| This week's sponsor is Premier Research. | | | Rare Cancer Drug Research: What to Know Going In
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Today's Rundown | Publisher’s Note: In preparation for the new GDPR taking effect this month, we would like to reconfirm your subscription to our newsletter(s). Please click this link to reconfirm your subscription. For more information about GDPR, please visit this page. | |
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Nabriva lines up FDA filing after antibiotic clears second pivotal test Galecto brings on GSK’s fibrosis lead as CMO Rain Therapeutics nets $18M to push lung cancer asset into phase 2 [Sponsored] Growing Requirements for Medicines for Children Allergy Therapeutics shows dose response in midphase trial, setting stage for pivotal program Bioverativ says data back twice-a-month dosing for hemophilia A drug ImmusanT goes on hiring spree ahead of phase 2 celiac vaccine trial U.K. targets AI-driven 10% drop in cancer deaths by 2033 Featured Story | | | Monday, May 21, 2018 A second phase 3 trial of Nabriva Therapeutics’ lefamulin has hit its primary endpoint. The positive readout further burnishes the prospects of the antibiotic, which is set to go before the FDA later this year. |
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Top Stories Monday, May 21, 2018 Galecto Biotech has hired Richard Marshall, M.D., a medicines development leader at GlaxoSmithKline, to be its new chief medical officer as the company moves into late-phase clinical trials of its galectin modulator in idiopathic pulmonary fibrosis. Monday, May 21, 2018 Bay Area biotech Rain Therapeutics raised $18.4 million in series A funding, which will advance its lead program, a hypoxia-activated prodrug, in a population of patients with non-small cell lung cancer for whom there are no treatments. Monday, May 21, 2018 Progress has been made in developing medicines for children with the passing of pediatric regulation, but gaps still exist. Here’s what you need to know about recent updates from an expert at Synteract. Monday, May 21, 2018 A phase 2 trial of Allergy Therapeutics’ grass pollen candidate met its primary endpoint of showing a dose-response relationship. With the trial also establishing a recommended dose of the short-course subcutaneous allergen-specific immunotherapy, Allergy is set to move into phase 3 next year. Monday, May 21, 2018 Sanofi is trumpeting new clinical data for a hemophilia A drug developed by Bioverativ that it contends could transform treatment of the bleeding disorder. Monday, May 21, 2018 ImmusanT is boosting its senior staff, bringing on Daiichi Sankyo’s SVP for internal medicine therapeutics, Ken Truitt, as its new chief medical officer. The company also hired VPs in clinical operations and program management, as well as a new finance director, as it looks to advance development of its treatments for celiac disease and Type 1 diabetes. Monday, May 21, 2018 The U.K. is aiming to cut cancer deaths by 10% by using artificial intelligence to diagnose patients sooner. Prime Minister Theresa May will set the target in a speech intended to set the U.K. on a path that leads to AI becoming a key industry and a driver of improved health outcomes. | This week's sponsor is IQVIA. | | | |
Resources Sponsored by: Seton Hall Law 4-day interactive educational program trusted by multi-national companies as part of their compliance training for employees. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating globally. Visit event homepage for session topics. Presented by: Patheon There are many parenteral dosage forms from which the pharmaceutical scientist can choose to develop their drug product. In this article, the author discusses the choices available and strategies which can be employed at the different stages of development. Sponsored by: Veeva Systems Learn how to reduce change management burden, keep systems current, and maintain compliance by applying a risk-based approach to change management of GxP systems. Sponsored by: Veeva Systems UCB took a more holistic approach to managing regulatory processes. Read how their efforts are paying off. Sponsored by: Veeva Systems Find out how to eliminate regulatory’s tracking spreadsheets for good. Sponsored by: Veeva Systems Learn how cloud-enabled solutions provide real-time insights and actionable analytics to improve clinical trial safety and performance in this short presentation. Sponsored by: Docusign Life science companies are experiencing a significant transformation in how they bring new products to market. Drug Approval, Manufacturing Quality & Regulation 2018 | Online Building your Program for Immunomodulating Therapeutics Wednesday, 6 June, 2018 | Paris, France BIO International Convention June 4-7, 2018 | Boston, MA
FierceBiotech Executive Breakfast at BIO 2018 – CAR-T 2.0: Innovation Never Stands Still June 6, 2018 | Boston, MA BioBasics: Biotech for the Non-Scientist June 13-14, 2018 | Toronto, Canada The Liquid Biopsy Summit June 20–22, 2018 | San Francisco, CA Sensors Expo & Conference Conference & Expo: June 26-28, 2018 | Pre-Conference Symposia: June 25, 2018 | San Jose, CA FierceBiotech 3rd Drug Development Forum October 1–3, 2018 | Hilton Boston Logan Airport Hotel | Boston, MA Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | Register and start preparing Today! | 