Top Regulatory News Stories – Week Ending April 6, 2018

This week saw the submission of two new NDAs, two complete response letters, and one refusal to file.  Here are the top regulatory news stories for this week:

Alkermes announced that it received a Refusal to File letter from the FDA regarding its NDA for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder:

Celltrion has received complete response letters from the FDA for two biologics license applications for rituximab and trastuzumab biosimilars

Sunovion Pharmaceuticals announced it submitted a NDA to the FDA for apomorphine sublingual film to treat OFF episodes in Parkinson’s disease.

Catalyst Pharmaceuticals has submitted a NDA to the FDA for Firdapse, a treatment for a rare degenerative neuromuscular disease.

Sancilio Pharmaceuticals announced that the European Commission has granted Orphan Designation to Altemia, a novel oral formulation being developed for the treatment of SCD in pediatric patients.

The FDA granted Proteostasis Therapeutics’ triple combination for cystic fibrosis Fast Track Designation.

The FDA expanded the use of Amgen’s leukemia drug Blincyto to include patients who are in remission but still have residual signs of the disease.

Allergan and partner Gedeon Richter plan to file an sNDA for Vraylar (cariprazine) based upon positive Phase III data for biopolar 1 disorder.  Vraylar was previously approved for schizophrenia and manic episodes.

The FDA finalized a revised draft guidance from 2015 on the unique aspects and the types of information sponsors should submit for NDAs and ANDAs for liposome drug products.

In other news…

New biotech company Allogene Therapeutics has raised $300 million in cash financing and inked a partnership with Pfizer’s CAR-T portfolio.

Roche has committed to a $25 million investment in Versant while also grabbing their star MS drug:

Ferring Pharmaceuticals is acquiring Rebiotix  along with their PhIII microbiome drug

Startup Macrolide Pharmaceuticals raised $20 million in a Series B round from three pharma giants, including the venture arms of GlaxoSmithKline (SR One), Novartis (Novartis Venture Fund), and Roche (Roche Ventures), among other investors.

Shares of Shire have surged based upon Takeda’s interest in a possible takeover.

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