Weekender: AstraZeneca wins first FDA approval for systemic lupus drug in a decade

Signup | Forward Weekender Aug.​ 7,​ 2021 | A roundup of this week's most read stories

BROUGHT TO YOU BY — ArcheMedX Uncover the preventable delays in your clinical trial Clinical trials waste millions because of preventable delays. This free scorecard could uncover more than 20% in savings in your trial. Get your scorecard now.   AstraZeneca wins first FDA approval for systemic lupus drug in a decade The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects. Moderna says vaccine protective through six months, but warns boosters needed this fall Final results from the Phase 3 trial that led to the shot's authorization showed efficacy remained high, at 93%, although that data was collected before the delta variant had spread widely. After controversial approval, doctors are still debating how to use Biogen's Alzheimer's drug Nearly two months since Aduhelm became available, many physicians have yet to use the first treatment approved in the U.S. to slow Alzheimer's disease. Sponsored Content by PRA Health Sciences, an ICON plc Company Practical approaches to operationalizing decentralized clinical trials When appropriate, DCTs can accelerate trial conduct, create a wealth of high-quality data and improve efficiency. How Bayer lured a biotech away from an IPO and into a buyout Vividion Therapeutics was headed toward an IPO earlier this year, but the company's co-founder said Bayer's $1.5 billion offer ended up being a more attractive option. FDA allows Novartis gene therapy trials to resume after nearly 2 year pause After reviewing animal study data submitted by the Swiss pharma, the FDA cleared spinal injections of Zolgensma for study in older patients with SMA. Featured Resources FROM: AmerisourceBergen Pave the way to increase confidence in Biosimilars Biosimilars pipeline report: A guide for understanding the growing market Biosimilars Podcast: How will insulin Biosimilars shake up the space? Learn more: Creating sustainability & longevity for biosimilars From Our Library Trendline What you need to know about oncology's research boom Playbook The Roadmap to Clinical, Regulatory, and Commercial Success in Medical Device Clinical Trials Medidata Webinar - on demand Demystifying the Role of Data Analytics in Digital Transformation PTC Webinar - on demand The Shifting Data Frontier in Life Sciences Snowflake View all resources Best of What We're Reading The Wall Street Journal FDA Covid-19 Vaccine Booster Plan Could Be Ready Within Weeks FierceBiotech Dicerna drops after mixed data on rival to Alnylam drug Science A giant trial of COVID-19 treatments is restarting. Here are the drugs it’s betting on Reuters Gilead says aware of counterfeit HIV medicines being distributed in U.S. ProPublica Thousands of Patients Were Implanted With Heart Pumps That the FDA Knew Could Be Dangerous Axios AbbVie's blockade of cheaper Humira options 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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