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Today's Rundown Featured Story | | | Monday, December 16, 2019 Both doses of GlaxoSmithKline’s BCMA-targeting antibody-drug conjugate shrank tumors in about one-third of patients with advanced multiple myeloma in a phase 2 study. The numbers are in line with response rates typically seen in studies involving very sick patients, but the candidate could do even better in earlier lines of treatment. |
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Top Stories Tuesday, December 17, 2019 The ink is barely dry on its second FDA approval, but Alnylam is already gearing up for the next one. Its kidney disease drug beat placebo at helping patients clear oxalate from their kidneys, teeing it up for U.S. and European filings in 2020. Tuesday, December 17, 2019 The FDA has picked holes in Epizyme’s filing for approval of tazemetostat, pointing to limited efficacy and safety concerns in its advisory committee briefing document. One analyst said the conclusions “read a bit harsh,” leading them to put the chances of a positive vote at no more than 25%. Tuesday, December 17, 2019 For someone who thought he’d retire, Nessan Bermingham, Ph.D., is a busy guy. Just two months after launching Korro Bio, he’s unveiling a new biotech, Triplet Therapeutics, with $59 million and a mission to develop drugs for repeat expansion disorders such as Huntington disease and fragile X syndrome. Monday, December 16, 2019 Four years after BioMarin’s vosoritide posted proof-of-concept data, the drug hit the mark in phase 3, helping children with achondroplasia, the most common form of dwarfism, grow more quickly than those on placebo. The company will discuss the drug’s path to market with regulators early next year, and analysts anticipate a 2021 launch. Tuesday, December 17, 2019 PharmaMar has filed for FDA approval of lurbinectedin in relapsed small cell lung cancer. The filing tees PharmaMar up to become the first company to win approval for a new chemical entity in the disease in more than 20 years. Tuesday, December 17, 2019 Congress has proposed increasing the National Institutes of Health’s annual budget by 7%. The proposal, which would give the NIH far more than was requested, is part of two packages filed in the House of Representatives to secure the funding of the government for 2020. Tuesday, December 17, 2019 When Astellas earlier this month unveiled its $3 billion Audentes buyout, it touted the biotech's gene therapy candidates as a fifth pillar of its future business. But big moves have small beginnings, and in Astellas' case, it all started with a furtive meeting in San Diego. 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: IBM Watson Health IBM’s highlighted solutions reside in a security-rich cloud environment—home for capturing, managing and analyzing clinical study data with control, accuracy and confidence. These solutions lay the groundwork for further integration with IBM® Watson® cognitive technology. Sponsored by: IBM Watson Health Inpatient View and Outpatient View are powered by robust data assets and use sophisticated projection methodologies to help ensure accuracy of reporting. Sponsored by: IBM Watson Health Acknowledging various stakeholder networks, as well as recognizing variances within the regulatory environment, we believe, is essential for companies looking to uncover the right decision-makers in support of biologics or biosimilars. Learn more. 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. | 
