Today's Rundown Biogen's Rorschach readout continues as detailed Alzheimer's data divide experts FDA hits Ipsen's $1B drug with clinical hold over safety signal UCB's bispecific outshines AbbVie's Humira in phase 3 psoriasis test [Sponsored] Thwarting Subjectivity in Clinical Trials FDA knocks down Enzyvant candidate on manufacturing concerns after plant inspection Novartis posts more phase 3 data as EMA reviews asthma combo Watch out, Keytruda. Ferring's bladder cancer gene therapy rival has new data—and they look competitive FiercePharmaAsia—Astellas' $3B gene therapy bet; China's PD-1 coverage; Hanmi-Rapt I-O deal Chutes & Ladders—Sanofi strategy chief Mansuri set to step away Featured Story | | | Friday, December 6, 2019 Biogen has shared the detailed data on aducanumab that it hopes will secure FDA approval in Alzheimer’s disease. The Clinical Trials on Alzheimer's Disease presentation cleared up some questions about the data set without delivering a telling blow for either side of the debate. |
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Top Stories Friday, December 6, 2019 The FDA has placed two trials of palovarotene on partial clinical hold eight months after Ipsen gained the drug in its $1 billion (€900 million) takeover of Clementia Pharmaceuticals. FDA staff took the action in response to cases of early growth plate closure in children on the retinoic acid receptor gamma agonist. Friday, December 6, 2019 UCB’s bispecific antibody recently beat Johnson & Johnson’s Stelara at clearing psoriasis symptoms in a phase 3 study, and now it has bested AbbVie’s Humira, too. After 16 weeks of treatment, more patients who received UCB’s drug achieved a 90% reduction of psoriasis area and severity and clear or almost clear skin. Monday, December 2, 2019 A clinical trial is a measurement system, but too often, we fail to calibrate the most significant of measurement instruments: trial participants. Friday, December 6, 2019 Privately held biotech Enzyvant was hoping its first shot at an FDA approval with a rare immunodeficiency disease candidate would come up in its favor. But the FDA has dashed those hopes, citing manufacturing concerns in a response letter—at least, for now. Friday, December 6, 2019 Novartis’ asthma combo already beat an inhaled corticosteroid at improving lung function, meeting the primary endpoint in a phase 3 study. Now, the Big Pharma is unveiling yet more data showing how the treatment fared against the standard of care: a combination of the same types of drugs. Friday, December 6, 2019 On the heels of an FDA speedy review for Keytruda’s potential use in non-muscle invasive bladder cancer, its close rival, a gene therapy by Ferring Pharmaceuticals spinout FerGene, has posted competitive late-stage data. But Merck has at least one upper hand. Friday, December 6, 2019 Astellas buys into gene therapy with $3 billion Audentes Therapeutics takeover. Keytruda and Opdivo lose out in latest China reimbursement talks. Hanmi Pharma expands immuno-oncology footprint with $118 million Rapt Therapeutics deal. And more. Friday, December 6, 2019 Mansuri will step down from Sanofi strategy role; Ratliff takes lead at AMRI after brief LabCorp stint; Caraway taps Williams for chief role. | | Experts in our field; with 20+ years’ experience in Viral Vector & plasmid DNA (R&D, High Quality and GMP) manufacture for pre-clinical, clinical & commercial supply. Take a virtual tour of our facilities & find out more about our expansion project. |
Enrollment Showcase | | | Sponsored by: University of Florida College of Pharmacy University of Florida precision medicine leaders highlight current knowledge and trends to advance the future of health care in this new webinar series. Register today. |
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Resources 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: Veeva Systems Medical Affairs 2025 brings together leading perspectives from AstraZeneca, Bristol-Myers Squibb, Merck, Lilly, and other innovative life sciences organizations on key challenges impacting medical affairs and a roadmap for success in the coming decade. Sponsored by: SHYFT Analytics This whitepaper provides a snapshot of where the biopharma industry is now, where it's heading, and how companies are allocating their resources to adapt & grow. 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: ON24 Discover solutions to the most common challenges faced by medical device companies. 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: Article Galaxy powered by Reprints Desk This white paper examines the skyrocketing cost of drug development and provides step-by-step guidance for executing a successful fail fast strategy. 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. 4th Microbiome Movement – Drug Development Europe Summit – London, UK February 4-6, 2020 | London, UK 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 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 | 