Tag Archives: GSK

GSK’s Gepotidacin Shows Promise as Gonorrhoea Treatment: Positive Results from EAGLE-1 Trial

(IN BRIEF) GSK plc has announced positive headline results from the pivotal EAGLE-1 phase III trial for gepotidacin, an oral antibiotic aimed at treating uncomplicated urogenital gonorrhoea in adolescents and adults. The trial demonstrated gepotidacin’s non-inferiority compared to the current … Read the full press release

GSK Expands Respiratory Biologics Portfolio with Aiolos Bio Acquisition

(IN BRIEF) GSK plc has finalized the acquisition of Aiolos Bio, bolstering its respiratory biologics portfolio with AIO-001, a promising long-acting anti-TSLP monoclonal antibody for treating asthma. AIO-001, set to enter phase II clinical trials, targets severe asthma patients with … Read the full press release

GSK’s Bepirovirsen Receives FDA Fast Track Designation for Chronic Hepatitis B Treatment

(IN BRIEF) GSK plc has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for bepirovirsen, an investigational antisense oligonucleotide (ASO) targeting chronic hepatitis B (CHB). The Fast Track designation aims to expedite the development … Read the full press release

GSK’s Omjjara Receives EU Approval for Myelofibrosis Treatment

(IN BRIEF) GSK has received marketing authorization from the European Commission for Omjjara (momelotinib), an oral inhibitor targeting JAK1/JAK2 and activin A receptor type 1 (ACVR1). Omjjara is the first approved treatment in the EU for disease-related splenomegaly (enlarged spleen) … Read the full press release

GSK Seeks Regulatory Approval to Extend RSV Vaccination to At-Risk Adults Aged 50-59

(IN BRIEF) GSK has submitted a regulatory application to the European Medicines Agency (EMA) to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease. The … Read the full press release

GSK’s Dostarlimab Shows Positive Results in Endometrial Cancer Trial

(IN BRIEF) GSK plc has announced positive results from Part 2 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial, evaluating the use of Jemperli (dostarlimab) in combination with standard chemotherapy and as maintenance therapy for patients with primary advanced or recurrent endometrial … Read the full press release

GSK’s Jemperli Gains EC Approval for Advanced Endometrial Cancer Therapy

(IN BRIEF) In a significant development, GSK plc has received marketing authorization from the European Commission (EC) for Jemperli (dostarlimab) in combination with carboplatin-paclitaxel chemotherapy as a treatment option for adult patients suffering from mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) … Read the full press release

GSK’s Belantamab Mafodotin Shows Promise as Second-Line Treatment for Multiple Myeloma in Phase III Trial

(IN BRIEF) GlaxoSmithKline (GSK) has reported positive results from the interim efficacy analysis of the DREAMM-7 phase III trial evaluating belantamab mafodotin as a second-line treatment for relapsed or refractory multiple myeloma. The trial successfully met its primary endpoint of … Read the full press release

GSK Initiates Phase III Trials for Low Carbon Inhaler to Drastically Cut Emissions

(IN BRIEF) GSK, a leading pharmaceutical company, has unveiled plans to conduct Phase III trials in 2024 for a low carbon version of its popular inhaler, Ventolin (salbutamol). The initiative aims to reduce greenhouse gas emissions associated with the inhaler’s … Read the full press release

ViiV Healthcare Receives Chinese Approval for Long-Acting HIV Treatment Vocabria and Rekambys

(IN BRIEF) ViiV Healthcare has received approval from China’s National Medical Products Administration (NMPA) for Vocabria (cabotegravir) in combination with Rekambys (rilpivirine), marking the first complete long-acting HIV-1 injectable treatment in China. This approval allows people living with HIV in … Read the full press release

GSK’s ViiV Healthcare to Share Latest Advances in HIV Treatment and Prevention at EACS 2023

(IN BRIEF) ViiV Healthcare, a global specialist HIV company, will present 23 abstracts at the 19th Annual European AIDS Conference (EACS 2023). These abstracts will cover various aspects of HIV treatment and prevention, including real-world data on long-acting and 2-drug … Read the full press release

GSK’s Jemperli Receives Positive CHMP Opinion for Frontline Treatment of Advanced Endometrial Cancer with Chemotherapy

(IN BRIEF) GSK has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of Jemperli (dostarlimab) in combination with chemotherapy as a frontline treatment for adult … Read the full press release

Seasoned Marketer Suresh Balaji Joins Lloyds Banking Group as CMO

(IN BRIEF) Lloyds Banking Group has appointed Suresh Balaji as its Chief Marketing Officer, effective from October 16. In his new role, Balaji will oversee the Brand, Marketing, and Experience function for the group. He will be responsible for developing … Read the full press release

GSK Resolves California Zantac Litigation Through Confidential Settlements

(IN BRIEF) GlaxoSmithKline (GSK) has announced a confidential settlement in the Cantlay/Harper case filed in California state court, which was scheduled for trial in November 2023. Additionally, GSK has settled the three remaining breast cancer bellwether cases in California, effectively … Read the full press release

