GlaxoSmithKline CEO Andrew Witty has said moving the European Medicines Agency (EMA) from London will cause “tremendous disruption.”
Witty is worried moving the EMA and its 900 staff from London to another European city post-Brexit will cause upheaval that affects the smooth running of the regulatory machinery.
The fate of EMA is one of many questions raised by the United Kingdom’s vote to leave the European Union. Politicians across Europe are lobbying for EMA to move to their country once the U.K. leaves the EU. And, faced with threats that foreign biopharma investment will fall if EMA leaves London, the U.K. is also pushing to retain the headquarters of the regulator even as it plans to sever its links to the EU.
Witty, like other pharma execs with major U.K. operations, wants EMA to stay in London. To make the case, Witty has branched out beyond the links between EMA and the U.K. regulator that others have played up. The CEO chose instead to focus on the best outcome for patients, which also happens to be his preferred result from a business perspective.
“A lot of staff are going to have to change positions,” Witty told Bloomberg Television. “Those who don’t leave have to relocate. This is a regulator who is keeping an eye on the health and safety of hundreds of millions of Europeans. You don’t want them with their eye off the ball.”
There is evidence the uncertainty created by Brexit is already affecting EMA. Talking to European politicians earlier this month, EMA Executive Director Guido Rasi said good candidates for jobs at the agency are withdrawing their applications, Regulatory Focus reports. Six employees resigned in the month following the Brexit vote. Rasi wants additional measures to support staff.
The uncertainty is likely to continue for some time. When asked about how the U.K. will handle drug approvals and other regulatory tasks post-Brexit, the politicians in charge of managing the process have given a range of noncommittal answers.
Some government politicians have proposed a Norway-style relationship that keeps the U.K. in the EU regulatory network. Others have shown a willingness to make a clean split. A middle-ground that sees the U.K. standardize its approval process with the EU in an attempt to avoid becoming a lower-priority market for drugmakers is also on the cards.
By Nick Paul Taylor
Source: Fierce Biotech
Novartis will acquire Mariana’s lead candidate MC-339, a radioligand therapy (RLT) designed to target small-cell lung cancer. Last year, Mariana had raised $175m in a Series B round from several funds and pharma giant Eli Lilly.
The company’s aspiration to expand the use of its obesity products to cardiovascular indications has been successful. In March, its blockbuster drug Wegovy was approved by the US Food and Drug Administration (FDA) for reducing the risk of cardiovascular diseases in obese or overweight adults.
Massachusetts-based Deciphera brings to the table an extensive kinase inhibitor pipeline, kinase drug discovery expertise, and a strong commercial and sales platform in the US and European markets that is meant to advance Ono’s capabilities and presence in the oncology space.
