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NHS England launches country-wide cancer vaccine trials

Drug Discovery World

Thousands of cancer patients in England are set to gain fast-tracked access to trials of mRNA personalised cancer vaccines following the launch of an NHS trial ‘matchmaking’ service to help find new life-saving treatments.

Vaccine 147
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Europe: Where is the drug discovery innovation?

Drug Discovery World

billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1. The city is host to many innovative biotech companies, including relative newcomers Orexa, a company that recently launched its first Phase II clinical trial.

Drugs 147
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How to advance AAV-based gene therapies

Drug Discovery World

4 Unfortunately, many AAV-based gene therapies fail during clinical trials, despite them appearing safe and efficacious in preclinical studies. For example, researchers may find that an AAV vector-based gene therapy displays excellent transduction efficiency in a preclinical model, only to see the efficiency drop in clinical trials.

Therapies 162
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Article Periodic Thank You France reintroduces pesticide plan, this time with EU indicator

Agency IQ

BY RAYAN BHARGAVA, MSC | MAY 9, 2024 11:03 PM CDT Regulatory background Until recently, the EU had plans to halve pesticide reduction by 2030. The proposal for a regulation on the sustainable use of pesticides (SUR), however, died in European Parliament in November 2023. Much financial weight is thrown behind Ecophyto 2030.

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Power to the Patient with Patient Generated Health Data

FDA Law Blog: Biosimilars

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

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Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

Vial

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. billion by 2030 at a compound annual growth rate (CAGR) of 7.5% between 2024 and 2030.

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Overcoming diverging regulatory expectations to bring CGTs to market

Drug Discovery World

By 2030, it’s expected to more than double, to $34.3 For instance, in a trial where patients are selected based on a specific human leukocyte antigen (HLA) type, the FDA requires the use of a fully certified, FDA approved Companion Diagnostic. Driven by the rapid pace of innovation, the market for CGTs is expected to grow from $4.4

Marketing 130