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GSK’s Blujepa Approved by FDA for Uncomplicated Urinary Tract Infections
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UK-based pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its drug Blujepa (gepotidacin). The approval allows the use of Blujepa in female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract…
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Bain Capital to Acquire Tanabe Pharma in JPY 510 Billion Deal
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Bain Capital is set to acquire Mitsubishi Tanabe Pharma Corporation (Tanabe Pharma) in a carve-out transaction from Mitsubishi Chemical Group Corporation. The deal, led by Bain Capital’s Private Equity teams in Asia and North America together with the firm’s Life Sciences team, values the business at approximately JPY 510 billion…
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GSK Acquires IDRx for $1B to Boost GIST Treatment Pipeline
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UK-headquartered GlaxoSmithKline (GSK; NYSE: GSK) has entered into an agreement with US-based biopharma IDRx, Inc. to acquire the company for an upfront payment of USD 1 billion, along with an additional USD 150 million in success-based regulatory approval milestone payments. This strategic acquisition is aimed at strengthening GSK’s portfolio in…
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GSK’s Shingrix Prefilled Syringe Accepted for FDA Review
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UK-headquartered GlaxoSmithKline (GSK; NYSE: GSK) has announced that a market filing for a prefilled syringe presentation of its recombinant zoster vaccine Shingrix has been accepted for review by the US Food and Drug Administration (FDA). This development marks a significant step towards enhancing the convenience and efficiency of vaccine administration.…
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GSK Launches Cabotegravir Injection in China for HIV Pre-Exposure Prophylaxis
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UK-based GlaxoSmithKline (GSK; NYSE: GSK) has announced the official commercial launch of its cabotegravir injection in China. The integrase strand transfer inhibitor (INSTI) was approved in May of last year for pre-exposure prophylaxis (PrEP) of HIV-1 in adults and adolescents (weighing ≥ 35kg) at risk of infection, to reduce the…
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GSK’s Nucala Receives New Indication Approval in China for CRSwNP
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UK-based pharmaceutical company GlaxoSmithKline’s (GSK; NYSE: GSK) has announced that it has received another indication approval in China for its anti-interleukin-15 (IL-15) biologic, Nucala (mepolizumab). The drug is now approved as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP)…
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GSK’s Blenrep and Star Pharma’s Topiramate Solution Target Priority Review in China
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The China’s Center for Drug Evaluation (CDE) website has signaled that GlaxoSmithKline’s (GSK; NYSE: GSK) Blenrep (belantamab mafodotin) and Star Pharmaceutical Ltd.’s topiramate oral solution are on track to receive priority review statuses in China. Blenrep: An Antibody-Drug Conjugate for Multiple MyelomaBlenrep is an innovative antibody drug conjugate (ADC) that…
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GSK Enters Multi-Program Partnerships with Relation Therapeutics for Fibrotic Diseases and Osteoarthritis
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UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) has formed two multi-program strategic partnerships with compatriot firm Relation Therapeutics. These deals are focused on the identification and validation of novel therapeutic targets for fibrotic diseases and osteoarthritis, with GSK obtaining global development and commercialization rights to any resultant targets. Financial Terms…
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Chongqing Zhifei Biological and GlaxoSmithKline Amend Distribution Agreement for Herpes Vaccine
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China-based Chongqing Zhifei Biological Co., Ltd (SHE: 300122) has entered into a supplementary exclusive distribution and co-promotion agreement with UK pharmaceutical major GlaxoSmithKline (GSK, NYSE: GSK), optimizing and adjusting the original deal concerning the recombinant herpes zoster vaccine. The revised agreement removes the original minimum procurement amount, allowing Zhifei Bio…
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GSK’s Blenrep BLA for Multiple Myeloma Treatments Accepted by FDA for Review
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UK-based pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Blenrep (belantamab mafodotin). GSK is seeking approval for the drug in combination with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex…
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GSK’s Arexvy Receives MHLW Approval for Expanded RSV Indication in Japan
