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Today's Big News

Jul 6, 2023

With full Alzheimer’s approval in hand, Eisai and Biogen kick off Leqembi’s launch in earnest


Aslan hopes fewer side effects can catapult atopic dermatitis med over Dupixent after mixed readout


Explore the categories of the Fierce 50


Renalytix scores long-awaited FDA de novo nod for AI-powered kidney disease test


Genentech CEO Hardy warns of 'unintended consequences' from the Inflation Reduction Act


ResMed acquires sleep and respiratory diagnostics software maker Somnoware

 

Featured

With full Alzheimer's approval in hand, Eisai and Biogen kick off Leqembi's launch in earnest

With a full approval in hand, Leqembi has become the first treatment shown to reduce the rate of disease progression and slow cognitive and functional decline in adults with Alzheimer’s disease under the FDA's traditional approval pathway. Now, the companies can start with their ambitious launch plans.
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July 18-19, 2023 | Jersey City, NJ
 

Top Stories

Aslan hopes fewer side effects can catapult atopic dermatitis med over Dupixent after mixed readout

Aslan Pharmaceuticals is trying to come for Dupixent’s billion-dollar crown in atopic dermatitis, but with mid-stage data showing a more comparable than superior profile, the company hopes less frequent dosing and lower rates of a known side effect may lure patients onto eblasakimab.

Explore the categories of the Fierce 50

Last week, I introduced you to the Fierce 50, a groundbreaking project that celebrates the leaders and visionaries igniting change in healthcare delivery, drug development, research and beyond. Today, I’m unveiling the five categories that will shape this special report.

Renalytix scores long-awaited FDA de novo nod for AI-powered kidney disease test

Nearly three years in the making, Renalytix has finally reeled in the FDA’s authorization for its prognostic test aimed at predicting an oncoming decline in kidney function.

Genentech CEO Hardy warns of 'unintended consequences' from the Inflation Reduction Act

It's been almost one year since Congress and the Biden administration passed the Inflation Reduction Act. As the Medicare negotiation measures creep closer, drugmakers such as Genentech are facing the "unintended consequences" of the law, CEO Alexander Hardy said in an interview.

ResMed acquires sleep and respiratory diagnostics software maker Somnoware

Still taking advantage of the fact that competitor Philips’ respiratory care business remains stanched by its ongoing CPAP machine recall, ResMed continues to carve out an even bigger foothold for itself in the shared space.

Sarepta sells FDA priority review voucher to mystery buyer for $102M as prices continue to slip

The price of priority review vouchers is falling. Just ask Sarepta Therapeutics. Since 2017, the company has sold off three PRVs—getting less in return for each successive sale. The most recent sale came Wednesday as Sarepta revealed a $102 million deal for its PRV which came along with the FDA’s endorsement of Duchenne muscular dystrophy treatment Elevidys.

Tessa Therapeutics dissolves after raising more than $200M

Tessa Therapeutics is closing its doors after reportedly failing to secure additional financing or find a buyer. The company had raised more than $200 million since 2017.

Thermo Fisher fronts over $900M for data intelligence company as M&A strategy takes shape

Thermo Fisher Scientific has given a glimpse into how its “disciplined capital deployment strategy” will work in reality, fronting close to a billion dollars to get its hands on real-world data intelligence company CorEvitas.

Pfizer pours $25M investment into Caribou's cell therapies

Pfizer is backing Caribou Biosciences with a $25 million equity investment, money the genome editing company will pour into its allogeneic CAR-T cell therapy for multiple myeloma.
 
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'The Top Line': The American Diabetes Association's annual conference, plus this week's headlines

This week on "The Top Line," we discuss the American Diabetes Association's annual conference, plus a statement about transgender care, light therapy, and the rest of the week's headlines.
 

Resources

Research

Develop a cost-effective cGMP chemical sourcing strategy

The right sourcing strategy can help save of millions of dollars—learn about developing a strategy for sourcing the cGMP chemicals critical to your processes.
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Discovering High-Affinity, Functional Anti-GLP-1R Antibodies

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Medical Affairs Metamorphosis

This eBook identifies the trends driving major change in the Medical Affairs (MA) function. It also outlines the strategic and tactical implications for MA leaders and team members.
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6 Tools Trial Sponsors Need to Take Action Earlier in Enrollment

Take a look at the reporting tools sponsors need to access insights earlier in the clinical trial enrollment funnel, so you can take informed actions.
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Enhance the cost-effectiveness of your GMP chemical supply chain

Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your bioprocessing workflows.
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Running Decentralized Trials at Scale

Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment.
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Clinical Supply Solutions for the Asia-Pacific Region

Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region.
 
 

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