GSK Forms Exclusive Partnership with Zhifei to Promote Shingrix Vaccine in China

(IN BRIEF) GSK plc has announced an exclusive agreement with Chongqing Zhifei Biological Products, Ltd. (Zhifei) to co-promote GSK’s shingles vaccine, Shingrix, in China for an initial three-year period, with the potential for extension. Zhifei, China’s largest vaccine company by … Read the full press release

GSK’s Arexvy RSV Vaccine Approved in Japan for Adults Aged 60 and Above, a First for the Country

(IN BRIEF) GSK plc has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) to prevent respiratory syncytial virus (RSV) disease in adults aged 60 and above. This marks … Read the full press release

GSK and Save the Children Extend Partnership to Boost Child Vaccination Rates in Ethiopia and Nigeria

(IN BRIEF) Pharmaceutical company GSK and international non-profit organization Save the Children have renewed their partnership for another five years, with GSK committing £15 million to the initiative. The collaboration will primarily focus on increasing child vaccination rates and reducing … Read the full press release

Nestwork Launches Peer-to-Peer Career Discovery Platform with £175,000 Investment

(IN BRIEF) A team led by current students and recent graduates has created Nestwork, a new platform that leverages peer-to-peer learning to help students find and secure their ideal careers. The platform simplifies career discovery through technology while supporting university … Read the full press release

Sandoz acquires Mycamine, reinforcing its anti-infectives portfolio

(IN BRIEF) Sandoz, a global leader in off-patent (generic and biosimilar) medicines, has signed an agreement to acquire worldwide product rights for leading systemic antifungal agent Mycamine® (micafungin sodium, Funguard® in Japan) from Astellas. This acquisition will reinforce Sandoz’s hospital … Read the full press release

Sandoz adquiere Mycamine, reforzando su cartera de antiinfecciosos

(NOTICIA EN BREVE) Sandoz, líder mundial en medicamentos sin patente (genéricos y biosimilares), ha firmado un acuerdo para adquirir los derechos de producto a nivel mundial del agente antifúngico sistémico líder Mycamine® (micafungina sódica, Funguard® en Japón) de Astellas. Esta … Read the full press release

New practical guide for businesses to measure air pollutant emissions across value chains

The Alliance for Clean Air, launched by the World Economic Forum and the Clean Air Fund, published a practical guide on how businesses can quantify the air pollutant emissions along their value chains The Alliance for Clean Air has adopted … Read the full press release

Nueva guía práctica para que las empresas midan las emisiones de contaminantes atmosféricos en las cadenas de valor

La Alianza para el Aire Limpio, lanzada por el Foro Económico Mundial y el Fondo de Aire Limpio, publicó una guía práctica sobre cómo las empresas pueden cuantificar las emisiones de contaminantes del aire a lo largo de sus cadenas … Read the full press release

Tony Wood tritt die Nachfolge von Dr. Hal Barron als Chief Scientific Officer bei GlaxoSmithKline R&D an

Tony Wood übernimmt im August 2022 die volle Verantwortung für die F&E von GSK Hal Barron wechselt im August 2022 vom CSO zu einem GSK Non-Executive Director mit zusätzlichen Verantwortlichkeiten zur Unterstützung von Forschung und Entwicklung (PRESSEMITTEILUNG) LONDON, 19-Jan-2022 — … Read the full press release

Tony Wood to succeed Dr Hal Barron as Chief Scientific Officer at GlaxoSmithKline R&D

Tony Wood to assume full accountability for GSK R&D in August 2022 Hal Barron to transition in August 2022 from CSO to a GSK Non-Executive Director with additional responsibilities to support R&D (PRESS RELEASE) LONDON, 19-Jan-2022 — /EuropaWire/ — GlaxoSmithKline … Read the full press release

Patients and R&D Leaders Jointly Present at EU Conference on Progress with Patient-Input to Transform Medicine Development

(PRESS RELEASE) New York, NY, United States, 5-Jan-2022 — /EuropaWire/ — The Conference Forum announced the launch of the 6th annual EU Patients as Partners in Medicines Development conference to take place virtually on January 24-25th, 2022 GMT time. ​​This … Read the full press release

Genetic diversity: GSK and Novartis launch Project Africa GRADIENT to optimise treatment responses for malaria and tuberculosis in Africa

Project Africa GRADIENT calls on local researchers to submit proposals exploring the link between genetic diversity and response to malaria and tuberculosis drugs in African patients. Combined funding commitment of GBP 2.8 million (USD 3.6 million) over five years. Researchers … Read the full press release

The COVID-19 vaccine based on Sanofi’s recombinant protein-based technology and GSK’s pandemic adjuvant system secures 300 million doses order from the European Commission (EC)

Agreement signed today supports scale-up of manufacturing capabilities in several European countries Vaccine candidate uses Sanofi’s recombinant protein-based technology combined with GSK’s pandemic adjuvant system (PRESS RELEASE) PARIS, 18-Sep-2020 — /EuropaWire/ — Sanofi (EPA: SAN), a global biopharmaceutical company focused … Read the full press release

