Top Regulatory News Stories – Week Ending July 19, 2019

Cellectar Biosciences announced the FDA has granted Fast Track Designation for CLR 131 in relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL).

Dicerna Pharmaceuticals announced that the FDA has granted a Breakthrough Therapy Designation (BTD) to DCR-PHXC for the treatment of patients with primary hyperoxaluria type 1 (PH1).

Neurocrine Biosciences said the FDA accepted its new drug application for opicapone, a therapy meant to prolong the benefits of existing Parkinson’s treatment levodopa.

Seattle Genetics and Astellas Pharma announced submission of a BLA for accelerated approval to the FDA for the investigational agent enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer.

Omeros Corporation announced agreement with the FDA on the response-based primary endpoint for its pivotal trial to support the BLA for narsoplimab to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

LifeMax Laboratories announced that the FDA granted rare pediatric disease designation to LM-030, an investigational therapy licensed from Novartis and ready to enter into pivotal clinical trials for the treatment of Netherton Syndrome.

AstraZeneca reported that the FDA has rejected its blockbuster drug Farxiga for Type 1 diabetes that can’t be controlled by insulin.

Aridis Pharmaceuticals announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to AR-501, the Company’s inhaled formulation of gallium citrate for treatment of lung infection in patients with cystic fibrosis.

The FDA warned Indian generic drugmaker Strides Pharma earlier this month over good manufacturing practice violations at its Puducherry facility that included uncontrolled shredding of documents and inadequate investigations into out-of-specification test results.

The FDA and EMA explained what their respective regulatory agencies look for in clinical trial risk-based monitoring (RBM) and how RBM can impact review times.

In other news…

Amgen and Novartis said they are ending early two trials of the experimental Alzheimer’s disease drug CNP520 after an interim review revealed “worsening in some measures of cognitive function” among patients enrolled in the studies.

Gilead Sciences will invest $5.1 billion to raise its stake in Galapagos NV and partner with the Belgian-Dutch biotech firm to develop and commercialize its treatments for a ten-year period.

Inovio Pharmaceuticals is slashing 28% of its workforce and axing several early-stage programs to bring its burn rate down.

Genmab A/S, located in Copenhagen, Denmark, raised $506 million with its initial public offering (IPO).

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