Industry News

The agency published draft guidance on prescription requirements, hospital pharmacies, and outsourcing facilities for compounders.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

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.

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%.

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.

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.

Solutions to circumvent heterogenous mixtures of antibody-drug conjugates and to ensure uniform drug-to-antibody ratio were discussed at a recent Catalent Applied Drug Delivery Institute symposium.

The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.

Although many immunotherapies focus on tumor-associated antigens, many of the peptide targets on the surface of cells have not be validated.

Researchers at the University of Pittsburgh say the compound may be more potent and selective than drugs currently available to treat epilepsy.

Industry is joining with academia and global health leaders to examine new approaches to biotech manufacturing.

The report examines the increased number of companies cited by regulators for data integrity issues.

A new 3D modeling and data-extraction technique Improves X-ray crystallography analysis of proteins.

The draft guidance outlines ways applicants can test for abuse deterrence in solid oral opioid drugs.

Generic drugs, market access, and foreign manufacturing are conference topics at CPhI Japan 2016.

The conference discussed key industry issues including serialization, innovation, and patient-centricity.

The agency announced enhanced warnings for immediate-release opioids to inform prescribers and patients of risks related to use.

Hospira recalls one lot of 8.4% Sodium Bicarbonate Injection, USP, due to particulate matter found within a single-dose glass fliptop vial.

The agency now allows production of water for injection by non-distillation technologies.

The agency cited Emcure Pharmaceuticals with CGMP violations.

During a clinical trial of 48 participants, 100% of those that received the TV003 vaccine were protected from infection.

The European Medicines Board elects Christa Wirthumer-Hoche as chair of their Management Board.