💊 Phase 3 success for Pfizer’s haemophilia drug; An Eli Lilly x XtalPi collab; Bird flu’s new North American look

#352 | Progress in Covid vaxx research; Barriers to Covid vaxx research; The unexpected perils of flying

Hello, and welcome back to The Kable!

For starters, the FDA is on board with Musk putting a chip in your brain, but have all concerns really been addressed?

In Ukraine, over 1000 attacks on healthcare have been recorded by the WHO since the start of the Russian invasion. This number is higher than recorded in any other conflict. Both patient and health worker lives have been lost.

Mpox vaccines have helped control the outbreak in the US, but in African countries where the disease is endemic, people are still waiting.

In Kenya, hundreds of refugees have been affected by a cholera outbreak. Doctors Without Borders is calling for international support to address sanitary concerns and stem the spread of disease.

Big Pharma, however, is not so blue. Pfizer has announced the outcome of the phase 3 trial of Marstacimab, its experimental haemophilia A and B drug. The results are positive, with the drug reducing bleeding frequency compared to on-demand or prophylactic regimens. There was no threat of dangerous blood clotting either, a setback which has affected similar drugs from Bayer and Novo Nordisk.

AstraZeneca also has positive trial data to announce. Compared to standard-of-care chemotherapy alone, using it in combination with Imfinzi, followed by either Imfinzi alone or both Imfinzi and Lynparza, was associated with improved progression-free survival when used as maintenance therapy in patients of endometrial cancer.

XtalPi doesn't seem to have had its fill of Big Pharma collabs. After Pfizer and Janssen, the biotech is now collaborating with Eli Lilly in a $250 million deal to design new drug candidates for an undisclosed target.

ADC collabs also continue as Adcendo and Duality Biologics expand their existing partnership to develop ADCs against two novel targets.

Lupin is partnering with Enzene Biosciences to launch Cetuximab, the first biosimilar for Lilly and Merck’s head and neck cancer treatment Erbitux, in India.

SK Bioscience has been granted marketing authorization by the UK MHRA for its SKYCovionprotein-based Covid vaccine. Since it can be stored at temperatures between 2 and 8° C, the shot is suitable for countries which don’t have ultra-low cold chain facilities.

Think Surgical has received clearance from the FDA for its TMINI miniature robotic system – a device which assists in total knee surgeries.

Meanwhile, robotic surgery giant Intuitive Surgical has entered a licensing deal with Titan Medical; for $7.5 million, Intuitive is getting a non-exclusive license to all of Titan’s intellectual property, barring the tech already licensed out to Medtronic in 2020.

In Belgium, an FDA inspection of UCB Pharma’s facility has yielded a Form 483 outlining issues with their quality unit surrounding the control of documents, amongst other concerns.

Putting an end to a years-long suit over artificially inflated drug prices, Eli Lilly is going to pay $13.5 million to settle the claims and continue to cap out-of-pocket insulin costs at $35 per month for the next four years.

And finally, even as the WHO put an end to the Covid emergency, its Scientific Advisory Group for the Origins of Novel Pathogens, or SAGO, stresses the importance of collaboration and transparency to minimize future pandemic risks.