Weekender: FDA seeking more consistency from cell, gene therapy developers, top official says

Signup | Forward Weekender May​ 22,​ 2021 | A roundup of this week's most read stories

BROUGHT TO YOU BY — Natera Why Biopharma partners with Signatera? Our personalized ctDNA assay for molecular residual disease can facilitate earlier "go/no go" decision-making in clinical trials. Partner with us today.   FDA seeking more consistency from cell, gene therapy developers, top official says Several drugmakers have recently faced development delays after the FDA's asked for more information on how they measure the potency of their products.  Off-the-shelf CAR-T, a Tagrisso rival and the next breast cancer drugs: a look ahead at ASCO Dozens of companies have released abstracts ahead of the American Society of Clinical Oncology's meeting next month. Here are three storylines to watch.  FDA approval sets stage for a showdown between Alexion and Apellis Apellis' newly approved drug, known as Empaveli, will compete against the blockbuster Soliris and Ultomiris franchises in the treatment of a rare and life-threatening blood disease. Sponsored Content by FedEx Office 6 tips to deliver information that matters using print communications As remote work continues, print is as important as ever for biopharmaceutical companies when it comes to reaching a varied audience that may include patients, doctor's offices, researchers and internal staff. Humira patents take center stage as House panel targets AbbVie pricing CEO Richard Gonzalez defended the company's practices, arguing its profits help spur innovation: "The products that are on the market today pay for the products of the future," he said. Bristol Myers details data for closely watched cancer immunotherapy Study results presented ahead of the year's biggest cancer meeting show, for the first time, that a drug blocking the protein LAG-3 improves on the benefit of another immunotherapy.  Recommended For You Improve your recommendations: click here to update your profile. Deep Dive Trump tax law cut what US drugmakers owed. Now they fear an increase. The 2017 law saved pharmaceutical companies billions of dollars, BioPharma Dive found. Executives are now fiercely opposing tax hikes proposed by President Biden, claiming they've since boosted domestic investment.  BROUGHT TO YOU BY — ZS 2021 real-world data and evidence industry outlook report What can real-world evidence and data insights from 25 pharma leaders tell us about how to maximize RWE/D value and create a competitive advantage? Read the report. From Our Library Playbook Modernizing Clinical Trial Analytics for Greater Patient Centricity SAS Trendline What you need to know about oncology's research boom Webinar - on demand Leveraging a Global Healthcare Provider Network to Acquire Insights into Real-Time Global Prescribing Trends Evidera Trendline Inside the rapidly changing world of gene therapy View all resources Best of What We're Reading Fast Company Tory Burch and Nobel Prize winner Jennifer Doudna are teaming up to help women scientists In The Pipeline CRISPR Editing in Primates Chemical & Engineering News To conquer COVID-19, create the perfect pill Fierce Biotech RenBio joins bigwigs Eli Lilly, Regeneron in hunt for next gen COVID-19 antibodies after $24M financing Science Why is the world’s largest COVID-19 vaccine campaign faltering? Bloomberg Law Roche’s Spark Sues Rival Bluebird for Infringing Trademark Suggest a story we should read Dive Into a Topic Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy Share BioPharma Dive: Daily Dive with others and get rewarded. You've referred 0 readers. To become an official Dive Insider, just successfully refer 10 contacts to BioPharma Dive: Daily Dive. Here's your link to share: https://www.biopharmadive.com/signup/insiders/?signup_referred_by=5f93078d7aa51972095c9316

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