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 legislation 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. | |
| Roche pens death notice for NewLink IDO/TDO cancer collaboration Special Report—The top 15 pharma companies by 2017 revenue Pfizer vet Travis Wager takes R&D reins at Aquinnah [Sponsored] Accelerating Timelines for Rare Disease Drug Development Zymeworks could get up to $485M in expanded Daiichi I-O deal Gene therapy startup MeiraGTx files for $86M IPO Celsius bags $65M to develop precision drugs for cancer, autoimmune disease Ansun raises $85M in series A to fund phase 3 antiviral study Imprimis offshoot raises $20M to develop dry-eye meds TapImmune to merge with Baylor adoptive T-cell startup Marker X4’s I-O combination pilot shows new activity compared to Opdivo alone Featured Story | Tuesday, May 15, 2018 Just a few weeks out from ASCO, and with more than a touch of inevitability, Swiss major Roche is axing its IDO/TDO inhibitor work “in its entirety” with partner NewLink Genetics as the fallout from a string of weak IDO trials across biopharma continues. |
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| Top Stories Tuesday, May 15, 2018 In many ways, 2017 was a “wait-and-see” year for biopharma as a new administration entered the White House. The industry came under fire early when President-elect Donald Trump said it was “getting away with murder” on pricing. More than a year later, biopharma has been spared real reform, and that’s reflected in overall revenues. Which pharma companies wound up on top? Tuesday, May 15, 2018 Aquinnah Pharmaceuticals' new vice president of research will head up its discovery efforts for treatments targeting neurodegenerative diseases, including amyotrophic lateral sclerosis and Alzheimer's disease. Monday, May 14, 2018 For children diagnosed with rare diseases, traditional drug development timelines are not good enough. Collaborative partnerships are imperative to accelerate those timelines and expedite time to market for rare disease therapies. Monday, May 14, 2018 Zymeworks granted two more licenses to Daiichi Sankyo for its antibody development technology in return for $18 million upfront and a potential $466.7 million in milestones to follow. Tuesday, May 15, 2018 MeiraGTx has filed for an $86 million IPO to advance a handful of gene therapies into and through clinical trials. The transatlantic biotech is initially targeting inherited retinal diseases with therapies designed to halt vision loss. Tuesday, May 15, 2018 Third Rock Ventures launched Celsius Therapeutics, which is setting out to develop therapeutics based on single-cell genomic sequencing. Armed with $65 million in series A funding, Celsius will sequence defined patient samples to identify the individual cells responsible for disease. It hopes to bring forth the first precision medicines for autoimmune disease. Monday, May 14, 2018 Ansun BioPharma has gathered up $85 million in series A financing and plans to use the funds for an upcoming phase 3 trial of its DAS181 antiviral medication, which has received fast-track and breakthrough designations from the FDA. Tuesday, May 15, 2018 Surface Pharmaceuticals has rung up about $20 million in a sale of series A preferred stock, completing its spinoff from Imprimis Pharmaceuticals into a separately financed and managed company. The money will support Surface’s push for FDA approval of three products in five ocular indications, including dry eye. Tuesday, May 15, 2018 TapImmune is planning to merge with T-cell therapy startup Marker Therapeutics. The agreement will give TapImmune control of adoptive T-cell therapies designed to provide more durable responses than CAR-Ts and other genetically engineered treatments. Tuesday, May 15, 2018 X4 Pharmaceuticals unveiled results from a pilot study showing that the addition of its CXCR4 antagonist to Bristol-Myers Squibb’s Opdivo spurred new antitumor activity in patients that had not responded to Opdivo treatment alone—laying the groundwork toward proving its combination can boost the effectiveness of anti-PD-1 checkpoint inhibitor immunotherapies. This week's sponsor is Eurofins Advinus. | | | 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. Sponsored by: USDM Life Sciences What are the biggest trends in life sciences this year? 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 Explore a new model for events management, and learn how to deliver more value. Sponsored by: Veeva Systems To deliver value to key opinion leaders, medical affairs needs to tailor their engagement with deeper analytics and insights. Sponsored by: Veeva Systems Learn how leading companies, from the world’s top pharma to emerging biotechs, are empowering their medical affairs teams. 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 MIXiii-Biomed 2018 May 15-17, 2018 | Tel-Aviv, Israel Drug Development Immersion May 17-18, 2018 | Boston, MA 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 BioBasics: Biotech for the Non-Scientist June 13-14, 2018 | West Windsor, NJ 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! |