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Frontier Biotechnologies Inc. Gets NMPA Approval for Phase II Study of Albuvirtide as HIV Therapy
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Nanjing-based Frontier Biotechnologies Inc. (SHA: 688221) has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study for its version of albuvirtide, marking a significant step forward for China’s first domestically developed innovative HIV therapy. The study will evaluate albuvirtide as a maintenance…
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Jiangsu Aidea Pharmaceutical Secures NMPA Approval for Expanded Indication of Fubangde in HIV Treatment
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China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced that the National Medical Products Administration (NMPA) has approved an additional indication filing for its HIV treatment Fubangde (ainuovirine, lamivudine, tenofovir disoproxil). The new indication targets two groups of adults infected with human immunodeficiency virus type 1 (HIV-1) weighing over…
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Gilead’s Lenacapavir Shows 100% Efficacy in Phase III HIV PrEP Study
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Gilead Sciences Inc. (NASDAQ: GILD), a U.S. biopharmaceutical company, has announced topline results from the Phase III PURPOSE 1 study. The study indicates that lenacapvir has successfully demonstrated its potential as a twice-yearly pre-exposure prophylaxis (PrEP) drug to prevent HIV infection. The trial involved 5,300 cisgender women and adolescent girls…
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Jiangsu Aidea Pharmaceutical Gets Green Light from NMPA for AINUOVirine APIs
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Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to manufacture the active pharmaceutical ingredients (APIs) for ainuovirine. The APIs correspond to ainuovirine tablets, which are a Category 1 oral therapy for…
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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’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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Gilead and MSD Report Positive Interim Data for Once-Weekly HIV Treatment in Phase II Trial
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Gilead Sciences Inc. (NASDAQ: GILD) and Merck & Co., Inc., known as MSD (NYSE: MRK), have this week unveiled preliminary findings from a Phase II clinical trial of their investigational antiretroviral combination therapy, islatravir plus lenacapavir, as a potential once-weekly oral treatment for HIV/AIDS. Despite the primary endpoint being influenced…
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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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Gilead’s Biktarvy Receives FDA Approval for Expanded HIV Treatment Indication
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Gilead (NASDAQ: GILD), a leading US pharmaceutical company, has been granted an indication extension approval for its antiretroviral combination Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide) by the Food and Drug Administration (FDA). The approval expands Biktarvy’s use as an HIV treatment for individuals who have suppressed viral loads and…
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Gilead’s 2023 Flat Sales Reflect Stagnation and COVID-19 Demand Decline
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Gilead Sciences Inc. (NASDAQ: GILD) has reported a stagnant performance for the year 2023, with total product sales remaining unchanged at USD 26.9 billion. Amid a broad decline in demand for COVID-19 treatments, the company’s antiviral Veklury (remdesivir) sales could not offset the downturn, although HIV sales increased by 6%…
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Gilead’s 2023 Stagnation Foresees Flat 2024 Sales as Veklury Revenues Dwindle
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Gilead Sciences (NASDAQ: GILD) has reported a stagnant performance for 2023, with product sales remaining flat at USD 26.9 billion. The company’s financials were affected by a widespread downturn in demand for COVID-19 treatments, as its antiviral Veklury (remdesivir) sales offset growth in other areas. HIV sales reached USD 18.2…
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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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Gilead’s Descovy Receives Additional Indication Approval from China’s NMPA for HIV-1 PrEP
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Gilead Sciences, Inc. (NASDAQ: GILD), a major player in the pharmaceutical industry in the U.S., has announced that it has received an additional indication approval from China’s National Medical Products Administration (NMPA) for its anti-viral drug Descovy (emtricitabine, tenofovir alafenamide fumarate). The NMPA has granted approval for the use of…
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Aidea Pharmaceutical Receives NMPA Approval to Clinically Test HIV-1 Treatment ACC017
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Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug, ACC017. This molecule is now cleared for assessment as a potential treatment for HIV-1 infection when…
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Jiangsu Aidea Pharmaceutical Partners with Fidson Healthcare for HIV/AIDS Treatments in Nigeria
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China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has reportedly entered into a strategic cooperation agreement with Nigeria-based Fidson Healthcare plc. The partnership aims to facilitate the import of innovative HIV/AIDS therapies into Nigeria, a country with a significant population of 1.9 million HIV-infected individuals. Multi-Layered Collaboration on HIV/AIDS TreatmentsThe…
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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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Jiangsu Aidea’s HIV-1 Drug ACC017 Accepted for NMPA Review in China
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China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for its Category 1 drug, ACC017, for the treatment of HIV-1 infection in combination with other antiretroviral drugs. Mechanism and Pre-Clinical FindingsACC017 is a human immunodeficiency virus…
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Vela Diagnostics Partners with SRL Inc. to Expand Molecular Diagnostics in Japan
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Singapore-based Vela Diagnostics, a global leader in integrated molecular solutions for diagnosing infectious diseases and cancer, has announced a strategic research collaboration with SRL Inc., a premier Japanese healthcare service provider. This partnership is designed to enhance the distribution of Vela Diagnostics’ advanced molecular diagnostic solutions within Japan, although financial…
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Jiangsu Aidea Pharmaceutical Partners with National Medical Center for Infectious Disease on HIV Drug Development
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Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488), a China-based pharmaceutical company, has entered into a strategic partnership with the National Medical Center for Infectious Disease/Beijing Ditan Hospital Capital Medical University. The collaboration will focus on the development of HIV drugs, encompassing various aspects of research and development. Collaborative Efforts in…
