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Today's Rundown

 

    

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

 

Featured Story

Novartis doesn't think optogenetics will completely cure blindness—but its new biotech is going to give it a try

Novartis already bought into optogenetic gene therapy technology last year, but the Swiss Pharma wants more. Enter Arctos Medical, which will now join Novartis with its gene therapy program for vision loss.

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Top Stories

Bristol Myers, Genentech and Celgene bought their old biotechs. Jeffrey Stafford and co. are ready for their next $60M act

Jeffrey Stafford and his team of industry veterans have seen their biotechs go on to be acquired by the likes of Genentech, Bristol Myers Squibb and Celgene. Now, the collective is ready for its next venture: launching RNA biotech 858 Therapeutics with a $60 million series A fundraising.

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Aerie CEO exits days after downplaying midphase eye disease flop

Maybe primary endpoints matter after all. Days after dismissing the importance of a midphase flop, Aerie Pharmaceuticals CEO Vicente Anido has left the company, leaving an interim leader to pursue what he claimed was “a clear path toward approval.”  

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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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BioMed bets $1.2B to ease U.K. life science capacity crunch

BioMed Realty is already a major force in the U.K. life sciences property game, with AstraZeneca and Illumina among the companies to occupy its sites in and around Cambridge. Now, the Blackstone company is set to invest a further £850 million ($1.2 billion) to double the size of its portfolio.

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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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Novartis veteran Barth takes the helm at autoimmune biotech MiroBio

As MiroBio gears up for its first clinical trial, the autoimmune biotech is getting a new CEO: Carolin Barth, M.D., joins after a 17-year run at Novartis, where she most recently led commercial and pipeline strategy for cell and gene therapies.

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Boehringer Ingelheim acquires Abexxa Biologics for precision cancer drug pipeline

Boehringer Ingelheim is acquiring Abexxa Biologics to continue building out its pipeline in immuno-oncology and cancer treatments. The German Big Pharma had initially seeded the Arlington, Texas-based biotech in 2016 and provided shared collaboration space.

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Apple taps Biogen, UCLA to explore adding mental health tracking to iPhone: report

Soon enough, the iPhone in your pocket could automatically detect mental health issues like depression, anxiety and cognitive decline—all based on the daily activity data already gathered by the device.

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Pfizer plans to seek FDA nod for COVID-19 shot in kids 5 to 11 after positive data

Pfizer and BioNTech reported that their COVID-19 vaccine is safe and generated a strong response in kids aged 5 to 11. The smaller dosage shot (10 micrograms) provided comparable antibody responses the the 30 microgram dose given to 16- to 25-year-olds. The companies will apply for EUA "as soon as possible."

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Hospital groups push back against stiffer penalties for failing to publish prices

Hospital groups push back on CMS proposal to raise penalties for failing to publish their prices, arguing health systems have prioritized fighting COVID-19 over complying with a new price transparency rule.

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Good ad or bad ad? FDA quiz reminds docs about its Bad Ad program to police problematic advertising

True or false: Pharmaceutical companies are required to send drug ads to FDA for approval before they're used. It’s false—but you'd already would know that if you took the FDA’s new interactive quiz to help promote its Bad Ad program.

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Verrica's lead drug VP-102 rejected by FDA thanks to issues at contract manufacturer

Verrica Pharmaceuticals, which is seeking approval for a medication to treat skin diseases, said the FDA issued a complete response letter that outlines problems at a CMO facility being used to manufacture the treatment.

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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.

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