Top Regulatory News Stories – Week Ending November 16, 2018

The FDA granted accelerated approval to Merck’s checkpoint immunotherapy pembrolizumab (Keytruda) for the treatment of certain patients with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer.


Exelixis, Inc. announced that its partner IPSEN received approval from the European Commission for CABOMETYX (cabozantinib) tablets as a monotherapy for hepatocellular carcinoma in adults who have previously been treated with sorafenib. This approval allows for the marketing of CABOMETYX in this indication in all 28 member states of the European Union, Norway and Iceland.

Ardelyx, Inc. announced that  the FDA has accepted for review the NDA for tenapanor for the treatment of patients with irritable bowel syndrome with constipation.

Palvella Therapeutics announced that the FDA has granted Fast Track designation for its lead product candidate PTX-022 (a novel, high-strength rapamycin topical formulation, optimized for dermal targeting) for the treatment of pachyonychia congenita.

NeuroRx has been granted Breakthrough Therapy Designation by the FDA for development of NRX-101 for treatment of Severe Bipolar Depression with Acute Suicidal Ideation & Behavior (ASIB).

Jazz Pharmaceuticals announced the submission of a MAA to the European Medicines Agency for solriamfetol, a selective dopamine and norepinephrine reuptake inhibitor, as a treatment to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy or obstructive sleep apnea.

With 110 approvals and 18 tentative approvals, the FDA approved more generic drugs in October 2018 than any month prior.

In other news…

Moderna Therapeutics, a developer of messenger RNA treatments, has disclosed plans to raise $500 million through the largest-ever initial public offering for a biotech, according to an S-1 registration statement filed with the U.S. Securities and Exchange Commission.

After spending the last six months lining up the necessary regulatory approvals, Takeda CEO Christophe Weber has scheduled an upcoming shareholder voter needed to seal its $62 billion deal to buy Shire.


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