Featured Story By Nick Paul Taylor Johnson & Johnson has filed for European approval of a six-month injectable version of its schizophrenia drug Invega. J&J is seeking approval for the longer-acting injectable on the strength of data showing it is as effective as the existing three-month formulation. read more |
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Top Stories By Nick Paul Taylor Shape Therapeutics has unveiled a capsid discovery platform designed to improve the delivery and safety of gene therapies. The platform is designed to generate adeno-associated virus (AAV) vectors that home in on specific tissues, thereby enabling gene therapy developers to achieve the desired effect without causing intolerable toxicity. read more By Nick Paul Taylor The FDA has accepted Toralgen’s polybile nanopill into its Emerging Technology Program. Getting into the program sets Toralgen up to meet with the FDA’s emerging technology team to resolve potential technical and regulatory issues that could slow the progress of its nanopill. read more By Nick Paul Taylor Lexaria Bioscience has released preclinical data on technology intended to enhance oral delivery of antiviral drugs. The data cover the use of application of DehydraTECH to HIV drugs, but Lexaria is also exploring its use in the enhancement of antivirals against the pandemic coronavirus. read more By Carly Helfand With Sanofi’s Sarclisa hitting multiple myeloma star Darzalex with its first in-class competition, Johnson & Johnson is working to convert patients to a newer, more convenient subcutaneous version of the med. And some new data just gave that mission a boost. read more By Kyle Blankenship Given the enormous manufacturing challenges posed by COVID-19, big biopharma players have increasingly leaned on contract manufacturers to help out. In anticipation of what could be multiple successful COVID-19 vaccines in the near future, Fierce Pharma has assembled its list of the top 10 contract manufacturers in the fight against COVID-19. read more Resources Sponsored by: ZS Learn how Aerie fueled their product launches with advanced analytics. 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Sponsored by: Catalent Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. Sponsored by: Catalent This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success. Sponsored by: Catalent In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Catalent Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. |