Formulation and Drug Delivery

Countries and partners have announced commitments to vaccinate 450 million children against polio each year and overcome barriers to reaching all children.

The guidance provides recommendations for the development and quality information that should be included in NDA and ANDA applications.

The agency’s approval of Abrilada (adalimumab-afzb), a biosimilar to Humira, brings the total of approved biosimilars to 25.

A new sucrose product from MilliporeSigma has reduced nanoparticle impurities.

Hovione Technology worked with Harro Höfliger on powder filling of blisters for the reusable Papillon DPI.

Roche’s ADC, Kadcyla, has been recommended for approval in the EU for for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment.

Norwegian clinical-stage immunoncology company, Lytix Biopharma, has entered into a clinical collaboration with US-based Iovance Biotherapeutics.

The plant in Singen, Germany will be used for formulation, filling, and packaging of Takeda’s vaccine candidate.

Developers of biosimilars have become dismayed with difficulties in gaining acceptance and reimbursement from the US healthcare system.

As they seek to increase the number of generics available, regulators are requiring that in-vitro and other test data be used for ANDAs, and promoting the concept of biowaivers that would allow such data to replace costly clinical studies.

Research examined the effects of varying excipient and polymer weight in coatings designed to optimize the release of diclofenac sodium. The goal was to release it at night to improve the treatment of rheumatoid arthritis.

Scientists from the University of Texas Medical Branch in Galveston and Profectus BioSciences of New York have developed the candidate quadrivalent VesiculoVax vaccine, an investigational vaccine that protected monkeys against four types of hemorrhagic fever viruses endemic to overlapping regions in Africa.

GE Healthcare Life Sciences will supply Akeso Pharmaceuticals with the FlexFactory platform to accelerate production of antibody drugs in the Guangzhou region.

PATH’s Microarray Patch Center of Excellence aims to accelerate transdermal patch technology for public health needs.

Several factors must be considered when reformulating APIs for pediatric, geriatric, and other specialty patient populations.

Palatability is crucial for adherence and compliance to oral drug regimens.

Intertek has announced that it has expanded its center of excellence for biopharmaceutical services in Manchester, United Kingdom, to support the development of biologics and gene therapies.

Start-up company, SeraNovo, has revealed that it has signed a license agreement with Carna Biosciences to expand the existing collaboration and jointly develop an oral formulation of Carna’s kinase inhibitor with increase bioavailability.

The companies will develop innovative formulations for drugs to treat rare diseases using Catalent’s oral disintegrating tablet technologies.

Phillips-Medisize, a Molex company, revealed its agreement with a biotechnology company to manufacture a wearable electronic-enabled combination product.

Lincoln Pharmaceuticals has received a patent, which is valid for 20 years, from the Government of India for its liquid diclofenac metered-dose rectal spray.

CHMP has recommended that Ervebo (rVSVΔG-ZEBOV-GP), a vaccine for active immunization against Ebola, be granted conditional marketing authorization in the EU.

CHMP has recommended that Baqsimi (glucagon), a non-injectable treatment for severe hypoglycemia, be granted marketing authorization in the EU.

Antimicrobial resistance is now the third leading cause of death in the US. As developers continue to leave an unprofitable market, legislation and new reimbursement models propose to stimulate development of new antibiotics.

The agency announced it has approved 1171 generic drugs in fiscal year 2019.