This week's sponsor is Premier Research. | | Tackling gene therapy's biggest challenges Gene therapy holds great promise, but despite revolutionary advances, a clear path from bench to bedside remains elusive. Download the white paper for more tips on seizing this unprecedented opportunity. Premier Research. Built for biotech. Visit us at BIO International, Booth 4049 to learn more. | Today's Rundown Special Report—The top 10 pharma R&D budgets in 2018 Sanofi's anti-CD38 combo boosts responses, extends lives in advanced multiple myeloma Amgen's closely watched KRAS drug, first to clinic, shrinks NSCLC, curbs colorectal tumors [Sponsored] How to Make the Most of Your Clinical Trial Data—All of it Ayala's ex-BMS drug shows promise in triple-negative breast cancer Astellas, Seattle Genetics' ADC banishes 12% of bladder cancers With FDA review nearing, Epizyme shares updated sarcoma data Complete response rate in Nektar melanoma trial hits 34% Shrinking 60% of lung cancers, Blueprint's RET drug poised for 2020 filing Death in Turning Point NSCLC trial overshadows 82% ORR GE Healthcare executive jumps ship to lead dermatology biotech LEO Featured Story | Monday, June 3, 2019 Big Pharma companies are still, naturally, the big spenders in drug R&D, and the numbers are impressive: Last year, and for the first time, the top 15 largest companies (by sales) funneled more than $100 billion into research, and we also saw the FDA approve more drugs than ever before. |
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| | Thank you to Lonza for sponsoring this week's coverage of BIO. | Top Stories Sunday, June 2, 2019 CHICAGO—Sanofi’s anti-CD38 antibody isatuximab added to the standard of care for relapsed multiple myeloma extended patients’ lives and nearly doubled the number of patients for whom the standard of care worked. Monday, June 3, 2019 CHICAGO—It’s been 30 years in the making, but the first clinical data from a KRAS inhibitor are finally here. In a small phase 1 study, Amgen’s prospect, AMG 510, stopped tumor growth in the majority of patients with non-small cell lung and colorectal cancers. Monday, June 3, 2019 Pharma and biopharma have endless data at their disposal. Why aren't they using it? Here's how to make the most of your data for clinical success. Sunday, June 2, 2019 Israeli biotech Ayala Pharmaceuticals has just added $30 million in a Novartis-backed series B round. As preclinical results have shown, the money could be used on clinical testing of its lead drug AL101 in triple-negative breast cancer. Monday, June 3, 2019 Astellas and Seattle Genetics unveiled data showing their antibody-drug conjugate shrank 44% of tumors and eliminated 12% of them in patients with advanced urothelial cancer. The treatment could become an option for patients whose cancer has worsened despite receiving chemotherapy and checkpoint inhibitors. Monday, June 3, 2019 Epizyme has posted updated data from the phase 2 trial it hopes will secure tazemetostat approval in epithelioid sarcoma. The data feature a slight uptick in objective responses offset by rises in the rates of some adverse events. Saturday, June 1, 2019 Nektar Therapeutics has posted updated data on its NKTR-214-Opdivo cocktail in first-line melanoma. The data feature four more complete responses, bringing the rate up 10 percentage points to 34%. Monday, June 3, 2019 Blueprint Medicines’ RET inhibitor BLU-667 shrank tumors in 60% of a difficult-to-treat group of lung cancer patients, teeing it up for a 2020 filing in patients with RET-altered non-small cell lung cancer who had already tried chemotherapy. Monday, June 3, 2019 A sudden, possibly drug-related death has overshadowed Turning Point Therapeutics’ update on repotrectinib in non-small cell lung cancer. More than four-fifths of patients responded to the tyrosine kinase inhibitor, but shares in Turning Point fell 10% amid worries about the death. Monday, June 3, 2019 After more than a decade, LEO Pharma is getting a new chief executive as it looks to the future for a boosted pipeline and launches. This week's sponsor is LabConnect. | | LabConnect offers innovative project & data management services connecting samples to data. We customize services to meet the unique needs of clients and their clinical studies. LabConnect is your connection to confidence. Contact us to learn more. | Resources Sponsored by: AlphaSense What is agile competitive intelligence, and how can it help take market research to the next level? Sponsored by: Reprints Desk, Inc. Get 5 quick tips for faster research and better results! Sponsored by: Blue Latitude Health In this publication, Blue Latitude Health maps the journey of stakeholders impacted by the rise of precision medicine today. Download the report. Sponsored by: Patheon, by Thermo Fisher Scientific Increase Safety & Flexibility with Flow Chemistry Sponsored by: Veeva IONIS shares best practices for implementing an end-to-end RIM solution in this on-demand webinar. Watch now. Sponsored by: WCG Increasingly complex clinical trials place a tremendous burden on study sites, exacerbating already-troubling recruitment and enrollment issues. Overwhelmed, many sites may not be up to the task or have the appropriate infrastructure, creating costly delays that keep new therapies from patients. Sponsored by: Catalent Download the case study to learn about the clinical supply management tools that helped a small sized pharma company during phase III of a multi-arm oncology study. Sponsored by: Catalent Watch a short video on demand led supply model. It is designed to meet the needs of patients, clinical sites, clinical team and sponsors and results in shorter lead time, less waste, less stock out risk and no booklet labels. Sponsored by: Catalent Download the eBook to explore a proactive approach for clinical supply management. Sponsored by: Catalent Download the executive summary to learn key considerations for a successful technology transfer for manufacturing drug products, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Patheon, part of Thermo Fisher Scientific Choosing the Best Sterile Dosage Form for Your Phase I Clinical Supply Needs. Sponsored by: Patheon, part of Thermo Fisher Scientific Designed with speed & flexibility,Quick to Clinic™ for Oral Solid Dose helps deliver products to Phase I Clinic in as little as 14 weeks. 2019 BIO International Convention June 3-6, 2019 | Philadelphia, PA Medical Sensors Design Conference June 25, 2019 | McEnery Convention Center | San Jose, CA Sensors Expo & Conference June 25-27, 2019 | McEnery Convention Center | San Jose, CA Drug Development Boot Camp® 2019 November 20-21, 2019 | Boston, MA | Register and start preparing Today! |