💊 GARDP, Orchid Pharma widen antibiotic access; Google’s funds SDG-focused AI projects; US FDA cracks down on unapproved eye drug marketing

#427 | Paraguay pained by COVAX contract; Treating yourself with turmeric lattes; The lowdown on lead exposure

Hello and welcome back to The Kable. The Gambia has learnt from last year’s cough syrup crisis. The country itself has no pharma testing facilities, but it has finalised an agreement with the Indian government to test India-made meds headed for the Gambia. Exporters will pay for testing by independent third-party laboratories before shipping. The Gambia is also working on a similar arrangement with China.

Paraguay had paid WHO’s COVAX nearly $6 million for roughly 3 million Covid vaccine doses. The country only received one million of those. Understandably, the country is critical of the COVAX mechanism, lamenting the untimely delivery of vaccines and refusing to accept the next batch of shots. In December 2022, Paraguay had already insisted on terminating their contract and requesting a refund of $5,670,990. COVAX, meanwhile, has proposed that the South American country either pay an exit fee or receive the remaining requested vaccines.

All the way across the globe, dengue is wreaking havoc in India. The city of Bengaluru alone has reported 4,427 dengue cases this year. Doctors are also witnessing a unique situation with dengue causing both severe thrombocytopenia and dengue hepatitis.

And if that wasn’t enough, the Indian state of Kerala has reported two “unnatural deaths”, sparking concerns of a Nipah virus outbreak. The state government claims that the four infections reported were from a strain of the Bangladesh variant, which has a low rate of infectiousness but a high mortality rate.

Japan-based Eisai has an all-new subsidiary named Theoria Technologies. Theoria was established to develop digital solutions within a broader dementia ecosystem. These solutions include a risk prediction algorithm and an app facilitating communication between patients, doctors and caregivers.

Agreeing to the proposal from the Pharmaceuticals Export Promotion Council of India (Pharmexcil), Oman will expedite the review of India-made medicines based on approvals by the US FDA, UK MHRA, and the EMA. Accordingly, Pharmexcil has requested exporters to register their interest latest by 15 September.

According to the CPHI Annual Report 2023, AI will transform every aspect of the pharma industry from drug discovery to development in the next two years. The report predicts that AI will be involved in the developing and/or manufacturing of over 50% of US FDA-approved drugs in 2030.

Meanwhile, Tedopi has become the first cancer vaccine to show positive results on survival in a phase 3 trial in non-small cell lung cancer patients. Compared to chemotherapy, the vaccine reduced the risk of death by 41%.

The US FDA has its work cut out for it. On Monday, the agency issued warning letters to 8 companies for illegally marketing unapproved treatments for eye conditions like conjunctivitis, glaucoma, and cataracts. CVS Health, Walgreens Boots Alliance, Boiron, and Natural Ophthalmics are some of the companies in the line of fire. CVS and Walgreens claim they have stopped selling unapproved eye products.

All while Novartis initiates a nationwide recall of a lot of its immunosuppressant, the cyclosporine oral solution Sandimmune. This is due to crystal formation which could lead to incorrect dosing.

And finally, Philips recently launched a new ultrasound tech to improve diagnostic accuracy in assessing lesion blood flow in cancer patients.