Dosage Forms

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

Articles

While some industry trade groups are gunning for distinct, nonproprietary names for biosimilars (mostly providers, brand manufacturers, and patient advocacy groups), and others for common names (mostly biosimilar manufacturers, insurers, pharmacies, and the Federal Trade Commission [FTC]), some are requesting that no decisions be made at all at this stage in the game. Express Scripts, a large pharmacy benefit manager (PBM), submitted a comment to FDA asking that the regulatory agency hold off on naming decisions until it releases formal guidance on interchangeability first.

Express Scripts to FDA: Hold Off on Biosimilar Naming Decisions for Now

Text from a merger prospectus reveals the termination fee for the proposed Pfizer-Allergan deal would change if any new tax regulations were passed prior to the closing of the transaction.

The $3.5-Billion Pharmaceutical Prenup

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Even though rising production and use of generic pharmaceuticals is saving billions for the nation’s healthcare system, policy makers continue to slap the industry with policies it claims will limit product development and sales.

Hard Times in Washington for Generic Drugs

USP responds to FDA's draft guidance on the naming of biological products.

USP Submits Comments to FDA on Biologics Naming Guidance

Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex process.

Biosimilar Development Continues to Challenge FDA and Industry

Data protection for biologics is reduced from 12 to five years as a result of the Trans-Pacific Partnership agreement.

TPP Discussions Conclude; Biologics Now Have Shorter Data Protection Periods

The agency releases guidance on controlled correspondences related to generic-drug development.

FDA Releases Guidance on Generic-Drug Development

In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.

FDA Promotes Its Scientific Mission

Manufacturers challenge details in new policies designed to promote access to important therapies.

FDA Faces Controversy Over Quality Metrics and Biosimilars

Lannett Company agreed to purchase Kremers Urban Pharmaceuticals, the US specialty generic-pharmaceuticals subsidiary of global biopharmaceuticals company UCB S.A., for $1.23 billion.