AstraZeneca edges out in front of competition with FDA nod for once-weekly diabetes drug in kids Otsuka’s dispersible TB drug for kids wins CHMP support Ex-Genzyme CFO takes up exec chair role at subcutaneous delivery specialist Stada scores rights to targeted oral steroid under review for an autoimmune kidney disease CDMO Recipharm continues its rapid expansion with a second fill-finish facility, this time in India Featured Story | By Nick Paul Taylor The FDA has approved AstraZeneca’s extended-release Type 2 diabetes drug Bydureon BCise for use in children aged 10 years and older. Securing the FDA approval provides a point of differentiation for AstraZeneca in the competitive GLP-1 market. read more |
| |
|---|
|
| | eBook: Drug Design and the Patient Journey Patient-focused drug design can be a key factor in real-world therapeutic outcomes and business success. But if successful treatments should be created with patients in mind, when is the optimal time to solicit this feedback? This eBook features insights from experts in the industry on patient-centric drug development challenges and strategies on advancing drug design and development effectively. Learn more. |
Top Stories By Nick Paul Taylor Europe's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Otsuka’s 25 mg dispersible tablet formulation of Deltyba. Otsuka developed the new formulation of the pulmonary multidrug resistant tuberculosis (MDR-TB) treatment for use in children. read more By Nick Paul Taylor ReForm Biologics has appointed former-Genzyme chief financial officer Jim Sherblom as its executive chairman. The subcutaneous delivery specialist disclosed the appointment alongside news that it raised $10 million and restructured to improve its access to capital markets. read more By Nick Paul Taylor Stada has teamed up with Calliditas Therapeutics to market an oral formulation that gets budesonide to the lower small intestine to treat the chronic autoimmune kidney disease IgA nephropathy. The candidate uses a two-step technology to delay absorption of the active ingredient until the lower small intestine. read more By Kevin Dunleavy Swedish CDMO Recipharm unveiled plans for a new fill-finish facility in India. The announcement comes less than three weeks after the company said it was building a new plant in Morocco. read more Resources Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Sponsored by: Patheon by Thermo Fisher Scientific Take a closer look at your supply chain to ensure it delivers with speed, efficiency, and quality — all within budget. Sponsored by: Patheon by Thermo Fisher Scientific Choose the right AAV platform for your viral vector-based therapy Sponsored by: Blue Matter Consulting E-book to get newcomers “up to speed” quickly on digital health and digital therapeutics while also addressing key issues important to those already familiar with the topic. Sponsored by: WCG Engage Independent Expert Endpoint Adjudication and Data Monitoring Committees in a strategic manner to identify methods for retrospective and prospective evaluations that may improve competitive advantage and bolster regulatory submissions. Sponsored by: PA Consulting What does the future of Cell & Gene Therapy look like? Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored By: Within3 We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met. Sponsored by: Catalent Discover the current state of patient-focused dose design through clinical evidence, real-world case studies and patient preference-driven drug design solutions that can help develop better treatments and successful real-world outcomes. Sponsored by: Catalent This eBook features insights from experts in the industry on patient-centric drug development challenges and strategies on advancing drug design and development effectively. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Medical Affairs Strategic Summit (MASS) September 13-15, 2021 | New Brunswick, NJ Promotional Review Committee Compliance & Best Practices September 13-15, 2021 | New Brunswick, NJ Clinical Quality Oversight Forum September 27-29, 2021 | Philadelphia, PA Digital Pharma East September 28-30, 2021 | Pennsylvania Convention Center, Philadelphia | October 5-8, 2021 | Virtual Event Fierce Pharma Marketing Awards September 29, 2021 | Philadelphia, PA TMF Summit October 25-27, 2021 | New Orleans, LA Diversity, Equity & Inclusion Week November 9–11, 2021 | Virtual Event | 