Industry

DUBLIN–(BUSINESS WIRE)–The “21 CFR Part 11, FDA’s Guidance for Electronic Records and Electronic Signatures” webinar has been added to ResearchAndMarkets.com’s offering. This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch … [Read more…]

DUBLIN–(BUSINESS WIRE)–The “Overview of the Financial Aspects of Clinical Research” webinar has been added to ResearchAndMarkets.com’s offering. Leveraging case studies and federal regulations, attendees will learn about the phases of a clinical research study, an overview of Medicare billing guidelines and developing study budgets. Individuals supporting the financial aspects of a clinical research study must … [Read more…]

DUBLIN–(BUSINESS WIRE)–The “Troubleshooting Dissolution Methods for Solid Oral Dosage Forms” webinar has been added to ResearchAndMarkets.com’s offering. By attending this webinar, you will learn how to approach dissolution OOS/OOT investigations in a systematic, rigorous manner. Pharmaceutical dissolution testing for solid oral dosage forms is a complex analytical procedure where the control of critical variables (environmental … [Read more…]

DUBLIN–(BUSINESS WIRE)–The “Validation Sampling Plans” webinar has been added to ResearchAndMarkets.com’s offering. This webinar will discuss methods for setting up sampling plans depending on the risk profile of the final product or production step. It will go into using the sampling plan to set statistically justified acceptance criteria for the validation. All companies in the … [Read more…]

BAAR, Switzerland–(BUSINESS WIRE)–Stallergenes Greer, a global healthcare company specialising in allergen immunotherapy (AIT), today announced positive data from its EfficAPSI real-world study. Presented at the 2022 European Academy of Allergy and Clinical Immunology (EAACI) congress in Prague (Czech Republic), the real-world study confirmed significant benefit of sublingual liquid allergen immunotherapy treatment (AIT) on the onset … [Read more…]

–Phase 2 trial showed chemotherapy-free TUKYSA combination resulted in clinically meaningful and durable tumor responses– –Results presented in late-breaking oral session at the ESMO World Congress on Gastrointestinal Cancer– BOTHELL, Wash.–(BUSINESS WIRE)–Seagen Inc. (Nasdaq:SGEN) today announced full results from the pivotal phase 2 MOUNTAINEER trial, which showed TUKYSA® (tucatinib) in combination with trastuzumab was well-tolerated … [Read more…]

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Scholar Rock (NASDAQ: SRRK), a Phase 3, clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today announced an e-poster presentation by Thomas Crawford, M.D., on the design of the company’s ongoing SAPPHIRE Phase 3 clinical trial in spinal muscular atrophy (SMA) at … [Read more…]

DUBLIN–(BUSINESS WIRE)–The “Good Documentation Practices” webinar has been added to ResearchAndMarkets.com’s offering. “Good Documentation Practices” is a “current” industry practice that is reviewed and cited by federal regulators when audited. Pharmaceutical/Biological documents are legal documents that are controlled by all regulatory agencies. The person or persons responsible for filling out these documents accepts the consequences … [Read more…]

DUBLIN–(BUSINESS WIRE)–The “Regulatory Affairs Outsourcing Market – Global Outlook and Forecast 2022-2027” report has been added to ResearchAndMarkets.com’s offering. The following factors will drive the global regulatory affairs outsourcing market growth during the forecast period: Increasing Use of Digital Platforms/Solutions in Regulatory Affairs Changing Regulatory Landscape Rising Demand For Fast Drug & Medical Device Approvals … [Read more…]

DUBLIN–(BUSINESS WIRE)–The “Branded Generics Market Research Report by Product (Trade Named Generics and Value-Added), Application, Distribution Channel, State – United States Forecast to 2027 – Cumulative Impact of COVID-19” report has been added to ResearchAndMarkets.com’s offering. The United States Branded Generics Market size was estimated at USD 64.00 million in 2021, USD 77.90 million in … [Read more…]