Tag: GSK

WHO roots for efficient malaria vaccines distribution

Frank

SWITZERLAND – The WHO has approved the RTS,S vaccine, for widespread use among Sub-Saharan African children and other regions with moderate to high malaria transmission rates, but now, the international agency has expressed that overcoming distribution hurdles will be critical to the vaccine’s success. Moving forward, WHO has warned that the rapid deployment of the malaria vaccine will be dependent on how quickly countries adopt the treatment and their availability of resources to support its rollout. The novel vaccine offers effective protection against Plasmodium falciparum, the deadly and widespread malaria…

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”Breakthrough” GSK malaria vaccine gets WHO approval for use in children in Africa

Frank

AFRICA – The World Health Organisation (WHO) has approved a ‘historic’ breakthrough vaccine against malaria that is set to save tens of thousands of lives in Africa and other developing countries. Developed by pharmaceuticals major GSK, the RTS,S/AS01 vaccine has received a rare approval to help manage the world’s leading killer of children under five and vulnerable people such as pregnant mothers. The recommendation by the WHO is based on results from an ongoing pilot programme in Ghana, Kenya and Malawi that has reached more than 800,000 children since 2019,  providing…

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ViiV Healthcare partners with Japan’s Shionogi to develop longer-acting HIV drug

Frank

USA – ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline (GSK) has agreed to collaborate with Shionogi on the development of ultra-long acting HIV drugs that could be administered as little as four times a year, potentially revolutionizing HIV treatment. GSK’s VIV has also developed the long-acting HIV injection Cabenuva, which combines cabotegravir with Janssen’s rilpivirine, as well as another combination therapy of dolutegravir and lamivudine, which is administered once every one or two months. Cabenuva is indicated as a complete regimen for the treatment of human…

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GSK and Vir Biotech COVID-19 antibody gets Japanese approval

Frank

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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GlaxoSmithKline, SK bioscience start final trial of COVID-19 jab

Frank

BRITAIN – British drugs giant GlaxoSmithKline and South Korean peer SK bioscience have announced the commencement of final stage trials of a Covid-19 jab after positive early results. The vaccine is facing a Phase 3 clinical trial to assess its safety and immunogenicity when compared with AstraZeneca’s Covid-19 vaccine, the two companies said in a joint statement. GSK is still trailing in the wake of Anglo-Swedish rival AstraZeneca, which rapidly developed a successful jab alongside Oxford University despite having little prior experience in vaccine development. The new jab combines SK…

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GSK-made malaria vaccine could save millions of children in Africa

Frank

AFRICA – A “game-changing” malaria vaccine developed by British researchers is poised to save the lives of millions of children in Africa after trial results beat all expectations. The jab, developed by the Brentford-based pharmaceutical company GSK, was found to reduce the rate of severe malaria by 70% in a study involving nearly 6,000 children aged between five and 17 months in Burkina Faso and Mali. However, the medical cocktail must be taken in the run-up to the rainy season. Malaria mainly affects children and young people, killing more than…

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U.S. FDA declines to approve FibroGen’s anemia drug citing insufficient trial data

Frank

USA – FibroGen Inc said has announced that the U.S. Food and Drug Administration has declined to approve its treatment for anemia of chronic kidney disease, citing the need for an additional clinical study. Last month, a panel of experts to the FDA voted against the approval of the company’s drug candidate, roxadustat, which the company is developing in partnership with AstraZeneca. FibroGen shares slipped 2.5% to $12.9 before the bell following the negative decision by the regulator. Ahead of the expert panel meeting, the FDA had raised concerns about…

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GlaxoSmithKline’s chronic rhinosinusitis drug therapy gains FDA’s approval

Frank

UK – The US Food & Drug Administration (FDA), has approved GlaxoSmithKline’s interleukin-5 (IL-5) inhibitor that will be used to treat chronic rhinosinusitis with nasal polyps (CRSwNP). FDA has cleared Nucala as an add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. The approval is based on data from GSK’s SYNAPSE study which evaluated the effect of Nucala versus placebo in over 400 patients with CRSwNP. In this trial, Nucala achieved significant improvement in reducing the size of nasal…

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Brian McNamara takes over as GSK’s CEO Designate for newly independent consumer healthcare company

Frank

UK – Brian McNamara, the CEO of GSK Consumer Healthcare (a Joint Venture between GSK and Pfizer) has been appointed as CEO Designate of the new, listed Consumer Healthcare company which will result from the proposed demerger of Consumer Healthcare from GSK in 2022. As set out at GSK’s Investor Update on 23 June 2021, subject to approval from shareholders, the separation of Consumer Healthcare will be by way of a demerger in mid-2022 of at least 80% of GSK’s holding to shareholders. The company will have a strong portfolio…

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Codexis receives milestone payment from GlaxoSmithKline as it focuses on commercializing its CodeEvolver technology

Frank

WORLD – Codexis, a leading enzyme engineering company, has received a huge sum of money from GlaxoSmithKline (GSK), a drug manufacturing giant, in a deal that will provide GSK licensing rights to utilize the CodeEvolver technology. This milestone earning marks the advancement of the commercialization of an enzyme, generated using CodeEvolver under the licensing agreement, that is engineered to improve a key step in the manufacturing process for a currently undisclosed drug. The milestone, which was expected in the second half of 2021, was recorded as revenue in the second…

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