Omicron be damned, Genfit bounces back
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Today's Rundown

Featured Story

Final Aduhelm coverage decision keeps the door cracked open for Alzheimer's therapies to come

Last night, the Centers for Medicaid & Medicare Serviced finalized its ruling restricting coverage of Biogen’s Aduhelm to only those participating in an approved clinical trial. But the ruling left the door open for therapies to come from Eli Lilly and Genentech, with a few caveats.

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Top Stories

Cut the music: Kaleido calls it quits after FDA crackdown thwarted its pipeline plans

Kaleido Therapeutics failed to find a buyer, so it's closing up shop. That means its remaining staff are out of a job and the company is delisting, a disappointing end to hopes that it could tap the microbiome for new therapies.

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Genfit bounces back from omicron to keep phase 3 trial on track

Genfit’s phase 3 liver disease clinical trial has recovered quickly from the short, sharp shock of the winter omicron wave, enabling it to reaffirm its targeted readout despite the disruption caused by the variant.

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Sponsored: Precision Recruitment at Scale: Rapid ID of High-Risk Participants

Evidation and BARDA researchers were able to directly recruit subjects for a COVID-19 study via mobile app, & create an AI risk model, while recruiting a representative cohort.

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In just 72 words, BioCryst pauses enrollment for 3 mid-stage trials and sends shares tumbling

In just 72 words, BioCryst announced it would pause enrollment for three phase 2 trials of its rare disease candidate BCX9930, sending shares tumbling 30%.

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GenSight seeks cash as runway enters final year with gene therapy still stuck at EMA

Delays to GenSight Biologics’ eye disease gene therapy are leading toward a cash crunch. With the cash runway due to end early next year and Lumevoq still being reviewed in Europe, GenSight is looking into “several financing options” to enable it to launch the gene therapy in 2023.

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Pandemic tears up Biophytis' plans, limiting data and blowing up timelines

Biophytis has had to limit data collection, delay studies and end patient enrollment early for certain studies, a disruption brought on by the pandemic that has impacted multiple pillars of the pipeline. 

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C2i Genomics snags European approval for blood test to detect residual cancer

The C2inform test’s findings can be used not only to detect lasting signs of cancer but also to keep track of its progression and monitor how well various treatments are working.

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Biogen's troubled Aduhelm hit with CMS slapdown—now what?

The Centers for Medicare & Medicaid Services has maintained its restrictive stance on Aduhelm. Now, it’s time for the drug’s developer, Biogen, to do some serious rethinking—including, as one analyst suggests, ceasing commercialization.

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Humana study highlights prevalence of social needs in MA before COVID

The pandemic has put social determinants of health and inequities into the spotlight. But a new study from Humana aims to highlight how common these challenges were among seniors before COVID-19 hit.

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Vertex CEO Kewalramani nabs more than $15M in 2021 pay, rivaling some male Big Pharma peers

All told, Kewalramani collected around $15.19 million last year, a 50% increase over the $9.11 million she made in 2020. Back in 2020, Kewalramani’s total compensation was about half the final-year pay for Vertex’s former CEO—and current executive chairman—Jeffrey Leiden, who scored nearly $18.8 million in his last year at the helm. 

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Chutes & Ladders—Fierce Biotech launches Layoff Tracker amid dizzying number of industry job cuts

Fierce Biotech is launching the Fierce Biotech Layoff Tracker amid mounting job cuts in the industry since the start of the year. Novartis says bye to CMO John Tsai after four years amid a corporate restructuring. Lauded stem cell researcher Doug Melton joins Vertex to further explore stem cell biology in pursuit of new therapies.

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Fierce Pharma Asia—Legend CSO's departure; Takeda's gene therapy deal; Pfizer's India revamp

Legend Biotech's co-founder has left the company without a new job. Takeda has signed on Evozyne to do protein work for gene therapies. Pfizer has launched a voluntary retirement scheme in India amid a digital push. And more.

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Resources

Infographic: United Cargo: Providing comprehensive solutions for the most critical shipments

The United Cargo team has made a commitment to pharmaceutical and medical partners that we are equipped to support their vaccine transportation needs safely and effectively across our expansive global and domestic network. The safety and security of these commodities is our priority, and we are proud to be a trusted partner in these efforts. Download infographic now.

Research: Get Access to AdisInsight A Year In Review

The journey of drug development in 2021 delivered to your inbox: top 10 AdisInsight drug profiles viewed, new drug profiles released, overview of drug launches, key deals, research trends in 2021 and much more (free of charge).

Whitepaper: Oncology Market Outlook: Key Trends to Watch

What’s in store for the oncology market in 2022 and beyond? This paper looks at 5 trends driving the market.

Whitepaper: Uncovering the hidden value of quality in chemical supply

Learn how to position quality as a central component within your raw material sourcing strategies for the chemicals used throughout your workflows. Download the free whitepaper from Thermo Fisher Scientific.

eBook: Leveraging Clinical Data for Study Success

The landscape of clinical trials has been permanently changed. Today's trials require sponsors to modernize their use of technology and data to adapt. This eBook provides an overview of how sponsors can empower trials with real-time performance data to improve study integrity, reduce risks, optimize patient safety, and increase trial success rates.

Whitepaper: Autologous CAR T-Cell Manufacturing: Semiautomatic, Closed, Modular Workflow

Learn how to navigate the top manufacturing challenges and achieve a seamless transition from discovery to clinical manufacturing across the CAR T-cell therapy workflow.

eBook: EMEA Regulatory Roadblocks around Decentralized Trials

Learn about ways to break down regulatory roadblocks and get closer to 100% clarity on regulatory positions to advance decentralized clinical trials in research.

Whitepaper: Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market

How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market?

Whitepaper: Versatility of Softgel Technology - Encapsulation of a Volatile Compound

Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound.

Whitepaper: The Most Suitable Dosage Form Technologies for the Oral Delivery of Lipid-Based Formulations

What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations?

Webinar: The Faster Path From Pre-Filled Syringe to Auto-Injector

Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar.

Whitepaper: Formulation Strategies When Transitioning From Vial to PFS

Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

Events