Regulatory Filings and Submissions

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.

The drug is marketed by Eli Lilly in the US, and will be available at the beginning of the second quarter of 2016.

Kovaltry is an unmodified, full-length recombinant factor VII product used to treat hemophilia A in adults and children.

FDA granted Immunomedics breakthrough therapy designation for the company’s investigational antibody drug conjugate for treatment of triple negative breast cancer.

FDA staff said Celltrion’s biosimilar form of infliximab is highly similar to Remicade.

Amgen announces FDA will review the company’s BLA for ABP 501.

NICE announces plans to back biosimilar alternatives to Merck’s Remicade.

On Jan. 27, 2016 FDA announced it plans to review Merck’s investigational antitoxin prevention bezlotoxumab.

More “me-betters” and more focused breakthroughs could enhance new drug development.

The agency has published draft guidance on safety assessment for investigational new drug application safety reporting.

FDA approves Kanuma, the first treatment for patients with lysosomal acid lipase.

FDA sets a July 2016 deadline for the final version of the rule on labeling changes for approved drugs and biologics.

FDA confirmed quality focus while Congress moved to bolster biomedical innovation.

There’s renewed optimism in the biomedical research community that years of effort finally may begin to pay off for developing cutting-edge gene and cellular treatments for debilitating and life-threatening conditions. Jill Wechsler reports.

All biosimilars for a specific product will be reimbursed with the same J-code under Medicare Part B regardless of manufacturer, according to a CMS rule that was proposed in July 2015 and finalized on Oct. 30, 2015. The rule was finalized prior to any formal guidance from FDA on interchangeable products.  CMS said it did not consider interchangeability into its decision, as there are no currently approved interchangeable biologics on the market.

The agency issued a draft guidance document on the requirements for submission of applications for liposome drug products.

The agency gives an update on the regulation of combination medical products.

In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.