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Novo Nordisk’s Sogroya moves closer towards EU approval

Novo Nordisk’s Sogroya (somapacitan) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use – moving closer towards approval in the EU. The CHMP has recommended marketing authorisation for Sogroya for the treatment of adults with growth hormone deficiency (AGHD). The recommendation is based on results from the Phase III REAL 1 clinical trial programme, which investigated the efficacy and safety of Sogroya in AGHD. “We are very pleased with the positive opinion for once-weekly Sogroya as we are committed to continuously developing innovative and efficient medicines for people living with growth hormone deficiency,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. “We are confident that Sogroya will make management of this serious chronic disease easier and help improve the quality of life for more people living with growth hormone deficiency,” he added. Sogroya is a ...
- Source: drugdu
- 399
- February 5, 2021
Novo Nordisk’s Sogroya
EU approves Chiesi’s triple combination asthma therapy Trimbow

The European Commission (EC) has approved a marketing authorisation for Chiesi Group’s triple combination asthma therapy Trimbow (beclometasone/formoterol/glycopyrronium). The marketing authorisation indicates Trimbow for use as a maintenance treatment for adult asthma patients, whose condition is not adequately controlled with a combination of long-acting beta2-agonist (LABA) and medium dose of inhaled corticosteroid (ICS). Patients must have also experienced one or more asthma exacerbations in the previous year. Chiesi’s triple asthma therapy has been shown to reduce exacerbations and improve lung function in patients with uncontrolled asthma, compared to ICS/LABA. Both the CHMP’s recommendation and the EC’s approval are based on efficacy and safety data from four clinical studies, involving almost 3,000 patients. “This is the first step towards taking our triple therapy for moderate to severe COPD patients and providing the same treatment option for appropriate asthma patients,” said Alessandro Chiesi, chief commercial officer of Chiesi Group. “The European Commission’ ...
- Source: drugdu
- 346
- February 3, 2021
asthma therapy Trimbow
NHS has offered COVID-19 vaccine to all eligible care homes in England

The NHS has now offered COVID-19 vaccinations to residents at all eligible care homes in England, according to official figures. In a statement, the health service said this marked a ‘major milestone for the NHS vaccination programme’, with vaccines having been offered to people living in over 10,000 care homes with older residents. The NHS added that a small number of care homes have had visits by vaccination staff deferred for safety reasons, although these homes will be visited as soon as possible. “Today marks a crucial milestone in our ongoing race to vaccinate the most vulnerable against this deadly disease,” said Prime Minister Boris Johnson. “We said we would prioritise and protect care home residents, and that is exactly what we have done,” he added. Johnson also added that 8.9 million people have now received the first dose of a COVID-19 vaccine. Older care home residents and staff were ...
- Source: drugdu
- 601
- February 2, 2021
Covid-19 vaccine
Roche’s faricimab hits primary endpoint in wet AMD studies

Roche’s investigational bispecific antibody faricimab has hit the primary endpoint in two Phase III studies in people living with neovascular or wet age-related macular degeneration (nAMD). In the identically designed studies – TENAYA and LUCERNE – faricimab, administered via injections at fixed intervals, met the primary endpoint, showing that people receiving the treatment achieved visual acuity outcomes that were non-inferior to those receiving Regeneron’s Eylea (aflibercept) injections every eight weeks. Within both studies, nearly half (45%) of participants were treated with faricimab every 16 weeks during the first year. “These results show the potential of faricimab as a new class of medicine that could extend time between treatments for people living with neovascular age-related macular degeneration,” said Levi Garraway, chief medical officer and head of Global Product Development, Roche. “We have now seen positive and consistent results in four Phase III studies for faricimab across both neovascular age-related macular degeneration ...
- Source: drugdu
- 466
- January 31, 2021
Roche
New NHS Medtech Funding Mandate welcomed by BIVDA

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 ...
- Source: drugdu
- 528
- January 30, 2021
IVD
Keytruda scores new EU approval in colorectal cancer

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 ...
- Source: drugdu
- 416
- January 29, 2021
colorectal cancer
Research finds decrease in radiotherapy treatments due to COVID-19

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 ...
- Source: drugdu
- 404
- January 28, 2021
Covid-19
Gilead’s Veklury should be effective against COVID-19 variants

Gilead Sciences has released a statement regarding the efficacy of its antiviral treatment Veklury (remdesivir), maintaining confidence in the its continued benefit against new COVID-19 variants. The new COVID-19 variants were discovered in the UK and South Africa, respectively. The UK variant, known as B117, was identified in the UK in early December, and was discovered to be much more transmissible than the original strain. The South African variant, known as B1351 or 501.V2, carries a number of mutations and is also thought to be more contagious. “We have completed genetic analysis of publicly available sequences for the UK and South African variants of SARS-CoV-2 and we believe remdesivir will continue to be effective against these variants,” said Gilead. “The mutations identified in these new variants have not significantly altered the part of the virus that remdesivir targets or have any association with known mutations conferring reduced susceptibility of coronaviruses ...
- Source: drugdu
- 315
- January 27, 2021
COVID-19 variants
Calquence tops Imbruvica in chronic lymphocytic leukaemia study

AstraZeneca’s Bruton’s tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) hit the primary endpoint in a Phase III study in chronic lymphocytic leukaemia (CLL). In the ELEVATE-RR trial, Calquence demonstrated non-inferior progression-free survival (PFS) compared to Janssen’s BTK inhibitor Imbruvica (ibrutinib) in adult patients with previously-treated, high risk CLL – the primary endpoint of the study. AZ’s drug also met a key secondary endpoint for safety, with Calquence-treated patients demonstrating a statistically significant lower incidence of atrial fibrillation compared to patients treated with Imbruvica. In a statement, AZ added that there was also a ‘descriptive’ trend for numerically favourable overall survival for Calquence. “With over forty months of follow-up, today’s results confirm that Calquence, a selective BTK inhibitor, displays superior safety in atrial fibrillation without compromising efficacy,” said José Baselga, executive vice president, Oncology R&D at AZ/ “The totality of the data confirm our confidence in the favourable benefit-risk profile of Calquence,” ...
- Source: drugdu
- 384
- January 26, 2021
Calquence
Servier and MiNA Therapeutics ink neurology pact

French pharma company Servier has entered into a research partnership with UK biotech MiNA Therapeutics to develop small activating RNA (saRNA) therapies for the treatment of neurological diseases. Under the terms of the deal, MiNA will engage its saRNA platform to identify new potential treatments with the aim of restoring normal cell function in neurological disorders. Meanwhile, Servier will be responsible for preclincial and clinical development of the lead candidates and will retain the rights for the commercialisation of any products resulting from the partnership. Although details of the specifics of the deal are sparse, the companies disclosed that MiNA would receive an upfront payment and exclusivity fee for certain ‘targets of interest’. MiNA will also be entitled to research and development, regulatory and commercial milestones and royalties. “MiNA’s innovative approach to activate gene expression through small activating RNAs is an exciting opportunity to unlock potential for the treatment of ...
- Source: drugdu
- 357
- January 25, 2021
neurology

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