Cambridge-based biotech company Alchemab has announced a new collaboration with British pharma AstraZeneca (AZ), aiming to accelerate research for prostate cancer. As part of the collaboration, Alchemab and AZ will collaborate on a proof-of-concept study to improve understanding of the ‘fundamental biology’ of prostate cancer. Alchemab will utilise its novel drug discovery platform as a diagnostic tool through the identification of disease biomarkers, with the potential to inform the development of new antibody-based medications. Under the agreement, Alchemab will sequence and explore antibody repertoires in patient samples gathered from a clinical trial of an undisclosed immuno-oncology agent within AZ’s pipeline. Alchemab may also be able to identify antibody sequence patterns that could be used as biomarkers for early detection and patient stratification by classifying patients into two groups – responders and non-responders. The overall purpose of the collaboration is to identify novel and disease-relevant antibodies which may generate therapeutic insights into ...
The Royal Pharmaceutical Society of Great Britain (RPS) has made new recommendations to increase the use of pharmacist independent prescribers (PIP) in the UK. In a statement, RPS highlighted that the role of PIPs has become ‘increasingly’ important in delivering high-quality clinical care. The Society added that it wants to see increased use of PIPs in multi-disciplinary teams to expand patient access to care, as well as create capacity in the healthcare system and improve health outcomes. The three core recommendations call on governments and healthcare organisations to proactively: establish the right infrastructure, systems and tools to enable patients to benefit from PIPs develop the PIP workforce required to work routinely as part of multi-professional teams in all health care settings provide ongoing professional development for PIPs as well as expand their role in teaching and peer support. “Non-medical prescribing was introduced in the UK some 30 years ago, but ...
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 ...
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 ...
The US Food and Drug Administration (FDA) has approved Kiniksa Pharmaceuticals’ interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) inhibitor Arcalyst (rilonacept) for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years and older. Recurrent pericarditis is an autoinflammatory cardiovascular disease that often presents with chest pain, and is associated with changes in electrical conduction and build-up of fluid around the heart. The FDA approval is based on positive data from the RHAPSODY trial in recurrent pericarditis. Data from this trial showed that Arcalyst treatment improved clinically meaningful outcomes associated with the significant unmet medical need in recurrent pericarditis. There were rapid and sustained reductions in both reported pain and inflammation as early as after the first dose of Arcalyst. “The approval of Arcalyst in recurrent pericarditis is an extremely important achievement for those suffering from this disease as there can be significant ...
The UK’s National Institute for Health and Care Excellence (NICE) has recommended selective internal radiation therapy (SIRT) for the treatment of advanced liver cancer in final draft guidance. NICE’s draft guidance recommends the use of SIR-Spheres – made by SIRTEX – and TheraSphere – made by Boston Scientific – for treating advanced liver cancer that can’t be removed surgically and when transarterial therapy is not appropriate. The recommendation also specifies that these two therapies should only be considered for people with Child-Pugh grade A liver impairment. Despite limited clinical trial data for SIRTs compared with other treatment options, NICE’s appraisal committee concluded that SIRT may have fewer and more manageable side effects compared to systemic therapy sorafenib. Although SIR-Spheres and TheraSphere are slightly less clinically effective than sorafenib, they cost less. The cost savings mean that these two therapies can be recommended as cost-effective options for people with Child-Pugh grade ...
The Competition Appeal Tribunal (CAT) has maintained a decision made last year by the UK’s Competition and Markets Authority (CMA) to fine pharmaceutical firm Lexon £1.2m after finding the company guilty of breaking competition law. Last year, the CMA found that Lexon, along with King Pharmaceuticals and Alissa Healthcare Research, had illegally shared commercially sensitive information in an attempt to drive up prices of the antidepressant nortriptyline. The CMA concluded that from 2015 to 2017 – when the cost of the drug was decreasing – the three companies exchanged information about prices, the volumes they were supplying and Alissa’s plans to enter the market. The CMA then fined all three companies, fining Lexon a total of £1.2m – however, Lexon maintained it had not broken the law and appealed the decision and fine. However, the CAT has decided to uphold the CMA’s original finding that Lexon broke competition law and ...
The UK trade association for in vitro diagnostics (IVD) companies BIVDA has welcomed the NHS Medtech Funding Mandate, a new policy aimed at accelerating the uptake of medical devices, diagnostics and digital products in the NHS. The new Mandate, which will come into effect from 1 April 2020, will aim to enable patients to access ‘pioneering’ IVD devices faster and with greater ease. For products to qualify under the Mandate, they must demonstrate that they are effective, deliver material savings to the NHS, are cost-saving in-year and are affordable to the NHS. The Mandate policy is set to be published annually in December, following a review and feedback improvement cycle. A list of technologies that meet the MedTech Funding Mandate criteria is expected to be published before the end of July. “The publication of the Mandate is an opportunity to celebrate the UK as a leader in technologies for health ...
MSD’s immunotherapy Keytruda (pembrolizumab) has been approved in the EU for the first-line treatment of metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) colorectal cancer. According to MSD, Keytruda is the first checkpoint inhibitor to be approved in the EU to treat MSI-H or dMMR colorectal cancer. The European Commission (EC) approval is based on results from the Phase III KEYNOTE-177 trail. In this study, Keytruda monotherapy significantly reduced the risk of disease progression or death by 40% compared to chemotherapy in this patient population. Treatment with Keytruda also more than doubled median progression-free survival (PFS) compared to chemotherapy – 16.5 months versus 8.2 months. For patients treated with Keytruda, the overall response rate (ORR) was 44%, with a complete response rate of 11% and a partial response rate of 33%. Meanwhile, in the chemotherapy arm, patients demonstrated an ORR of 33%, a complete response rate of 4% and ...
New research has revealed ‘dramatic changes’ in the delivery of radiotherapy treatments for cancer during the first wave of the COVID-19 pandemic in England. The study – led by the University of Leeds with Public Health England and the Royal College of Radiologists – is the first to evaluate the impact of the pandemic on radiotherapy services in England. Researchers discovered that the use of much shorter radiotherapy courses increased – in particular for breast cancer patients. The use of a shorter treatment course went from 0.2% of all breast cancer radiotherapy courses in April 2019, up to 60.0% of all courses in April 2020. The change to shorter courses of treatment was also observed in other types of cancer, with clinicians likely making the switch to keep patients safe and services running during the pandemic. According to the researchers, this change was made possible in part by results of ...
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