Top Regulatory News Stories – Week Ending August 10, 2018

The FDA approved Kyowa Kirin’s Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of two rare types of non-Hodgkin lymphoma: relapsed or refractory mycosis fungoides and Sézary syndrome.

An FDA Advisory Committee has recommended approval of Paratek’s Omadacycline for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia:

The FDA’s Antimicrobial Drugs Advisory Committee voted 12 to 2 in favor of the safety and effectiveness of Insmed’s ALIS (amikacin liposome inhalation suspension) for adults with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) who have limited or no treatment options.

60 Degrees Pharmaceuticals announced that the FDA has approved ARAKODA™ (tafenoquine) tablets for the prevention of malaria in patients aged 18 years and older. For the first time in more than eighteen years, the U.S. FDA approved a new drug for the prevention of malaria.

The FDA issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment drugs for the treatment of opioid use disorder.

The FDA issued a Complete Response Letter Pain Therapeutics rejecting their marketing application for Remoxy once again. Remoxy was licensed from Durect back in 2002:

The FDA on Wednesday approved several versions of Apotex’s potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy (CGT) designation, which allows generic drugs to come to market faster than they otherwise would have:

Pliant Therapeutics reported that the FDA has granted orphan drug designation for the company’s anti-fibrotic lead compound, PLN-74809, for the treatment of idiopathic pulmonary fibrosis.

Array BioPharma has received the FDA’s breakthrough therapy designation for an investigational drug encorafenib, in combination with binimetinib and cetuximab for treatment of a type of metastatic colorectal cancer:

Castle Creek Pharmaceuticals announced that the FDA has designated as a Fast Track development program the investigation of diacerein 1%, ointment (CCP-020) for the treatment of epidermolysis bullosa simplex.

Sesen Bio, Inc. announced that the FDA has granted Fast Track designation to Vicinium™ for the treatment of BCG-unresponsive high-grade non-muscle invasive bladder cancer.

The FDA expanded the list of drugs being recalled that contain valsartan due to cancer concerns.

In other news…

Ironwood Pharmaceuticals said it dropped its licensing deal for AstraZeneca’s lesinurad franchise, which includes Duzallo and Zurampic. Ending the agreement will lead to the loss of 125 jobs.

Sarepta Therapeutics expanded its gene therapy pipeline in an equity deal with Lacerta Therapeutics, gaining access to Lacerta’s AAV-based CNS-targeted gene therapies.

PaxVax, Inc. announced that it has entered into a definitive agreement to be acquired by Emergent BioSolutions:

Perrigo Company announced a plan to separate the company’s prescription pharmaceuticals Rx business from its OTC consumer business.

OvaScience and privately-held Millendo Therapeutics, Inc. announced that they have entered into a definitive agreement under which the two companies will merge in an all-stock transaction.

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