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, overĀ 1000 attacks on healthcareĀ 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,Ā people are still waiting.
In Kenya, hundreds of refugees have been affected by a cholera outbreak. Doctors Without BordersĀ 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 fromĀ Bayer and Novo Nordisk.
AstraZeneca also hasĀ positive trial dataĀ 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 nowĀ collaborating with Eli LillyĀ 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 toĀ develop ADCs against two novel targets.
Lupin is partnering with Enzene Biosciences to launch Cetuximab, theĀ first biosimilar for Lilly and Merckās head and neck cancer treatment Erbitux, in India.
SK Bioscience has been grantedĀ marketing authorization by the UK MHRA for its SKYCovionprotein-based Covid vaccine. Since it can be stored at temperatures between 2 and 8Ā° C, the shot is suitable for countries which donāt have ultra-low cold chain facilities.
Think Surgical has received clearance from the FDAĀ for its TMINI miniature robotic system ā a device which assists in total knee surgeries.
Meanwhile, robotic surgery giant Intuitive Surgical has entered aĀ licensing deal with Titan Medical; for $7.5 million, Intuitive is getting a non-exclusive license to all of Titanās intellectual property, barring the tech already licensed out to Medtronic in 2020.
In Belgium, an FDA inspection of UCB Pharmaās facility has yielded aĀ Form 483 outlining issues with their quality unitĀ surrounding the control of documents, amongst other concerns.
Putting anĀ 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 theĀ importance of collaboration and transparency to minimize future pandemic risks.Ā