Search Results for “GSK ” – media

$2.2 billion settlement, GSK pays for safety

Zantac was originally a popular heartburn drug. From being popular all over the world to being withdrawn from the market due to carcinogenic risks, the years-long litigation disputes can be regarded as a slow and bumpy roller coaster for patients and manufacturers. This storm can be traced back to June 2019. At that time, Valisure discovered and informed the FDA during routine batch testing that the active ingredient ranitidine in Zantac would degrade under certain conditions and produce N-nitrosodimethylamine (NDMA), a Class 2A carcinogen. In September of the same year, Valisure formally submitted a citizen petition to the FDA, requesting the recall of all products containing ranitidine. Since then, Zantac has been deeply involved in the carcinogenic storm. The FDA further found that the higher the storage temperature or the longer the storage time of Zantac, the higher the risk of exceeding the standard of NDMA, which was originally very ...
- Source: drugdu
- 72
- October 14, 2024
GSK, Flagship Pioneering Commit $150M to Start R&D Pact for Novel Drugs and Vaccines

Respiratory disease and immunology are the initial focus areas of GSK’s new drug discovery partnership with Flagship Pioneering. A similar Flagship alliance with Pfizer recently announced it is pursuing novel obesity treatments. By Frank VinluanGSK already has a strong presence in respiratory disease and immunology, two of its core therapeutic areas. The pharmaceutical giant is now teaming up with Flagship Pioneering in an alliance intended to discover novel medicines to bolster its pipelines in both disease categories. The deal announced Monday calls for the partners to fund up to $150 million up front for an exploration phase intended to identify concepts that can leverage the technologies of Flagship’s portfolio companies. Flagship forms and incubates startups, each one based on a platform technology that focuses on some aspect of biology. The research stemming from these platforms informs the discovery and development of novel medicines. The best known of these “bioplatform” companies ...
- Source: drugdu
- 108
- July 31, 2024
GSK buys COVID, influenza vaccines from retrenching CureVac

British drugmaker GSK on Wednesday, July 4 2024, bought partner CureVac out of their alliance on influenza and COVID-19 vaccine development, boosting its messenger RNA credentials and extending the German biotech company’s financial lifeline. According to the statement, GSK, will take control of CureVac’s leading experimental vaccines to fight infections, including seasonal flu and bird flu. It will pay CureVac 400 million euros ($430 million) upfront and up to 1.05 billion euros contingent on achievements. CureVac said it would cut about 30 per cent of its jobs as it focuses on mRNA-based cancer therapies and other earlier-stage projects. It added GSK’s cash payment extends funding, which would have run out at the end of next year, into 2028. Under the partnership that began in 2020 during the COVID-19 pandemic, the companies have worked together to develop mRNA vaccines for infectious diseases. Wednesday’s agreement reflects GSK CEO Emma Walmsley’s focus on ...
- Source: drugdu
- 97
- July 6, 2024
GSK Pays CureVac €400M to Pick Up Clinical-Stage mRNA Vaccines for Infectious Diseases

GSK is taking over development of an avian influenza vaccine candidate as a bird flu outbreak continues in U.S. dairy cows. Meanwhile, CureVac is restructuring and returning its attention to cancer vaccines, which was the initial focus of the mRNA company. By Frank VinluanGSK and CureVac forged their relationship during the Covid-19 pandemic, setting out to develop vaccines that could protect against the novel coronavirus and other infectious diseases. The collaboration has advanced two vaccine candidates into clinical testing, and now GSK is taking over both, one of them in development for an infectious disease target that’s particularly hot right now. Under terms of the restructured agreement announced Wednesday, GSK will now have full control of developing and manufacturing the avian influenza vaccine, currently in Phase 1 testing, and a Covid-19 vaccine in Phase 2 testing. GSK is paying €400 million (about $431.4 million) up front to obtain global rights ...
- Source: drugdu
- 90
- July 5, 2024
FDA Approves GSK’s Arexvy to Prevent Respiratory Syncytial Virus in Adults Aged 50-59 with Increased Risk

Don Tracy, Associate Editor Arexvy receives expanded indication to include adults aged 59 years and younger to prevent RSV lower respiratory tract disease. GSK’s Arexvy (RSV Vaccine, Adjuvanted) has been approved by the FDA for an expanded indication to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in adults aged 50-59 years with an increased risk. The approval for this age group was based on encouraging results from a Phase III trial (NCT05590403) that evaluated the immune response and safety of Arexvy in adults aged 50-59, including those with underlying medical conditions. Arexvy was previously approved for adults aged 60 years and older for the same purpose in May 2023. Additionally, the Advisory Committee on Immunization Practices (ACIP) recommended its use through shared clinical decision-making.1 “[This] approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50-59 who are at increased risk. For those ...
- Source: drugdu
- 102
- June 12, 2024
GSK acquires Elsie to unlock oligonucleotide therapeutics

