UnaCom Product News Round Up

                                                        10th September- 16th September

                    


Monday 10th September

GSK's Nucala rejected by US Regulators for Coronary Pulmonary Obstructive Disorder

GSKs aim to expand Nucala's global outreach received a major setback today. GSK is hoping to have Nucala as an additional treatment for the reduction of patients with Coronary Pulmonary Obstructive Disorder (COPD). The FDA has issued a response letter asking for more clinical data to support the claims. The GSK when applying for approval from the FDA submitted the data from two trials, METREX and METREO. METREX, showed a statistically significant reduction in the frequency of moderate and severe exacerbations for Nucala compared to a placebo in patients with a broad range of eosinophil counts. However METREO, included just patients with higher eosinophil levels, showed a reduction in the frequency of moderate and severe exacerbations for Nucala compared to placebo, but the difference did not reach statistical significance. GSK has said that it “work closely with the FDA to determine the appropriate next steps” for the application. 

UK the first country in Europe, to launch flutiform k-haler for asthma

Napp Pharmaceuticals says the UK is the first European country to launch this new inhaler for adolescents and adults living with asthma. What makes this inhaler different is that it is activated by a low breathing-in force that makes it easier to use correctly. This is crucial as an estimated 2.5 million asthma sufferers make errors with their inhalers and are not taking them properly leading to exacerbation of the symptoms.

Tuesday 11th September 

NICE Rejects Opdivo for preventing melanoma recurrence 

NICE is blocking NHS funding for Bristol Myers Squibb Opdivo, as an adjuvant treatment for resected stage III and IV melanoma. The firm released data from its Phase three trial Checkmate, showing that, at 24 months, nearly two-thirds (63%) of patients treated with Opdivo (nivolumab) had longer recurrent-free survival compared to those treated with Yervoy (ipilimumab; 50%). However, in its draft guidelines, NICE said that clinical effectiveness was 'uncertain' and noted that there were no trails directly comparing the use of Opdivo, with the current treatment used (routine surveillance for completely resected stage III and IV melanoma.) With the uncertainty in the clinical trials data, it is therefore impossible for NICE to decide if Opdivo is cost effective.

Four New Medicines Avaliable in NHS Scotland

The Scottish Medicines Consortium has approved funding for four new treatments. Sanofi's Dupixent is the first biologic drug made available routinely from NHS Scotland for the treatment of moderate to severe atopic dermatitis in adults who do not respond well to the immunosuppressants. Also endorsed was Roche's /Chugai’s RoActemra (tocilizumab) for the treatment of Giant Cell Arteritis (GCA) in adult patients. This condition results in inflammation of blood vessels, which can be difficult to diagnose because of its wide range of symptoms, including severe headaches, scalp tenderness and jaw pain. NHS funding was approved for ViiV HealthCare’s Juluca (dolutegravir/rilpivirine), the first dual therapy treatment for HIV. Also, for HIV, Gilead’s Biktarvy was approved.

Thursday 13th September 

New cell/gene therapy production approved by MHRA

The production of cell/gene therapies in Stevenage for across the world has been approved by the MHRA. The MHRA has approved two licenses, a Manufacturing and Importation Authorisation (MIA) and an MIA for investigational medicinal product (MIA IMP), which fulfil an EU requirement to produce commercial medicines for patient use or to support clinical trials. This enables firms working in Stevenage to develop therapies that progress faster to clinical trials. Catapult, the main company at Stevenage accredited this swift approval by the MHRA, due to "close engagement with MHRA during the design, build and qualification of the centre." What makes the centre special is that its operating model allows collaborator companies to manufacture their therapies at scale with expertise and practical support from CGT Catapult experts across scientific research, manufacturing, supply and regulation.

Friday 14th September  

Landmark Multiple Sclerosis Trial starts in the UK

The biggest ever trial for secondary progressive multiple sclerosis (SPMS) has kicked off in the UK.  This trial has been co-founded by the MS (Multiple Sclerosis) Society, and the hopes of the trial are to confirm whether simvastatin could be one of the first drugs to slow or stop the progression of disability for SPMS, a form of the condition that currently has little effective treatment. The trial will involve 1,180 people at 30 UK sites. This follows results from a smaller trial, which showed simvastatin slowing disease progression and that it reduced the rate of brain atrophy, suggesting that is might protect nerves from damage in patients with the disease. The trial is co funded by the MS society, NICE and UK universities.

                                    

                       

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