Top Regulatory News Stories – Week Ending August 3, 2018

Shionogi & Co announced that, after completing a Priority Review, the FDA has approved Mulpleta (lusutrombopag), a once-daily, orally administered, small molecule thrombopoietin  receptor agonist for the treatment of thrombocytopenia in adult patients with chronic liver disease.


Indivior PLC announced that the FDA has approved PERSERIS™, the first once-monthly subcutaneous risperidone-containing, long-acting injectable for the treatment of schizophrenia in adults.

Fresenius Kabi has received FDA approval for Omegaven (fish oil triglycerides) as treatment for pediatric patients with parenteral nutrition-associated cholestasis.

Progenics Pharmaceuticals’ Azedra was approved by the FDA for two types of rare adrenal gland tumors, making it the first drug approved in the United States for this use.

The FDA granted Daiichi Sankyo a breakthrough drug designation for quizartinib for treatment-resistant acute myeloid leukemia.

Apellis Pharmaceuticals announced that the FDA has granted Fast Track designation to the Company’s APL-2, a novel inhibitor of complement factor C3 as a next generation monotherapy, for the treatment of patients with geographic atrophy (GA), an advanced form of age-related macular degeneration.

ArmaGen, Inc. announced that the FDA Office of Orphan Products Development granted Orphan Drug Designation to AGT-184 for the treatment of mucopolysaccharidosis type IIIA (also known as Sanfilippo Syndrome A or MPS IIIA).

AstraZeneca and Merck & Co. announced that the EMA has granted orphan designation to selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1 (NF1).

Alteogen announced that the FDA granted an orphan drug designation to ALT-P7, a gastric cancer drug candidate with antibody-drug conjugate (ADC).

In other news…

Pernix-backed Nalpropion Pharmaceuticals has picked up Orexigen’s weight loss pill Contrave for $74 million:

Otsuka’s $886 million drug just flopped in its first crucial PhIII trial for frontline AML

Indivior Plc notched a legal victory on Tuesday after a U.S. court reaffirmed that a generic rival could not re-launch cheaper versions of the British drugmaker’s best-selling opioid addiction treatment in the United States.

Shire has quietly cut the trial of an FDA fast-tracked fatty liver disease drug, although it’s not giving much away about what happened.

NewLink Genetics revealed a corporate restructuring including a reduction of its workforce by 30%, as well as a realignment of some senior management positions.

Dendreon was acquired in an $832 million deal by Nanjing Xinbai, a department store conglomerate that’s been beefing up its pharmaceutical business.


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