| This week's sponsor is Premier Research. | | | Rare Cancer Drug Research: What to Know Going In
Rare cancer drug research requires oncology and rare disease expertise and careful attention to trial design and regulatory demands. Get started with our white paper. Premier Research. It's what we do. Best. |
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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Spark hemophilia B gene therapy clears test en route to Pfizer-sponsored phase 3 Celgene pays Evotec $65M to access source of solid tumor drugs Allergan acquires NMDA depression drug from Aptinyx collaboration [Sponsored] Growing Requirements for Medicines for Children New year, new name, new bladder cancer data for Sesen Bio Gates Foundation and U.K. pledge $50M to superbug treatment drive Icon launches new electronic financial disclosure form software Celgene, stricken by setbacks, bids a quiet goodbye to deal-making czar Golumbeski Featured Story | | | Tuesday, May 22, 2018 Spark Therapeutics has presented data on hemophilia B patients who received a version of its gene therapy manufactured using a modified process. Early data on the patients suggest the new batch of therapies is at least as effective as its predecessor, clearing away a potential pitfall on Spark’s path to market. |
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Top Stories Tuesday, May 22, 2018 Celgene is paying $65 million upfront to secure an option on cancer drugs discovered by Evotec. The strategic partnership tasks Evotec with applying its R&D toolkit to the discovery of solid tumor drugs that Celgene will then pick up and advance. Tuesday, May 22, 2018 Allergan has acquired an investigational NMDA receptor modulator discovered by Aptinyx, exercising its option under an ongoing collaboration, and plans to pair it with its rapastinel depression therapy currently under development. 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 Sesen Bio presented three-month data showing that the antibody-drug conjugate Vicinium had a 43% complete response rate in patients with non-muscle-invasive bladder cancer. Tuesday, May 22, 2018 A project that aims to reinvigorate the search for drugs to treat antimicrobial-resistant infections has just picked up two more deep-pocketed backers. Tuesday, May 22, 2018 Icon has launched a paperless solution for managing the clinical investigator financial disclosure forms mandated by the FDA. Monday, May 21, 2018 Celgene's business development head George Golumbeski left the company in April, at a time when the big biotech is struggling to recover from a series of setbacks and stumbles over the last year. | 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! | 