Biologic Drugs in Development

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

The antisense drug will be the first in the companies’ joint development deal for medications to treat autoimmune disorders of the gastrointestinal tract.

FDA said in briefing documents ahead of a July 13, 2016 meeting that Sandoz’s biosimilar GP2015 has “no clinically meaningful differences” with the US-licensed and EU-licensed versions of Enbrel (etanercept) in terms of safety, purity, and potency.

The acquisition will give Bristol-Myers Squibb full rights to Cormorant’s HuMax-IL8 antibody program.

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.

Emergent is seeking approval for the manufacture of BioThrax at the company’s large-scale manufacturing facility.

A new indication for Emergent BioSolutions’ BioThrax will give the drug market exclusivity through November 2022.

Keytruda was shown to be superior to chemotherapy in the treatment of patients with non-small cell lung cancer.

In Phase III clinical trials, ixekizumab showed to be superior to etanercept and placebo in treating moderate-to-severe plaque psoriasis.

J&J’s Darzalex, in combination with two older drugs, was found to significantly extend progression-free survival in patients with relapsed refractory multiple myeloma.

New research presented at the American Society of Clinical Oncology meeting demonstrates that atezolizumab could be a promising first-line therapy for the treatment of bladder cancer in cisplatin-ineligible patients.

Results of the HERITAGE study were announced at the 2016 American Society of Clinical Oncology meeting.

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).

Genentech received accelerated approval for its immunotherapy atezolizumab for the treatment of bladder cancer.

The Phase I trials will examine AX-1602’s clinical efficacy for the treatment of psoriasis and eczema.

Developers of CAR-T cell therapies with products showing successful early-stage clinical results are currently seeking manufacturing capacity that will enable the production of the larger quantities of material needed for Phase III trials and eventual commercialization.

Two main safety issues have been identified in the early-phase clinical trials conducted to date for chimeric antigen receptor (CAR)-T cell therapies.

The agency publishes draft guidance on assay development and validation for immunogenicity testing.

Linker technology and drug combinations play an important role in the efficacy of ADCs.

Inflectra is the second biosimilar to hit the market in the United States.

The company received a positive recommendation for it’s Remicade biosimilar, Flixabi (infliximab).

The BARDA-supported monoclonal antibody was approved both as a treatment after anthrax exposure and as an anthrax prophylactic.

The studies, conducted across eight countries with nearly 600 inflammatory bowel disease (IBD) patients, further support claims by Celltrion that Remsima is highly similar its reference product.