Regulatory Roundup: Top News Stories – Week Ending June 16, 2017

This week the FDA granted Breakthrough Therapy designation to multiple programs, granted an Orphan Drug designation and also rejected a biosimilar application.  Here is a summary of the top 10 regulatory stories to follow this week:

Proteon Therapeutics received FDA Breakthrough Therapy Designation for Vonapanitase for chronic kidney disease. Full Story Here

The FDA’s Oncologic Drugs Advisory Committee (ODAC) will meet on July 12 to discuss a BLA from Novartis’s CAR-T therapy Full Story Here

The FDA granted Breakthrough Therapy Designation for Burtomab, a drug for metastatic neuroblastoma, created by Memorial Sloan Kettering Cancer Center and licensed to Y-mAbs Therapeutics, Inc. Full Story Here

The FDA rejected Coherus’s application for a biosimilar of Amgen’s Neulasta.  There was no request for new data, but regulators asked for a new analysis of samples involving a revised immunogenicity assay and the FDA also asked for more “manufacturing related process information.” Full Story Here

Gilead Sciences announced that it has submitted a NDA to the FDA for an investigational, once-daily single tablet regimen containing bictegravir and emtricitabine/tenofovir alafenamide for the treatment of HIV-1 infection in adults. Full Story Here

The FDA granted breakthrough therapy designation to Omeros’ lead human monoclonal antibody mAb) OMS721 for the treatment of immunoglobulin A (IgA) nephropathy.  Full Story Here

Cascadian Therapeutics’ lead candidate, Tucatinib, received Orphan Drug Designation from the FDA for the treatment of breast cancer:  Full Story Here

Mateon Therapeutics received FDA Fast Track Designation for OXi4503 in patients with acute Myeloid Leukemia Full Story Here

Pfizer and Eli Lilly have secured fast track status from the FDA for tanezumab to treat chronic pain in patients with osteoarthritis and chronic low back pain. Pfizer and Lilly have a worldwide co-development and co-commercialization agreement to advance the development of tanezumab, a monoclonal antibody, which can selectively target, bind and inhibit nerve growth factor.  Full Story Here

The US Supreme Court on Monday ruled unanimously that biosimilar companies will not have to wait an additional six months after FDA approval before launching their new biosimilars. – Full Story Here

In other news…

Endocyte announced it will be cutting their workforce by 40% after their Phase 1 trial was discontinued Full Story Here

Novan is laying off 20% of its workforce following a late-stage clinical trial failure:   Full Story Here

Celgene has signed a five-year immuno-oncology collaboration deal with two-year-old biotech Dragonfly Therapeutics:  Full Story Here

Following the recent approval of two new biologics and a pipeline full of large-molecule drugs, Sanofi says it will invest as much as €2 billion on its biologics manufacturing network over the next several years.  Full Story Here

A federal jury has cleared Bayer and Johnson & Johnson of liability in the second trial to stem from thousands of lawsuits blaming injuries on the blood thinner Xarelto.  Full Story Here

Cancer drug developer Athenex raised $66 million through an IPO on Wednesday.  These funds will likely be used to support two late stage oncology programs.  Full Story Here


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