| | Exclusive Orphan Drugs Industry Survey Results In a survey of nearly 600 respondents, Catalent explored the driving forces & challenges across the orphan drug development and commercialization phases. To learn more about motivations that inspire researchers, how partnerships can play a role in orphan drug development and more, read the survey! |
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United Therapeutics lands blow in inhaled drug patent dispute, pushing back approval of generic rival Targeting $500M opportunity, Amneal files for FDA approval of extended-release Parkinson's prospect Futura's topical erectile dysfunction therapy hits phase 3 goal, igniting race to FDA After buying in candidate, Mannkind wraps up phase 1 trial of inhaled lung infection prospect 'The Top Line': Depth in the Alzheimer's pipeline, the staying power of 2012's Fierce 15 honorees and more Featured Story | By Nick Paul Taylor United Therapeutics has struck a blow to Liquidia Technologies’ generic formulation of Tyvaso. With a court ruling the generic infringes a United patent, Liquidia faces the prospect of being kept off the market until 2027—unless it gets the decision overturned or prevails in a related dispute. read more |
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Top Stories By Nick Paul Taylor Amneal Pharmaceuticals has filed for FDA approval of an extended-release Parkinson’s disease prospect that is tipped to deliver peak U.S. sales of up to $500 million. With Amneal hitting its third quarter filing goal, the company is on track to bring the therapy to market around the middle of next year. read more By Nick Paul Taylor Futura Medical has reported phase 3 data on its topical erectile dysfunction treatment MED3000, teeing it up to file for FDA approval of the therapy as an over-the-counter medicine by the end of the month. read more By Nick Paul Taylor MannKind has wrapped up a phase 1 clinical trial of an inhaled formulation of clofazimine, teeing it up to talk to the FDA about advancing the candidate as a treatment for bacterial lung infections. read more By Querida Anderson This week on "The Top Line," we discuss just how deep—and broad—the Alzheimer’s pipeline is despite major players dominating the headlines. We also chat about our research into the 2012 class of Fierce 15 and where those biotechs are now. read more Resources How a new app brings the power of CRM to a leading lab instruments provider’s field service engineers Learn how a private health insurance company uses analytics to deliver exceptional service to its employees and members Sponsored by: ReachBio | The Cell Biology Expertsᵀᴹ How can we predict the ability of a preclinical drug to inadvertently cause or intentionally inhibit cytokine secretion and T cell activation Sponsored by: DocuSign Today’s healthcare systems are adapting to an ever changing landscape with declining margins, M&A pressures, and the need for staff flexibility due to shortages. Read our whitepaper and dive into the way healthcare providers can digitally transform day-to-day work by streamlining costs and increasing agility by removing manual paper burdens. Sponsored by: Blue Matter, strategic consultants in the life sciences This paper explores how Medical Affairs is increasingly playing a key leadership role in evidence planning and generation (part 3 in a series). Sponsored by: Unlearn TwinRCTs require fewer patients and shorten trial timelines for rare neurodegenerative diseases. Sponsored by: Ferma.AI, a Product of ZoomRx Improve your congress competitive intelligence and cut down costs by 50% Sponsored by: Catalent Learn more about how the transition from early to late phase of a small molecule program plays a pivotal role in a program’s ultimate success. Sponsored by: Thermo Fisher Scientific Set a solid foundation for successful scale-up of buffer preparation. Sponsored by: JLL Read through this library of resources to find out how you can strengthen innovation and efficiency, improve safety and quality, and prioritize resources to support your long-term goals. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Carla Vozone discusses the significant trends in the OINDP segment including large molecules and novel indications, changes within CDMOs and various challenges facing the industry. Sponsored by: Catalent Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Events European Healthcare Compliance Certificate Program Septemeber 19-23, 2022 Promotional Review Committee Compliance and Best Practices Summit West (PRC West) September 20-22, 2022 | San Diego, CA Fierce New Product Planning Summit September 19-20, 2022 | Boston, MA Medical Affairs Strategic Summit West (MASS West) September 20-22, 2022 | San Diego, CA Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Good Clinical Practice Summit (GCP): Part of the Fierce Clinical Collective October 24-26, 2022 | Philadelphia, PA | Presented by Fierce Pharma Clinical Quality Oversight Forum: Part of the Fierce Clinical Collective Oct 24-26, 2022 | Philadelphia PA | Presented by: Fierce Pharma Decentralized Clinical Trials Summit: Part of the Fierce Clinical Collective Oct 24-26, 2022 | Philadelphia, PA | Presented by: Fierce Pharma Fierce European Trial Master File Summit November 14-16, 2022 | London, UK Drug Development Boot Camp® 2022 November 16-17, 2022 Fierce Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Free Virtual Event | 