| Editor’s Note: FierceBiotech will not publish on Monday next week due to the Presidents Day holiday, but we’ll be back in your inbox on Tuesday, Feb. 19.
Today's Rundown FDA funding set to jump as Congress votes to avert shutdown Nimbus brings on Janssen discovery head as CSO with plans to expand its portfolio India’s Glenmark spins out NMEs into U.S. company [Sponsored] Invert to Convert: Rethinking Patient Recruitment & Enrollment Strategies TCR2 IPO hits midpoint, setting stage for trials of CAR-T rivals Passage Bio to tackle CNS diseases with $115M and UPenn gene therapy programs EuroBiotech Report—AstraZeneca clear-out, uniQure data, Grey Wolf, Pathios and CureVac FiercePharmaAsia—AstraZeneca’s China business; Pfizer Japan valsartan recall; Xofluza resistance Chutes & Ladders—Sanofi's CMO takes on chief digital officer role Featured Story | | | Friday, February 15, 2019 Congress has approved a budget deal to avert another government shutdown. The deal, which is due to be signed into law by President Trump, includes the biggest increase in FDA funding in several years. |
|
|
| This week's sponsor is Camargo. | | | [Webinar] Maximizing the Value of Your Drug Development Program
Thursday, February 21 | 11am ET / 8am PT
This webinar will benefit executives at Biotech and Pharmaceutical companies interested in learning more about 505(b)(2) drug development and how to save time and money while maximizing the value of their drug development program. Register Now! |
Top Stories Thursday, February 14, 2019 Digital drug miner Nimbus Therapeutics has brought on Janssen’s global head of lead discovery, Peter Tummino, Ph.D., to serve as its chief scientific officer. Friday, February 15, 2019 India’s Glenmark is rolling all of the new molecular entities (NMEs) in its pipeline into a separate U.S. company in an effort to speed the programs to market. Monday, February 11, 2019 90% of clinical trials will meet their enrollment goals if their original timelines are doubled. WCG breaks down the barriers to ramping up and meeting patient enrollment goals. A new approach addresses root causes and accelerates study timelines by 33%. Friday, February 15, 2019 TCR2 Therapeutics has priced its IPO at the midpoint of the target range. The offering stands to net TCR2 $67 million, setting it up to move cell therapies designed to better CAR-Ts through early-phase development. Thursday, February 14, 2019 Passage Bio reeled in a $115.5 million series A on Thursday, which will support the development of five programs aimed at treating rare monogenic central nervous system (CNS) diseases. Passage Bio is working on those five under a research, collaboration and license agreement with the University of Pennsylvania. Thursday, February 14, 2019 In this week's EuroBiotech Report, AstraZeneca clears out cancer projects, uniQure's hemophilia B drug clears another test and Grey Wolf raises £10 million. Friday, February 15, 2019 AstraZeneca's China business soared 25% in 2018 as cancer and respiratory drugs pulled through; Pfizer Japan is recalling valsartan combo drugs made using Mylan's tainted API; Japanese doctors recorded resistance to Shionogi and Roche's novel flu drug Xofluza; and more. Friday, February 15, 2019 Sanofi's new chief digital officer joins executives looking to leverage tech; Parexel nabs four high-profile FDA staffers; and Nimbus brings on Janssen's discovery head as CSO. Those moves plus more hirings, firings and retirings throughout the industry. Enrollment Showcase | | | Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. |
|
|
Resources Sponsored by: AlphaSense It’s never been more challenging to stay on top of trends and innovation shaping the future of healthcare. Discover how AI can help competitive intelligence teams achieve more proactive strategies. Presented by: SDC If commonly used statistical phrases like two-sample t-test, difference in proportions, or hazard ratio intimidate you, join this webinar for an introduction to statistical analyses in clinical trials. Sponsored by: Patheon, part of Thermo Fisher Scientific When a biologics company prepares to launch a new product, it must forecast the manufacturing capacity it will need, factoring in its estimate of the size of future sales, the timing of the launch, the dosage of the product, its strategy for building its market and a host of other variables. Sponsored by: Oracle Health Sciences 92% of survey respondents make changes to their RTSM/IRT systems due to study changes. See what else puts a strain on their clinical trials. Download the Research Whitepaper. Sponsored by: Patheon, part of Thermo Fisher Scientific Download this whitepaper to learn more. Sponsored by: The Kinetix Group Explore how the pharma industry can adapt its approach to the changing healthcare marketplace in the era of the Quadruple Aim Sponsored by: Cofactor Genomics Learn how Health Expression Models provide increased sensitivity, specificity, and accuracy for characterizing immune response in solid tumor specimens. Sponsored by: BioAnalytix, Inc. This whitepaper reviews fundamental aspects of HCPs that pertain to biologic drug development and presents current and emerging approaches to HCP analysis. Sponsored by: Veradigm Clinical trials take too long and cost too much—here's what needs to change. Sponsored by: Reprints Desk, Inc. Go from Search to Full-Text Scientific Papers in a Single Click! Sponsored by: Blue Latitude Health This white paper consists of original data and expert interviews. Download it today for exclusive tools, tips and analysis on achieving launch excellence in challenging pharma markets. Sponsored by: Outer Edge Technology With FDA approval imminent, start-up Life Sciences company partners with an industry focused MSP to design and manage its regulated cloud-based infrastructure to speed time to market. Sponsored by: DeciBio Consulting With the liquid biopsy market maturing and >80 companies still competing with liquid biopsy offerings, it is crucial for investors to be able to cut through the noise and identify the winners. Presented by: Veeva Share your thoughts on the life sciences industry's progress in improving study execution. Sponsored by: Biotech Primer The Biopharma industry is moving at lightning speed and it can be a challenge to keep pace. Here at Biotech Primer we spend hours each week researching, writing, and editing original content for the Biotech Primer WEEKLY with one goal in mind: to help everyone better understand the latest science and technology driving today’s healthcare industry. BIO Asia International Conference March 5-6, 2019 | Grand Hyatt Tokyo | Tokyo, Japan PEGS: The Essential Protein Engineering Summit April 8 – 12, 2019 | Boston, MA Middle East Life Sciences Compliance Training April 29, 2019 – May 2, 2019 | Dubai U.A.E. Drug Development Boot Camp® 2019 November 20-21, 2019 | Boston, MA | Register and start preparing Today! | 