n this week’s pharma news, drug firms demand answers from Brexit negotiators, EMA says it will increase fees, Novartis mulls virtual trials, FDA lauds cell culture flu vaccines and more…
Industry warns Brexit negotiators to safeguard supply chains and patients
European drug firms have sent EU and UK Brexit negotiators a list of “unanswered questions” and warned that time is running out to safeguard patient interests.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) raised its concerns about Brexit last Thursday, calling on negotiators to prioritise patient safety and public health in talks due to start this month.
The questions cover a range of issues, including several related to how the UK’s withdrawal from the EU will impact drug supply lines.
EFPIA made the announcement the same day that European Council President Donald Tusk said the UK needed to solve how Brexit will impact the border between Norther Ireland and Ireland before negotiations can continue.
Earlier in the month, Prime Minister Theresa May suggested the UK could continue its membership of certain EU agencies, including the EMA.
EMA to increase review fees from April
The EMA has said it will increase what it charges pharmaceutical firms for the majority of its services from next month.
The currently London-based regulatory agency said it will raise fees for drug submissions and reviews by 1.7%, adding that it will publish specific details later this month.
The only services not impacted by the increase will be the EMA’s pharmacovigilance activities.
Novartis to run 10 remote clinical trials with Science 37 tech
Novartis has teamed up with US communications tech firm Science 37 to run so called “remote” clinical trials.
The Swiss drug manufacturer announced the plan last week, explaining it will use Science 37’s mobile technology to allow people to take part in studies from home rather than clinics.
Novartis said the idea is to boost participation and accelerate recruitment, adding that it will use the technology for 10 studies.
Cell culture flu vaccine out performs shot made in hens eggs
Early data suggests an influenza vaccine made in cell culture is more effective than vaccines made in hens eggs according to US FDA Commissioner Scott Gottlieb.
Gottlieb made the announcement during a meeting of the US House of Representatives’ Committee on Energy on Commerce Last Thursday.
He later told Stat the cell-based vaccine – called Flucelvax – is around 20 percent more effective.
Gottlieb explained, “Cell-based and recombinant protein influenza vaccines provide alternatives to the traditional egg-based process of manufacturing, and provide the potential for a faster vaccine manufacturing process.”
Also in the news
The Australian Therapeutic Goods Administration (TGA) has updated its guidelines on clinical trials. Read more here.
Martin Shkreli, the exec whose decision to hike the price of a drug used to treat infections in HIV patients prompted condemnation, has been sentenced to seven years in prison for securities fraud. Get more from Fiercepharma.
Pfizer’s contracting arm – Pfizer CentreOne – has launched a progesterone API made using processes that have a significantly smaller carbon footprint than traditional production methods.