News

Shire announces plans to build a flexible biopharmaceutical manufacturing facility in County Meath, Ireland.

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

Through two acquisitions, Recipharm will acquire Kemwell’s United States, Swedish, and Indian operations.

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.

The agency published guidance on data integrity as it is relates to CGMP compliance.

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The agency published draft guidance on prescription requirements, hospital pharmacies, and outsourcing facilities for compounders.

FDA’s breakthrough drug initiative is more popular and successful than ever.

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

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

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

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

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.

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%.

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

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

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

Jack Lew, Obama’s secretary of the treasury, announced on April 4, 2016, that the US Department of the Treasury and the Internal Revenue Service (IRS) is issuing temporary and proposed regulations to limit the “benefits of and limit the number of corporate tax inversions.” The government bodies also plan to address earnings stripping in these inversions, so it will examine past inversion deals that have already been completed.

Microchannels show potential benefits for inertial cell sorting and for introducing genetic material into cells.

Even though the organizers of New York’s Tribeca Film Festival decided not to air the anti-vaccine film by discredited British researcher Andrew Wakefield, the so-called documentary is getting a healthy run and further perpetuating the myth of a link between childhood vaccination and autism.