CHMP meeting highlights – June 2024
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended several new medicines, including positive opinions for treatments for rare disorders.
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In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended several new medicines, including positive opinions for treatments for rare disorders.
Preference for small molecule prefilled syringes and a greater demand for prefilled insulin syringes for diabetes is driving growth of the pharmaceutical parenteral packaging market, a report states.
As a newly independent company, Sandoz will concentrate on developing generic and biosimilar medicines, while its former parent company Novartis plans to drive its business forward with a strategic focus on innovative medicines.
In its September 2023 meeting, the EMA’s human medicines committee (CHMP) recommended nine medicines for approval and the extension of therapeutic indications for 11 medicines.
The European patent landscape is expected to change in 2023 with the launch of the Unified Patent Court. Owners of classic European patents can decide now if their patent will be litigated in the UPC or withdraw from it. Here, Jules Fabre and Sarah Taylor, lawyers at Pinsent Masons, detail some…
A positive opinion has been adopted by the CHMP for a citrate-free high concentration formulation of its biosimilar Hyrimoz® (adalimumab).
A total of five drugs were recommended for approval at the CHMP’s December meeting, including a gene therapy and two cancer drugs.
The 2022 Access to Medicine Index shows all 20 pharma companies have an over-arching access to medicine strategy, benefitting low and middle-income countries.
The US biosimilars market experienced dramatic growth in 2022, particularly for therapies helping to treat oncological and inflammatory conditions, Amgen suggested in a recent report.
A spin-off from parent company Novartis aims to set Sandoz up as the premier European generics company.
Under a new agreement, licenced manufacturers will be able to supply generic versions of ViiV’s long-acting cabotegravir HIV pre-exposure prophylaxis (PrEP) medication to developing nations.
Dr Eric Hughes will join Teva as Executive Vice President, Global R&D and Chief Medical Officer in August, assuming the role from Dr Hafrun Fridriksdottir, who has been with Teva for 25 years.
Sanofi Global Health — a nonprofit unit of Sanofi set up in 2021 — has launched Impact®, a new brand of standard of care medicines dedicated for nonprofit distribution in 40 of the world’s lower-income countries.
The March meeting saw the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommend five medications for approval including a multiple myeloma gene therapy.
Pfizer’s oral COVID-19 treatment nirmatrelvir will be produced by 35 generic manufacturers to increase supply for low- and middle-income countries.