With first-in-human trial results, Intellia shows the world that gene editing has arrived FDA’s renewed focus on oncology dosing spooks investors, but companies say they're ready ADA: Eli Lilly’s next-gen GLP-1 moves the needle in early-stage diabetes ahead of FDA filing Sponsored: The Far-Reaching Value of Deeply Understanding the Patient Journey AstraZeneca names Galbraith as Baselga successor in cancer R&D Anavex’s neuro drug slows decline in Parkinson’s disease as it boosts levels of its biomarker AstraZeneca kick-starts new COVID variant-busting vaccine test Polyphor flops a phase 3, jeopardizing its future as shares more than halved AstraZeneca, Sanofi post RSV data ahead of 2022 approval filings Biopharma M&A set for a strong H2 despite political noise—and Biogen and Gilead look like buyers: analysts CMR Surgical amasses giant £425M funding round to take its surgery robot global ADA: TB vaccine repurposed in Type 1 diabetes restores gene expression in key immune cells We're looking for 2021's Fiercest Women in Life Sciences Featured Story | By Annalee Armstrong Interim results are in for Intellia and partner Regeneron’s in vivo CRISPR/Cas9 genome editing candidate, NTLA-2001, in patients with transthyretin (ATTR) amyloidosis: and the numbers look good. This is the first time gene editing has been proven to work in humans, which “opens up a whole new area of therapies for patients that wasn't there.” read more |
| |
|---|
|
Top Stories By Annalee Armstrong The FDA is launching Project Optimus from the FDA’s Oncology Center of Excellence, which will develop guidelines for cancer drug makers to test a wider range of doses early in development. At least two companies—Amgen and Kura Therapeutics—have already experienced the new program firsthand. Both say they were ready. Investors, on the other hand, were not. read more By Amirah Al Idrus Chalk another one up for Eli Lilly’s next-generation diabetes drug. All three doses of tirzepatide beat placebo at lowering blood sugar and body weight in adults with early-stage Type 2 diabetes, more than half of whom had never tried a diabetes-specific treatment. read more Sponsored by: Alexion An experiential learning program where Alexion employees “walk in the shoes” of patients to deepen understanding of the rare disease journey and develop impactful solutions. Learn more about LEAP. read more By Nick Paul Taylor AstraZeneca has appointed Susan Galbraith as the successor to the late José Baselga. Galbraith is taking up the post of executive vice president, oncology research and development after spending 11 years working on cancer therapies at AstraZeneca. read more By Amirah Al Idrus Anavex’s Parkinson’s disease treatment beat placebo at slowing the progression of motor and non-motor symptoms, a benefit that correlated with an increase in SIGMAR1, the drug’s target and the biomarker the company will use to forecast its efficacy. Anavex will now submit the phase 2 data to the FDA to figure out the drug’s path forward. read more By Ben Adams AstraZeneca has come under a lot of slack for its perceived poor communication and weaker results than its mRNA rivals, but the U.K. Big Pharma is still gunning in the COVID vaccine R&D game as its steps up to beat back new variants. read more By Ben Adams Swiss biotech Polyphor has seen its key cancer asset balixafortide fail a late-stage trial, leaving its future in the balance. read more By Nick Paul Taylor AstraZeneca and Sanofi’s respiratory syncytial virus drug candidate nirsevimab has performed similarly to the incumbent product Synagis in a phase 2/3 assessment of safety and tolerability. read more By Arlene Weintraub Biopharma and medical devices chalked up 201 deals in the first half of 2021, double the life sciences M&A during the same period a year ago, PwC found. All signs suggest that'll continue, despite an FTC crackdown, and several Big Biotechs—plus Merck, J&J and Bristol Myers—are likely shoppers, analysts said. read more By Conor Hale CMR Surgical has shown it aims to compete with the biggest players in robotic surgery—and with a truly colossal 425 million euro funding round, or nearly $600 million gathered from SoftBank, Ally Bridge Group and others—it may just have the means. read more By Arlene Weintraub Researchers at Massachusetts General Hospital have spent the last two decades building up data to support their idea of repurposing the old tuberculosis vaccine BCG in type 1 diabetes. Now they have new data backing up their finding that the vaccine restores the ability of regulatory T cells (Tregs) to prevent the destruction of insulin-producing pancreatic islets. read more By Amirah Al Idrus Each year at Fierce, we spotlight women who are leading the way in biotech, pharma and medtech. Be sure to submit your nominations by 11:59 p.m. EDT Monday, Aug. 2, for consideration in this year’s list. read more | | Health Care Is Home Care From study drug administration to blood draws, Marken’s fully integrated home healthcare solutions make participation in clinical research as simple as possible for patients. Learn more. |
Resources Sponsored by: WCG Engage Independent Expert Endpoint Adjudication and Data Monitoring Committees in a strategic manner to identify methods for retrospective and prospective evaluations that may improve competitive advantage and bolster regulatory submissions. Sponsored by: PA Consulting What does the future of Cell & Gene Therapy look like? Sponsored by: Clinical Ink For faster deployment, improved patient engagement, and better-quality data — go where your patients are. GO BYOD with Lunexis™ from Clinical Ink. Sponsored by SDG Group Discover how Ashfield Healthcare uses the power of data and analytics to enable pre-call planning, inform sales rep actions and drive higher market share for its target pharmaceutical products. Sponsored by: BBK Worldwide Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning the barriers to participation and the strategies to overcome them. Sponsored by: Thermo Fisher Scientific Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Optimized automation of certain steps of the workflow may decrease hands-on time and the cost of the cell manufacturing process. Sponsored By: Veeva Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored by: Catalent 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. Sponsored by: Catalent 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. Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Biopharma Supply Chain June 29-30, 2021 | Virtual Event Diversity, Equity & Inclusion Week August 9-11, 2021 | Virtual Event Medical Affairs Strategic Summit (MASS) September 13-15, 2021 | New Brunswick, NJ Clinical Quality Oversight Forum September 27-29, 2021 | Philadelphia, PA | 