FDA approves Chimerix's oral suspension smallpox antiviral, giving treatment option to dysphagic patients Noveome posts clinical data on nose-to-brain delivery device LianBio bags Chinese rights to Lyra's nasal implantable matrix PharmaTher, TSRL ally to create microneedle patches to deliver psychedelics and antivirals Regeneron leaps ahead in COVID-19 antibody race, scoring FDA nod for lower dose and subcutaneous injection Featured Story | By Nick Paul Taylor Chimerix has received FDA approval for tablet and oral suspension formulations of its smallpox drug Tembexa. The approval makes Tembexa the first smallpox antiviral authorized for use in infants and people who have difficulty swallowing. read more |
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Top Stories By Nick Paul Taylor Noveome Biotherapeutics has presented phase 1 data on its nasally delivered glaucoma candidate ST266. The safety and tolerability data tee Noveome up to advance into efficacy clinical trials in a range of neurological and ophthalmological indications. read more By Nick Paul Taylor LianBio has licensed exclusive rights to Lyra Therapeutics’ nasally administered treatment for chronic rhinosinusitis (CRS) in China and other Asian markets. Lyra is receiving $12 million upfront in return for the regional rights to the clinical-phase, mometasone furoate-eluting implantable matrix. read more By Nick Paul Taylor PharmaTher and TSRL have teamed up to co-develop microneedle patches. The collaboration sets the partners up to pool resources to create intradermal delivery devices for use in their respective therapeutic areas of focus. read more By Kevin Dunleavy The FDA has adjusted its emergency use authorization for Regeneron's COVID-19 antibody cocktail, allowing it to be administered in a smaller dose and by subcutaneous injection. The action gives the company another leg up in its antibody battle with Eli Lilly. 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: 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 | 