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Today's Rundown

Featured Story

Perlmutter steps down as Merck R&D lead as early research chief Li steps in

After seven years running Merck’s R&D engine, much of which has revolved around cancer blockbuster Keytruda and, now, COVID-19 vaccines, Roger Perlmutter, M.D., Ph.D., is hitting the exit.

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Top Stories

Mesoblast hit by FDA rejection, request to run another trial

The FDA has issued a complete response letter to Mesoblast’s request for approval of allogeneic cell therapy remestemcel-L in children with steroid-resistant graft-versus-host disease. FDA officials want to see data from at least one additional clinical trial before granting full authorization, but Mesoblast is still hoping to snag an accelerated approval using its existing data.

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GSK's ex-vaccine, pharma lead jumps ship to run G1 Therapeutics

Nearly two months after GlaxoSmithKline’s vaccine head left the Big Pharma in the middle of it making a pandemic shot, Jack Bailey has penned a deal to lead cancer biotech G1 Therapeutics.

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FDA lifts clinical hold on Solid Bio gene therapy trial

The FDA has lifted the clinical hold on a phase 1/2 clinical trial of Solid Biosciences’ gene therapy treatment for Duchenne muscular dystrophy. Solid Bio secured clearance to resume dosing in the trial after making manufacturing changes to cut the number of viral particles given to patients. 

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Synthetic Biologics cans phase 2 IBS trial deemed likely to fail

Synthetic Biologics and Cedars-Sinai Medical Center are pulling the plug on a phase 2b study in irritable bowel syndrome because it’s unlikely to hit its primary objective. Cedars-Sinai, the sponsor, will do a “comprehensive review” of the data and publish the findings.

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Ex-Ipsen boss de Garidel takes the helm at AZTherapies

As Corvidia CEO, Marc de Garidel saw the heart disease biotech through a $2.1 billion acquisition by Novo Nordisk. Barely two months later, he’s back in the saddle, this time at AZTherapies, a company working on treatments for Alzheimer’s and other neurodegenerative diseases.

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FDA authorizes oral rinse-and-spit test for COVID-19

By swishing and gargling a small amount of solution for 30 seconds and then spitting it into a funnel and vial, the test both eliminates the need for a nasal swab and assists people who may have trouble in providing sufficient saliva for a direct test.

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Sixfold Bioscience snares U.K. grant to test cancer-fighting siRNA delivery system

Sixfold Bioscience snared an Innovate UK Smart Grant to run early tests on its targeted cancer drug delivery system. Set to run for 18 months, the project will yield a preclinical data pack to help Sixfold hustle its platform into the clinic, potentially by early 2022.

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FiercePharmaAsia—CStone-Pfizer deal; Gilead's filgotinib nods; Takeda-Ovid epilepsy data

Pfizer injected $200 million into CStone Pharmaceuticals for exclusive local commercial rights to the Chinese biotech's PD-L1 agent. After an FDA rejection, Gilead's rheumatoid arthritis med filgotinib won a nod in Japan. Takeda and Ovid shared mixed data for a rare epilepsy med. And more.

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Chutes & Ladders—Merck KGaA names insider Garijo as CEO in glass ceiling-busting promotion

Merck KGaA names Garijo to top spot; Vico Therapeutics adds Bayer vet Sandbrink as CMO; TriSalus appoints Katz to chief medical role.

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Resources

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Whitepaper: Five Imperatives for Becoming More Patient-Centric

Achieving patient centricity depends on evolving how evidence is generated.

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Case Study: QED Therapeutics accelerates launch of rare cancer drug into niche market with analytics-driven insights

In 2020, QED Therapeutics launched first-in-class infigratinib for cholangiocarcinoma (CCA). Learn how the launch team precisely identified and characterized eligible patients by taking an evidence-based approach to its commercial strategy.

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Don’t oversimplify your solubility challenges.

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Whitepaper: Learn How Collaboration (Not Competition) Will Bring Better Pediatric Medicines to Market

Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research.

Whitepaper: Achieving a Successful Drug Product Technology Transfer

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Traditionally, pharma companies use a combination of prescription data & internal sales reports to look for potential buyers. Such practice provides only a LIMITED VIEW without competitor information.

Whitepaper: New data models to gain insight on medication adherence

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Executive Summary: Keys to a Successful Rapid Commercial Launch

Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better.

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In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management.

Case Study: Establishing Parameters for Success

Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study.

Fact Sheet: Forecasting to Optimize Clinical Trial Supply Management

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