Welcome to the latest edition of the Life Sciences Voice Top Five Newsletter, your source for the top developments in the life sciences industry! This week we take a look at Tragedy striking Pfizer’s gene therapy trial with a young death, Pfizer & AstraZeneca’s investments in France almost totaling $1B, Eisai, and Biogen’s Alzheimer; ‘s therapy being submitted to the FDA, and other top news!
Pfizer and AstraZeneca Invest Nearly $1B in France
Pfizer and AstraZeneca have announced significant investments in France, totaling nearly $1 billion. Pfizer has confirmed an investment of $538M, while AstraZeneca has earmarked $388M. AstraZeneca will be using this amount for its lab located in Dunkirk, France to facilitate its presence in the country. The investments come at a time when France has launched its “Choose France” program for business investment in the country.
Medtronic’s Field Ablation System Approved in Japan
Medtronic has received approval from Japanese regulators for its Field Ablation System. The technology is designed to treat patients with atrial fibrillation, a common heart rhythm disorder. The system uses pulsed electric fields to ablate heart tissue targeting cardiac cells which are responsible for the irregular heartbeat but not damaging surrounding healthy cells. This approval allows Medtronic to introduce its new treatment option in the Japanese market.
Eisai and Biogen Submit Alzheimer’s Drug to FDA
Eisai and Biogen have begun rolling submissions to the FDA for their Alzheimer’s drug, Leqembi. This experimental treatment, designed to slow cognitive decline in Alzheimer’s patients, is administered via infusion. The rolling submission process allows for the incremental review of the drug’s data by the FDA, which could expedite its approval.
Roche Gains FDA Approval for HPV Self-Test
Roche has obtained FDA approval for its Human Papillomavirus (HPV) self-testing kit in the United States. This test allows women to collect their own samples in a healthcare facility, providing a method for HPV screening that can help in the early detection of cervical cancer. The approval is expected to increase the rates of screening as it is less invasive than a medical professional taking a sample for testing. Currently, over 50% of women diagnosed with cervical cancer have not been routinely screened.
Pfizer Pauses Phase 3 Gene Therapy Trial After Child’s Death
Pfizer has halted its Phase 3 gene therapy trial following the death of a young participant who suffered a cardiac arrest. The gene therapy was intended to treat a rare genetic disorder named Duchenne muscular dystrophy (DMD), but the incident has led to an immediate pause and an investigation to determine the cause of the fatality and ensure patient safety.
Exclusive Sponsor: Axtria – the leading global provider of cloud software and data analytics solutions to the life sciences industry.
