After FDA found a “significant shift in the route of abuse,” Endo voluntarily removes OPANA ER from the market.

Recro Gainsville expands its tableting capacity with the addition of a tablet press and film coater.

The suite installation increases PCI’s Hay-on-Wye site’s serialization capability to support clients in advance of meeting the implementation dates of the European Falsified Medicines Directive.

Fresenius Kabi has added two new antibiotics production lines at its plant in Santiago de Besteiros, Portugal.

A $5.5 billion acquisition brings Capsugel’s oral dosage delivery capabilities to Lonza’s portfolio.

TruTags, the company’s silicon dioxide microtags, won Frost & Sullivan's 2017 North American Award for Technology Innovation.

Sienna Biopharmaceuticals has filed for an IPO, expecting to raise over $74 million

Lilly will provide up to $52 million in funding for research, making this Purdue’s largest strategic corporate collaboration

The agency has pushed back by one year the deadline for compliance with DSCSA serialization requirements.

SOBI003 is a chemically modified variant of a recombinant human sulfamidase product candidate, using Sobi’s proprietary glycan modification technology.

Partners will use an AI-enabled platform to discover new small molecules across different therapeutic areas.

Samsung BioLogics signs $55.5 million agreement to manufacture tildrakizumab for Sun Pharma.

Patheon will add spray drying, sterile manufacturing, and packaging capabilities to four facilities.

ADV7103 is being evaluated in a Phase III trial in Europe in children and adults with distal renal tubulopathy acidosis. Results from the study are expected in the coming months.

The Spanish CDMO has installed a new automatic capsule filling machine at its EU GMP-approved plant in Pamplona, Spain

The collaboration will focus on the discovery, development, and commercialization of novel therapeutics targeting an undisclosed G protein-coupled receptor (GPCR) that plays an important role in inflammatory diseases.

A staggering percentage of people do not take their medication correctly, but pharmaceutical packaging aims to improve patient compliance using new technology to address reasons for non-adherence.

Industry experts discuss the single-use revolution and changes to upstream and downstream processing equipment.

Oral solid-dosage and parenteral drug manufacturing equipment and systems have made great strides in safety and efficiency.

Anil Kane, executive director, Global Head of Technical & Scientific Affairs at Patheon, shared his perspective of changes to solid-dosage pharmaceutical manufacturing.

Industry experts discuss how advances in analytical testing tools have helped address challenges in pharmaceutical analysis.

CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.

Poly(lactide-glycolide) has been used for drug-delivery applications because of its beneficial physicochemical properties, long safety record, and reliable commercial supply.

Materials and equipment innovations have advanced tablet coating from sugar to copolymers and simplified pharma production.

Industrial-scale continuous API manufacturing may offer cost and safety benefits.

Real-time alternatives to dissolution testing are required for continuous manufacturing to reach mainstream use.

New ADC therapies must overcome manufacturing challenges to reach market.

As commercial manufacturing considers single-use materials, a look shows how industry moved to the technology.