Keeping tabs on pharma: Clinical trials on pause in Russia

Pharma pauses clinical trials in Russia

Big pharma companies including Merck and Johnson & Johnson have announced they are pausing clinical trials in Russia, but will not stop the supply of medicines citing that healthcare products are exempt from sanctions as the reason. Pfizer has stated that while it will continue supplying medication to Russia, all profits from its Russian subsidiary will go towards humanitarian efforts in Ukraine.

A number of business leaders from the life sciences sector have expressed their disagreement with the companies that continue to trade with Russia. In an open letter they have condemned the invasion of Ukraine and call for “complete economic disengagement” with Russia, saying it should only be reversed “upon the restoration of peace and democracy in a sovereign Ukraine.” At the time of writing more than 870 executives had signed the letter, from companies including Ovid Therapeutics, Sensei, Biogen, Bain Capital Life Sciences and Adverum.

New alliance to develop digital measure for Alzheimer’s

The Digital Medicine Society (DiMe) has announced a new collaboration with Alzheimer’s Drug Discovery Foundation, Biogen, Boston University, Eisai, Eli Lilly and Company, Merck and Oregon Health & Science University to build a set of digital clinical measures for Alzheimer’s disease and related dementias (ADRD).

The organizations will work together to develop a standard to measure the symptoms of ADRD via digital tools such as wearable sensors, with the aim of improving drug development and clinical care.

“Digital measures offer enormous promise to bolster collective understanding of Alzheimer’s disease and related dementias,” says Jian Yang, Associate Vice President of Digital Health at Eli Lilly and Company.

“These measures can deepen our knowledge of disease progression, define new disease phenotypes, and support earlier diagnosis – all critically important insights for a condition where inaccurate and delayed diagnosis is common and the current standard of care does not target the underlying plaque pathology,” Yang added.

Bayer’s treatment for kidney disease approved in UK

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the use of Bayer’s Kerendia (finerenone) in Great Britain for the treatment of chronic kidney disease associated with type 2 diabetes in adults. Finerenone is the only drug that has been developed exclusively for chronic kidney disease, after randomized clinical trials found it significantly reduced the risk of kidney failure.

Professor David Wheeler, Professor of Kidney Medicine at University College London and Honorary Consultant Nephrologist at the Royal Free London NHS Foundation Trust said: “Chronic kidney disease associated with type 2 diabetes is the most common cause of kidney failure and often leads to patients requiring dialysis or a kidney transplant to stay alive.

“There remains a critical medical need to protect these patients by delaying kidney disease progression and reducing their risk of cardiovascular events, which is why this is welcoming news for patients living with the condition" Wheeler added. "Physicians in the UK now have another new treatment option to help improve kidney outcomes in this patient population.”

Also in the news:

• The World Health Organization (WHO) has advised Ukraine to destroy any pathogens in its health labs to prevent the spread of disease if any sites are destroyed during the war. Ukraine is an important R&D hub and runs approximately 500 clinical trials each year.
• Sickle cell disease could be treated with cutting edge gene therapies within a year, with Vertex Pharmaceuticals and Bluebird Bio both hoping to gain approval from the US Food and Drug Administration (FDA).
• Bristol Myers Squibb’s cancer drug Revlimid faces generic competition for the first time after 16 years of exclusivity. Sandoz and Stada Arzneimittel have already launched versions of the drug in Europe, while Teva has released its own product. 

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