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September 02, 2019
Providing regulators with a holistic approach to addressing deficiencies is the best response to an inspection, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
August 30, 2019
EMA issued its recommendations surrounding the dosing of methotrexate in the treatment of inflammatory diseases, such as rheumatoid arthritis, psoriasis, and Crohn’s disease.
August 29, 2019
While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.
August 23, 2019
Joint analysis from the EMA and the US FDA has shown that the regulatory bodies are highly aligned in the majority of marketing authorization decisions.
A biosimilar to Eli Lilly’s Forsteo, biosimilar teriparatide, has been launched across Europe by Gedeon Richter following the patent expiration of the reference product.
August 15, 2019
The European Commission has approved an extension of the use of Dupixent (dupilumab) within the EU to include patients aged 12 to 17 years old with moderate-to-severe atopic dermatitis.
August 02, 2019
Harmonization of regulatory guidelines not only reduces workloads for manufacturers and regulators but can potentially help to accelerate patient access to vital therapies.
European Union regulators have taken a significant step towards resolving some of the major supply-chain difficulties behind medicine shortages.
Machine vision systems have been an integral part of pharma manufacturing and packaging for many years and, with the introduction of stricter safety regulations, are set to become more vital.
Much has changed in the bio/pharma industry over three decades. In this special feature, the editors take a trip down memory lane, highlighting some of the major happenings of the past 30 years.