Two companies explain why they believe the European Medicines Agency was wrong to say that they do not have sufficient study data to prove that their products should be approved for sale in the EU.
Emmaus Life Sciences and Mitsubishi Tanabe Pharma have both challenged the European Medicines Agency’s view that they do not have enough proof to show that their respective drugs for sickle cell disease and amyotrophic lateral sclerosis (ALS) are fit for sale in the EU.
The EMA said yesterday that it was recommending against the approval of Emmaus’s Xyndari (glutamine), and that Mitsubishi Tanabe had...
Despite pushback by industry, the government is standing by its new statutory scheme rebate rates for branded medicines, including one that doubles the rate that companies must repay on the sales of newer products to the National Health Service to 31.3%.
EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.
The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.
The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.
EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.
The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.
The 14 July deadline for the Citeline Japan Awards 2025 in Tokyo is approaching fast, so here's a reminder to take a look at the categories and criteria and be sure to get your submissions in by this date. Sponsorship opportunities and tables for the event are also available.
