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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’s Blenrep Shows Survival Benefit in Phase III Multiple Myeloma Study
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UK-based pharmaceutical company GSK plc (NYSE: GSK) has reported positive results from a Phase III trial for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma (RRMM). The DREAMM-7 head-to-head study demonstrated that GSK’s BCMA-targeted antibody drug…
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Vesalius Therapeutics Partners with GSK for Novel Parkinson’s Disease Treatments
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US-based Vesalius Therapeutics has entered into a strategic agreement with UK pharmaceutical giant GSK plc (NYSE: GSK, LON: GSK) to discover and develop innovative treatments for Parkinson’s disease (PD) and another undisclosed neurodegenerative condition. The alliance leverages Vesalius’ platform to identify novel intervention points in PD and an additional neurodegenerative…
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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GlaxoSmithKline (GSK; NYSE: GSK), a leading pharmaceutical company based in the UK, has reportedly withdrawn from the US industry trade group Biotechnology Innovation Organization (BIO).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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GSK Reports Mixed Q3 2024 Results with 2% YOY Revenue Growth
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UK pharmaceutical giant GlaxoSmithKline (GSK; NYSE: GSK) has released its financial report for the third quarter of 2024, showing a modest 2% year-on-year (YOY) increase in revenue to GBP 8 billion (USD 10.496 billion) at constant exchange rates. The quarter’s performance was propelled by a 19% surge in the Specialty…
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GSK Secures Global Rights to Chimagen Biosciences’ T Cell-Engager in $850 Million Deal
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UK pharmaceutical company GSK plc (NYSE: GSK) has entered into a licensing agreement with Chimagen Biosciences, securing all global rights to CMG1A46, a clinical-stage dual CD19 and CD20-targeted T cell-engager (TCE). GSK will pay an upfront fee of USD 300 million and is committed to making success-based development and commercial…
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Clover Biopharmaceuticals Reports Strong Phase I Results for RSV Vaccine SCB-1019
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China-based Clover Biopharmaceuticals Ltd. (HKG: 2197) has announced encouraging additional immunogenicity and safety data from its Phase I trial of SCB-1019, a non-adjuvanted bivalent RSV prefusion-stabilized F (PreF)-Trimer subunit vaccine candidate. The trial assessed SCB-1019 against GSK (NYSE: GSK)’s AS01E-adjuvanted RSV vaccine, Arexvy, in elderly subjects. In the ongoing Phase…
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GSK Commits USD 800 Million to New State-of-the-Art Manufacturing Facility in Pennsylvania
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GSK plc (NYSE: GSK), a leading UK pharmaceutical company, has announced a significant investment in the United States with the establishment of a multi-purpose facility in Marietta, Pennsylvania. The company will invest USD 800 million to develop a state-of-the-art drug substance manufacturing facility and additional drug product manufacturing capabilities, creating…
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GSK and Cambridge University Forge £50 Million Partnership to Tackle Immune Diseases
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UK pharmaceutical giant GSK plc (LON: GSK, NYSE: GSK) has unveiled a significant five-year partnership with the University of Cambridge and Cambridge University Hospitals, backed by a financial commitment of £50 million. This collaboration aims to enhance research and development efforts targeting immune-related diseases. Dubbed the Cambridge-GSK Translational Immunology Collaboration…
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GSK Appoints Li Weidong as Vaccine Business Head for China
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GSK plc (LON: GSK, NYSE: GSK), a leading pharmaceutical company based in the UK, has announced the appointment of Li Weidong to the role of Vice President and Head of Vaccine Business for GSK China. Li will report directly to Sherman Yu, GSK Vice President and General Manager of GSK…
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GSK’s Blenrep-BorDex Combo Earns Breakthrough Therapy Designation in China for Multiple Myeloma
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The UK-based pharmaceutical colossus, GSK (LON: GSK, NYSE: GSK), has secured a Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its antibody-drug conjugate, Blenrep (belantamab mafodotin), used in combination with bortezomib and dexamethasone (BorDex). This regulatory milestone for the treatment of relapsed or refractory multiple myeloma…
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GSK’s Nucala Shows Promise in Phase III COPD Trial, MATINEE Results Positive
