Top Regulatory News Stories – Week Ending September 14, 2018

The US FDA approved AstraZenea’s Lumoxiti (moxetumomab pasudotox-tdfk) for certain patients with relapsed or refractory hairy cell leukemia.


Amryt announced that the FDA has granted IND clearance for AP101. This enables the Company to begin opening US clinical trial sites as part of its ongoing global EASE Phase III clinical trial in Epidermolysis Bullosa (“EB”).

The FDA has told Amicus Therapeutics it cannot file for accelerated approval of Pompe disease drug AT-GAA using its existing data. Amicus must now continue adding to its existing phase 1/2 data with a view to sitting down again with the agency next year.

FDA’s Oncologic Drugs Advisory Committee will meet on Oct. 10 to review Celltrion’s resubmitted BLA for CT-P10, the company’s biosimilar of Rituxan/MabThera rituximab.

Genentech announced today that the FDA has approved the subcutaneous (SC) formulation of Actemra® (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients two years of age and older.

Acorda Therapeutics reported Thursday that the FDA extended its review of a filing seeking clearance of Inbrija (levodopa) by three months to January 5, 2019.

So far this year the FDA has approved 35 new molecular entities.  You can see the full list here:

In other news…

Alcon, the eye care unit of Novartis, plans to relocate its global headquarters from Fort Worth, Texas to Geneva, Switzerland after a planned spinoff from the pharma giant that would create a separately traded, standalone company.

Takeda said Tuesday that it will close its US headquarters in suburban Chicago and move those operations to the Boston area.

Takeda’s buyout of Shire has driven a wedge between the deal’s mastermind, CEO Christophe Weber, and the founding Takeda family, as a senior member of the family has publicly voiced his opposition to the $62 billion deal.

Due to poor results in their last clinical trial, Vital Therapies will not be pursuing further clinical trials and may be winding down operations:

Supernus Pharmaceuticals announced that it entered into a merger agreement to acquire Biscayne Neurotherapeutics, a privately-held company developing a novel treatment for epilepsy.

This is a weekly recap of selected industry news stories. You can read other additional blogs, see our recent job postings and learn more about us at   You can also visit us on LinkedIn at