Catalent acquires Pharmapak Technologies, a pharmaceutical packaging company based in New South Wales, Australia.

GlaxoSmithKline announces global vaccines research and design facility to be based in Rockville, MD, USA.

Efficient freeze-drying processes result in time and energy savings, reduced failure rates, and improved batch consistency.

NIH announced positive safety results from the vaccine, VSV-ZEBOV, and found that all patients in the study experienced a strong antibody response.

Drug developers understand the importance of early communication with regulators, but is EMA providing enough flexibility and support to companies?

In this article, industry experts discuss critical analyses for demonstrating biosimilarity.

FDA approves a biosimilar and loses a commissioner in March.

Hope abounds for local drug discovery companies despite challenges at home.

The authors outline a validation approach for the manufacture of a “legacy product,” taking into consideration recent guidelines. The aim is to demonstrate the validity and capacity of the manufacturing process following a change in the manufacturer.

A review of some of the latest packaging and drug-delivery innovation presented at Pharmapack Europe.

USP announces an implementation date of Jan. 1, 2018 for General Chapters Elemental Impurities-Limits and Elemental Contaminants in Dietary Supplements.

Merck Serono announces that it will work with Intrexon to develop a cancer therapy using chimeric antigen receptor T-cells.

Rentschler Biotechnologie launches 2000-L single-use bioreactor and announces additional expansion.

Xcellience receives approval to handle both analytical and manufacturing of DEA Scheduled products.

As an affiliate member, TraceLink brings serialization expertise to the Pharma & Biopharma Outsourcing Association.

Drug makers back alternative to FDA labeling update rule.

Horizon Pharma offers to buy Hyperion Therapeutics for $1.1 billion in cash.

Novartis announced that it entered into a multiyear alliance with Aduro Biotech to develop cancer immunotherapies, offering up to $250 million in upfront payments and equity investments.

The agency outlines recommendations for the development and submission of near infrared analytical procedures.

Commissioner Margaret Hamburg discusses globalization challenges and the need for investment in regulatory science during her last weeks at the agency.

Biosimilar applicants will not be required to hand over their biosimilar applications and manufacturing dossiers to innovator companies, determines FDA.

The White House confirmed that it would release a plan to tackle the growing problem of antibiotic-resistant superbugs.

Adroit Science AB will support Recipharm’s pharmaceutical development with solid-state characterization services.

The WHO report outlines possible policies that may help governments reduce the high prices of new medicines.

Germany is a mature market with high healthcare expenditure and pharmaceutical production but future growth could be potentially hindered by cost-saving government policies.

FDA has concluded that Kemwell’s facility, systems, and practices comply with FDA’s requirements and no observations were reported on Form 483.

Bristol-Myers Squibb acquired an exclusive license for Novo Nordisk’s discovery biologics research program.

Genentech plans to invest more than $125 million in an expansion of its fill/finish facility in Hillsboro, OR.