France is tightening restrictions on early-phase clinical trials in the wake of one study that left one patient brain-dead and hospitalized five others. Source: International Pharmaceutical Regulatory Monitor
The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, guidelines and GMP compliance. Source: International Pharmaceutical Regulatory…
Italian regulatory authorities have cited two Indian drugmakers for dozens of GMP issues, ranging from data security to quality management issues. Source: International Pharmaceutical Regulatory Monitor
Indian API maker Dhanuka Laboratories could lose its EU GMP certificate after an inspection turned up 32 violations. Source: International Pharmaceutical Regulatory Monitor
The European Medicines Agency has begun a public consultation on planned revisions to Module V of the good pharmacovigilance practices on risk management systems, which clarifies what risk management plans…
An FDA advisory committee gave South Korea’s Celltrion’s biosimilar candidate for Remicade a strong show of support Feb. 9, backing its approval for six indications. Source: International Pharmaceutical Regulatory Monitor
Heparin is back in the news, after France’s National Agency for Medicines and Health Products Safety issued a GMP noncompliance statement to China’s Dongying Tiandong Pharmaceutical, which manufactures the active…
Generics giant Mylan N.V. has struck a tentative deal to purchase Swedish drugmaker Meda AB for $7.2 billion in cash and stock. Source: International Pharmaceutical Regulatory Monitor
Six new drugs have scored wins at the European Medicines Agency, scooping up recommendations for marketing authorization from the Committee for Medicinal Products for Human Use. Source: International Pharmaceutical Regulatory…
With 12 nations signing off on the Trans-Pacific Partnership, the clock has started on ratification of the treaty providing up to eight years of exclusivity for biologics. Source: International Pharmaceutical…