Protocols

GAO pokes holes in FDA’s orphan designation process; Takeda Traditionalists make one more appeal against Shire buyout ahead of vote

→ In response to several senators’ inquiry, the Government Accountability Office has taken a closer look at how the FDA handles orphan drug designation requests, and it does not like what it found. “The Commissioner of FDA should ensure that information from orphan drug designation applications is consistently recorded in [Office of Orphan Products Development] review templates and evaluated by OOPD reviewers when making an orphan designation decision,” GAO recommended. While the report does not directly address the abuses of incentives to obtain the designation for a drug that actually reaches a larger, non-orphan population, the HHS pledged to follow the recommendations in improving training for reviewers.

→ On Wednesday, Kazuhisa Takeda will wage a last-ditch effort to put a stop to Takeda’s $62 billion buyout of Shire — but he knows he doesn’t have the votes to stop it. The senior Takeda family representative says he’s marshaled investors with 20% of the equity to vote against the deal, well short of what’s needed. But he hasn’t stopped fighting. “We are definitely against [it]…. [The] financial risk is too big, while [the] expected merit is quite limited,” Takeda told reporters in Tokyo. “M&A is quite necessary for Takeda’s future, but this deal is too risky.”

 


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