Development Drug Trials Marketing Regulation 
Drug Discovery World
NOVEMBER 3, 2023
New UK therapy option for hard-to-treat lymphoma The MHRA has granted conditional marketing authorisation for Abbvie’s Tepkinly (epcoritamab) as a bispecific treatment for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
Advarra
MARCH 21, 2023
Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?
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pharmaphorum
DECEMBER 1, 2022
Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine. About the author.
pharmaphorum
AUGUST 4, 2020
Several factors make it difficult for HTA bodies often to assess orphan drugs, including a lack of robust trial data due to difficulties in finding patients, the absence of randomised controlled trials, the use of surrogate endpoints, and the lack of active drug comparators. Source: CRA Analysis.
Delveinsight
AUGUST 12, 2021
LQTT has a portfolio of in-licensed compounds from Sanofi that prohibit serum/glucocorticoid-regulated kinase 1, or SGK1. That kinase plays a role in inappropriate sodium regulation, a hallmark of arrhythmias like Long QT Syndrome. The original agreement had Finch responsible for early-stage development through phase 2 studies.
The Pharma Data
MAY 17, 2021
Regeneron resumes enrollment in lymphoma drug trials ( Reuters ). Incyte’s vitiligo treatment meets main goal in late-stage trial ( Reuters ). China backs developing countries’ call to waive IP rights on COVID-19 vaccines ( Reuters ). Now they fear an increase.
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