Iain Mackay will be GSK’s next Chief Financial Officer (CFO); he also joins GSK Board

Brentford, United Kingdom, 14-Aug-2018 — /EuropaWire/ — GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that Iain Mackay has been appointed GSK’s next Chief Financial Officer (CFO). He has also been appointed as an Executive Director to the GSK Board. Mr Mackay will … Read the full press release

Kevin Sin appointed new SVP and Head of Worldwide Business Development for R&D at GSK

Critical role appointed as part of ongoing activities to strengthen and accelerate the Pharmaceuticals pipeline LONDON, 20-Apr-2018 — /EuropaWire/ — GlaxoSmithKline plc (GSK) today announced the appointment of Kevin Sin as Senior Vice President and Head of Worldwide Business Development for … Read the full press release

GSK: We are delighted to start the phase III study and evolve our research programme for belimumab in systemic lupus erythematosus (SLE)

LONDON, 22-Mar-2018 — /EuropaWire/ — GSK today announced the start of a phase III study investigating Benlysta (belimumab) in combination with rituximab in adult patients with systemic lupus erythematosus (SLE). Belimumab and rituximab have different but potentially complementary mechanisms of action. … Read the full press release

GSK: NDA submission to US FDA for single-dose tafenoquine for the radical cure of Plasmodium vivax malaria

Regulatory milestone affirms GSK’s strong commitment and scientific capabilities to fighting infectious diseases  LONDON/GENEVA, 29-Nov-2017 — /EuropaWire/ — GSK and Medicines for Malaria Venture (MMV) today announced the submission of a new drug application (NDA) by GSK to the United States … Read the full press release

GSK on UK Government’s Industrial Strategy: Meaningful targets, sustained efforts and coherent implementation will be critical to this strategy’s success

LONDON, 29-Nov-2017 — /EuropaWire/ — Responding to the launch of the Industrial Strategy White Paper, published today by the UK Government, Phil Thomson, President, Global Affairs, at GSK said: “A new, long-term industrial strategy for the country is important and welcome. We … Read the full press release

ViiV Healthcare begins phase III study on long-acting two-drug regimen in virally suppressed adults with HIV-1 infection

The ATLAS-2M study will evaluate injections every two months in virally suppressed patients LONDON, 29-Nov-2017 — /EuropaWire/ — Today (27 November 2017) ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, … Read the full press release

GSK: US FDA VRBPAC’s vote brings us one step closer to approval of Shingrix

LONDON, 14-Sep-2017 — /EuropaWire/ — GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) voted unanimously that the data support the efficacy and safety of Shingrix … Read the full press release

GSK: Benlysta plus standard of care prolonged control of disease activity in patients with active systemic lupus erythematosus (SLE)

Final efficacy and safety results from phase II continuation study Madrid, Spain and London, UK, 19-Jun-2017 — /EuropaWire/ — GSK today announced results from a 10-year continuation study, which showed that Benlysta (belimumab) plus standard of care prolonged control of disease … Read the full press release

Relieve the Stress from Asthma Management with New MyAsthma App

NOTTINGHAM, 18-Apr-2017 — /EuropaWire/ — A new and unique smartphone app to help people with asthma manage their condition has been developed by lung experts at the Nottingham Respiratory Research Unit and the pharmaceutical company GlaxoSmithKline (GSK). The MyAsthma app has been launched … Read the full press release

ViiV Healthcare’s phase III programme starts to support regulatory filings for two-drug regimen of dolutegravir and lamivudine as a treatment for HIV-1

LONDON, 22-Aug-2016 — /EuropaWire/ — ViiV Healthcare today announced the start of a phase III programme to support regulatory filings for a two-drug regimen of dolutegravir (Tivicay®) and lamivudine (Epivir®) as a treatment for HIV-1 infection in adults who have not … Read the full press release

Oncology study: GSK starts phase I clinical trial with an investigational inducibile T-cell costimulator (ICOS) agonist antibody

GSK3359609 is the first investigational ICOS agonist antibody to enter human clinical trials LONDON, 01-Jul-2016 — /EuropaWire/ — GSK today announced the start of a phase I clinical trial with GSK3359609, an investigational inducibile T-cell costimulator (ICOS) agonist antibody. ICOS is … Read the full press release

University of Cambridge / GSK: Human genetics can support the development of new therapies

An approach that could reduce the chances of drugs failing during the later stages of clinical trials has been demonstrated by a collaboration between the University of Cambridge and pharmaceutical company GlaxoSmithKline (GSK).  CAMBRIDGE, 02-Jun-2016 — /EuropaWire/ — The technique involves … Read the full press release

Japanese Ministry of Health, Labour and Welfare (MHLW) granted approval for GSK’s Nucala® as a treatment for bronchial asthma

LONDON, 29-Mar-2016 — /EuropaWire/ — GlaxoSmithKline plc (LSE/NYSE:GSK) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for Nucala® (mepolizumab) as a treatment for bronchial asthma in patients with refractory asthma whose symptoms are inadequately … Read the full press release