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Latest From Ian Schofield
Another inquiry investigation into the consequences of Brexit in the life sciences area has been launched, this time by the House of Commons health committee. Stakeholders are asked to comment on issues like the impact on the regulation of medicines and medical devices, how to ensure continued access to medicines, and whether transitional arrangements will be needed.
Sept. 30 is the date by which the European Commission must complete its assessment of member states’ bids to host the European Medicines Agency after Brexit. The agency has again highlighted the pressures it is under as a result of the relocation, and the situation has worsened after some LGBT staff members expressed concern about their rights in certain potential host countries in eastern Europe.
French patients who have experienced adverse reactions to a new formulation of Merck KGaA’s hypothyroidism drug Levothyrox are to be given temporary access to the original formulation, pending the availability of other brands of levothyroxine. Merck says the vast majority of patients have had no problems with the new version.
Australian regulators completed more Level 2 compulsory audits of applications to include class III and active implantable medical devices on the Australian Register of Therapeutic Goods in 2016-17.
New drug submissions to the Australian TGA remained at the same level in 2016-17 as in the previous year, while the number of generic filings fell significantly. Extension of indications applications were up noticeably, as were adverse drug reaction reports for medicines and vaccines.
Samsung Bioepis’s Ontruzant is set to be the first biosimilar version of Roche’s Herceptin on the EU market after getting the all-clear from the EMA’s CHMP on Sept. 15. The committee has also OKd another version of AbbVie’s Humira, this time from Boehringer Ingelheim.