Although control measures are applied, falsified medicines are present in the supply chain in Niger, with solutions requiring cross-country collaboration, says the country’s Ministry of Health.
As African countries look to secure their supply chains, head of the WHO’s team on fighting falsified and substandard medicine speaks about how to ‘demand quality’.
With efforts to tackle fake drugs in Africa increasing, the WHO's director-general speaks on the need to shorten the supply chain with local manufacturing.
Heads of state of seven African countries met in Lomé, Togo, to sign the Lomé Initiative, a political declaration to tackle fake medicine distribution on the continent.
Mylan and Micro Labs receive US FDA approval for two generic versions of Pfizer and BMS’ Eliquis, marking the first generic approvals of direct oral anticoagulants.
Celltrion receives EMA marketing authorisation for Remsima SC, the first subcutaneously-administered option for delivery of infliximab, a treatment for rheumatoid arthritis.
Recro Pharma announces the separation of its acute care business to launch Baudax Bio as a developer of products, including non-opioid analgesics, to concentrate on its CDMO business.
A lease agreement has been signed for the EMA to move into tailor-made premises in Amsterdam, with staff set to begin working from the space in January.
US FDA approves Fetroja, an antibiotic developed by Shionogi, for the treatment of complicated urinary tract infections, as part of the effort to fight AMR.
FDA’s Janet Woodcock testifies to Congress about the potential risks to US national security of the pharmaceutical industry’s reliance on Chinese imports.
FDA urges manufacturers to ‘sell quality’ to fight drug shortages, releasing a report on the potential introduction of a rating system to reward transparency and investments in quality management.
The divergence across global market penetration of generic medicines is broad, with some countries’ markets worth close to half of the entire sector or as low as one fifth, according to IGBA.
The company’s Shanghai facility passes the European regulator’s inspection with no ‘critical’ or ‘major’ findings regarding the commercial products produced at the site.
Representatives from the EMA and China’s NMPA convene to share expertise on GMP for APIs, GCP standards, and on the environmental impact of manufacturing.
UK government signs freight capacity contracts to mitigate the risk that trade disruption will stop medicines from reaching patients related to a potential no-deal Brexit.
Novo Nordisk completes the construction of a wastewater treatment plant in Clayton, North Carolina, which will be donated to the city to aid biopharma growth.
US FDA gives marketing authorization to Lilly’s oral medication for the acute treatment of migraines in adult patients, adding to its Emgality approval almost exactly a year ago.
After an investigation last year, the FDA cites problems across multiple sites within the Lupin manufacturing network, raising questions about ‘management oversight and control’.
US FDA expands the approval of Gilead’s Descovy to make it available for the PrEP indication, coming ahead of the entrance of generic rivals to the company’s Truvada product.
Johnson & Johnson reaches $20m settlement with two US counties on lawsuits regarding the opioid crisis, exits the upcoming federal trial involving several drug manufacturers.
With nitrosamines back in the headlines due to the recent discovery of contaminants in ranitidine, the EMA releases the five potential causes of the impurities plaguing the industry.
