| This week's sponsor is TD2. | | | The Quick-Start Guide to Clinical Strategy for Oncology Trials
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Today's Rundown Former Novartis U.S. oncology head Bill Hinshaw jumps ship to metabolic startup Gilead, Galapagos hit goal in psoriatic arthritis phase 2 Bayer could be sharpening the ax for R&D cuts: German media Madrigal shares jump on midstage NASH results In a twist, new Arcturus board restores old CEO Despite ASCO wobble, Syndax pals up with Nektar on entinostat combo trial FDA puts Vertex, CRISPR sickle cell trial on hold Denali acquires F-star's blood-brain barrier bispecific antibody tech in deal worth up to $471M Featured Story | | | Thursday, May 31, 2018 Novartis continues its hemorrhaging of executives seeking new careers at smaller, younger biotechs as its EVP and head of U.S. oncology Bill Hinshaw takes the reins at Axcella Health. |
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| This week's sponsor is Catalent. | | | |
Top Stories Thursday, May 31, 2018 A phase 2 trial of Gilead and Galapagos’ filgotinib in psoriatic arthritis has met its primary endpoint. The midphase trial linked the JAK1 inhibitor to significant improvements on a symptom score, laying the groundwork for psoriatic arthritis to join the partners’ growing pot of late-phase opportunities. Thursday, May 31, 2018 Under the oddly code-named “Super Bowl,” German pharma company Bayer is said to be reviewing its R&D locations, with fears this may lead to the swinging of an ax across some ops. Thursday, May 31, 2018 Using an old Roche drug, Madrigal Pharmaceuticals has seen its stock soar 60% on its latest fatty liver disease trials data. Thursday, May 31, 2018 In a settlement approved by an Israeli court, Arcturus and its ex-CEO Joseph Payne agreed to drop litigation against each other and to appoint a new board of directors. The new board rehired Joseph Payne and CSO/COO Pad Chivukula into their old roles. Thursday, May 31, 2018 Syndax’s shares slid after an ASCO abstract revealed lackluster data with entinostat, but it's forging ahead with a new combination study with Nektar. Thursday, May 31, 2018 The FDA has placed a clinical hold on Vertex and CRISPR Therapeutics’ sickle cell disease candidate. Shares in CRISPR fell 15% as investors digested the delay to the start of the gene-editing startup’s first U.S. clinical trial. Wednesday, May 30, 2018 Denali Therapeutics and F-star teamed up in 2016 on bispecific antibodies to deliver drugs across the blood-brain barrier. Now, Denali is acquiring the latter's F-star Gamma unit, picking up the rights to antibodies developed under their collaboration. | 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 Innovation, Collaboration and Entrepreneurship in Drug Discovery June 28, 2018 | Cambridge, UK 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 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! | 