| | Flexible Biomanufacturing Solutions Your molecule has the power to change lives and shape the future. Take advantage of our science-driven, risk-based approach to every step of the biologic development and manufacturing process. Unleash the potential of your discovery. Download the Brochure. |
Today's Rundown Boehringer's $250M NASH drug hits the skids as development path gets rockier Amid FDA partial hold, Meek jumps ship from Ipsen to lead new gene therapy startup Aduro stung as Novartis drops work on STING drug Xencor nabs new CMO from Jazz Pharma Takeda taps brain-focused Cerevance in quest for new GI targets After SABCS stunner, Seattle Genetics nabs FDA breakthrough tag for tucatinib C-suite change-ups at Science 37 continue with new CCO AZ, Merck's Lynparza narrowly snags FDA panel backing in pancreatic cancer Featured Story | | | Wednesday, December 18, 2019 We may be nearing the first-ever approval for a NASH drug next year, but the road to approval is not getting easier. |
|
|---|
|
Top Stories Wednesday, December 18, 2019 A new gene therapy spinout has nabbed Ipsen chief executive David Meek to help sell its new drug. Wednesday, December 18, 2019 Aduro started the year badly with cuts and a refocus: It’s now ending the year on an equally bad note after a quiet SEC posting says Big Pharma partner Novartis is dropping work on a STING agonist from the biotech. Wednesday, December 18, 2019 As a senior vice president at Jazz, Allen Yang, M.D., Ph.D., headed clinical development and served as acting CMO. He will now oversee clinical development and operations as Xencor pushes a suite of bispecific antibodies through the clinic. Tuesday, December 17, 2019 Takeda and Cerevance are inking a research deal focused on identifying new protein targets in the central nervous system to develop new treatments for gastrointestinal disorders. They kept details close to the vest but said Cerevance could net more than $170 million in milestones per target. Wednesday, December 18, 2019 Just a week after posting strong data at the San Antonio Breast Cancer Symposium, Seattle Genetics has nabbed the coveted FDA breakthrough label for its oncology hopeful. Wednesday, December 18, 2019 Virtual clinical trial company Science 37 is continuing its executive shuffle with the appointment of Steven Geffon as its chief commercial officer. Tuesday, December 17, 2019 AstraZeneca and Merck’s Lynparza is looking to become the first in its class of PARP inhibitors to break into the pancreatic cancer market. And a majority of FDA advisers thinks it should be—if only a small one. Tuesday, the agency’s panel of experts voted 7-5 to approve Lynparza in the tough-to-treat disease. Resources Sponsored by: Colorcon Learn more: Best practices for defending supply chain security and compliance by efficiently managing product authentication. Sponsored by: Metabolon Small or emerging pharmaceutical and biotech companies pursuing novel molecules and targets have two important goals: achieve clinical success and attract new rounds of funding. While there’s never a guarantee of either, certain actions can influence the outcome in your favor. Sponsored by: Catalent Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric. Sponsored by: Altran This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future. Sponsored by: Clarivate Analytics Get your copy of the Q2 2019 Life Sciences M&A notes and trends to understand the mergers and acquisitions (M&A) activity in the life sciences sector which drove 136 new M&A deals and provides a forward look to 2020 activity ahead. Sponsored by: Thermo Fisher Scientific Are you facing costly delays in your API scale-up? Sponsored by: Roche and IQVIA This global landscape study identifies and assesses innovative funding models for cancer and other high-cost chronic NCDs across Africa, Asia, Europe, Latin America and Middle East. The study aims to enable readers to better understand the possibilities that innovative funding models bring to bridge the current and future funding gap, while stressing the key success factors that enable sustainability and success such as stakeholder collaboration. Sponsored by: Catalent Pharma Solutions In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey. Sponsored by: Amazon Web Services From IoT to data management to high-performance computing and machine learning, leading life sciences organizations are using Amazon Web Services (AWS) to develop scalable, global, predictable, and secure solutions to modernize clinical trials while mitigating risks Sponsored by: Outer Edge Technology, LLC See why visionaries outsource the design and management of the infrastructure allowing their scientists to innovate. Sponsored by: Eli Lilly and Company in partnership with Xcenda Download this complimentary paper that explores the practice of step therapy and its impact on key stakeholders in the US healthcare system. Sponsored by: Catalent Download the case study to learn about the clinical supply management tools that helped a small sized pharma company during phase III of a multi-arm oncology study. Sponsored by: Catalent Watch a short video on demand led supply model. It is designed to meet the needs of patients, clinical sites, clinical team and sponsors and results in shorter lead time, less waste, less stock out risk and no booklet labels. Sponsored by: Catalent Download the eBook to explore a proactive approach for clinical supply management. Asia-Pacific Healthcare Compliance Certificate Program March 9-12, 2020 FierceBiotech Executive Breakfast at the J.P. Morgan Healthcare Conference 2020 January 14, 2020 | The Fairmont Hotel | San Francisco, CA 11th Annual SCOPE Summit: Summit for Clinical Ops Executives February 18-21, 2020 | Orlando, FL 4th Annual Gene Therapy for Rare Disorders March 30 – April 2, 2020 | Boston, MA Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now and begin Pre-Boot Camp Preparation. | Take your new medicine development skills to the next level. Middle East Healthcare Compliance Certificate Program March 23-26, 2020 | 