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

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

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

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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Merck and BioMedX set to partner as they strive to bolster their fight against cancer in a new joint cancer research programme

GERMANY – German based pharma company, Merck, and BioMed X, an independent research institute located at the University of Heidelberg in Germany have partnered to focus on their oncology related research. This is the eighth collaboration between the two organizations and is set to explore the role of extrachromosomal DNA (ecDNA) in cancer. BioMedX currently has two other ongoing oncology related programmes focused on DNA damage response and RNA splicing that this new research program is set to compliment. Extrachromosomal DNA (ecDNA) is any DNA that is found off the…

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Breakthrough as phase 1 clinical malaria vaccine trial results come positive with proof to give strong lasting protection against malaria

US – The National Institute of Allergy and Infectious Diseases’ (NIAID) phase 1 clinical trials of its malaria vaccine, Sanaria (PfSPZ), have found that the regimen conferred unprecedentedly high levels of durable protection when volunteers were later exposed to disease-causing malaria parasites. Trials were conducted at the National Institutes of Health (NIH) Clinical Centre in Bethesda, Maryland led by Patrick E. Duffy, M.D., of the NIH National Institute of Allergy and Infectious Diseases (NIAID), and Stephen L. Hoffman, M.D., CEO of Sanaria Inc., Rockville, Maryland. In the CVac trials, healthy…

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GSK unveils new portfolio and strategy, set to specialize on vaccines and medicines in a bid to grow its market scope

UK – GlaxoSmithKline (GSK), one of British pharmaceutical giants has updated its strategy, outlook and growth plans on its vaccines and specialty medicine portfolio as it is set to split its consumer healthcare and pharmaceutical businesses in mid-2022. GSK will now prioritize R&D and investment in vaccines and speciality medicines, which are expected to grow to around three-quarters of the company’s sales by 2026. The British drug maker said it will also ‘optimise’ various therapies, with a newly defined product group containing all of new GSK’s primary care brands. In…

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Sanofi’s and translate bio’s mRNA influenza vaccine now in its first phase clinical trials

US – Sanofi Pasteur, the vaccine global unit of Sanofi and Translate bio, is initiating the first phase clinical trials of its mRNA influenza vaccine. This is a move that proceeds positive preclinical safety and immunogenicity data of the mRNA vaccines which will assess the safety and immunogenicity (immune response) of the monovalent (single-strain) vaccine candidate in up to 280 participants.  The development of this vaccine has been ongoing since a joint venture collaboration between Translate Bio and Sanofi Pasteur that involved an exclusive license agreement that has been ongoing…

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Enhanze drug delivery technology brings ViiV Healthcare and Halozyme into a collaboration

UK – ViiV Healthcare, a global specialist HIV that is majorly owned by GlaxoSmithKline plc have announced a global collaboration and license agreement that gives exclusive access to Halozyme’s ENHANZE drug delivery technology, recombinant human hyaluronidase PH20 enzyme (rHuPH20), for specific targets used in the treatment and prevention of HIV. The license gives ViiV exclusive use of Halozyme’s proprietary rHuPH20 technology for four, specific HIV medicine targets that will expand opportunities for development of nearly all of ViiV’s pipeline assets. Under the terms of the agreement, ViiV Healthcare will make…

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Biosphere tenant Iksuda Therapeutics raises $47m to reinforce Antibody Drug Conjugate pipeline

UK – UK-headquartered Iksuda Therapeutics has announced the closing of a $47m (£34m) financing round, with the funds to be used to support the advancement of its lead antibody drug conjugate (ADC) assets. This includes the company’s lead pre-clinical ADC candidate IKS03, a potentially ‘best-in-class’ CD19-targeted asset for B-cell cancers. Iksuda will use the funds to support the progression of IKS03 into first-in-human Phase clinical trials, and will also be used to fast-track its earlier-stage programs. Currently, the company’s drug development pipeline is focused on the improved safety and efficacy…

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