Formulation and Drug Delivery

Ravi Limaye gives an overview of the biosimilar industry and projects for 2020.

Alan Sheppard, Principal, Global Generics at IMS Health and CPhI expert panel member, discusses generic medicine opportunities in the 2016 CPhI Annual Industry Report.

Containing costs and improving compliance will be crucial to ensuring the growth of generic pharmaceuticals in the future, says Dilip Shah, CEO of Vision Consulting Group, in CPhI’s 2016 Annual Report, which will be formally issued at CPhI 2016 in Barcelona.

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

PCI will be participating in two Speakers Corner slots at the ICSE Exhibitor Showcase.

West will showcase several drug-delivery systems and packaging component technologies such as its NovaPure plungers and SmartDose technology platform.

The agency published the guidance to help generic-drug facilities comply with the GDUFA self-identification requirement.

R-Pharm facility in Yaroslavl, Russia, is designed to produce biological drugs with GE Healthcare's FlexFactory manufacturing platform.

Aptar Stelmi will present PremiumCoat, an alternative coated stopper for sensitive drugs, at CPhI 2016.

Researchers from the Wyss Institute explain a potential method for transporting and producing temperature-sensitive pharmaceuticals at a reduced cost.

Genentech’s biologics drug substance plant is the overall winner of the International Society for Pharmaceutical Engineering’s 2016 FOYA Awards.

The company said it has plans to address global health challenges including vaccines, antimicrobial resistance, and preparation for future pandemics.

GE Healthcare’s GE BioPark Cork will hold four KUBio manufacturing facilities; GE will also collaborate with NIBRT for biopharmaceutical training.

The autoinjector is based on core technology licensed from Bespak.

The project aims to address challenges facing the development, manufacture, and delivery of vaccines.

The Novelia system has been approved as a packaging component and delivery system of multidose drug product formulated without preservatives.

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

If FDA’s proposed generic-drug labeling rule is passed in 2017, generic drug companies would need documented processes for safety tracking and label updates.

Companies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.

Nanoparticulate technologies are showing promising potential in delivering both small-molecule drugs and biomacromolecules across the blood brain barrier.

Aptar Pharma has signed a license agreement with BD to jointly develop and bring a new autoinjector to market.

One of the major challenges in working with excipients today is understanding, and adjusting to, complexity in materials and formulations.

A study demonstrates the feasibility of a novel solid-dose formulation injection technology to effectively deliver a therapeutic treatment without the aid of a needle.

IPEC consultant Irwin Silverstein discusses third-party audits and regulatory compliance issues facing suppliers and their customers.

Analytics and science-based approaches are shedding more light on these complex dosage forms, promising to improve process control and product design.

The authors review the regulatory changes associated with the use of dimethyl sulfoxide in finished pharmaceutical dosage forms.

The platform combines an expression system with equipment and process controls to enable rapid development and scale-up of robust titers.

The merger of Avantor Performance Materials and Nusil Technology positions the company for growth in bioprocessing.

GPhA and PBOA commend agreement to reauthorize Generic Drug User Fee Amendments.

Can Competition Block Excessive Pharma Price Hikes? EpiPen Saga Shows It’s Hard