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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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GSK’s Nucala Accepted for EMA Review for COPD Treatment
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UK-based GSK plc’s (LON: GSK, NYSE: GSK) application for expanding the use of its anti-interleukin-15 (IL-15) biologic Nucala (mepolizumab) has been accepted for review by the European Medicines Agency (EMA). The proposed new use is as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) who have…
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Clover Biopharmaceuticals Receives FDA Approval for SCB-1019 RSV Vaccine Trial
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China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) has announced receiving clinical approval from the US Food and Drug Administration (FDA) for its SCB-1019, a non-adjuvanted bivalent RSV prefusion-stabilized F (PreF)-Trimer subunit vaccine candidate. The company has initiated the first subjects for the Phase I revaccination study, assessing the safety, reactogenicity, and…
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Hansoh Pharmaceutical Reports 21% Revenue Growth, Boosted by Innovative Drugs
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) released its 2024 financial report last week, recording revenues of RMB 12.26 billion (USD 1.69 billion) after a 21.3% year-on-year (YOY) expansion. The main growth drivers, innovative drugs and collaborative products, generated combined sales of RMB 9.48 billion (USD 1.31 billion), up…
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GSK’s Nucala Receives NMPA Review for COPD Treatment
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GSK plc (LON: GSK, NYSE: GSK) announced that the National Medical Products Administration (NMPA) has accepted another indication approval filing for its anti-interleukin-15 (IL-15) biologic Nucala (mepolizumab) for review. The UK-based company is seeking approval for the drug’s use as an add-on maintenance treatment for patients with chronic obstructive pulmonary…
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GSK and Abbott Announce Leadership Changes in Key Roles
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Recent days have seen significant leadership changes at two pharmaceutical giants: UK-based GSK plc (LON: GSK) and US-based Abbott Laboratories (NYSE: ABT). GSK Appoints Jocelyn Luo as Mix Team LeaderJocelyn Luo has been appointed as the leader of GSK’s Mix team, reporting to Westly Yu, head of GSK’s respiratory business…
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GSK’s Penmenvy Meningococcal Vaccine Approved by FDA for Ages 10-25
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UK-based multinational GSK plc (LON: GSK) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Penmenvy (meningococcal groups A, B, C, W, and Y vaccine) for use in individuals aged 10 through 25 years. The vaccine targets the five major serogroups of…
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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 Reports 7% Full-Year Sales Growth in 2024, Driven by Specialty Medicines
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UK-based pharmaceutical giant GSK plc (NYSE: GSK) released its Q4 and full-year 2024 financial results, reporting a 7% year-on-year (YOY) growth in sales over the 12 months to GBP 31.38 billion (USD 40.1 billion). Excluding the impact of COVID-related products, the firm’s sales increased by 8% to GBP 31.36 billion.…
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GSK’s Jemperli Approved for First-Line Endometrial Cancer Treatment in EU
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UK-based GSK plc (NYSE: GSK, LON: GSK) has announced receiving approval from the European Commission for a new indication for its PD-1-blocking antibody Jemperli (dostarlimab). The drug is now approved for use in combination with chemotherapy (carboplatin and paclitaxel) as a first-line treatment for adult patients with primary advanced or…
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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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Ouro Medicines Launches with $120M Series A Financing for CM336 Development
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Ouro Medicines, the licensee of China-based Keymed Biosciences Inc.’s (HKG: 2162) CM336, has successfully launched with a USD 120 million Series A financing round. The California-headquartered biotech, founded by Monograph Capital in partnership with GSK plc (NYSE: GSK), saw the funding co-led by TPG Life Sciences Innovations, NEA, and Norwest…
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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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Hansoh and GSK’s HS-20093 Receives FDA Breakthrough Therapy Designation for Osteosarcoma
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China-based Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692) and its UK partner GSK plc (LON: GSK, NYSE: GSK) have announced that they have received another breakthrough therapy designation (BTD) from the US FDA for their B7-H3-targeted antibody drug conjugate (ADC), HS-20093 (GSK5764227). The indication this time is for the drug’s…
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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 Jemperli Combo Shows Improved PFS in Phase III Ovarian Cancer Trial
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UK-based GSK plc (NYSE: GSK) has announced a positive readout from the Phase III FIRST-ENGOT-OV44 trial for Jemperli (dostarlimab), a programmed death-1 (PD-1) inhibitor, when combined with Zejula (niraparib) for the first-line treatment of advanced ovarian cancer. The trial evaluated the addition of Jemperli to the standard of care carboplatin-paclitaxel…
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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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Vocabria Receives Positive CHMP Opinion for HIV Treatment in Adolescents
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GSK plc (NYSE: GSK) has announced that ViiV Healthcare, an HIV specialist majority owned by GSK with Pfizer and Shionogi as shareholders, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The recommendation is for the approval of…
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GSK’s Jemperli Receives Positive CHMP Opinion for Endometrial Cancer Indication Extension
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The UK-based pharmaceutical giant GSK (NYSE: GSK) has received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for the indication extension approval of its PD-1 inhibitor Jemperli (dostarlimab). The drug is proposed for use in combination with chemotherapy (carboplatin and paclitaxel)…
