News

Linker technology and drug combinations play an important role in the efficacy of ADCs.

The National Institute of Health will conduct an internal review of the National Cancer Institute’s cell manufacturing facilities, which will affect multiple Kite projects.

FDA explains the rewards that may be associated with switching from batch to continuous manufacturing.

The agency published draft guidance on prescription requirements, hospital pharmacies, and outsourcing facilities for compounders.

The company has recalled one lot of 50% magnesium sulfate injection, USP due to particulates.

The IMS Institute for Healthcare Informatics report examines spending on medicine in the US, drivers of growth, major market segments, prescription volume, patient costs, and healthcare delivery changes.

The agencies detail the results of their three-year collaboration.

The Office of Generic Drugs highlights the agency’s work to advance generic drugs.

The valve received the highest cycle rating after completing the test at three times the required test pressure.

By focusing on laying strong technology foundations, pharmaceutical businesses can make informed decisions, equip themselves with the capabilities to eliminate threats, and future-proof operations.

JW Biotechnology will focus on developing novel cell-based immunotherapies.

The new system will be used for multiparticulate dosages.

The conference will take place from May 16–18, 2017 in Philadelphia, Pennsylvania.

GE Healthcare Life Sciences has expanded production capabilities at its Pasching, Austria facility for sterile liquids.

FDA approved an update in the manufacturing of Prezista (darunavir) using a continuous manufacturing line at Janssen Supply Chain’s facility in Puerto Rico.

The companies will collaborate on two CSCS supply chain security studies.

The agency issues safety guidance to minimize medication errors relating to product design and container closure design.

Cornell researchers reveal that an existing FDA-approved drug can facilitate the delivery of other large molecules across the blood-brain barrier.

The Ethiopian government said it is offering tax and loan incentives to encourage local pharmaceutical production in the country

The American College of Rheumatology released a statement encouraging FDA to apply distinct names to biosimilars and maximize clarity in labels.

Sanofi says the program will vaccinate one million students from 6000 public schools in dengue-epidemic regions of the Philippines.

The FDA guidance describes information to provide to the agency when submitting a proposed proprietary name.

FDA added warning labels to medications containing saxagliptin and alogliptin after clinical trials linked the drugs to increased risk of hospitalization for heart failure.

WellSpring Pharma formed a strategic partnership with IDT Australia and invested $3 million in new equipment.

A report by Reuters found that four of the top 10 most widely used drugs increased 100% since 2011, while the other six increased 60%.

Pharma companies must weigh cost efficiencies of global API sourcing with increased complexities of monitoring for compliance and quality.

Inflectra is the second biosimilar to hit the market in the United States.

The companies announced that they have mutually decided to terminate the planned merger after the US Department of Treasury and the IRS issue temporary and proposed regulations on tax inversion.

The agency has announced the creation of the Combination Products Policy Council to address issues related to combination products.

The agency released a draft reflection paper on the extrapolation of data from adults to children in the development of pediatric drugs.