Chasing Allergan, Eyenovia hits endpoint in vision phase 3 Acer prepares to file for FDA approval of taste-masked formulation to challenge Horizon Phillips-Medisize creates low-waste digital drug delivery device Stallergenes Greer gets positive opinion for sublingual allergy immunotherapy Vectura, after reinventing itself as a CDMO, accepts $1.4B buyout offer from Carlyle Featured Story | By Nick Paul Taylor A phase 3 clinical trial of Eyenovia’s MicroLine in patients with age-related long-sightedness has hit its primary endpoint. The formulation has the same active ingredient, pilocarpine, as a near-approval Allergan drug but is administered via a dispenser designed to improve on conventional eyedroppers. read more |
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Top Stories By Nick Paul Taylor Acer Therapeutics is set to file for FDA approval of a taste-masked sodium phenylbutyrate product after meeting with the agency to discuss its data. The product is designed to eliminate a cause of non-compliance with existing treatments for urea cycle disorders such as Horizon’s Buphenyl. read more By Nick Paul Taylor Phillips-Medisize has introduced a digital drug delivery device designed to reduce the environmental impact of autoinjectors. The product, the Aria Smart Autoinjector, consists of a reusable drive and disposable cassette that Phillips-Medisize claims can reduce waste by up to 50%. read more By Nick Paul Taylor Stallergenes Greer took a big step toward providing its sublingual house dust mite immunotherapy tablet to the European market. The positive outcome of the decentralized registration procedure sets Stallergenes Greer up to challenge ALK for the European market. read more By Fraiser Kansteiner For years, Vectura had been on its own treatments for asthma and chronic obstructive pulmonary disease until a series of setbacks prompted a change in course. Vectura pivoted to become a CDMO for inhaled medicines and is now at the center of a $1.4 billion buyout offer. read more Resources Sponsored by: Clinical Ink For faster deployment, improved patient engagement, and better-quality data — go where your patients are. GO BYOD with Lunexis™ from Clinical Ink. Sponsored by: BBK Worldwide Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning the barriers to participation and the strategies to overcome them. Sponsored by: Thermo Fisher Scientific Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Optimized automation of certain steps of the workflow may decrease hands-on time and the cost of the cell manufacturing process. Sponsored By: Veeva Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials. Sponsored By: Veeva One top 10 pharma outlines three key steps to launching a modular content strategy to generate localized content faster. Sponsored By: Blue Matter This 77-page e-book explores 7 keys to success that any biopharma company needs to keep in mind as it enters Europe. Sponsored By: AmerisourceBergen Developing a quality product and getting it approved for distribution is not enough to guarantee commercial success. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored By: August Bioservices How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond? 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. Next Gen: What’s beyond the leading edge of biotech and pharma? June 22-23, 2021 | Virtual Event | 