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GSK plc (LON: GSK, NYSE: GSK), a leading UK-based pharmaceutical company, has announced positive results from a Phase III trial for its auto-immune therapy Nucala (mepolizumab) in treating chronic obstructive pulmonary disorder (COPD). The MATINEE trial demonstrated that GSK’s interleukin-5 (IL-5) inhibitor met the primary endpoint, showing a significant and…
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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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Jiangsu Hansoh and GSK Receive FDA Breakthrough Designation for B7-H3 Targeted ADC in Small-Cell Lung Cancer
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Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), a prominent Chinese pharmaceutical company, and its UK counterpart GSK plc (NYSE: GSK) have jointly announced that they have received the prestigious Breakthrough Therapy Designation (BTD) from the US FDA for their candidate HS-20093, also known as GSK5764227. This B7-H3-targeted antibody-drug conjugate (ADC)…
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Jiangsu Hansoh Pharmaceutical and GSK Win FDA Breakthrough Therapy Designation for B7-H3 Targeted ADC in Small-Cell Lung Cancer
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LONDON/HONG KONG—Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), in collaboration with UK-based GSK plc (NYSE: GSK), has been awarded the Breakthrough Therapy Designation (BTD) by the US FDA for their jointly developed antibody-drug conjugate (ADC) HS-20093, also known as GSK5764227. The therapy is intended for the treatment of patients with…
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GSK’s Ma Zheng to Depart as Head of Communication and Government Affairs in China
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Ma Zheng, the head of communication and government affairs for GSK plc (NYSE: GSK) in China, is set to leave the company, with his final day on August 30. Before joining GSK, Mr. Ma held senior government affairs positions at Kodak, Pepsi, and Cargill. A successor has yet to be…
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GSK Initiates Phase III Study for RSV Vaccine in China Following U.S. Approval
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GSK (NYSE: GSK), the UK-based pharmaceutical giant, has registered a Phase III bridging study for its recombinant RSV vaccine in China on ClinicalTrials.gov. The vaccine, which received marketing approval in the U.S. in May 2023, will undergo a study that aims to complete its primary endpoint follow-up by March 2025.…
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GSK’s Jemperli Receives EC Approval for Endometrial Cancer Treatment in Combination Therapy
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GSK plc (NYSE: GSK), a leading UK pharmaceutical company, has announced that the European Commission (EC) has granted a new indication approval for its programmed death-1 (PD-1) inhibitor, Jemperli (dostarlimab). The approval allows for the use of Jemperli in combination with carboplatin-paclitaxel, a chemotherapy regimen, for the treatment of adult…
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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…
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GSK Finalizes Acquisition of Oligonucleotide Specialist Elsie Biotechnologies for Up to $50 Million
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GlaxoSmithKline (GSK; NYSE: GSK), a leading UK pharmaceutical company, has announced the completion of the acquisition of Elsie Biotechnologies, an expert in oligonucleotide therapeutics, for a potential total consideration of up to USD 50 million. This strategic move comes as part of GSK’s ongoing efforts to expand its portfolio in…
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GSK Confronted with Whistleblower Allegations Over Zantac and NDMA Link
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GlaxoSmithKline (GSK; NYSE: GSK), the UK-based pharmaceutical giant, is facing legal action in the form of a whistleblower lawsuit filed by Valisure, a US-based chemical analysis company. Valisure alleges that GSK intentionally concealed the carcinogenic link between its popular antacid Zantac (ranitidine) and N-Nitrosodimethylamine (NDMA), a potentially harmful impurity. The…
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ViiV Healthcare’s HIV-PreP Therapy Approved by China’s NMPA, Offers Alternative to Daily Medication
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GlaxoSmithKline’s (GSK; NYSE: GSK) subsidiary, ViiV Healthcare, has announced that it has received marketing approvals from China’s National Medical Products Administration (NMPA) for both cabotegravir tablets and cabotegravir injection. These medications are intended for pre-exposure prophylaxis (PrEP) of HIV-1 in adults and adolescents weighing at least 35kg who are at…
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GSK Shakes Up Leadership with Promotion of Cecilia Qi and Appointment of Sherman Yu
