The UK regulator has clarified its guidance on the use of the anticancer Avastin for age-related macular degeneration, saying that reformulating the drug into small vials for ophthalmic injection represents an off-label use of the Roche product and does not create an unlicensed medicine.
The UK regulatory agency, the MHRA, has changed its advice on the use of Roche’s Avastin (bevacizumab) in the unapproved indication of age-related macular degeneration (AMD) at the request of the High Court, which last year rejected attempts by Novartis and Bayer to stop Avastin being used for the degenerative eye condition in the UK.
The agency now says that if a health professional prescribes or uses Avastin for AMD after it has been compounded...
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
Despite pushback by industry, the government is standing by its new statutory scheme rebate rates for branded medicines, including one that doubles the rate that companies must repay on the sales of newer products to the National Health Service to 31.3%.
The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.
The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.
The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.
The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
