Novartis’ Pluvicto has been recommended for conditional marketing authorisation (CMA) in the EU to treat adult patients with prostate cancer.

The CMA is for patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC)
Prostate cancer is the most frequently diagnosed cancer in 112 countries, with more than 1.4 million new cases and 375,000 deaths in 2020 alone. More than 80% of patients with prostate cancer have a biomarker called PSMA, making it a promising diagnostic and therapeutic target for radioligand therapy, according to Novartis.

The decision from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is based on positive results from the company’s phase 3 VISION study in which Pluvicto plus best standard of care (BSoC) demonstrated ‘significantly improved’ overall survival in PSMA-positive mCRPC patients previously treated with AR pathway inhibition and taxane-based chemotherapy compared to BSoC alone.

Specifically, patients treated with Pluvicto plus BSoC had a 38% reduction in risk of death and a 60% reduction in the risk of radiographic disease progression or death compared to BSoC alone. Moreover, 29.8% of patients with evaluable disease at baseline demonstrated an overall response with Pluvicto plus BSoC, compared to 1.7% for BSoC alone.

Boehringer Ingelheim and HeartBeat.bio have entered into a collaboration to accelerate the development of new therapy options and achieve better outcomes for people with heart disease.

The collaboration will focus on the investigation of human cardiac organoids (Cardioids) for high-throughput early safety assessment and drug discovery.

Using selected reference compounds from its research and development programmes, Boehringer Ingelheim will work with the scientists from HeartBeat.bio to further advance the company’s 3D biology screening platform.

Heart and circulatory diseases are responsible for a quarter of all deaths in the UK, totalling more than 160,000 deaths each year – an average of 460 deaths each day or one every three minutes in the UK.

Up to one-third of investigational new drugs across all therapy areas fail in late-stage clinical trials due to safety concerns – in most cases due to adverse cardiovascular reactions – and existing cardiac safety screening models, such as cardiomyocytes, are limited in predictability as they are not able to adequately recapitulate human heart physiology, HeartBeat.bio outlined.

The company’s 3D biology screening platform aims to overcome these limitations by using self-organising, highly scalable Cardioids as translational models for high-throughput early safety assessment and drug discovery.

HeartBeat.bio explained that its heart organoids are stem-cell derived 3D cell culture systems that mimic the human heart physiology in a ‘totally new way’.

Dexcom has announced the launch of Dexcom G7, its next-generation continuous glucose monitor for people with diabetes aged two years and older in the UK, Ireland, Germany, Austria and Hong Kong.

The launch follows news that the Dexcom ONE Real Time-CGM is now available for prescription on the NHS to all those with type 1 diabetes. The monitor uses a sensor that attaches to the wearer’s arm for up to ten days and measures glucose levels from just under the skin, allowing those with diabetes to keep track of their glucose levels without having to scan or take a finger prick test.

The Dexcom G7 builds on the Dexcom CGM, with new features including a 60% smaller, all-in-one, discreet wearable, as well as a 30-minute sensor warm-up, and allows for remote monitoring, enabling users to share glucose data with healthcare professionals, parents and carers.

Other new features include a 12-hour grace period to replace finished sensors for an easier transition between sessions and a simplified mobile app, to which the wearer’s real-time glucose readings are sent.

The company also outlined its plans to introduce G7 in New Zealand and South Africa in the coming months, with additional markets planned soon after.

The NHS has announced its plans to launch an innovative laser therapy – known as laser interstitial thermal therapy (LITT) – for those diagnosed with epilepsy, who have not previously responded well to other therapies.

The first surgeries are set to take place in early 2023 and could benefit up to 150 NHS patients each year, offering hope to thousands of people living with the condition.
The fibre optic laser requires a 1.5mm-wide probe into the skull and destroys the brain tissue that causes epilepsy from the inside by using heat.

The treatment uses an MRI scanner and the specialist clinical team carefully navigates through the brain, avoiding blood vessels and other critical structures, while also monitoring the temperature of the surrounding areas to ensure healthy brain tissue does not overheat.

For those undergoing the treatment, the small wound heals quickly, allowing patients to go home the next day with minimal risk of infection or other side effects.

The launch of the laser is the latest result of the NHS’s Long Term Plan commitment, ensuring patients across the country are able to access the latest treatments available.
Approximately 600,000 people in the UK have epilepsy and, of those, one in three are unable to control their seizures with drugs alone and may need invasive neurosurgery to remove the part of the brain that is causing the seizures.