Top Ten Regulatory News Stories – Week Ending August 18, 2017

The new FDA commissioner Scott Gottlieb said brand name drug companies are “gaming the system” to block generic competition and vowed to do something about it.

The EMA Committee for Human Medicinal Products (CHMP) adopted an updated guideline on what manufacturing process information should be included in the marketing authorization application (MAA).’s-CHMP-Adopts-Updated-Guideline-on-Manufacture-of-Finished-Dosage-Form

Pfizer announced that the FDA has approved BESPONSA® (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.  The therapy was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs.

Seattle Genetics announced that the FDA accepted its sBLA and granted priority review for ADCETRIS in Cutaneous T-Cell Lymphoma.

H3 Biomedicine Inc. announced that the FDA has granted Orphan Drug Designation for H3B-8800, its lead clinical compound for the treatment of patients with Acute Myelogenous Leukemia (AML) and Chronic Myelomonocytic Leukemia.

Anthera Pharmaceuticals announced that the FDA granted Orphan Drug Designation for Blisibimod for the treatment of IgA nephropathy.

The FDA has removed a clinical hold on CEL-SCI’s Phase 3 clinical trial testing Multikine (Leukocyte Interleukin) in patients with head and neck cancer.

Lipocine Inc. announced that the FDA has acknowledged receipt of the company’s NDA resubmission for Tlando, its oral testosterone product candidate for testosterone replacement therapy. The FDA has deemed the resubmission a complete response to its June 2016 Complete Response Letter.

The FDA has also accepted a resubmitted BLA filing  for Portola Pharmaceutical’s lead pipeline candidate, AndexXa, an anticoagulant reversal agent.

Heron Therapeutics is pushing forward with two pivotal trials of its experimental painkiller HTX-011, following an end-of-Phase-2 meeting with the Food and Drug Administration the company described as positive.

In other news…

Bristol-Myers Squibb’s flagship immunotherapy Opdivo missed a key goal in a Phase 3 study testing the drug in combination with Yervoy for a common type of kidney cancer, hindering the drugmaker’s plans to expand its immuno-oncology franchise.

The New York Times published a story this week indicating that there are not enough patients to test the current volume of experimental cancer drugs in clinical trials at this time.

Ionis Pharmaceuticals said that it has regained full rights, from GSK, to a drug called inotersen, for a rare, debilitating nerve disease called familial amyloid polyneuropathy.  GSK dumped the drug—as well as another experimental medicine Ionis plans to develop as part of their recent R&D shakeup.

A new study in the Journal of the American Medical Association indicates that many drugs which are granted Accelerated Approval by the FDA lack clear evidence of safety and effectiveness.

Mylan announced that it will pay $465 million to settle claims relating to the classification of EpiPen auto-injectors in the Medicaid Drug Rebate Program.

Alvogen has agreed to acquire Omega Bittner, a Russia-based pharmaceutical firm owned by Perrigo Company.

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