Original news and analysis on international IP policy
The first biosimilar of the blockbuster breast cancer drug trastuzumab is being prepared for launch in United States, following a decision by the Food and Drug Administration (FDA) to approve it earlier this month. The product, Ogivri, has been created by a joint venture between US Mylan and Indian company Biocon.
A case at the High Court in India set for 15 December could decide whether a patent on some of the most important drugs to fight hepatitis C should be removed. It is one of many attempts to challenge patents on hepatitis C drugs in various countries around the world and serves as an opportunity to learn more about the group leading the legal case.
Hidden amongst the thousands of Facebook pages given over to holiday snaps and gossip are groups of patients who have hepatitis C, a disease that affects more than 70 million worldwide and kills around 400,000 people a year. But importantly, these groups of patients from Russia to Australia have got together to help each other import a relatively new class of drug that is able to cure most of the patients who take it.
Despite a massive worldwide push to improve access to contraceptives, generic manufacturers say they’re not yet getting a good share of the pie. [Updated with response from UNFPA]
The problem of fake medicines is a big one. But precisely how big? The problem is, when reporting numbers, news stories, reports and institutions have historically bundled the different kinds of medicines together, says an expert at the WHO.
An African medicines agency, the continent’s first super-regulator, could be approved as soon as next year.
Cardiovascular diseases (CVD), a group of conditions that can result in heart attacks and strokes, is the world’s number one killer, accounting for one-third of deaths throughout the world, according to research released recently (17 May) by the Institute for Health Metrics and Evaluation (IHME) at the University of Washington.
The WHO last week announced plans to explore options for prequalifying insulin, a process that already assesses the quality, safety and efficacy of medicinal products, such as tuberculosis and malaria drugs. The WHO is considering whether to extend the prequalification process to manufacturers creating me-too versions of insulins, more commonly known as biosimilars.
With the looming threat of antimicrobial resistance (AMR), there is growing pressure to use vaccines because they obviate the need to prescribe antibiotics in the first place.
It’s early February in Tchaourou district, Borgou in Benin, and a pregnant woman is admitted to hospital. Her premature baby is born by caesarean section but she dies a day later on February 12th. It turns out she had Lassa fever, a deadly viral haemorrhagic disease. But that’s only discovered after the baby is discharged from hospital and taken to northern Togo. The newborn also becomes ill and is taken to hospital for treatment.