Japan and Ireland have a history of mutual investment and medicine exchange, and an upcoming merger could be the latest and greatest chapter. Osaka-based Takeda announced in May that it would acquire the Dublin-based Shire for $62B, and it looks like its last regulatory hurdle with the EU will be cleared. Unlike these hurdles. Officials are slightly concerned about an IND in Shire’s pipeline that could treat Crohn’s Disease, which would overlap with Takeda’s biggest selling drug Entyvio. But Takeda’s happy to lose that investigational drug if it means closing the deal. After all, the new company would instantly become a global top 10 drugmaker. Keep your head on a swivel though, a few Takeda investors are still against the deal, citing the considerable debt Takeda will have to take on to make the purchase.
PM Theresa May wants the UK to remain in the European Medicines Agency post-Brexit. She’s essentially arguing that allowing the UK to contribute will be beneficial due to the nation’s prestigious universities and its regulatory body which assesses more medicines than any EU member. Staying in would mean UK patients get faster access to newly approved EMA medicines. But being part of the agency would mean following its rules, paying dues, and possibly being subject to its legal authority via the European Court of Justice instead of national UK courts. That’s a big no-no for May and pro-Brexit factions in the UK, so they’re trying to avoid that part of the deal. British biopharma is behind May’s stance—they still want some cake from this Great British Break Off.
Apparently, pharma companies, CROs, and universities will have new EU privacy rules to contend with in about eight months. Great. The EU’s General Data Protection Regulation (GDPR) applies to all types of data, but it will have a special impact on clinical trials. According to Debra Diener, an attorney and Certified Information Privacy Professional. “Sensitive data now includes, under this regulation, genetic data, biometric data, that is a broader set of data than is covered by HIPAA.” InsightCity has to ask, if you’re a US-based pharma company or CRO, why conduct trials in Europe, why risk it? That said, the informed consent process definitely needs an overhaul. The GDPR indicates the IC must be unambiguous, with affirmative action by the individual. Hard to argue with that. So, sharpen your regulatory pencils and get ready.
If demographic stereotypes hold, drug company employees in the UK probably voted to remain in the EU. Makes sense. Conventional wisdom holds that remaining would have been better for business. Now that the vote has gone the other way, a task force of drug company CEOs and government officials has been put together to combat problems such as uncertainty, added complexity and potential drug approval delays. Several large-scale concerns are on the table. Will British patients have to go to the back of the line, behind the EU, for new medicines? Will Britain need to recreate its own regulatory body for the approval and regulation of medicines? Only (a long) time will tell.
ICYMI: Britain is holding a referendum on June 23 to decide whether or not to leave the European Union. There are lots of feelings on both sides, but now a group of senior-level European Oncologists have added their two-cents, arguing that a Brexit could put European cancer patients at risk. The group wrote in the May edition of Lancet Oncology that continued collaboration and data sharing among EU countries is vital to the UK’s strength in cancer research and care, arguing that isolation policies and formal borders are not good for science. UK scientists also receive a great deal of EU cancer research grants, which the Guardian reports Britain would not be able to generate on its own.