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Mike Crichton, Senior Vice President of GlaxoSmithKline (GSK, NYSE: GSK) for the Greater China and Intercontinental Region (GSK GCI), has announced significant personnel changes within the organization. Cecilia Qi, currently the Global Vice President of GSK and General Manager (GM) of China, has been promoted to Vice President and Head…
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GSK’s Q1 2024 Results Beat Forecasts with 10% YOY Revenue Increase; Upgrades Full-Year Outlook
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GSK plc (NYSE: GSK), the UK pharmaceutical giant, announced its financial results for the first quarter of 2024, with revenues increasing by 10% year-on-year (YOY) to GBP 7.4 billion (USD 9.3 billion), excluding COVID-19-related sales. Core operating profit also showed a robust performance, rising 27% YOY in constant currency terms…
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GSK’s Gepotidacin Shows Non-Inferior Efficacy in Phase III Gonorrhoea Tria
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GlaxoSmithKline (GSK; NYSE: GSK, LON: GSK), a leading UK pharmaceutical company, last week announced positive results from a Phase III clinical trial for gepotidacin, a first-in-class triazaacenaphthylene antibiotic, in the treatment of uncomplicated urogenital gonorrhoea (GC). The study demonstrated non-inferiority to the standard azithromycin-based treatment, with a microbiological response rate…
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GSK’s Shingrix Vaccine Maintains High Efficacy for Over a Decade, Phase III Data Show
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GlaxoSmithKline (GSK, LON: GSK, NYSE: GSK), the UK-based pharmaceutical giant, has this week released long-term data from a follow-up Phase III trial of its recombinant herpes zoster vaccine, Shingrix. The vaccine demonstrated robust efficacy in adults aged 50 and above, with a 79.7% efficacy rate sustained from year 6 to…
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GSK’s ViiV Healthcare Expands Dovato Indication to Include Adolescents with HIV-1 Infection
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GlaxoSmithKline’s (GSK; NYSE: GSK) ViiV Healthcare has received an indication extension from the US Food and Drug Administration (FDA) for its antiretroviral treatment Dovato (dolutegravir + lamivudine). The drug is now approved for use in virologically suppressed or treatment-naive adolescents aged 12 years and older with HIV-1 infection, a demographic…
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GSK’s Jemperli Shows Survival Benefits in Phase III Endometrial Cancer Study
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GlaxoSmithKline (GSK; NYSE: GSK), a leading UK pharmaceutical company, has presented early results from a Phase III study for its PD-1-blocking antibody Jemperli (dostarlimab) in the treatment of primary advanced or recurrent endometrial cancer. The placebo-controlled trial aims to expand the current indication for frontline mismatch repair deficient (dMMR)/microsatellite instability-high…
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GSK Reports US Adult Non-Flu Vaccination Rates Recover Post-Pandemic
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GlaxoSmithKline (GSK; NYSE: GSK), a leading pharmaceutical company based in the UK, has reported that adult non-flu vaccination rates in the US have rebounded from the impact of the COVID-19 pandemic. According to data from GSK’s Vaccine Track platform, immunization rates between the first and third quarters of 2023 were…
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ViiV Healthcare Presents Phase I Data for Ultra-Long-Acting Cabotegravir in HIV Treatment and Prevention
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GlaxoSmithKline (GSK; NYSE: GSK) unit ViiV Healthcare has presented Phase I results for an ultra-long-acting formulation of the antiretroviral cabotegravir, which is being investigated for the treatment and prevention of HIV. The safety and pharmacokinetic data from the study support the potential to double dosing intervals to four months or…
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AstraZeneca’s Fasenra Matches Nucala in EGPA Trial and Shows Steroid Reduction Benefits
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UK pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has presented results from a Phase III trial that previously announced the non-inferiority of its IL-5 antagonist Fasenra (benralizumab) against GlaxoSmithKline’s (GSK; NYSE: GSK) Nucala (mepolizumab), the current standard of care for relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The data revealed…
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GSK and Peers Respond to FTC Criticism, Withdraw Patent Listings from US Orange Book
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Three pharmaceutical companies, including the UK’s GSK (NYSE: GSK), have responded to the Federal Trade Commission’s (FTC) allegations of “abusive” patents by withdrawing several listings from the US Orange Book. This action follows the FTC’s challenge in November against over 100 patents held by manufacturers of branded asthma inhalers, epinephrine…
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FDA Grants Priority Review for GSK’s Arexvy to Expand RSV Vaccine Age Range to 50-59
