A new tool helps assess risks and standardize data acquisition and processing options.

Finding Data Integrity Harmony 

Dissolution testing provides stability parameters and helps predict drug behavior.

Defining Drug Stability with Dissolution Testing

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Articles

The approval of Nucala (mepolizumab) for treating hypereosinophilic syndrome represents the first drug approved for this group of rare blood disorders in nearly 14 years.

FDA Approves GSK’s New Drug for Rare Blood Disorders 

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

With little more than a month to go until the national election, President Trump announced a revised initiative designed to reduce what consumers pay for prescription drugs, while also promising to protect coverage for pre-existing health conditions. 

Trump Health Policies Again Thrust Drug Pricing and Access into the Spotlight

FDA and EMA have accepted the biologics license application and marketing authorization application, respectively, for bimekizumab.

EMA and FDA Accept UCB’s Marketing Applications for Bimekizumab

A strategic serialization partnership has been announced by advanco and Syntegon, aimed at tackling the global issue of counterfeit drugs. 

Advanco and Syntegon Launch Strategic Serialization Partnership

Telstar has reinforced its consultancy service to aid pharmaceutical companies in the compliance of the latest version of the EU GMP Annex 1 guidance.

Telstar Reinforces Consultancy Service in Accordance with New Annex 1

The Korean MFDS has given its approval for Celltrion to initiate a Phase II/III trial of its anti-COVID-19 monoclonal antibody treatment candidate, CT-P59.

Korean MFDS Approves Celltrion’s IND for Phase II/III Trial of COVID-19 Treatment

ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.

ISPE Releases Cleaning Validation Guide

Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.

COVID-19 Vaccine Concerns Prompt Clinical Trial Transparency

The guidance document offers information on the placement and content of geriatric information in labeling of drugs and biologics.

FDA Gives Guidance on Geriatric Information in Labeling

The agency’s human medicines committee is endorsing the use of dexamethasone in COVID-19 patients requiring oxygen therapy.

Quality Systems