Diabetes is one of the most common chronic diseases and is mainly classified into type 1 diabetes, type 2 diabetes, gestational diabetes and others. Worldwide, 90% of diabetic patients suffer from type 2 diabetes, which greatly promotes the development of the diabetes drug market.
People who understand the process of medical registration for India would know that Indian registration is divided into two steps, which are Marketing Approval and Product Registration.You can find the details of the registration profile and flowchart from different countries we have prepared for you on Ddu (Drugdu.com). Ddu has listed the key points about what we need to do after the first official submission of Marketing Approval documents. 1. Wait for the official feedback, and follow the feedback to make the corresponding data revisions and supplements; 2. Get prepared for the plan of clinical Phase; You may have doubts while reading this point, why do we need to prepare a clinical plan during the first stage of registration, which is the Marketing Approval stage? First, the clinical Phase 3 study is a major premise for vaccine products to enter the Indian market; Secondly, the review ...
The UK has sequenced over 600,000 positive COVID-19 tests, providing ‘invaluable data’ in the fight against the virus, the Department of Health and Social Care (DHSC) announced last Friday. According the DHSC, the UK is estimated to contribute around 23% of all COVID-19 sequencing across the globe uploaded to GISAID. In the early stages of the pandemic, the COVID-19 Genomics UK (COG-UK) consortium was created to enable the delivery of large-scale and rapid whole-genome virus sequencing for local NHS centres and the government. The data collected by COG-UK has aided public health agencies in decision making for managing COVID-19 outbreaks and for informing vaccine development efforts. When sequenced, virus genome data can then be combined with clinical and epidemiological datasets to help inform UK public health interventions and policies. In a statement, the DHSC added that this information will also enable the evaluation of novel treatments and non-pharmacological interventions in ...
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 ...
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 ...
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, ...
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 ...
Many vaccines have highly specific storage requirements that if not met can reduce their potency significantly, even rendering them completely ineffective. Vaccines must be stored correctly from the moment they are manufactured until they are ultimately administered, and this is the shared responsibility of the manufacturer, distributor, and healthcare provider. What are the most common storage conditions? The vast majority of vaccines should be stored at between 2-8⁰C in a refrigerator, with a preferred average of 5⁰C, though some should remain frozen in a range between -15 to -50⁰C. Additionally, many should be protected from light and are packaged appropriately, as UV-light can damage them. Many live-virus vaccines can tolerate freezing temperatures and rapidly deteriorate once defrosted, while inactivated vaccines more commonly require stable temperatures of 2-8⁰C and are damaged at temperature extremes. The commonly administered measles, mumps, rubella (MMR) vaccine can be stored either frozen or refrigerated, while the MMRV vaccine ...
Vaccines must be stored in specific conditions to avoid degradation, usually defined specifically by the manufacturer. Across the stages of manufacture, distribution, storage, and ultimately administration, these conditions must be adhered to, and this process is known as the cold chain. Should the cold chain be broken at any point during transport or storage, via exposure to temperate extremes, then the potency of the vaccine risks being reduced, or the vaccine is even rendered completely ineffective. The vast majority of vaccines must be refrigerated at between 2-8⁰C, with a preferred average of 5⁰C with minimal fluctuations. Specially designed lab refrigerators are usually used for this purpose, which has comparatively minimal temperature fluctuation across days and seasons, do not present any temperature extremes on any interior surface, and may bear an external temperature display that automatically logs the internal temperature at particular time intervals. Many live vaccines tolerate freezing, and depending on the ...
Researchers in Canada have conducted a study suggesting that novel Cannabis sativaextracts may decrease levels of the host cell receptor that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) uses to gain viral entry to target tissues. SARS-CoV-2 is the agent responsible for the current coronavirus disease 2019 (COVID-19) pandemic that continues to sweep the globe threatening public health and the worldwide economy. The team – from the University of Lethbridge and Pathway Rx Inc., Lethbridge – developed hundreds of new C. sativa cultivars and tested 23 extracts in artificial 3D human models of the oral, airway and intestinal tissues. As recently reported in the journal Aging, 13 of the extracts downregulated expression of the SARS-CoV-2 host cell receptor angiotensin-converting enzyme 2 (ACE2). “The observed down-regulation of ACE2 gene expression by several tested extracts of new C. sativa cultivars is a novel and crucial finding,” say the researchers. “While our most effective extracts require further large-scale validation, ...
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