GW Pharmaceuticals’ Epidyolex has received approval from the European Commission (EC) for the treatment of seizures associated with tuberous sclerosis complex (TSC) – its third indication in Europe. Specifically, Epidyolex (cannabidiol) has been approved as an adjunctive treatment of seizures associated with TSC for patients aged two years and older. TSC is a rare genetic condition that causes mostly benign tumours to grow in vital organs including the brain, skin, heart, eyes, kidney and lungs. The condition is typically diagnosed in childhood and the most common neurological feature in TSC is epilepsy. It is also associated with an increased risk of autism and intellectual disability, although the severity of the condition can vary widely. The EC approval is based on data from a Phase III trial evaluating Epidyolex for the treatment of seizures associated with TSC. This study hit its primary endpoint of reduction in seizure frequency, with seizure reduction ...
New real-world data has suggested that Russia’s Sputnik V vaccine is 97.6% effective against COVID-19, the Gamaleya Institute and the Russian Direct Investment Fund (RDIF) announced yesterday. The new efficacy rate is based on the analysis of data from 3.8 million Russians vaccinated with both components of Sputnik V from between 5 December 2020 and 31 March 2021. In a statement, the RDIF said the Ministry of Health of Russia maintains a register of those who have been vaccinated, as well as citizens who have been infected with COVID-19. According to the data, the infection rate starting from the 35th day from the date of the first injection was 0.027%. The incidence among the unvaccinated adult population was found to be 1.1% for a comparable period starting from the 35th day after the launch of the mass-scale vaccination in Russia. The data and calculations used to determine the vaccine’s efficacy will be ...
Gilead’s antibody drug conjugate (ADC) Trodelvy has received an accelerated approval from the US Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic urothelial cancer (UC), the most common form of bladder cancer. The approval covers the use of Trodelvy (sacituzumab govitecan-hziy) in patients with advanced UC who have previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. Trodelvy was approved on the basis of results from Gilead’s Phase II TROPHY study, which evaluated the drug as monotherapy or as a combination therapy in patients with metastatic UC after progression on a platinum-based chemotherapy and PD-1/L1 inhibitor. In 112 patients who were evaluable for efficacy, 27.7% of those who were treated with Trodelvy responded to treatment, with 5.4% experiencing a complete response and 22.3% experiencing a partial response. The study also found a median duration of response of 7.2 months for those treated ...
The Scottish Medicines Consortium (SMC) has approved NHS funding for four new medicines, including treatments for multiple myeloma and severe migraine in its April 2020 decisions. Firstly, Sanofi’s Sarclisa (isatuximab) has been accepted by the SMC for the treatment of relapsed or refractory multiple myeloma, in combination with two other medicines – pomalidomide and dexamethasone. This treatment was accepted following consideration through the SMC’s Patient and Clinician Engagement (PACE) process, which is used for medicines for end of life and rare conditions. Another medication developed by Sanofi – Dupixent (dupilumab) – was also accepted for use on NHS Scotland, for the treatment of a subgroup of patients with severe asthma. Dupixent will be offered as an option for patients with severe asthma who do not fully respond to standard treatment and require more intensive therapies, such as oral corticosteroids, to control their symptoms. “This is a very positive day for ...
Novartis has received green lights from both the European Commission and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to market its multiple sclerosis (MS) therapy Kesimpta (ofatumumab). The drug is a fully human anti-CD20 monoclonal antibody (mAb) thought to work by binding to a distinct epitope on the CD20 molecule, inducing potent B-cell lysis and depletion. It enables faster repletion of B cells versus other anti-CD20 monoclonal antibodies and so may offer flexibility in the management of RMS, according to the drugmaker. As per its licence, Kesimpta can be used to treat adults with relapsing forms of multiple sclerosis (RMS) with active disease, defined by clinical or imaging features. Novartis says it has the potential to become a recognised treatment option for eligible UK patients that can be self-administered, with initial guidance from an appropriately trained healthcare professional, once monthly at home via the Sensoready autoinjector pen. Initial ...