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The U.S. Food and Drug Administration (FDA) has initiated a priority review of GlaxoSmithKline’s (GSK; NYSE: GSK) application to extend the age range for its respiratory syncytial virus (RSV) vaccine, Arexvy, to include individuals aged 50 to 59 who are at increased risk for RSV disease. Arexvy was previously approved…
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GSK Posts 5% YOY Growth in 2023 Financials, Vaccines Business Drives Expansion
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GSK plc (NYSE: GSK), the UK pharmaceutical giant, announced its financial results for the fourth quarter and full-year 2023, with a 5% year-on-year (YOY) growth to GBP 30.3 billion (USD 38.5 billion) in revenue over the 12-month period. When excluding the impact of COVID-related products, the company’s sales surged by…
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GSK Secures Second Indication Approval for Nucala in China for Severe Eosinophilic Asthma
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GSK plc (NYSE: GSK) has received approval for a second indication in China for its anti-interleukin-15 (IL-15) biologic, Nucala (mepolizumab). The drug is now authorized as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older. Nucala was initially approved in China in…
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GSK Secures Exclusive Rights to Hansoh’s ADC Candidate HS-20093 in New Licensing Deal
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GlaxoSmithKline (GSK; NYSE: GSK), a major UK pharmaceutical company, has entered into its second licensing agreement with Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) within two months, focusing once again on an antibody-drug conjugate (ADC) product candidate. Hansoh has granted GSK exclusive rights to develop, manufacture, and commercialize its novel…
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GSK’s CCO Calls China a Hotbed for Innovative Molecules and Licensing Deals
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In an interview with the Financial Times, Luke Miels, Chief Commercial Officer of UK-based GlaxoSmithKline (GSK; NYSE: GSK), highlighted China as a key source of innovative molecules for licensing agreements. Miels attributes this trend to China’s robust chemistry capabilities and the willingness of local companies to out-license their rights: “You…
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AstraZeneca Acquires Icosavax to Boost Infectious Disease Pipeline with VLP Vaccine Technology
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UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has announced the acquisition of US vaccines specialist Icosavax (NASDAQ: ICVX), including its protein virus-like particle (VLP) platform. AstraZeneca will pay approximately USD 800 million upfront for all outstanding shares, plus about USD 300 million in milestone payments. The acquisition is set to…
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GSK Reports Modest 2% YOY Growth in Q3 2023 Finances, Vaccines Unit Soars 24%
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UK-based pharmaceutical giant GlaxoSmithKline (GSK; NYSE: GSK) has released its financial report for the third quarter of 2023, showing mixed results over the first three quarters. The company experienced a modest 2% year-on-year (YOY) expansion, reaching GBP 22.3 billion (USD 27.7 billion) at constant exchange rates. Vaccines Unit and General…
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GSK’s ViiV Healthcare Secures NMPA Approval for Vocabria in HIV-1 Treatment
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UK pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) has announced that its HIV joint venture, ViiV Healthcare, has received approval from China’s National Medical Products Administration (NMPA) for Vocabria (cabotegravir injection). The drug is approved for use in combination with Johnson & Johnson/Janssen Pharmaceutical’s (J&J, NYSE: JNJ) Rekambys (rilpivirine long-acting injection)…
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Hansoh Pharmaceutical and GSK Ink Global Licensing Deal for Innovative ADC HS-20089
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has entered into a licensing agreement with UK pharmaceutical giant GSK (NYSE: GSK), granting GSK development, manufacturing, and commercialization rights to its pipeline antibody drug conjugate (ADC) HS-20089 for all global territories outside Greater China. HS-20089: Targeting B7-H4 in OncologyHS-20089 is an…
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Asieris Pharma Launches Generic Votrient for Renal Cell Carcinoma in China
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China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd, trading as Asieris Pharma (SHA: 688176), has announced the issuance of the first prescription for its generic version of the UK pharmaceutical major GSK’s (NYSE: GSK) Votrient (pazopanib) in China. This milestone not only marks the entry of a new treatment…
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Chongqing Zhifei Partners with GSK for Shingrix Distribution in China
