Europe – EMA recommendation paper: Safety, data integrity key to decentralized trial conduct
The European Medicines Agency (EMA), European Commission (EC), and Heads of Medicines Agencies (HMA) recently acknowledged the growing role of decentralized elements in the...
UK – Bristol Myers Squibb’s Opdivo recommended by NICE for rare gastroesophageal cancers
Specifically, NICE’s recommendation is extended to patients with untreated HER2-negative, advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma if the tumours express PD-L1...
International – WHO proposes updated excipient GMPs in wake of contaminated cough syrup
The World Health Organization (WHO) recently proposed updated guidance to assist pharmaceutical manufacturers in assessing the quality of excipients after child deaths were reported...
UK – AstraZeneca’s heart failure treatment recommended by NICE for expanded use
Forxiga, sold as Farxiga in certain markets, has previously been recommended by NICE as a treatment option for HF patients with reduced ejection fraction...
USA – FDA finalizes guidance on considerations for evaluating drug’s benefits and risks
The US Food and Drug Administration (FDA) has finalized guidance that clarifies how the benefits and risks of a drug or biologic factored into...
USA – CBER chief on remote work, CRISPR-Cas9, and rare disease gene therapy accelerated...
The use of CRISPR-Cas9 gene editing technology has potential to transform the field of gene therapy through its simple and cost-effective delivery mechanism, said...
UK – Digital cognitive behaviour therapies recommended by NICE across the NHS
The National Institute for Health and Care Excellence (NICE) has conditionally recommended digital cognitive behaviour therapies (CBT) for use in the NHS. It is...
Europe – EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine
EMA’s human medicines committee (CHMP) has recommended authorising the COVID-19 vaccine VidPrevtyn Beta as a booster in adults previously vaccinated with an mRNA or...
International – ICH advances guidelines on selective reporting of safety data, viral safety
The International Council for Harmonisation (ICH) recently announced the adoption of its E19 guideline, which outlines a risk-based approach for collecting safety data for...
USA – Industry experts tout potential for master protocols in pediatric clinical trials
Using master protocols in pediatric clinical trials could speed the development of drugs for pediatric indications that already have development programs for adults, according...
