💊 J&J gains two new lymphoma therapies; Pfizer dumps three drug candidates; US provides draft guidance for decentralised clinical trials
#332 | AstraZeneca takes on asthma in India; Nigeria don’t need no bird flu shots; EU wants to get self-reliant
Hello and welcome back to The Kable for the latest developments in the life sciences industry.
Johnson & Johnson is expanding its presence in the cancer space by acquiring the rights to two next-gen CAR T therapies from Cellular Biomedicines. The two treatments for diffuse large B-cell lymphoma – one in phase 1 testing and the other set to begin human testing this year – are making their way to the pharma giant’s portfolio in a $245 million deal.
Pfizer may have acquired Arena Pharmaceuticals for $6.7 billion in 2021, but now it wants to lighten that load a little bit. Pfizer is dumping three mid-stage medicines it procured through that acquisition, placing its bets on Etrasimod (currently in development for five diseases) alone.
Incyte, too, is cutting down its R&D pipeline, with 6 discovery programmes – one in anaemia and five in different cancers – going down the drain. The company still has 8 high potential candidates in the pipeline.
Boehringer Ingelheim, meanwhile, is investing over $300 million in a Chemical Innovation Plant at its headquarters to manufacture chemicals and APIs. The facility is expected to be operational by 2026.
The US’s Rockwell Medical is making its way into the UAE with a long-term supply agreement with Global Medical Supply Chain LLC to provide its haemodialysis products.
In the UK, over a million NHS staff are set to receive a 5% pay hike, putting an end to some of the strikes. But private companies aren’t so lucky; 6 of GSK’s manufacturing sites in the UK are being affected by worker strikes – the first wide-ranging strikes in the company’s history.
The US has released draft guidance for the conduct of decentralised clinical trials for medicines, biologics and medical devices. Decentralised clinical trials imply conducting trial-related activities at sites other than traditional set ups. The hope is that these can reduce the barriers to participation, improving the diversity of trial data and including those with accessibility issues.
Meanwhile, the US FDA has granted Breakthrough Therapy Designation for the investigational use of Boehringer Ingelheim’s Spesolimab in the prevention of flares in adult patients of generalised pustular psoriasis (GPP).
Another company is issuing a recall due to a labelling error. This time it is Teva recalling 13 batches of its Fentanyl Buccal tablets used as opioid agonists, indicated for breakthrough pain management in adult cancer patients.
In India, AstraZeneca is launching five Centres of Excellence as hubs for the treatment and management of severe asthma, hubs which will, in turn, support evolving asthma centres for a systematic approach to diagnosing and treating the condition.
In Thailand, researchers from Chulalongkorn University have developed an MTB strip test kit to diagnose tuberculosis, a disease with severe incidence in the country.
In Korea, the Korea Advanced Institute of Science & Technology has signed MoUs with the US’s Massachusetts General Hospital, Moderna and other partners to improve scientific and medical training and also develop new drugs and vaccines and conduct mRNA research in the country.
We seem to be finally bouncing back from the consequences of the pandemic, with a new WHO report saying that health systems have started showing the first major signs of recovery as the delivery of routine health services sees fewer disruptions. But limited availability of health workers, medicines and other resources still plague health delivery in some countries. Continued investments in recovery and resilience are key.
The WHO has also issued a medical product alert concerning the use of valproic acid, or sodium valproate, for the treatment of epilepsy and bipolar disorder in women of childbearing potential. This comes amidst concerns of high risks of birth defects and developmental disorders in children exposed to the substance in the womb.
In Latin America and the Caribbean region, PAHO and the AIDS Healthcare Foundation have announced their intention to collaborate on efforts to eliminate HIV/AIDS, TB, viral hepatitis, mpox, and other STIs like syphilis.
In Africa, Malawi is set to become the eighth country to ratify the African Medicines Agency treaty, following in Kenya’s footsteps as it signed the treaty in February this year. All eyes are still on South Africa, the region’s economic powerhouse, to sign the treaty.
The Nigeria Sovereign Investment Authority, in the meantime, has launched two flagship companies: NSIA Advanced Medical Service Ltd and Equilease Systems Limited to expand access to quality healthcare services and lease specialised medical equipment, respectively.
In Brazil, the dengue outbreak has seen 6,889 new cases and 6 deaths in the past week.
In Tanzania, an 18-month-old child succumbed to the Marburg virus, taking the country’s Marburg death toll to 6 this year.
And finally, in Nigeria, the agriculture and rural development minister is calling for a “no vaccination policy” for bird flu. It’s just a waste of money, he claims. Before rushing into vaccine imports, it would be better to conduct activities for virus strain identification, risk assessment and vaccine efficacy testing.