Biologic Drugs in Development

At the American Society of Hematology Annual Meeting, Novartis and Kite Pharma both released results from early-phase clinical trials with CAR-T therapies.

The development of mAb formulations poses challenges at the manufacturing, stability, analytical, and administration levels.

The company announced plans to begin shipping Inflectra to the US market in late November 2016.

Results from the Phase III POLLUX trial with Janssen’s Darzalex showed that the drug was effective at reducing disease progression in patients with relapsed or refractory multiple myeloma.

The companies are collaborating on the commercialization of two biosimilar candidates in the US and Canada.

Allergan entered into a licensing agreement with AstraZeneca for MEDI2070, an anti-IL-23 monoclonal antibody in phase IIB development for the treatment of patients with moderate-to-severe Crohn’s disease.

An approach to stabilize PBS-based formulations could provide a simple physiological solution for use of proteins in research, preclinical, diagnostics, and clinical studies, as well as commercial biotherapeutic products.

The agency approves Amjevita (adalimumab-atto) for the treatment of inflammatory diseases.

Mucodel reported that the study met its objectives, and effectively delivered a dose of naloxone using an oromucosal route.

The agency granted accelerated approval to Sarepta’s controversial DMD treatment, under the condition the company conduct additional studies to demonstrate efficacy.

The agency has recommended marketing authorization for Ibrance in the European Union.

Results of Phase III trials involving AbbVie’s blockbuster drug Humira (adalimumab) for the treatment of noninfectious uveitis were released on Sept 7, 2016. FDA approved the drug for noninfectious intermediate, posterior, and panuveitis in June 2016, bringing Humira’s list of approved US indications to 10.

This study offers a strategy for stabilization of biotherapeutics for long-term frozen storage in PBS-based formulations.

In Phase Ib trials, Biogen’s aducanumab reduced amyloid-beta in the brains of patients with Alzheimer’s disease.

Sandoz won FDA approval for its biosimilar version of Enbrel.

The cyclin dependent kinase inhibitor received Breakthrough Therapy Designation as a first line treatment for advanced breast cancer.

The study demonstrates a systematic approach to stabilize PBS-formulated mAbs against freeze-thaw degradation.

Amgen discussed the drug-delivery approaches to two of its biologics in a recent second-quarter earnings call.

The move follows a warning from FDA wherein FDA cited ALK-Abello with numerous manufacturing violations.

The mAb, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, was granted a Breakthrough Therapy Designation from FDA for the treatment of multiple myeloma.

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

The agency will review Mylan and Biocon’s biosimilar to pegfilgrastim.

Amgen and Allergan’s biosimilar to popular breast cancer drug Herceptin is comparable to the innovator molecule, Amgen recently announced.

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.