| This week's sponsor is TD2. | | | The Quick-Start Guide to Clinical Strategy for Oncology Trials
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Today's Rundown Roche scraps €120M SMA drug after hitting ‘many difficulties’ Right-to-try is designed to weaken the FDA, law’s author says Immuno-oncology player Neon Therapeutics looks for $115M in IPO Cortexyme gathers $76M to fund efficacy study of antibiotic for Alzheimer’s Amgen to ramp up early-stage immuno-oncology with 2 MD Anderson deals Xynomic preps broad push for HDAC cancer drug after series B Call for this year's Fierce 15 nominations EuroBiotech Report—Gilead-Galapagos, Nouscom hire, Prothena cuts, Crescendo-Zai and EMA FiercePharmaAsia—Takeda investors’ fear, WuXi’s 6-fold stock jump, Gardasil-made billionaires Chutes & Ladders—Former Novartis oncology head jumps to metabolic startup Featured Story | | | Friday, June 1, 2018 Roche has stopped development of the spinal muscular atrophy drug it acquired for €120 million ($140 million) upfront three years ago. The Swiss pharma is walking away from olesoxime after running into “many difficulties in developing” the oral mitochondria-boosting drug. |
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| This week's sponsor is Catalent. | | | |
Top Stories Friday, June 1, 2018 The author of right-to-try legislation is pressuring Scott Gottlieb, M.D., to implement the law in a way that weakens the FDA. “This law intends to diminish the FDA’s power over people’s lives, not increase it,” wrote Sen. Ron Johnson. Thursday, May 31, 2018 Neon Therapeutics plans to use its IPO cash to push its lead candidate, a personalized neoantigen cancer vaccine, through phase 1 and to nudge its preclinical programs into the clinic. Thursday, May 31, 2018 Alzheimer’s disease startup Cortexyme was able to round up $76 million in funding for a potentially first-in-class treatment, while other companies are looking to move away from the field. Thursday, May 31, 2018 Amgen and the University of Texas MD Anderson Cancer Center are teaming up to accelerate up to 16 preclinical and clinical programs in blood cancers, small-cell lung cancer and other small-cell cancers. Friday, June 1, 2018 U.S.-China biotech Xynomic Pharma has raised additional funding to take an HDAC inhibitor in-licensed last year into seven new cancer trials. Thursday, May 31, 2018 It’s that time of year again when we are looking for the best, the brightest and the fiercest for our annual Fierce 15 biotech awards. Thursday, May 31, 2018 In this week's EuroBiotech Report, Gilead and Galapagos hail JAK1 success, Nouscom poaches a Pfizer executive, Prothena cuts deep into its workforce and more. Friday, June 1, 2018 A group of 12 Takeda shareholders demand a vote on the Shire deal out of fear for "high risks"; WuXi AppTec becomes the largest-cap CRO after its stock jumped sixfold in three weeks since listing in Shanghai; Gardasil franchise's Chinese nods propelled two families into Bloomberg’s billionaires club. Friday, June 1, 2018 Novartis' ex-oncology head jumps to startup; Axovant poaches Allergan's CMO; and Biogen brings on Pfizer dealmaker—plus more hirings, firings and retirings throughout the industry. | This week's sponsor is ExL Events. | | | |
Enrollment Showcase | | | Sponsored by: Bioinformatics at UTHealth SBMI UTHealth SBMI now offers a M.S. track in clinical and translational bioinformatics. |
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Resources Sponsored by: Blue Latitude Health Blue Latitude Health explores the commercial barriers and new stakeholder connections for pharma companies developing precision medicines, and reveals how to grasp novel opportunities in the new era of healthcare. Presented by: Patheon, part of Thermo Fisher Scientific “Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market faster. Quickly proving efficacy in first-in-human (FIH) trials is a make-or-break milestone for these cash-strapped companies whose hopes hinge upon one or two molecules. Read how CDMOs are responding to this pressure. 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 Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | Register and start preparing Today! | 