💊 The UK’s Life Sci for Growth package; The WHO’s new NCD best buys; Korea’s new global biomanufacturing training hub
Good cholesterol is bad too; Afternoons are for exercise; The risks accompanying irregular menstrual cycles
Hello and welcome to a brand new week with The Kable. Things are busy over in Europe, what with the European Medicines Agency’s committee for medicinal products for human use (CHMP) recommending that Novartis’ marketing authorization for Adakveo, its treatment for vaso-occlusive crises caused by sickle disease, be revoked. The CHMP concluded that the treatment’s benefits did not outweigh its risks. Now we wait and watch how the US FDA responds to the new data about this drug, after the agency had approved it in 2019.
Meanwhile, the European Commission has reworked its Covid vaccine contract with Pfizer-BioNTech, moving towards a reduced dose volume extended over a longer delivery timeline, with continued access to vaccines adapted to new variants as they receive authorization from regulators. Some EU member states, however, have opted out of this amendment.
In the UK, the Medicines and Healthcare products Regulatory Agency, or MHRA, has announced new international regulatory recognition routes for medicines. This means that the MHRA can streamline assessment of some products, with drugs approved by regulators in the EU, Switzerland, the US, Canada, Australia, Singapore and Japan getting a pathway to accelerated access in the UK.
In a further boost to the life sciences sector in the UK, the Chancellor has announced funding of £650 million as part of a Life Sci for Growth package. The package includes £121 million to improve clinical trials, up to £48 million for innovation in preparation of a future health emergency, and £154 million to increase the capacity of the UK’s biological data bank.
The UK government also announced that there are more doctors and nurses working in the NHS than ever before. Can developing countries finally stop worrying about losing more medical professionals to the UK? Probably not.
Over in the US, Pfizer and Moderna have been hit with all new lawsuits by Alnylam Pharmaceuticals. Only the third time Alnylam has sued the two companies for allegedly violating its lipid nanoparticle (LNP) technology patents with their Covid vaccines.
The US FDA, meanwhile, has granted approval to Lexicon’s Sotagliflozin, marketed as Inpefa, to reduce the risk of cardiovascular death and heart failure-linked hospitalization or urgent visits in adults with heart failure, type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors.
In India, the Ministry of Minority Affairs has announced a grant of Rs 45.34 crore to advance the Unani medicine system in the country. Rs. 35.52 crore has been approved for the Central Council for Research in Unani Medicine and Rs. 9.81 crore for the National Institute of Unani Medicine in Bengaluru.
Elsewhere in Asia, South Korea’s HanAll Biopharma and Daewoong Pharmaceuticals have entered a co-development agreement with US-based NurrOn Pharmaceuticals – a preclinical-stage biopharma firm which develops therapies for neurodegenerative diseases like Parkinson’s. The two Korean companies had participated in NurrOn’s Series A fundraising round in 2021.
In Japan, the government is pledging $200 million to the Global Health Innovative Technology, or GHIT, Fund to support its third phase of operations to prevent TB, malaria and neglected tropical diseases prevalent in LMICs. Eisai has also announced a grant of 625 million yen to the GHIT Fund for this third phase.
We’ve already established several times that the world is mostly doom and gloom. In the past, humanitarian organisations have stepped in with silver linings for many of these dark clouds, but their ability to do that is dwindling. The World Food Programme is facing severe funding shortfalls– so severe that it has to make difficult decisions about which hungry people to feed. The WFP is cutting the amount of food and cash it provides in regions all over the world, it is reducing its number of beneficiaries, and is bringing its food distribution activities to a complete standstill in some areas. There are just too many ongoing crises, combined with inflation driving up costs of food and fuel. Last year, the US provided a much larger sum of money than the year before that, but this year, the WFP can’t count on such out-of-the-ordinary spending.
On the polio front, there was a lot of optimism about the introduction of the novel oral polio vaccine type 2, or nOPV2, which overcame problems posed by the earlier vaccine. But even with this new and improved vaccine, a challenge remains: the failure to vaccinate enough children against the disease, especially as the new shot may require a higher percentage of children to be inoculated to actually be effective.
Along with its best buys to reduce NCDs (more on this in Newsworthy), the WHO is urging governments to grow food, not tobacco.
In Egypt, the customs authority has temporarily exempted some imported raw materials used in the pharma industry from value-added tax.
In Morocco, subsequent to widespread public opposition to soaring medicine prices, the Ministry of Health has reduced the prices of 24 medicines used to treat common chronic diseases.
In sub-Saharan Africa, the illicit trade of substandard and counterfeit medicines is resulting in hundreds of thousands of deaths. This feature, part of a UN News series, covers the extent of the problem and the measures being taken to control it.
In Afghanistan, 10 cases and two deaths from Congo-Crimea haemorrhagic fever have been reported in the past week.
In North Korea, a mysterious flu-like illness is affecting military workers, with at least one of them having died of the disease. How mysterious.
And finally, experts are stressing the need for better wastewater sampling in African countries to get a holistic picture of the antimicrobial resistance problem on the continent.