Top Regulatory News Stories – Week Ending October 26, 2018

The US FDA has approved a new treatment for the flu for the first time in nearly 20 years. Roche’s Xofluza (baloxavir marboxil) was approved in people 12 years of age or older.

Principia Biopharma announced that PRN1008, an oral, reversible covalent Bruton’s Tyrosine Kinase (BTK) inhibitor, has been granted Orphan Drug Designation by the FDA for the treatment of patients with immune thrombocytopenic purpura (ITP).

Kadmon Holdings announced that the FDA has granted Breakthrough Therapy Designation to KD025, the company’s ROCK2 inhibitor, for the treatment of patients with chronic graft-versus-host disease (cGVHD) after failure of two or more lines of systemic therapy. Kadmon is currently enrolling patients in a pivotal Phase 2 clinical trial of KD025 in patients with cGVHD.

Loxo Oncology announced that the FDA has granted Breakthrough Therapy Designation to LOXO-292, a selective RET inhibitor, for the treatment of patients with advanced RET fusion-positive thyroid cancer who require systemic therapy, have progressed following prior treatment and have no acceptable alternative treatment options.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended Seqirus’ four-strain, cell-based flu vaccine for approval, setting up an expected nod by the end of the year.

Regeneron Pharmaceuticals said the FDA declined to approve a pre-filled syringe version of its blockbuster eye drug Eylea, and has sought additional information regarding its manufacturing and supply processes.

At a plenary session at the American University in Washington, DC four former US FDA commissioners argued for FDA to become an independent regulatory agency.

In other news…

The Trump administration’s new plan to pay for certain drugs in Medicare based on international prices quickly set off a war with the drug industry after it was unveiled Thursday.

Adam Koppel and his team at Bain Capital are carving out the neurosciences pipeline that Pfizer shuttered at the beginning of the year, setting aside $350 million to back a startup called Cerevel which will now take control of the work.

OrbiMed launched San Francisco-based 89Bio with a $60 million Series A financing round to develop Teva’s NASH drug.

Milestone Pharma raised $80 million to finance a trial of its new cardio drug, etripamil:

Both Sanofi and Genentech are considering US expansions which could add up to 2,300 jobs:


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