News

The company announced that a pharmacokinetic study comparing ONS-1045 to US- and EU-sourced Avastin will conclude shortly.

The single-use clarification system eliminates centrigues; harvesting can be performed in one step; and process robustness and predictability are ensured.

Spending on prescription medications reached $373.9 billion in 2014, representing the largest increase in 13 years.

The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.

Hydra Biosciences enters into an agreement with Boehringer Ingelheim to research and develop small-molecule TRP inhibitors for renal diseases and disorders.

Agency teams work together to encourage manufacturers to seek approval for previously unapproved drugs.

Udit Batra, current head of Merck KGaA’s life science business, will lead the combined life science businesses following successful completion of Sigma-Aldrich acquisition.

The grants will be offered to investigators conducting research in the field of PCSK9 biology.

Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.

Cornell Stamoran, Catalent Pharma Solutions vice-president, is elected to the board of trustees of the Pharma & Biopharma Outsourcing Association.

Mylan announces that it would offer Perrigo $29 billion in cash and stock to buy the Irish company.

Novartis will make payments to Juno to settle a patent dispute covering chimeric antigen receptor T-cell (CAR-T) therapies.

The system is compatible with a wide range of industrial CHO cell lines.

Facilities in China, Ireland, Germany, and the United States have been recognized by ISPE in the 2015 Facility of the Year Awards program.

Pall’s acquisition of BioSMB from Tarpon Biosystems expands its downstream continuous processing offerings.

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

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

Making the switch from batch to continuous manufacturing requires a thorough understanding of the process.

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

Physician-administered biosimilars under Medicare Part B will be reimbursed at a rate based on innovator drug prices and new changes will make costly innovator Part D drugs easier to exclude from formularies.

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

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

A consensus-based standard issued by NSF International incorporates regulatory and industry requirements into a single standard for the manufacturing and distribution of pharmaceutical excipients.

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

Drug makers back alternative to FDA labeling update rule.

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

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.