The UK would remain subject to EMA regulations during a "transition period" to minimize drug supply disruptions, drawing industry praise. But a trade group was also concerned that a draft political declaration could jeopardize drug safety.
The Fitch Solutions report, released this week, notes that the number of clinical trials taking place in the UK has already fallen more than 25 percent.
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
With a positive CHMP decision, the European Commission is expected to rule in two months, but equity research analysts foresee significant headwinds for the gene therapy.
Negotiations with country-level reimbursement authorities will follow. The UK's NICE turned down Gilead's Yescarta Tuesday.
European Medicines Agency faces greater loss of staff than anticipated, forcing it to scale back or suspend some activities.
The decision comes at a time of regulatory upheaval in the European Union.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
North Carolina biotech company Talecris Biotherapeutics has received an orphan drug designation in Europe for a blood clot treatment under development. Talecris is developing Plasmin to treat acute peripheral arterial occlusion.
An experimental epilepsy drug co-developed by GlaxoSmithKline has received a recommendation for market approval in Europe. But the drug maker still needs to address Food and Drug Administration concerns before it can get U.S. approval.
GlaxoSmithKline's Avandia problems are resulting in the company setting aside $3.4 billion to pay for legal costs related to its former diabetes drug, which has been linked to greater cardiovascular risks. Though the drug is now scarce in the European and U.S. markets thanks to greater regulatory scrutiny, GSK faces mounting expenses as Avandia legal claims continue to be filed.