Featured Story By Nick Paul Taylor Ultralong-acting regimens and home administration could rapidly shift the HIV market away from daily orals as the sector enters its “last cycle of innovation,” according to physicians surveyed by analysts at Jefferies. read more |
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| Webinar: Comparing the FDA, EMA & PMDA In Vitro DDI Guidance Thursday, April 14, 2022 | 11am ET / 8am PT In January 2020, the FDA published its final guidance for industry on in vitro drug-drug interaction (DDI) studies. Dr. Taylor will offer his expert perspectives on major changes, challenges and impacts to development strategies that resulted, compare it with the current EMA and PMDA in vitro guidance documents and discuss how to harmonize your drug development strategies to meet the expectations of all three. Register Now! |
Top Stories By Nick Paul Taylor HMNC Brain Health and Develco Pharma are forging ahead with development of oral prolonged-release ketamine after seeing a “positive trend” in treatment-resistant depression, with a midphase study slated to start in the second quarter. read more By Nick Paul Taylor Nobelpharma America has become the first company to win FDA approval for a topical treatment for facial angiofibroma associated with tuberous sclerosis complex (TSC). The approval covers a topical gel formulation of sirolimus, a mTOR inhibitor also known as rapamycin. read more By Nick Paul Taylor Genprex has begun testing a drug candidate based on its systemic gene therapy delivery platform in combination with Merck’s Keytruda. The phase 1/2 clinical trial marks the start of Genprex’s effort to determine whether a delivery system based on opposing electrical charges can help improve the efficacy of the checkpoint inhibitor in patients with late-stage non-small cell lung cancer. read more By Kevin Dunleavy Antares and development partner Lipocine have gained FDA approval for Tlando, an oral testosterone replacement therapy for hypogonadism. The twice-daily oral drug is an alternative to Antares' Xyosted, a weekly injected TRT, which has been on the market for four years. read more Resources Sponsored by: Blue Matter, strategic consultants in the life sciences What’s in store for the oncology market in 2022 and beyond? This paper looks at 5 trends driving the market. Sponsored by: Thermo Fisher Scientific Learn how to position quality as a central component within your raw material sourcing strategies for the chemicals used throughout your workflows. Download the free whitepaper from Thermo Fisher Scientific. Sponsored by: Medidata, a Dassault Systèmes company The landscape of clinical trials has been permanently changed. Today's trials require sponsors to modernize their use of technology and data to adapt. This eBook provides an overview of how sponsors can empower trials with real-time performance data to improve study integrity, reduce risks, optimize patient safety, and increase trial success rates. Sponsored by: Thermo Fisher Scientific Learn how to navigate the top manufacturing challenges and achieve a seamless transition from discovery to clinical manufacturing across the CAR T-cell therapy workflow. Sponsored by: Oracle Health Sciences Learn about ways to break down regulatory roadblocks and get closer to 100% clarity on regulatory positions to advance decentralized clinical trials in research. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? 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: WIRB-Copernicus Group Sites receiving augmentation support enroll more than 30,000 patients in just over three months. See how additional site resources can make a difference. Sponsored by: Thermo Fisher Scientific Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific Drug Development Boot Camp® HYBRID and VIRTUAL in real time November 16-17, 2022 Fierce Medical Affairs Strategic Summit (MASS) East April 12-14, 2022 | New Brunswick, NJ Fierce Promotional Review Committee Compliance and Best Practices Summit April 12-14, 2022 | New Brunswick, NJ Accelerating Immuno-Oncology and Oncology Drug Development Using Humanized Mice Thursday, April 21, 2022 | 12pm ET / 9am PT Fierce Trial Master File Summit May 2-4, 2022 | New Orleans, LA & Streaming Live Fierce Leaders in Life Sciences Forum May 24, 2022 | Free Virtual Event Fierce Digital Pharma Engage June 14-15, 2022 | Huntington Beach, CA Fierce Digital Pharma Innovation Week June 21-23, 2022 | Free Virtual Event Fierce Pharma PR & Communications Summit July 19-20, 2022 | Jersey City, NJ Promotional Review Committee Compliance and Best Practices Summit West (PRC West) September 2022 | San Diego, CA Fierce Health Payer Summit October 12, 2022 | Free Virtual Event Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Fierce Pharma Marketing Awards October 19, 2022 | Philadelphia, PA Fierce Biotech Cell & Gene Therapy Forum October 19, 2022 | Virtual Event Drug Development Boot Camp® HYBRID/VIRTUAL November 16-17, 2022 Fierce New Product Planning Summit November 30 - December 1, 2022 | Boston, MA Fierce Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Virtual Event Fierce JPM Week 2023 January 2023 | San Francisco, CA & Virtual |