| Discover how the development of orphan drugs to treat rare diseases has become an industry priority. Download today!
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This Week Sep 14, 2022 Glaukos has reported wins in a pair of late-phase clinical trials, teeing it up to seek FDA approval of its travoprost intraocular implant next year. The studies found the implant was noninferior to the active control. Otsuka and Lundbeck are ahead of Glaukos in the queue at the FDA, having secured acceptance for a filing for approval of their two-month, ready-to-use, long-acting injectable treatment for schizophrenia and bipolar I disorder. The PDUFA date is April 27. Elsewhere, researchers found asthma patients who use Teva Pharmaceutical’s Digihaler System are more likely to improve control of their condition than their counterparts who use standard-of-care albuterol inhalers. Featured | | By Nick Paul Taylor Glaukos has reported wins in a pair of late-phase clinical trials, teeing it up to seek FDA approval of its travoprost intraocular implant next year. The studies found the implant was non-inferior to the active control, twice-daily topical timolol ophthalmic solution, in glaucoma and ocular hypertension patients. |
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Top Stories | Read more on low-volume drugs, commercial packaging and supply challenges, and potential solutions. Download today!
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| | By Zoey Becker,Kevin Dunleavy,Fraiser Kansteiner,Angus Liu |
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Fierce podcasts Don't miss an episode | | 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. |
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| Monday, September 26, 2022 | 11am ET / 8am PT In this webinar Cambrex wil discuss how their facility and the Cambrex network are evolving to enhance capabilities and accelerate API development. Register now.
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Resources Whitepaper Supporting your product development programme through experience, expertise, and efficiency. Sponsored by: Almac Pharma Services eBook Improve patient engagement, adherence, and outcomes Sponsored by: Health Catalyst Webinar Understand HCP specialists’ channel habits, preferences, and common themes regardless of speciality. Our syndicated HCP engagement offering, Engage, informs which channels are offering value across the board and where differences lie, so you can target your audience with the optimal channel mix. Sponsored by: Sarah Brown, Commercial Research Lead, Lumanity Video Can an optimized research process--including AI-powered workflow and process automation tools--help get breakthrough drugs to market faster? Sponsored by: Proscia Video Learn how a centralized platform for pathology images, metadata, and analysis results can connect previously siloed research initiatives and advance our collective understanding of tissue. Sponsored by: Proscia eBook Improve your congress competitive intelligence and cut down costs by 50% Sponsored by: Ferma.AI, a Product of ZoomRx Whitepaper What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent Research Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent Whitepaper How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Executive Summary How a new app brings the power of CRM to a leading lab instruments provider’s field service engineers Sponsored by: Cognizant Webinar Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics Whitepaper 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 Biologics Custom Resource Center 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: JLL Whitepaper How can we predict the ability of a preclinical drug to inadvertently cause or intentionally inhibit cytokine secretion and T cell activation Sponsored by: ReachBio | The Cell Biology Experts™ eBook Could cloud be the cure for your EHR headaches? See our infographic on how moving to the cloud can slash financial and administrative burdens. Sponsored by: NetApp Whitepaper 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: DocuSign Research Learn how a private health insurance company uses analytics to deliver exceptional service to its employees and members Sponsored by: Genpact eBook Improve your congress competitive intelligence and cut down costs by 50% Sponsored by: Ferma.AI, a Product of ZoomRx Whitepaper Clarus Therapeutics (Clarus) is a men’s specialty pharmaceutical company that partnered with Catalent to develop a unique and convenient drug delivery form for their hormone replacement therapy. Sponsored by: Catalent Whitepaper 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: Catalent Whitepaper 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: Blue Matter, strategic consultants in the life sciences Whitepaper Explore how Thermo Scientific’s Process Liquid Preparation Services can help you plan for scalable buffer preparation. Sponsored by: Thermo Fisher Scientific Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored by: Catalent eBook Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored by: Catalent Whitepaper 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 Research TwinRCTs require fewer patients and shorten trial timelines for rare neurodegenerative diseases. Sponsored by: Unlearn AI Industry Events European Healthcare Compliance Certificate Program Septemeber 19-23, 2022 Universe of Pre-Filled Syringes and Injection Devices Conference October 18-19, 2022 | Palm Springs, CA 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 | 