💊 Gavi and partners' experimental vaccine stockpile; BMS gets European approval for Camzyos; Sanofi's eczema drug sees promising mid-stage results
#372 | Lysol against Covid; The shadow of long Covid in Europe; The liver-brain axis
Hello, and welcome back to The Kable. Today’s a good day for drug approvals as the US FDA approves UCB’s Rystiggo for the treatment of the rare neuromuscular disorder, generalized myasthenia gravis.
The European Commission has approved Bristol Myers Squibb’ Camzyos for the treatment of symptomatic obstructive hypertrophic cardiomyopathy. The drug was also approved by the US FDA a couple of months ago.
In India, the DCGI has approved Akums Drugs and Pharmaceuticals’ epilepsy treatmentPerampanel oral suspension, which is bioequivalent of the US FDA-approved Fycompa.
Not a drug approval yet, but Sanofi has reason to celebrate as its $1.1 billion acquisition of UK-based Kymab in 2021 is paying off. The drug it acquired through the deal, Amlitelimab, showed statistically significant improvements in the symptoms of moderate-to-severe eczema (or atopic dermatitis) in a phase 2b study.
But of course, no news day is ever all good. The US FDA has sent China-based API manufacturer Chengdu KeCheng Fine Chemicals a warning letter for ghosting and lying to the agency.
Meanwhile, two US-based manufacturers have also recently received FDA warning letters – RemedyRepack for significant cGMP violations and skin care product manufacturer Mr Lulu, also for cGMP violations and for an inadequate response to Form 483.
If people in the US don’t trust vaccines, we hope they at least trust Lysol because Reckitt’s Lysol disinfectant brand is set to begin US sales of its air sanitising spray, which can reduce the spread of airborne pathogens like cold, flu and coronavirus.
The Global Alliance for Patient Access, the Global Heart Hub, a number of other organisations in Asia, as well as corporates like Amgen, Novartis and Roche, have come together to launch the APAC Cardiovascular Disease Alliance to reduce the CVD burden in Australia, China, India, Indonesia, Japan, Malaysia, South Korea, Thailand and Vietnam.
In Hong Kong, the genomics-driven health sciences company Prenetics Global has agreed to set up a JV named Insighta with Prof Dennis Lo of the Chinese University of Hong Kong. This $200 million deal is the largest private life sciences deal ever in Hong Kong.
In India, the Union Ministry of Fisheries, Animal Husbandry & Dairying has launched a portal to facilitate and streamline regulatory approval for veterinary products transparently.
In the US, the Small Business Administration inspector general is projecting that over $200 billion from Covid relief initiatives - the Paycheck Protection and the Covid-19 Economic Injury Disaster Loan programmes – were disbursed to potentially fraudulent actors. But these new numbers have been disputed by other SBA officials who claim that the new approach used has serious flaws and greatly overestimates fraud.
And finally, in Europe, the WHO says that Covid still causes at least 1000 new deaths every week, all while the 36 million people in the region who suffered from long Covid find the return to regular life quite difficult.