💊 India’s NITI Aayog recommends new drug regulation standards; Sanofi gives Ghana affordable insulin; The fight against hep C gets $$$

#321 | Argentina targets mosquito DNA; Iraq targets Turkish poultry exports; Maternal infections target baby brains

Hello there. Welcome to another action-packed day with The Kable.

Yesterday, the US FDA’s Antimicrobial Drugs Advisory Committee unanimously decided to support Innoviva Inc’s experimental antibiotic for bacterial pneumonia - including the multidrug-resistant kind - associated with hospitalisations. Though not obligated to, the agency usually takes its cue from the expert panel and is expected to decide by May 29.

Yesterday, the US FDA also approved using Omisirge, Israel-based Gamida Cell’s cell therapy to cut infection risks in patients 12 years of age and older undergoing stem cell transplantation to treat blood cancer. This approval could potentially reduce racial disparities in stem cell transplants as patients from underrepresented communities are less likely to find unrelated matching donors.

Meanwhile, Moderna and Merck have released further data, building on their December 2022 announcement that their personalised experimental mRNA vaccine can cut the risk of death from or recurrence of melanoma, the most deadly skin cancer, by 44% compared to Merck’s Keytruda alone. Phase 3 trials are expected to commence soon.

Vaxcyte’s experimental pneumococcal vaccine succeeded in its second phase 2 trial, paving the way for phase 3 testing of the shot.

Kinnate Biopharma’s monotherapy pan-RAF inhibitor, which, unlike its competitors, also targets class II and class III mutations, has shown early efficacy in tumour reduction.

Continuing with its manufacturing expansion spree, Eli Lilly is injecting another $1.6 billion into its new manufacturing sites in Boone County, Indiana. It will also create an additional 200 new jobs, bucking the layoff trend in the industry.

Pipeline Therapeutics is joining hands with Janssen in a $1 billion global license and development agreement involving PIPE-307, its small-molecule compound for relapsing-remitting multiple sclerosis.

Philips and Amazon Web Services have announced a partnership to develop generative AI applications for the former’s HealthSuite.

Across the pond, the European Commission has approved the use of AbbVie’s Rinvoq in adults with moderate-to-severe Crohn’s disease who do not respond adequately to conventional therapies. In the US, the drug is under review for the same indication. In the UK, Rinvoq is already authorised.

In Spain, a Barcelona hospital is pioneering a new approach to lung transplants using a robot and a new access route, cutting through only soft tissues and no bones.

In India, the subject experts' committee under the Drugs Controller General of India is set to review Gennova Biopharmaceuticals’ Covid booster shot – the first Omicron-specific one in the country.

While its neighbour Brazil is releasing Wolbachia-infected mosquitoes to control the spread of dengue, Argentina is altering mosquito DNA by sterilising them using radiation before releasing them back into the wild.

In Sweden, after detecting salmonella contamination in a packing plant, egg giant CA Cedergren has stopped all consumer egg deliveries. Salmonella’s not good news, but we’re just glad it’s not more bird flu.

In Iraq, however, it is bird flu affecting poultry supply. The country has banned poultry product imports from Turkey because of the avian influenza outbreak.

In Nigeria, the National Agency for Food and Drug Administration and Control has provisionally approved Oxford’s R21 malaria vaccine. Other than Ghana, Nigeria is the only country in the world to give the shot a go-ahead. Even the WHO hasn’t arrived at a decision yet.

Even outside the African region, affected countries could use this new vaccine. In the ongoing outbreak in Costa Rica, the Ministry of Health has reported a total of 115 positive cases in the Huerta Caribe region.

And in Ghana, the malaria situation is only getting more complex as a new, more dangerous mosquito strain known as Anopheles stephensi has been detected. The country has set up a task force to tackle the problem and is urging the public to take precautions as well. 

And finally, it seems the Covid origin theory mystery will never be put to rest. A US Senate report is more inclined to believe the lab leak theory than the wet market one.