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November 01, 2018
… Brexit may be a bumpy ride. Here, the new European editor of the PharmTech Group, Felicity Thomas, discusses Brexit and its implications for the pharma industry.
October 23, 2018
Takhzyro (lanadelumab) is the first monoclonal antibody therapy approved for the prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
October 19, 2018
The recommended drugs include one biosimilar, two orphan medicines, and three extensions of therapeutic indication.
This article explores major aspects for United States biotech companies to consider when creating a compliant post-Brexit strategy.
October 18, 2018
The contract development and manufacturing organization released its first serialized products to Europe from its facilities in Lisbon, Portugal and Stockholm, Sweden.
October 16, 2018
The guidance describes the agency's recommendations on how to group patients with different molecular alterations and approaches for evaluating the benefits and risks of targeted therapies where some molecular alterations may occur at low frequencies.
October 05, 2018
The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation to seek views on how legislations and procedures of the agency may need to be modified should there be a ‘no-deal’ Brexit scenario.
October 02, 2018
Experts blame the recalls, not on cGMP failures, but on inadequate risk assessment of processes that can generate toxic impurities.
Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.
A European task force outlines its upcoming efforts to combat drug shortages.