Dosage Forms

As the biopharma industry awaits FDA’s guidance on biosimilar naming, brand and generic manufacturers establish positions.

OXY-CAPT brings together properties of plastic and glass containers through the combination of oxygen absorption and cyclic olefin copolymer (COP) high barrier layers.

Medicago's new production facility will make plant-based vaccines and therapeutics.

CVS Health signed a definitive agreement to acquire Omnicare for $12.7 billion to expand its reach to assisted living and long-term care facilities.

Economic benefits, equipment availability, research results, and FDA support are driving progress in continuous processing.

The new guideline replaces the previous version-CHMP/EWP/240/95 Revision 1.

Symbiosis Pharmaceutical Services is now offering a new bulk lyophilization (freeze drying) service in response to increasing demand in the manufacture of bulk intermediates and APIs by lyophilization.

Alexion will construct a biologics facility in Ireland that is its first outside the US.

This article looks at data gathered from several studies of a widely marketed chlorobutyl rubber formulation used for vial stoppers and prefilled syringes.

This study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.

Pall has agreed to be acquired by Danaher for $127.20 per share.

With acquisition of Oncaspar portfolio for leukemia from Sigma-Tau Finanziaria, Baxter BioScience adds an oncology infrastructure and biologic.

CombiLac is a lactose-based, co-processed excipient, designed to ease oral solid dosage form development and manufacture in direct compression.

The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.

A vaccine patch may eliminate the need for traditional means of vaccine distribution, according to an article in NPR.

The US Court of Appeals granted Amgen’s request to block Novartis’ Neupogen biosimilar, Zarxio, from the US market until the court resolves litigation between the two companies.

Eleven of the leading US biosimilar developers have collaborated to form the Biosimilars Forum, a nonprofit organization formed to expand patient access to biosimilars.

Advances in transdermal drug delivery, particularly with microneedles, are enabling a wider range of drugs to be delivered through the skin.

Capsugel extends inhaled biotherapeutics delivery capability to Phase 2 clinical trials.

Intellectual property lawyers estimate biosimilar litigation will swell as early as 2018.

While the United States and Europe still dominate, CMOs and CROs based in emerging markets continue to capture market share.

Adjusting the tablet press and its systems can prevent manufacturing and product quality problems.

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

Mylan announces a recall of eight lots of injectable products due to visible foreign particulate matter.

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

Catalent’s Zydis technology will be used to develop thermo-stable and cold-chain independent vaccines.

The agency has recommended granting marketing authorization for Opdivo.

Dicerna Pharmaceuticals announces that FDA granted its primary hyperoxaluria type 1 (PH1) treatment Orphan Drug designation.

Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.

A presentation by Jim Miller will offer a detailed review of the contract services landscape.