💊 A historic, non-binding pandemic declaration; India tries to build back pharma trust; Repeat offender Novartis under PMCPA fire

#433 | When are we happiest?; Eating what makes us saddest?; What makes T cells exhausted?

Hello hello. Welcome back to The Kable for another busy day in this unrelentingly busy week. Our first story today is an article from The Conversation on antimicrobial resistance in northern Nigeria. The authors, both microbiologists with extensive experience in Africa, lament the lack of laboratory data which hinders appropriate antibiotic use. They have recently had a study published in Scientific Reports, in which they assessed the effectiveness of antimicrobial agents in northern Nigeria; they found that Tigecycline and Fosfomycin were among the few antibiotics which remained very active even against highly resistant bacterial strains. On the flip side, these antibiotics are expensive and not easily available on the continent.

Coming to the state of local manufacturing in the country. None of the 120+ pharma manufacturers in Nigeria is pre-qualified by the WHO to produce drugs for global procurement. Bloom Health is keen to change that with a three-day, World Bank-funded capacity building training intervention for Nigerian pharma manufacturers.

In case you needed a refresher on the health worker crisis in Africa, Zimbabwe’s The Herald has just that. Ahead of the CPHIA 2023 conference in Zambia, the article recommends fortifying public health supply chain management, including community health workers in health sector planning, and making the most of digital solutions.

Meanwhile, Switzerland’s Acino has acquired the Mexico City-based specialty biopharma M8 Pharmaceuticals which licenses, markets, and distributes medicines in Mexico and Brazil.

Yesterday, PAHO announced that it has inked an agreement with the global non-profit FIND to expand access to essential medical diagnostics and promote testing at the first level of healthcare in LatAm and the Caribbean. The partners will also fortify regional development, manufacturing, and regulatory capacity relating to diagnostic technologies.

In a first for a Bangladeshi pharma company, Eskayef Pharmaceuticals has received US FDA approval for its third manufacturing facility, a sterile injectables unit located in the Tongi township.

At a UN General Assembly side event yesterday, the WHO’s Director-General had not-so-nice things to say about TB and lots of nice things to say about the newly inaugurated WHO TB Vaccine Accelerator Council. The platform will facilitate the development, licensing, and equitable use of new TB vaccines by addressing financing, access, and affordability issues.

While consultants and junior doctors are on strike in the UK, the government is mulling introducing minimum service levels (MSLs) for nurses and doctors. Such regulations would require some of them to work during strikes to ensure patient safety, particularly in urgent, emergency, and time-critical hospital services.

The latest in a string of AI-driven drug discovery deals are the collaborations that Merck KGaA has announced with the UK-based BenevolentAI and Exscientia. These agreements are focused on the therapeutic areas of oncology, neurology, and immunology.

Roche’s Genentech has inked a collaboration and licensing deal with Japan’s Peptidream to discover and develop macrocyclic peptide-radioisotope, or peptide-RI, drug conjugates. Genentech will pay its Japanese partner $40 million upfront and up to $1 billion in potential milestone payments, plus tiered royalties of any product sales linked to their collab. But that’s not the only deal Genentech announced yesterday – the company is also partnering up with Orionis Biosciences to discover novel small molecule medicines for cancer and neurodegeneration treatment. This deal, which includes molecular glues to promote interactions resulting in target degradation or function modulation, is worth $47 million upfront and another $2 billion+ in potential milestones.

Novartis’ UK business is yet again under fire from the country’s Prescription Medicines Code of Practice Authority (PMCPA) for “bringing discredit upon, and reducing confidence in, the pharmaceutical industry.” After its heart drug Entresto and other therapies were linked to similar cases in the past, this time around, a Novartis website, promoting its MS drug Mayzent, is in focus.

Over in the US, a report obtained by Reuters via a Freedom of Information Act request reveals details of a US FDA inspection of Novo Nordisk’s North Carolina facility, its main factory in North America. Apparently, there were quality control lapses here, where GLP-1 drug API Semaglutide is made, as early as May 2022. Similar concerns, regarding microbial contamination prevention, were raised more recently in a July 2023 inspection as well.

Meanwhile, a former senior director at AstraZeneca is taking her former employer to court in the US after the company refused to pay her promised bonuses and stock options, all because she chose to work from home. We’re just glad we don’t work for AstraZeneca, considering how much we love WFH. 💻🏠

In India, Aurobindo Pharma has received a Form 483 from the US FDA. It includes one procedural observation concerning its formulation production facility in the state of Andhra Pradesh.

As bird flu does the rounds in backyard flocks in the Brazilian state of Mato Grosso do Sul, Japan is temporarily saying 🚫 to poultry imports from the state.

Come September 25, once again, households in the US will be able to order four free Covid tests. The government is providing $600 million to 12 manufacturers to produce 200 million OTC teststo replenish federal stockpiles for government use, in addition to meeting the demand for ordered tests. But Covid is over, isn't it?

Speaking of Covid, over the next five years, the US government is awarding a total of $45 million in grants to help 9 clinics treating long Covid to develop new models of care and to widen access to treatment.

And finally, in an attempt at being both the problem and the solution (not really), a couple of years ago, Marlboro maker Philip Morris had bought UK-based pharma Vectura, which makes asthma inhalers. Now, the Wall Street Journal reports that Philip Morris is considering bringing a partner on board – through a majority or minority stake sale, licensing or royalties deal, or a potential commercial partnership – to grow Vectura’s drug manufacturing outsourcing business.