Pfizer and BioNTech have revealed positive top-line data for their COVID-19 vaccine – BNT162b2 – in adolescents aged 12 to 15 years old. The vaccine demonstrated 100% efficacy in a Phase III trial in adolescents aged 12 to 15 years old, with or without prior evidence of SARS-CoV-2 infection. BNT162b2 also produced ‘robust’ antibody responses in the younger population, exceeding those reported in an earlier trial in participants aged 15 to 25 years old. The jab was also found to be well tolerated in the 12 to 15 age group. The companies are now planning to submit the data to the Food and Drug Administration (FDA) in the US and the European Medicines Agency (EMA) to extend the use of the vaccine for this age group ‘as quickly as possible’. Pfizer and BioNTech will also continue to monitor the participants for long-term protection and safety for an additional two years after their ...
Bristol Myers Squibb (BMS) has revealed top-line data from a Phase II/III trial evaluating its PD-1 inhibitor Opdivo plus its investigational anti-LAG-3 antibody relatlimab in previously untreated metastatic or unresectable melanoma. The RELATIVITY-047 trial is evaluating a fixed-dose combination of Opdivo (nivolumab) and relatlimab compared to Opdivo alone in these patients. According to BMS, the trial met its primary endpoint of progression-free survival, with follow-up for the secondary endpoint of overall survival still ongoing. Although the company did not disclose the actual figures for the combination treatment, BMS said it would present the results at an upcoming meeting and discuss the findings with regulatory authorities. Lymphocyte-activation gene 3 (LAG-3) is expressed on effector T cells and regulatory T cells (Tregs). It regulates an inhibitory immune checkpoint pathway that limits the activity of T cells, which is believed to cause an impaired ability to attack tumour cells. In cancer, T cells exhibit progressive exhaustion ...
The NHS has announced that thousands of people will benefit from the extension of ‘COVID-friendly’ cancer treatments which can be taken at home. Since April, approximately 8,000 people have benefitted from treatment swaps, to enable cancer treatment to continue during the COVID-19 pandemic, with over 250,000 people beginning treatment for cancer since the start of the pandemic. The NHS will continue to fund effective and ‘less risky treatment[s]’ for patients during the pandemic, with access to these drugs now extended until summer and potentially continuing until the end of March 2022. Among the options available are targeted hormone therapies such as enzalutamide (Xtandi; Astellas/Pfizer) for prostate cancer and broadened use of lenalidomide (Revlimid; Bristol Myers Squibb) for myeloma. Some ovarian cancer patients will also be able to receive trametinib (Mekinist; Novartis) as a tablet alternative to chemotherapy, to help reduce the impact on their immune systems. “Cancer has been a priority throughout ...
Novartis UK and digital health company Cievert have announced a digital innovation partnership to help streamline the management of rheumatological and dermatological diseases. The initiative aims to support patient care in rheumatology and dermatology by utilising patient-reported data and allowing clinicians to prioritise appointments on a needs-based model of care. The partnership, which was identified via the Novartis BIOME selection procedure, will see Novartis and Cievert work closely with the NHS to launch pilot programmes across the UK. The digital platform will aim to collaborate with patients, healthcare professionals (HCPs) and the NHS across the UK and support them in three areas. Firstly, the partnership will aim to capture patient digital health records in one platform to reduce misalignment among healthcare teams. Secondly, the programme will aim to coordinate and prioritise appointments based on patient need, rather than routinely scheduled reviews. Lastly, the initiative will collect real-time patient data in ...
Cambridge, UK-based PhoreMost has announced the closing of a £33m Series B investment round from new and existing investors. The completed financing round was led by UK growth economy investor BGF as well as new investors XtalPi Inc., Astellas Venture Management, Trend Investment Group and o2h ventures. Additional contributions were made by existing investors Parkwalk Advisors, Morningside Ventures and Jonathan Milner. PhoreMost will use the financing to progress its PLK1 programme, which is initially targeted for the treatment of brain cancer, into the clinic within 18 months. The biopharma company will also advance multiple additional internal drug discovery programmes in oncology and ageing therapeutic indications. PhoreMost platform – SITESEEKER – is designed to identify new therapeutic targets for any disease setting, and identify how to develop novel drugs against these targets. In a statement, the company said it had recently used the platform to identify novel E3-ligands, which could have ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.