Following the announcement in February that South Korea had been chosen by the WHO as the location for a global biomanufacturing training hub, a video shared by the IGBA has shed more light on what can be expected from the initiative.

Looking back over the third quarter of 2022, Generics Bulletin executive editor Dave Wallace picks out highlights from July to September that include changes in ownership on the horizon for major industry players, executive reshuffles at the top of leading companies and regulators, Generics Bulletin’s annual Top 50 and the announcement of our annual awards shortlist.

Medicines for Europe calls for the pharmaceutical industry to be excluded from energy restriction policies for winter 2022 in an open letter to EU governance bodies. Inflation and energy costs threaten European drug makers with closures and rationing, says the industry body.

Sandoz has had its say on its biosimilar rivals with largely branded portfolios, as well as the recent EMA statement supporting biosimilar interchangeability.

Italian API and CDMO specialist Olon is expanding its high-potency capabilities at a site in India, at the same time as unveiling plans to invest a further €30m in a domestic biotech hub.

Apotex is to be acquired by SK Capital, the private investment firm has announced. The Canadian generics giant’s new owner has promised to invest in the firm to “support Apotex’s next phase of growth and continued innovation for patient affordability.”

The joint action on ensuring security of medicines supply will be supported by the EU regulators’ shortages task force, which is to track efforts to coordinate member state activities on the supply and availability of medicines.

Looking back over the third quarter of 2022, Generics Bulletin executive editor Dave Wallace picks out highlights from July to September that include changes in ownership on the horizon for major industry players, executive reshuffles at the top of leading companies and regulators, Generics Bulletin’s annual Top 50 and the announcement of our annual awards shortlist.

Medicines for Europe calls for the pharmaceutical industry to be excluded from energy restriction policies for winter 2022 in an open letter to EU governance bodies. Inflation and energy costs threaten European drug makers with closures and rationing, says the industry body.

Several stakeholders across the off-patent industry, including trade groups and manufacturers, have encouraged the FDA to scrap its proposal to require companies to submit citizen petitions for requesting therapeutic equivalence evaluations for 505(b)(2) applications.

Sandoz has had its say on its biosimilar rivals with largely branded portfolios, as well as the recent EMA statement supporting biosimilar interchangeability.

Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.

Looking back over the third quarter of 2022, Generics Bulletin executive editor Dave Wallace picks out highlights from July to September that include changes in ownership on the horizon for major industry players, executive reshuffles at the top of leading companies and regulators, Generics Bulletin’s annual Top 50 and the announcement of our annual awards shortlist.

Medicines for Europe calls for the pharmaceutical industry to be excluded from energy restriction policies for winter 2022 in an open letter to EU governance bodies. Inflation and energy costs threaten European drug makers with closures and rationing, says the industry body.

In a dramatic twist, Gilenya ANDA sponsors are now unable to launch their generic products in the US after the US Supreme Court intervened in favor of originator Novartis, superseding the US Federal Circuit.

Looking back over the third quarter of 2022, Generics Bulletin executive editor Dave Wallace picks out highlights from July to September that include changes in ownership on the horizon for major industry players, executive reshuffles at the top of leading companies and regulators, Generics Bulletin’s annual Top 50 and the announcement of our annual awards shortlist.

Several stakeholders across the off-patent industry, including trade groups and manufacturers, have encouraged the FDA to scrap its proposal to require companies to submit citizen petitions for requesting therapeutic equivalence evaluations for 505(b)(2) applications.

A busy October will include planned biosimilar launches and key appointments for the off-patent sector.

A busy October will include planned biosimilar launches and key appointments for the off-patent sector.

Health Canada approves Ryaltris for allergic rhinitis, opening up yet another major market for Glenmark’s branded specialty medicine. Bausch Health will sell the drug in Canada.

Stada advances its Specialty ambitions by launching the EU’s first authorized treatment for the rare kidney disease immunoglobulin A nephropathy in the form of its modified-release budesonide capsules.