Weekender: FDA documents show how controversial Alzheimer's drug decision was reached

Signup | Forward Weekender June​ 26,​ 2021 | A roundup of this week's most read stories

BROUGHT TO YOU BY — ZS How patient burden impacts trial design Join this webinar for insights from a global study, including applications for an algorithm that scores patient burden. Register here.   Reader Survey Closing Soon Do you have five minutes? In a few days we'll be closing out our third annual BioPharma Dive reader survey and we'd love to hear your opinion. The feedback you provide will directly inform the way we provide the journalism you see in the newsletter and on our site. And all respondents will be entered for a chance to win a $200 gift card as an extra bonus. Take the survey If you've already completed the survey, thank you! We appreciate you reading, supporting, and trusting our publications. Sean Griffey CEO Industry Dive Twitter | Email FDA documents show how controversial Alzheimer's drug decision was reached A group of statisticians who had argued for rejection were overruled, internal memos show, as high-ranking agency officials got behind an accelerated clearance for Biogen's drug.  Third Rock-backed startup launches to develop cell therapies for MS, diabetes Led by CEO Samantha Singer, Abata Therapeutics has $95 million to advance its plans to engineer regulatory T cells for treating autoimmune diseases. Blackstone to invest $250M in cell therapy startup backed by Intellia, Cellex The new company aims to pair Intellia's CRISPR gene editing technology with a CAR-T cell therapy platform built by Cellex subsidiary GEMoaB.  Sponsored Content by Millipore-Sigma® Incorporating automation and digitalization into the industrial microbiology workflow A closer look at the impact of automated and digitalized technologies on the industrial microbiology workflow. Reversing course, Lilly to seek fast approval for experimental Alzheimer's drug The drugmaker said it will file an application with the FDA later this year for accelerated approval of donanemab, a change of plans that comes weeks after the FDA's controversial clearance of Biogen's Aduhelm. A year after getting UniQure's gene therapy, hemophilia patients are still doing better New results from a key study show the treatment's benefit is holding up well over time. But the FDA wants to see more data, delaying when UniQure and partner CSL expect to file for approval. Recommended For You Improve your recommendations: click here to update your profile. Deep Dive 8 key clinical trials to watch for the rest of 2021 The next six months could feature clinical milestones for CRISPR gene editing, the treatment of COVID-19 and gene-targeted cancer therapy. Featured Resources FROM: Regulatory Affairs Professionals Society Keep Your Regulatory Knowledge Current Further your knowledge of chemistry, manufacturing and controls at your own pace Hot off the press! Get your copy of International Combination Products Advance your regulatory career: enroll in RAPS Regulatory Affairs Certificate Program for pharmaceuticals From Our Library Trendline Behind the scenes of gene therapy manufacturing Webinar - on demand Early Go-to-Market Considerations for Cell & Gene Therapies Guidehouse Trendline How medtechs are navigating the sales environment after the pandemic View all resources Best of What We're Reading Associated Press Nearly all COVID deaths in US are now among unvaccinated STAT Pfizer halts global distribution of smoking cessation pill Reuters U.S. approves Roche drug for emergency use against severe COVID-19 The Washington Post Here's why we approved the first new Alzheimer's drug in two decades POLITICO FDA to add warning about rare heart inflammation to Moderna, Pfizer vaccine fact sheets USA Today Behind the US COVID vaccine effort is Peter Marks, FDA division chief Suggest a story we should read Upcoming Event Overcoming Challenges in Bringing Precision Medicine Therapies to Market June 29, 2021 - June 29, 2021 | Webinar 2pm ET 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

More Than A Newsletter Related Publications Healthcare Dive | MedTech Dive Connect With Us Twitter | LinkedIn Editorial Contact an editor | Meet the team Advertising Contact our team About BioPharma Dive BioPharma Dive provides in-depth journalism and insight into the most impactful news and trends shaping biotech and pharma. The newsletter and website cover topics ranging from clinical readouts to FDA approvals, gene therapy to drug pricing and M&A to research partnerships. BioPharma Dive is a leading industry publication operated by Industry Dive. Our business journalists spark ideas and shape agendas for 10+ million decision makers in the most competitive industries. Sign up for the newsletter This email is optimized for display on mobile phones. BioPharma Dive: Daily Dive is a product of Industry Dive, Inc. 1255​ 23rd Street NW, Suite 550, Washington,​ DC 20037. We value your privacy. We won't share your email address with anyone else without your permission. This message was sent to edwardlorilla1986.acciyo123@blogger.com. You can unsubscribe or switch to a weekly newsletter subscription anytime. See our full privacy policy.

Sign up | Manage subscription | Advertise with us | Submit story tip