In this week’s news, Ireland hikes review fear, Delpharm bids for Famar sites and more…
Ireland’s drug regulator to hike fees citing Brexit-related costs
Ireland’s Health Products Regulatory Authority (HPRA) has said it will hike fees, citing challenges like Brexit as the basis for the increase.
The Irish regulator announced the move last week, explaining it will raise fees for reviews and other work involving human medicines, blood, tissue and organs and medical devices 3% next year.
It also plans to roll out new fees, one of which will be charge of up to €15,450 for mutual recognition procedures applied for within six months of a national procedure ending.
The HPRA wrote, “2019 has been a challenging year for both the HPRA and the industry. Brexit has brought considerable uncertainty to the regulatory framework and both industry and the HPRA have expanded their resources in preparation for Brexit.
“While there has been some increase in regulatory activity, it is primarily related to Brexit (transfers and manufacturing variations) undertaking UK RMS roles and changes from the falsified medicines directive.”
Delpharm bids for five Famar facilities
Delpharm is in talks to buy manufacturing plants from fellow contract manufacturing firm Famar.
The other two locations involved are a plant in Pointe-Claire in Quebec, Canada and a facility in Bladel in the Netherlands.
According to Contract Pharma, the five manufacturing sites generate turnover of €250m a year and have a combined workforce of more than 1,300 employees.
US FDA’s generic competition plan yet to take effect
US FDA efforts to stimulate competition in the generics sector are yet to have an impact according to research reporting in the Journal of the American Medical Association.
The study – available here – looked at the impact of agency programmes designed to encourage the generics sector to develop products lacking non-branded alternatives.
The results suggests little progress has been made to date. The FDA approved 1832 ANDAs between July 2016 and December 2018. Around 20% of the products were found to have limited competition – defined as when there are two or fewer manufacturers making the same product.
Despite this the researchers are upbeat about the FDA’s plan.
They wrote “Although our results suggest that there have not yet been noticeable effects of the FDA’s initiatives to expand approvals for generic drugs at risk for price spikes and shortages, ANDAs take time for the manufacturer to prepare and then another 6 to 12 months for regulatory review.”
Also in the news
Measles cases are increasing at an “alarming” rate according to the WHO. According to a Reuters, the WHO has ascribed the disease’s resurgence to gaps in vaccination programmes.
US Industry group PHrMA has shared details of members’ efforts to develop treatments for mental illness. According to the report 138 candidate treatments are in development.
Nature covered trends in new drug approvals in the third quarter of the year in a paper published last week.
Some developments of note in the CDMO space
Avid Biosciences has completed work on its process development lab in Orange County, California. See press release.
Alcami has rolled out a sterility testing service. See press release.
Lonza will develop and manufacture Prevail Therapeutics’ portfolio of AAV9 gene therapies for neurodegenerative diseases. See press release.