| This week's sponsor is TD2. | | | The Quick-Start Guide to Clinical Strategy for Oncology Trials
Ready your trial for success with this free white paper from TD2. It's packed with action items to ground medical research in a solid clinical strategy—from start to finish. Unlock More Potential with TD2. Learn More |
Today's Rundown Axovant poaches Allergan CMO to lead R&D recovery FDA starts speedy review of Loxo’s site-agnostic cancer drug larotrectinib EMA lays cornerstones for new Amsterdam headquarters Arcturus and ex-CEO put monthslong legal scuffle to rest Looking to unseat Sanofi and Shire drugs, Atlas gene therapy startup Avrobio files for $86M IPO European cancer vaccine startup Nouscom poaches Pfizer I-O executive Johnson & Johnson's Darzalex ambitions take a hit with scrapped I-O trials Featured Story | | | Tuesday, May 29, 2018 Axovant has put Gavin Corcoran in charge of its R&D recovery. Corcoran is stepping down as CMO of Allergan to take up the position, which will see him try to guide Axovant back from the implosion of its Alzheimer’s R&D strategy. |
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| This week's sponsor is Catalent. | | | |
Top Stories Tuesday, May 29, 2018 Loxo Oncology is preparing for a November verdict from the FDA on larotrectinib as a treatment for solid tumors carrying a specific mutation—regardless of where they appear in the body Tuesday, May 29, 2018 The European Medicines Agency has begun laying the foundation for its new Amsterdam headquarters, aiming to finish construction by November 2019. Tuesday, May 29, 2018 In a settlement approved by Israeli District Court on Sunday, Arcturus Therapeutics and its ousted CEO Joseph Payne agreed to end litigation against each other. The deal comes nearly four months after the RNA biotech's board voted to terminate Payne. Tuesday, May 29, 2018 Avrobio has filed for an $86.25 million IPO. The offering would give the Atlas Venture-backed startup the means to run clinical trials of gene therapies designed to supplant enzyme replacement therapies from Sanofi, Shire and Pfizer. Tuesday, May 29, 2018 Swiss oncology biotech Nouscom has nabbed Pfizer’s former global clinical leader of early and late stage immuno-oncology/hematology Adrian Woolfson, M.D., Ph.D., as its new CMO. Tuesday, May 29, 2018 Drugmakers have raced to pair their cancer drugs with immuno-oncology therapies, hoping to see an improved benefit from a combination. But that’s not how things are looking for Darzalex partners Genmab and Johnson & Johnson. | This week's sponsor is ExL Events. | | | |
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! | 