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Today's Rundown

 

    

   Thank you to IQVIA Biotech for sponsoring Fierce Biotech's
  
2021 Fierce 15 editorial feature.

 

Featured Story

UPDATE: Merck's oral COVID-19 antiviral slashes hospitalizations, prevents deaths in phase 3, sparking race to file with FDA

The wait for an oral antiviral against COVID-19 may almost be over. Friday, Merck reported its prospect halved the risk of hospitalization and death in phase 3, spurring it to stop the study and race to get emergency use authorization.

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Top Stories

BioNTech looks beyond Pfizer COVID-19 shot with an mRNA vaccine for colorectal cancer

What will BioNTech do after helping Pfizer make a COVID-19 vaccine that has been delivered to hundreds of millions of people worldwide? Biotech insiders and the general public alike now have an answer: A phase 2 study of a different mRNA in a vaccine for colorectal cancer.

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AstraZeneca, others send newly private Cellular on its immuno-oncology path with $120M

Novartis-backed Cellular Biomedicine Group is hitting the ground running as a newly private company with $120 million from AstraZeneca and others after delisting from the Nasdaq in February. 

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Sponsored: Navigating the complexities of oncology clinical trials in an increasingly competitive landscape

With the shift from traditional chemotherapy agents to innovative immuno-oncology drugs and cell and gene therapies, oncology clinical trials have increased in complexity.

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Laurent's COVID-19 pill fails phase 2, but data help narrow down patients who may benefit

Another small biotech trying to make a play in COVID-19 treatment has hit a brick wall in clinic trials. This time it’s Laurent Pharmaceuticals, which reported that an oral candidate for hospitalized patients was unsuccessful in a midstage trial.

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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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Ventyx Biosciences lines up $100M IPO with busy clinical schedule ahead

Ventyx Biosciences is headed from California to Wall Street with plans for a customary $100 million IPO just six months after consolidating two biotechs under its roof. 

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Micreos lands $37M to show whether antibiotic alternative delivers in the clinic

Investors have bought into Micreos’ vision for a sustainable alternative to antibiotics. With backers putting up 32 million euros ($37 million), Micreos is now poised to show whether its platform can generate more targeted, harder-to-resist ways of taking out bacteria.

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Researchers unravel the genetic cause of a childhood disorder and a potential way to prevent it with drugs

A UCSD-led team reported a potential way to prevent a newly discovered genetic condition called Zaki syndrome, which impacts the prenatal development of the eyes, brain, hands, kidneys and heart. The researchers found that children born with Zaki had genetic mutations that, in preclinical models, could be successfully targeted with a drug.

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Blood storage tech developer Hemanext adds $15M to VC stores as it preps for FDA submission

Hemanext is hoping to give standard blood storage practices a transfusion of their own—but of innovation, rather than blood cells.

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Right-wing physicians profit off of fake COVID-19 treatments, report finds

A network of right-wing health providers has profited at least $15 million off of tens of thousands of patients seeking consultations for and buying ineffective COVID-19 treatments including hydroxychloroquine and ivermectin, The Intercept reported Tuesday.

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Trouble builds for Merck's $11.5B Acceleron buy as activist investor behind Gilead's Immunomedics deal says too early, too cheap

Merck hopes its $11.5 billion Acceleron buy will quickly wrap up in the fourth quarter. But revolt from an activist investor threatens to derail that plan. Avoro Capital, known for nixing Immunomedics’ tie-up with Seattle Genetics, slammed Merck’s $180-apiece price “drastically undervalues” Acceleron.

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New map of protein interactions offers opportunity to 'do such damage to cancer,' scientists say

University of California researchers produced a map of protein interactions in cancer, uncovering previously unrecognized mutations they believe could drive metastasis. The detailed insights that emerged could explain disparities in the effectiveness of cancer drugs while also leading to new drug targets, they believe.

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Fierce Pharma Asia—Biogen-Eisai's Alzheimer's drug filing; Samsung-Roche deal growth; Sunovion-Otsuka neuro pact

Biogen and Eisai have started an FDA rolling submission for another Alzheimer's disease drug. Samsung Biologics' long-term partnership with Roche has grown in value. Otsuka has penned a near-$1 billion deal for four Sunovion neuropsychiatric candidates. And more.

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Chutes & Ladders—FDA's vaccine office gets new leader as 2 officials head toward exit

FDA's vaccines office is now headed by Peter Marks after the agency's top two vaccine officials questioned the need for booster doses last month as they head toward the exit later this fall. Houston biotech incubator Sporos Biosciences snagged ex-Ovid Therapeutics Chief Medical Officer Amit Rakhit as its new CEO. In spinning off its gene therapy unit, Amicus' CEO will head to the new company being launched via a SPAC.

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Resources

Research: eTMF Implementation Quick Guide

Check out the eTMF Implementation Quick Guide to see a checklist TMF experts developed to help you reduce risks, maintain compliance, and establish effective processes in your eTMF.

Whitepaper: Modernizing Key Clinical Trial Processes with Artificial Intelligence

This whitepaper addresses where AI can make the biggest impact in clinical trials.

Whitepaper: Big Challenges for Small Sponsors: Competition in Oncology Research

Every biopharma sponsor faces the challenge of initiating, running and closing trials on time, but oncology studies pose several unique hurdles.

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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