Protocols

Ignyta jumps on an FDA ‘breakthrough’ nod for entrectinib; Thermo Fisher buying Patheon in $7.2B deal

Ignyta has fresh reason to focus more on entrectinib, its TRK inhibitor for the treatment of NTRK fusion-positive tumors. The FDA has handed out its breakthrough therapy designation for the program, helping ignite a surge in its share price ($RXDX, up 11%). The therapy, now in Phase II, should receive open door treatment by regulators, now charged with helping speed the drug through to an approval.

Thermo Fisher Scientific is extending its reach into contract drug manufacturing, buying Patheon in a deal with a purchase price of $7.2 billion. Patheon has been led by former Biogen CEO Jim Mullen since 2011. This latest buyout follows a long string of deals for CMOs and CROs.

→ Cambridge, MA-based Dragonfly Therapeutics has drawn in new investors, including Celgene Switzerland “and a number of family office investors including Disney family members and the Duke of Bedford.”

→ Israel’s Alcobra said that CEO Yaron Daniely is stepping down to head up the tech transfer arm at Hebrew University.

→ Shares of Amicus Therapeutics $FOLD got a boost out of positive early-stage data it gathered on its drug for Pompe disease.


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RAPS Regulatory Convergence 2017