💊 Takeda withdraws Qdenga's US FDA application; BMS' licensing agreements with Evotec, Prothena; BioNTech's Chinese connection
#382 | Identifying mania risks; Identifying osteoarthritis severity using AI; Identifying genetic abnormalities in infants
Hello, reader. Welcome back to The Kable. Do you want to hear today’s good news first or the bad? Let’s go with the bad. In the US, the FDA has classified the recall of over 21,000 pieces of a J&J unit’s electrosurgery tools as Class I, or “most serious”. The use of MEGA 2000 and MEGA SOFT patient return electrodes could lead to burn injuries and even death.
Takeda’s dengue vaccine Qdenga has gained regulatory approval in the EU, the UK, Brazil, Argentina, Indonesia, and Thailand. But it’ll be a while before the US gets added to this list. Citing data collection issues, the Japanese company is voluntarily withdrawing its dengue vaccine candidate’s FDA application.
Seven patient deaths and five severe respiratory events have led ADC Therapeutics to stop enrollment in its phase 2 study of Zynlonta in patients with diffuse large B cell lymphoma.
That’s all the bad news for Synopsis, fortunately. Bristol Myers Squibb has good news to share. Its cancer immunotherapy Opdivo, combined with chemotherapy, has improved survival in patients with a type of bladder cancer in a late-stage trial.
BMS is also exercising its option to enter an exclusive global licensing agreement with Evotec. This agreement extends the companies’ productive neurodegeneration collaboration, which began in 2016. The details of the selected programmes have not yet been disclosed. What we do know is that Evotec will get $40 million now and potential milestone payments in the future.
Dissatisfied with just one agreement, BMS is also paying Prothena $55 million for a global license to the latter’s clinical-phase Alzheimer’s candidate.
Meanwhile, the UK and Taiwan have signed an MoU on health cooperation. Specifically, the MoU will provide the framework for cooperation on activities in pandemic preparedness, digital health, health insurance, mental health, and healthy ageing.
The West’s Eastern affairs continue with Germany’s BioNTech entering a license agreement with China’s Zhejiang Doer Biologics. BioNTech will get a global license to use one of Doer’s discoveries to develop, produce and commercialise biotherapeutics against an undisclosed target.
Additionally, European specialty pharma company Neuraxpharm is expanding beyond its home continent into Brazil and Mexico.
But then the West’s endogamous relationships also continue. Pfizer is investing $25 million in genome editing company Caribou Biosciences. The company is also making a separate strategic investment of the same amount in the UK’s CellCentric to support the development of a groundbreaking oral treatment for cancer.
Further, in a deal worth up to $962 million, Astellas has inked a license agreement with 4D Molecular Therapeutics to use the latter’s viral vector for a rare monogenic eye disease. Which specific disease, we don’t yet know.
Back in the US, drug shortages are still not a thing of the past. The US intends to import more doses of the chemotherapy drug Cisplatin, which is in short supply, from China.
Since tech companies suddenly care about people’s well-being, 27 global investors managing $2.1 trillion are collaborating to help hardware, software, media, internet, gaming, edtech and telecom firms develop action plans to protect the mental health of consumers.
And finally, in the Americas, the National Regulatory Authorities of Regional Reference intend to develop a joint action plan to strengthen the regulation of medical products in the region.