Patents: a necessary evil?
Dave Elder explores US patent developments amid growing concerns that current approaches potentially delay generic drugs and biosimilars entering the market.
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Dave Elder explores US patent developments amid growing concerns that current approaches potentially delay generic drugs and biosimilars entering the market.
Rising demand for cancer drugs, combined with high in-house manufacturing costs is driving growth in the high-potency API outsourcing market.
Outsourcing the production of oral solids is estimated to be the primary influencer for the contract manufacturing market in the next decade, using lessons learnt from the COVID-19 pandemic.
Research suggests a Transferable Exclusivity Extension (TEE) system is “the only existing option capable of incentivising antibiotic R&D in a sustainable manner” for Europe.
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 medicines for approval, including those for rare diseases, osteoporosis and cancer.
Biosimilar medicines can now be interchanged with their reference medicine or an equivalent biosimilar, says European Medicines Agency (EMA).
Here IQVIA’s Dr Sophie Jouaville discusses the importance of risk minimisation measures, how their effectiveness can be assessed and why transparent reporting of these effectiveness studies is crucial.
A spin-off from parent company Novartis aims to set Sandoz up as the premier European generics company.
A new health technology regulation is due to be applied to help EU countries determine the effectiveness of novel technologies and decide on pricing and reimbursement by health insurers or health systems. Here, Professor Vincenzo Salvatore and Giuseppe Ragucci from BonelliErede reflect on what this means for the UK and…
Securing 18 million doses of GSK’s RTS,S malaria vaccine, UNICEF calls the contract a major breakthrough for child health.
Through the acquisition of Global Blood Therapeutics, Pfizer aims to enhance its presence in rare haematology and particularly sickle cell disease (SCD).
New global alliance launched by UNAIDS, UNICEF and WHO aims to overcome “outrageous” disparities in the AIDS response and ultimately end AIDS in children by 2030.
The draft Regulation aims to enhance the protection of donors and recipients of substances of human origin (SoHO) therapies, while facilitating supply and innovation.
The market for counterfeit pharmaceutical products remains strong, with dishonest actors proving perennially tenacious. Here, Rich Quelch offers guidance on the technologies and practices that are helping to impede fraudsters.
In this article, Samantha Lane of the UK’s Drug Safety Research Unit discusses the development of an evidence-based medicine (EBM) methodology to assess the positive impact of withdrawing or revoking licences for medicines on public health. The approach leverages electronic health records to model the estimated number of adverse reactions…