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China-based Chongqing Zhifei Biological Co., Ltd. (SHE: 300122) has entered into a sole distribution and co-promotion agreement with UK pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) for its shingles vaccine, Shingrix (recombinant zoster vaccine; RZV). This partnership marks a significant step in enhancing the availability of Shingrix in the Chinese market.…
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GSK’s Ojjaara Approved by FDA for Anemic Myelofibrosis Patients
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The US Food and Drug Administration (FDA) has granted regulatory approval to GlaxoSmithKline (GSK; NYSE: GSK), a UK-based pharmaceutical company, for its JAK1/JAK2/ACVR1 inhibitor Ojjaara (momelotinib). The drug is indicated for anemic adults with intermediate or high-risk myelofibrosis, a blood cancer affecting approximately 25,000 people in the United States. This…
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China’s CDE Proposes Removal of Ambroxol Inhalation Solution and Four Other Drugs
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The Center for Drug Evaluation has issued a notification concerning the Chemical Generic Drug Reference Preparation Adjustment List, inviting public feedback on the draft proposal before the deadline of October 7, 2023. The list proposes the removal of Ambroxol inhalable solution and four other varieties, totaling nine specifications. Specific Drugs…
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Japan’s MHLW Reviews GSK’s Momelotinib for Myelofibrosis Treatment
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The Ministry of Health, Labour and Welfare (MHLW) in Japan has accepted for review a filing by UK-based GlaxoSmithKline (GSK; NYSE: GSK) for its first-in-class candidate, momelotinib, as a potential treatment for the blood cancer myelofibrosis. The submission is supported by Phase III clinical trial results that show significant improvements…
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AstraZeneca’s Fasenra Shows Non-Inferior Efficacy to Nucala in EGPA: Phase III Results
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UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has unveiled the results of a Phase III study, demonstrating the non-inferiority of its IL-5 antagonist Fasenra (benralizumab) compared to GlaxoSmithKline’s (GSK; NYSE: GSK) Nucala (mepolizumab) in the treatment of relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The study highlights that Fasenra…
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FDA Addresses Looming Migraine Treatment Shortage with Tonix Pharmaceuticals Commitment
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The US Food and Drug Administration (FDA) is actively engaging with pharmaceutical companies to address an impending shortage of a critical migraine treatment. This follows the UK-based GlaxoSmithKline’s (GSK; NYSE: GSK) decision to discontinue the production of Imitrex (sumatriptan) nasal spray from January 31, 2024. The move has prompted concerns…
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Japan’s MHLW Reviews GSK’s Nucala for Chronic Rhinosinusitis with Nasal Polyps Indication
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The Ministry of Health, Labour and Welfare (MHLW) in Japan has begun the review process for an indication extension filing submitted by the UK pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK). The filing seeks to expand the use of GSK’s anti-IL-5 biologic Nucala (mepolizumab) as a treatment for adults with chronic…
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Sandoz Expands Anti-Infective Portfolio with Acquisition of Astellas Pharma’s Antifungal Mycamine
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Switzerland-based Novartis (NYSE: NVS) subsidiary Sandoz has bolstered its global anti-infectives portfolio with the acquisition of Mycamine/Funguard (micafungin sodium) from Japan’s Astellas Pharma (TYO: 4503). Mycamine is the highest-selling antifungal of the echinocandin class, and while the transaction amount was not disclosed, the product generated JPY 14.2 billion (USD 105…
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GSK’s Shingrix Proves 100% Efficacy in Phase IV Trial for Chinese Patients
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UK-based pharmaceutical giant GSK plc (NYSE: GSK) has released efficacy data for its shingles vaccine, Shingrix (recombinant zoster vaccine; RZV), in a Chinese patient population. The Phase IV post-marketing ZOSTER-076 trial, conducted in China, involved nearly 6,000 participants aged 50 and over. The trial reported no cases of shingles in…
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WuXi Biologics Reports 17.8% Revenue Growth and Expands Service Scope in H1 2023
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China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has released its unaudited interim financial report for the period ended June 30, 2023. The report indicates a 17.8% year-on-year (YOY) increase in revenues, reaching RMB 8.49 billion (USD 1.17 billion). This growth is attributed to the successful…
