Pharmaceutical Technology Editors

The 2017 CPhI Pharma Awards program features 20 categories covering achievements in the pharma industry.

GE Healthcare’s Dharmacon business and CordenPharma contract manufacturing enter a strategic collaboration to accelerate the oligonucleotide development process.

In an FDAVoice blog post, the CDER director highlighted two recent scientific advances.

The assay assesses the ability of antibodies to neutralize the Ebola virus.

FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.

The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.

The National Institutes of Health says a new study showed that hydroxychloroquine reduced the transmission of Zika in pregnant mice.

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.

A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.

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.

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

Russell Madsen, president, The Williamsburg Group, and member of the Pharmaceutical Technology editorial advisory board, shares his thoughts on technology innovations and regulatory implications.

Biotech-based therapies and a move to single-use processes highlight recent industry changes.

Excipients play a key role in the development in emerging dosage forms but attention to quality is crucial.

ISPE measures impact of biotechnology and globalization on personalized medicine.

Drug costs, biosimilars, and cloud-based technologies will shape the pharmaceutical industry in the years to come.