💊 AstraZeneca’s Andexxa prevents intracranial bleeding; Bayer and Acuitas team up for LNPs; US FDA tackles cancer drug shortage
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Hello and welcome back to The Kable, dear reader. Today’s edition is packed with updates from the annual meeting of the American Society of Clinical Oncology, and also a few from the WHO and UN climate talks. But before that, some more Big Pharma news.
Having collaborated with each other since 2021, Novo Nordisk and Biocorp want to take things further. Novo Nordisk has entered exclusive negotiations to acquire a controlling stake in the diabetes device maker. Minority shareholders are also set to hand over their shares to Novo Nordisk. The total purchase price for this deal is proposed to be €154 million (~$164.5 million).
Bayer is teaming up with Acuitas Therapeutics, with the former gaining access to the biotech company’s lipid nanoparticle, or LNP, technology to support its in vivo gene editing and protein replacement programmes for targeted delivery of RNA payloads as well as antisense oligonucleotides and DNA.
AstraZeneca has announced that it is stopping its post-marketing, phase 4 trial of Andexxa to prevent intracranial bleeding in patients who have received factor Xa inhibiting blood thinners. The study is being stopped early as it has already achieved primary endpoints of superior haemostatic efficacy, successfully limiting the expansion of a potentially life-threatening bleed in the brain. Next on the cards is full approval.
Novavax’s head of R&D has said that the company’s updated Covid vaccine, which it is already producing, is likely to provide protection against dominant circulating viral strains.
The ongoing annual meeting of the American Society of Clinical Oncology, or ASCO, has many updates streaming in, one of which is regarding AstraZeneca and Daiichi Sankyo’s ADC Enhertu. Already marketed for certain breast, lung and gastric cancers, new data suggests Enhertu – which targets the cancer protein HER2 – could be used to treat more types of cancers.
Also at the ASCO meeting, J&J is revealing clinical trial results which demonstrate that its CAR-T cancer cell therapy Carvykti is an effective option to treat multiple myeloma earlier, to be used in the case that the mainstay medicine Revlimid doesn’t work rather than after multiple other options have failed.
Moderna and Merck revealed promising phase 2 data from a trial assessing their personalized cancer vaccine, demonstrating that the shot in combination with Merck’s Keytruda reduced the risk of developing deadly metastases by 65% compared to Keytruda alone.
In our final ASCO update for today’s Synopsis, Novartis said that its drug Kisqali cut the risk of recurrence of breast cancer by more than 25%.
In the US, a continuing shortage of the cancer drug Cisplatin has the FDA allowing temporary importation of the drug from China-based Qilu Pharmaceutical. The injection in question is marketed and manufactured in China, with no approval from the FDA, but the agency is assuringthat it will carefully assess product quality and safety.
In India, a focus on equity in access to drugs, diagnostics and vaccines has the country proposing the establishment of a medical countermeasure coordination platform. During emergencies, this platform aims to facilitate effective tech and product transfers as well as develop global R&D and manufacturing networks.
Belarus, a gateway to the Central European market, is seeking collaborations in terms of joint ventures with Indian pharma companies in the space of anti-cancer and immunosuppressant drugs.
Pfizer Vietnam and the Vietnam Paediatrics Association have signed an MoU to enhance healthcare professionals’ capacity in paediatric diagnosis and treatment for respiratory and neonatal conditions, emergency resuscitation, infectious diseases, and surgery for the years 2023-2026.
Japan’s Fujifilm Cellular Dynamics has announced the global commercial launch of its human iPSC-derived iCell Blood-Brain Barrier Isogenic Kit. This kit, designed for researchers working in neuroscience and drug discovery for neuroactive drugs, can advance the development of treatments for central nervous system disorders.
South Korea’s Seegene has obtained the EU’s In Vitro Diagnostic Medical Device Regulation (IVDR) certification for 30 diagnostic assays for indications including 8 for gastrointestinal infections, 7 for women’s diseases, five for respiratory diseases, and more for TB, meningitis, HPV, and drug resistance.
Further, the country’s Ministry of Health and Welfare is looking to institutionalize telemedicine, with a three-month pilot now underway.
In India, labels of pharmaceutical products currently only declare the active substances in it. But the country’s drug regulator is considering mandating the mention of the excipients on strips of medicine as well.
In Ghana, healthcare facilities are facing dire consequences as more and more nurses leave the country for jobs in the UK and other wealthy countries which are also facing health worker shortages.
In Egypt, the Armament Authority has signed a contract with the Orascom Weitz consortium to design, set up and operate 6 central self-financed warehouses for pharma and medical equipment to ensure their equitable distribution all across the country.
And finally, in the Philippines, the Bureau of Animal Industry (BAI) has recommended the Vietnam-manufactured Avac vaccine for African Swine Fever for approval to the FDA. After approval, the BAI intends to import at least 600,000 doses.