Tag: Roche

Sanofi’s Kevzara shortage looms as Actemra scarcity spills over

Frank

FRANCE – Actemra from Roche has been in high demand since its efficacy in treating severe COVID-19 was established, resulting in shortages. Sanofi’s rival therapy Kevzara has now been impacted by supply constraints as well. According to Sanofi, based on current demand, supply of all four Kevzara (sarilumab) formats – 150 mg or 200 mg pre-filled syringes or auto-injectors – will be limited until early 2022. Roche’s arthritis medication Actemra has quickly risen to the forefront of the pandemic fight for critically ill COVID-19 patients. In August, Roche’s Genentech division…

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AMREF inks partnership with Roche EA to support Community Health Workers

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KENYA – Amref Health Africa has entered into a partnership with Roche East Africa Limited to implement a two-year program aimed at addressing and reducing the burden of cervical and breast cancer among women in rural and low resource settings using Community Health Workers (CHWs) living with disabilities. Amref Health Africa’s Global CEO Dr. Githinji Gitahi said the organisation is working with county Governments and the Ministry of Health to ensure that CHWs with disabilities are not left out in advancing critical health information to communities. He noted that since…

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GSK and Vir Biotech COVID-19 antibody gets Japanese approval

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JAPAN – Sotrovimab, a COVID-19 antibody therapy developed by GlaxoSmithKline in collaboration with Vir Biotechnology has received Special approval for emergency use in Japan for patients who are not severely ill. Sotrovimab, is a monoclonal antibody that attacks the virus, is given intravenously, became the fifth medicine in Japan for treating COVID-19. The fast-tracked approval of sotrovimab came after a health ministry expert panel gave a positive nod for the therapy.   FDA granted Sotrovimab an Emergency Use Authorization (“EUA”) in May for the treatment of mild-to-moderate COVID-19 in people…

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Biogen’s wet AMD drug receives US FDA nod posing competition to Roche’s Lucentis

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USA – Biogen Inc together with Samsung Bioepis Company Limited have announced that the USFDA has granted their neovascular age-related macular degeneration (wet AMD) drug, Ranibizumab, approval for use against macular edema. This drug will be in competition with Lucentis, Roche’s blockbuster drug which was approved in 2006 and has accumulated sales of over US$1.61 billion in U.S. this past year. FDA’s approval is another win for Biogen, which in the recent months has been hitting headlines due to its controversial yet trendsetting Alzheimer’s drug Aduhelm. Ranibizumab is an anti-vascular…

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Roche strikes US$3 billion deal with Adaptimmune to develop cell therapies for cancer

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SWITZERLAND – Roche has acquired rights to a group of off-the-shelf cancer cell therapy programs from Adaptimmune, agreeing to work with the biotech on five “shared cancer targets” as well as some additional personalized T cell therapies. The Swiss drugmaker will pay Adaptimmune US$150 million now and could add another US$150 million over five years if the deal remains active that long. The deal could be worth more than US$3 billion if various milestones are met, though that money isn’t guaranteed. Adaptimmune could also opt for royalties on sales or…

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India’s Hetero given green light to make Roche’s COVID-19 drug

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INDIA – Hetero, an Indian drug developer, has received emergency use approval from the country’s health authorities to make a generic version of Roche Holding AG’s COVID-19 drug. Hetero expects to make the treatment, tocilizumab, available in India by the end of the month under the brand name Tocira. Tocilizumab has been facing a global shortage as the highly contagious COVID-19 Delta variant drives up cases in several countries. COVID-19 cases in India have declined from levels hit during the second wave in April and May, although health experts believe…

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Roche gets approval for diagnostic tumor test as WHO warns unfair distribution of COVID-19 Arthritis drug

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SWITZERLAND – Roche has received approval from the U.S. Food and Drugs Administration for its Ventana MMR RxDx panel, a diagnostic test to help identify patients with solid tumors which could turn cancerous. The test evaluates a panel of DNA mismatch repair (MMR) proteins in tumors to provide important treatment information to clinicians, the company said. When MMR is deficient, cells mutate which can lead to cancer. Even as the Swiss drug maker celebrates this milestone, the World Health Organization has called on the company to ensure fair distribution of…

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Roche sets bar in early lymphoma treatment with Polivy study results

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SWITZERLAND – Swiss pharmaceutical giant, Roche, has said its cancer drug Polivy combined with a common chemotherapy regimen holds lymphoma in check for longer than the standard drugs, in patients who have not been previously treated. According to Roche, the drug is the first treatment shown to improve outcomes in such patients in 20 years. Polivy is currently approved for patients with an aggressive form of lymphoma after their disease has progressed following two prior treatments. Lymphoma is a cancer of the lymphatic system, which is part of the body’s…

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FDA gives priority review to Roche’s Tecentriq lung cancer drug

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SWITZERLAND – The United States Food and Drugs Administration (FDA) has granted a priority review for Roche’s Tecentriq treatment for people suffering with early, non-small-cell lung cancer (NSCLC), the Swiss company has said. The FDA is due to decide on approval by Dec. 1 for the use of Tecentriq as an adjuvnt treatment, where a substance is used to increase the efficacy or potency of certain drugs, Roche said. “New treatment options are urgently needed in early-stage non-small cell lung cancer to help the nearly 50% of people who currently…

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Roche ventures into Indian market with its muscular atrophy prescription drug

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SWITZERLAND – Pharmaceutical giant, Roche have launched a prescription medicine Evrysdi in India, which is used for treatment of spinal muscular atrophy (SMA) in adults, children aged 2 months and older. Evrysdi was first approved by the United States Food and Drug Administration (US FDA) in August 2020 and is now available in India within 11 months of the US approval. Since its launch, over 4,000 SMA patients across over 50 countries have benefited from the drug, this is according to Roche. Roche has also had its data related to…

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