mission to develop a pipeline of cancer drugs with radically low prices? Exscientia and EQRx are determined to find out, with the help of a newly formed strategic collaboration.

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Harnessing the immune response against common moles to combat melanoma

About a third of melanomas begin with benign moles. Now, researchers at Massachusetts General Hospital have found an immune mechanism for these noncancerous skin cells that could be leveraged to treat melanoma or prevent its recurrence.

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Roche's Genentech launches new alliance aimed at achieving greater diversity in cancer trials

Roche’s biotech arm Genentech has created a new coalition of clinical research sites aimed at boosting diversity in oncology studies.

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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.

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

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.

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