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UK-based pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK) has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved an expansion of the indication for Arexvy to include adults aged 50-59 who are at an increased risk of respiratory syncytial virus (RSV) infection. This marks a significant step in…
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GSK’s Linerixibat Demonstrates Efficacy in Phase III GLISTEN Study for Cholestatic Pruritus
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UK-based pharmaceutical giant GlaxoSmithKline (GSK; NYSE: GSK) has announced positive headline results from the Phase III GLISTEN study, which assessed the efficacy of its ileal bile acid transporter (IBAT) inhibitor, linerixibat, in treating cholestatic pruritus (relentless itch) associated with primary biliary cholangitis (PBC). Study Design and Primary Endpoint AchievementThe GLISTEN…
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GSK Leaves BIO, Joining Other Major Companies in Withdrawing Membership
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GlaxoSmithKline (GSK; NYSE: GSK), a leading pharmaceutical company based in the UK, has reportedly withdrawn from the US industry trade group Biotechnology Innovation Organization (BIO). This decision follows a similar trend set by Pfizer (NSE: PFIZER), UCB (EBR: UCB), WuXi AppTec (HKG: 2359, SHA: 603259), Takeda (TYO: 4502), and other…
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China’s Evopoint Biosciences and UK’s GSK Eye Breakthrough Therapy Designations for Cancer Therapies
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BEIJING/LONDON—The Center for Drug Evaluation (CDE) in China has indicated that Evopoint Biosciences’ EZH2 inhibitor XNW5004 and GlaxoSmithKline’s (GSK) antibody drug conjugate (ADC) belantamab mafodotin are on track to receive breakthrough therapy designations (BTDs). Evopoint Biosciences’ XNW5004 is targeting the recurrent or refractory peripheral T-cell lymphoma indication and has demonstrated…
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BioAge Labs Taps Former GSK CEO Jean-Pierre Garnier as Chairman
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NEW YORK—BioAge Labs, a US-based biotechnology company specializing in anti-aging therapies, has announced the appointment of Jean-Pierre Garnier, the former chief executive officer of GlaxoSmithKline (GSK, NYSE: GSK), as Chairman of its board of directors. Garnier’s extensive experience in the pharmaceutical industry is expected to provide strategic guidance as BioAge…
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GSK Reports Q2 2024 Earnings with 13% Growth, Vaccines Unit Sees Mixed Results
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UK pharmaceutical giant GlaxoSmithKline (GSK; NYSE: GSK, LON: GSK) has reported its financial results for the second quarter of 2024, showing a robust year-on-year (YOY) growth of 13% in constant currency terms, reaching £7.88 billion ($10.12 billion). The company’s performance was marked by growth across all business units, with the…
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GSK Enters into Strategic Partnership with Flagship Pioneering to Develop Novel Medicines and Vaccines
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UK pharmaceutical giant GlaxoSmithKline (GSK; NYSE: GSK, LON: GSK) has announced a new partnership with Flagship Pioneering, a biotech company based in Cambridge, Massachusetts, known for its role as a bioplatform for innovation across a diverse portfolio of over 40 companies. The collaboration will see an initial joint funding of…
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Innovax Biotech and GSK Terminate Collaboration on Next-Generation HPV Vaccine
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Xiamen Innovax Biotech Co., Ltd., a Chinese biopharmaceutical company, and GlaxoSmithKline (GSK, NYSE: GSK), a leading UK pharmaceutical giant, have agreed to terminate their alliance for the development and commercialization of next-generation human papillomavirus (HPV) vaccines. The partnership, which began in September 2019, resulted in the creation of HPV9-AS04, a…
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GSK Secures Global Rights to CureVac’s mRNA Vaccine Candidates in Expanded Partnership
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GlaxoSmithKline (GSK, NYSE: GSK) , a UK-based pharmaceutical giant, is poised to expand its partnership with CureVac N.V. (Nasdaq: CVAC), a German mRNA specialist. The revised agreement will grant GSK full global rights to develop, manufacture, and commercialize mRNA candidate vaccines for influenza and COVID-19, encompassing related combination regimens. As…
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GSK Partners with Ochre Bio to Access Liver Data for Hepatology Therapy Development
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GlaxoSmithKline (GSK; NYSE: GSK), a UK-based pharmaceutical giant, has entered into an agreement with fellow UK biotechnology firm Ochre Bio, announcing this week that it will pay up to USD 37.5 million for access to Ochre Bio’s human liver data. This strategic collaboration aims to bolster the development of hepatology…
