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Positive results for Pfizer/BioNTech’s COVID-19 vaccine in 12-15 year olds

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 ...
- Source: drugdu
- 406
- April 2, 2021
Covid-19 vaccine
BMS’ Opdivo plus LAG-3 antibody relatlimab show promise in melanoma

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 ...
- Source: drugdu
- 362
- April 1, 2021
Melanoma
NHS extends ‘COVID-friendly’ at-home cancer care

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 ...
- Source: drugdu
- 209
- March 31, 2021
Covid
Novartis UK signs digital partnership with Cievert for chronic disease management 29th March 2021

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 ...
- Source: drugdu
- 369
- March 29, 2021
Novartis
Cambridge start-up PhoreMost raises £33m to progress PLK1 programme

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 ...
- Source: drugdu
- 311
- March 26, 2021
PLK1
FDA nod for Kiniksa’s Arcalyst in recurrent pericarditis

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 ...
- Source: drugdu
- 281
- March 23, 2021
Kiniksa
UK approval for Daiichi Sankyo’s cholesterol-lowering treatments

Daiichi Sankyo’s cholesterol-lowering drugs Nilemdo and Nustendi have been approved by the UK National Institute for Health and Care Excellence (NICE) for use on the NHS. Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe) have been recommended for the treatment of primary hypercholesterolaemia or mixed dyslipidaemia (heterozygous familial and non-familial). It is authorised as an adjunct to diet and when statins are contraindicated or not tolerated, or when the standard cholesterol treatment ezetimibe alone does not control low-density lipoprotein cholesterol (LDL-C) adequately. “Today’s decision is a landmark step forward for patients and the NHS in working towards a national ambition of preventing cardiovascular disease and events in line with the Long Term Plan,” said Manuel Reiberg, managing director, Daiichi Sankyo UK. “We are now more dedicated than ever to reduce the impacts of the UK’s biggest killer through our ongoing collaboration with the medical community and the NHS,” he added. In the UK, ...
- Source: drugdu
- 271
- March 19, 2021
cholesterol-lowering
Frontline charities sign open letter backing COVID-19 vaccination drive

A partnership of frontline health charities has signed an open letter encouraging people with underlying conditions to book in for a COVID-19 vaccine. The charities, including Mencap, Diabetes UK and Lupus UK, have urged people with conditions including cancer, diabetes and heart disease to protect themselves and others around them from the coronavirus by receiving a vaccine. Although over half of those in this priority group – known as cohort six – have already received their first vaccine dose, the charities’ letter is ‘hoped’ to further increase take-up among this group. Cohort six includes individuals aged 16 to 64 years old who have certain long-term conditions, identified by the Joint Committee on Vaccination and Immunisation (JCVI), that puts them at a higher clinical risk from COVID-19. It also includes carers who are eligible for a carer’s allowance, as well as those who are the sole or primary carer of an ...
- Source: drugdu
- 357
- March 18, 2021
Covid vaccine
AZ’s vaccine safety review shows ‘no evidence’ of an increased risk of blood clots

AstraZeneca (AZ) has issued an update on the safety of its COVID-19 vaccine, saying a review showed no evidence of an increased risk of blood clots among people vaccinated with its jab. In a statement, AZ said that across the EU and UK, there have been 15 events of deep vein thrombosis (DVT) and 22 events of pulmonary embolism reported among people given its vaccine – based on the number of cases the company has received as of 8 March. AZ added that a ‘careful’ review of all available safety data – including more than 17 million people vaccinated in the EU and UK with its COVID-19 vaccine – has shown ‘no evidence of an increased risk of pulmonary embolism, DVT or thrombocytopenia, in any defined age group, gender, batch or in any particular country.’ The cases reported so far are ‘much lower’ than what would be expected to naturally ...
- Source: drugdu
- 377
- March 16, 2021
Covid-19 vaccine
GSK to leverage the Cell and Gene Therapy Catapult’s facility in Stevenage

GlaxoSmithKline (GSK) is set to leverage the Cell and Gene Therapy (CGT) Catapult’s facility in Stevenage to expand its own clinical trial manufacturing capacity for cell and gene therapy. GSK will use the Stevenage facility to perform GMP cell processing to accelerate its pipeline of cell and gene therapy for clinical trials and streamline technical transfer. “The UK already has significant capabilities in cell and gene therapy, and this agreement illustrates how strategic investments by GSK can make them even stronger,” said Tony Wood, senior vice president, medicinal science and technology, GSK. “Working more closely with CGT Catapult will help us advance our promising cell and gene therapy programmes, and bring these transformative medicines more quickly to the patients who desperately need them,” he added. There has been a 48% increase in the UK GMP manufacturing space for cell and gene therapies in 2020, according to CGT Catapult. It added that ...
- Source: drugdu
- 319
- March 12, 2021
GSK

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