GSK has acquired Elsie Biotechnologies for $50m to unlock the potential of oligonucleotide therapeutics. Elsie Biotechnologies has been at the forefront of oligonucleotide therapeutic development, focusing on increasing potency, reducing toxicity, and optimising delivery to harness the potential of the modality fully. The acquisition is set to enhance GSK’s research and development (R&D) in gene modulation. Elsie Biotechnologies offers technologies that can modulate gene expression. This feature is particularly valuable for targeting therapeutic areas that are not responsive to traditional small-molecule drugs or biologics. The integration of Elsie’s technologies for the discovery, synthesis and delivery of oligonucleotide into GSK’s R&D framework is expected to advance the company’s platform capabilities significantly. The move follows a successful initial partnership between the two companies which began in July 2023 and allowed GSK to assess and validate Elsie’s technology. GSK’s use of AI and machine learning, combined with data from Elsie’s platform, aims to ...
- Source: drugdu
- 85
- June 11, 2024
GSK’s Quest to Bring Myeloma Drug Back to the Market Stops for a Data Drop at ASCO

GSK’s Blenrep has pivotal clinical trial results showing the multiple myeloma therapy reduced the risk of disease progression or death by nearly 50%. The results were presented Sunday during the annual meeting of the America Society of Clinical Oncology.A GSK multiple myeloma drug that was withdrawn from the market is accumulating new clinical data that could support its return — perhaps as an earlier line of therapy. With the latest results, clinicians and GSK executives say they may have figured out how to address a lingering question about how to safely dose the drug, Blenrep. The new data were presented Sunday during the annual meeting of the American Society of Clinical Oncology in Chicago. Blenrep is an antibody drug conjugate (ADC) that targets the BCMA protein on multiple myeloma cells, delivering to them a payload of toxic chemotherapy. There are many multiple myeloma drugs available, but frequent relapse in this ...
- Source: drugdu
- 115
- June 4, 2024
GSK’s Five-in-One Meningococcal Vaccine Under Review by the FDA

Don Tracy, Associate Editor With a final decision expected next February, MenABCWY combines the protective elements of GSK’s existing vaccines to target the five primary serogroups of Neisseria meningitidis. GSK announced that the FDA has accepted for review an application for its five-in-one meningococcal vaccine MenABCWY. MenABCWY is a combination of GSK’s two existing vaccines, Bexsero and Menveo, and targets the five primary serogroups (A, B, C, W, and Y) of Neisseria meningitidis. These serogroups are credited with causing the majority of meningococcal disease (IMD) cases around the world. According to the company, a final decision is expected on February 14, 2025.1 “In the Phase III trial (NCT04502693), all primary endpoints were achieved for the MenABCWY vaccine candidate, including immunological non-inferiority to one dose of GSK’s Meningococcal Groups A,C,Y and W Vaccine, and non-inferior immune responses against 110 diverse MenB invasive strains (representing 95% of MenB strains circulating in the ...
- Source: drugdu
- 143
- April 20, 2024
GSK’s Omjjara recommended by NICE to treat myelofibrosis patients with anaemia

GSK’s Omjjara (momelotinib) has been recommended by the National Institute for Health and Care Excellence (NICE) as a treatment option for myelofibrosis-related splenomegaly or symptoms in adults with moderate-to-severe anaemia. The agency’s final draft guidance applies to both newly diagnosed and previously treated patients, although those eligible will need to have either not been treated with JAK inhibitors before or been treated with Novartis’ Jakavi (ruxolitinib). Estimated to affect more than 1,900 people in England, Wales and Northern Ireland, myelofibrosis is a rare blood cancer that disrupts the body’s normal production of blood cells. About 40% of myelofibrosis patients have moderate-to-severe anaemia at the time of diagnosis and nearly all patients develop anaemia at some point over the course of their disease. Omjjara is a once-a-day oral JAK1/JAK2 and ACVR1 inhibitor that aims to address the key manifestations of the disease. NICE’s recommendation comes shortly after the Medicines and Healthcare ...
- Source: drugdu
- 158
- February 21, 2024
GSK concludes Aiolos Bio acquisition for $1.4bn

GSK has successfully concluded the acquisition of Aiolos Bio in a deal that could reach $1.4bn, marking a significant expansion of GSK’s respiratory biologics portfolio. The agreement, signed last month, includes an upfront payment of $1bn and $400m in regulatory milestone payments. The acquisition introduces AIO-001, a long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody, into GSK’s pipeline. The antibody is ready to enter Phase II clinical development. It targets adults with asthma and has the potential for extended dosing intervals, possibly every six months, due to its extended half-life and high potency. AIO-001 operates by attaching to the TSLP ligand, a key player in asthma inflammation, to hinder its signalling pathway. The acquisition significantly benefits the estimated 40% of severe asthma patients who suffer from low Type 2 (T2) inflammation. GSK’s commitment to respiratory diseases is further solidified with the addition of AIO-001, potentially redefining standard care for asthma patients. ...
- Source: drugdu
- 166
- February 20, 2024

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