Regulatory Filings and Submissions

Drug companies are pushing Congress to action on funding for FDA programs and staff to expedite drug reviews and approvals.

A new report from HBM Partners said FDA new molecular entity approvals have dropped to 19 in 2016 from 45 in 2015.

FDA’s Center for Drug Evaluation and Research (CDER) approved 22 new molecular entities (NMEs) in 2016, according to a January 4, 2016 release from the agency. Of the 22 NMEs, 12 were large-molecule therapeutics. Of CDER’s 45 novel drug approvals in 2015, 17 were considered large-molecule therapeutics (larger than 900 Daltons).In 2016, 11 of the 12 large-molecule drugs that were approved were biologics. This includes seven monoclonal antibodies (mAbs), one hormone, and three DNA-derived medications. The remaining large-molecule medication was a diagnostic agent.

The agency recommended nine drugs including treatments for diabetes, hepatitis B, and HIV.

What’s ahead for the healthcare and pharmaceutical industries?

NICE recommended eribulin for the treatment of patients with breast cancer, reversing its 2012 decision.

FDA leaders insist that the decision to approve Sarepta’s Exondys (eteplirsen) should not be considered a model for future development of orphan drugs.

The agency clarifies how FDA determines when a risk evaluation and mitigation strategy is necessary.

The agency provides a qualified context of use for the biomarker plasma fibrinogen.

Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.

Sandoz won FDA approval for its biosimilar version of Enbrel.

The guidance assists in the development, analysis, and presentation of microbiology data during antibacterial drug development.

The new guidance addresses FDA refuse-to-receive decisions in regards to impurity limits.

The companies filed a BLA for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis.

The committee voted unanimously in favor of approving the drug, but the majority supported implementing additional risk management.

The agency says the increasing requests for orphan drug designation has resulted in a change in FDA’s review goals.

The drug received breakthrough therapy and orphan drug designation as a monotherapy for the treatment of chronic graft-versus-host-disease.

The monoclonal antibody for the treatment of two forms of multiple sclerosis has a target action date of December 28, 2016.

FDA approved dalizumab a monoclonal antibody for the treatment of multiple sclerosis.

Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.

FDA accepted for review Samsung Bioepis’ BLA for SB2, a biosimilar to Remicade (infliximab).

Phase I clinical trials of PfSPZ revealed it may protect healthy adults, who have not been exposed to Malaria before, for more than on year.

FDA’s breakthrough drug initiative is more popular and successful than ever.

The FDA guidance describes information to provide to the agency when submitting a proposed proprietary name.

The agency has announced the creation of the Combination Products Policy Council to address issues related to combination products.