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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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Generics
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CHMP meeting highlights: February 2024
Ten new medicines, including a new oligonucleotide therapy for ALS, were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s recent meeting.
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CHMP meeting highlights: January 2024
In its first meeting of 2024, the CHMP recommended a generic medicine for schizophrenia and refused a marketing authorisation (MA) for geographic atrophy.
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Medicines for Europe calls for simpler SPC manufacturing waiver
To ensure timely market entry of generics and biosimilars in the EU, the Supplementary Protection Certificate (SPC) Manufacturing Waiver must be clearer, asserts Medicines for Europe.
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Novartis completes Sandoz spin-off
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.
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Outsourcing APIs put EU patients at risk
Teva warns APIs could disappear from European factories in five to 10 years if the industry does not see outsourcing essential medicine manufacture as risky.
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British generics manufacturers call for Northern Ireland supply to be sorted
Mark Samuels, Chief Executive of the British Generic Manufacturers Association (BGMA), urges EU and UK to put patients above politics in solving medicine supply challenges for Northern Ireland.
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EU court rules GSK committed ‘pay-for-delay’ in paroxetine case
The Competition and Markets Authority (CMA) announced the EU Court of Justice agreed that GSK had paid to delay other competitors entering the UK paroxetine generics market.
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Supply chain and drug pricing reform required to lower US healthcare costs
Price caps and government regulations will not lower US healthcare costs, instead supply chain and drug pricing reforms are required, says a brief by medical economist.
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Efforts to advance the development of complex generic drugs
The FDA has issued a statement to promote the development of complex generic drugs to ensure access for patients and healthy drug competition...
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Europe ‘needs uniform policy’ to help generic pharmaceuticals market grow: report
A Europe-wide policy covering the generic pharmaceuticals market would significantly boost growth in the sector, reveals a new report from Frost & Sullivan...
