Search Results for “vaccine” – Page 3 – media

HilleVax slashes workforce by 40% after norovirus vaccine trial failure

US-based vaccine company HilleVax is slashing its workforce by 40% after its lead vaccine failed a Phase IIb study last month. HilleVax announced that it will let go of 41 employees, after a Phase IIb trial (NCT05836012) with its norovirus vaccine, HIL-214, failed to meet primary and secondary endpoints. The company’s stock plummeted by more than 80% following the 8 July announcement of the failed results. The vaccine showed an efficacy of 5% in the 2,800 infants enrolled in the study aged four months of age at the time of enrolment in the US and Latin American countries, who had norovirus-related acute gastroenteritis (AGE). The study did not meet the key endpoint of demonstrating efficacy against moderate or severe AGE events caused by the GI.1 or GII.4 norovirus genotypes. The experimental vaccine had previously shown success in adults, with one Phase IIb field efficacy trial (NCT02669121) in 4,712 adults showing ...
- Source: drugdu
- 80
- August 3, 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
- 111
- July 31, 2024
ANKE Bio received clinical approval for another therapeutic mRNA vaccine

ANKE Bio (Group) Co., Ltd. and Hefei Alfana Biotechnology Co., Ltd. jointly developed a Class 1 new drug that received clinical approval from the Drug Administration (Drug Clinical Trial Approval Notification: 2024LP01608), with an indication for the treatment of cervical intraepithelial neoplasia. It is reported that this is the first therapeutic mRNA vaccine approved for clinical use in cervical intraepithelial neoplasia in China. Pre-cancerous lesions and their eventual malignant changes caused by viral infections are a serious threat to people’s lives and health. Globally, approximately 600 million people are infected with human papillomavirus (HPV), in addition to approximately 250 million people infected with hepatitis B virus (HBV), and 71 million people infected with hepatitis C virus (HCV). People infected with each of these viruses face a potential cancer risk. For example, approximately 30 million women are diagnosed each year with cervical intraepithelial neoplasia (CIN), an important precursor to cervical cancer. ...
- Source: drugdu
- 82
- July 25, 2024
MAXVAX’s recombinant herpes zoster vaccine (CHO cell) enrolled in Phase III clinical trials

On July 13, the Phase III clinical trial of recombinant herpes zoster vaccine (CHO cell) of Chengdu MAXVAX Biotechnology Co., Ltd (MAXVAX) completed the enrollment of the first subject in Liangyuan District, Shangqiu City, Henan Province, marking the successful start of the Phase III clinical trial of the recombinant herpes zoster vaccine of MAXVAX. The vaccine product adopts recombinant protein technology route and carries independently developed new adjuvant system MA105, which is the first innovative vaccine with composite adjuvant system with independent intellectual property rights to enter phase Ⅲ clinical trial in China. The results of Phase I and Phase II clinical trials show that it has good safety, tolerability and immunogenicity. Phase III clinical trials will further verify the safety, immunogenicity and protective efficacy of the vaccine in a large sample of people, providing key data for the product’s marketing application. About Herpes Zoster Vaccine Herpes zoster is a ...
- Source: drugdu
- 59
- July 16, 2024
Sinopharm’s Quadrivalent HPV Vaccine Marketing License Application Accepted

On July 4, 2024, Sinopharm’s application for marketing authorization of quadrivalent recombinant human papillomavirus vaccine (type 6, 11, 16, 18) (Hansenula polymorpha), which was jointly declared by Sinopharm’s Chengdu Institute of Biological Products of China Biological and China Academy of Biological Sciences (National Engineering Research Center for Novel Vaccines), was accepted by the State Drug Administration under acceptance No. CXSS2400063, the first domestic quadrivalent HPV vaccine in China. This is the first quadrivalent HPV vaccine in China, which mainly covers four subtypes of HPV virus, including 6, 11, 16 and 18, and is suitable for preventive vaccination for women aged 18-45. The vaccine was independently researched and developed by China Academy of Biological Sciences and industrialized and developed by Chengdu Institute of Biological Products, and the two sides jointly conducted clinical research and initiated Phase III clinical trial in May 2018, and obtained a positive recommendation from the interim analysis ...
- Source: drugdu
- 87
- July 10, 2024
OLYMVAX Trivalent Influenza Virus Cracking Vaccine (MDCK Cells) Clinical Trial Application Accepted

Recently, the State Drug Administration website announced that it agreed to accept OLYMVAX’s application for clinical trials of trivalent influenza virus lysate vaccine (MDCK cells), which is also the first cell-based trivalent influenza vaccine to be declared for clinical use in China. Influenza vaccination is an effective means of preventing influenza and reducing the burden of influenza-associated severe illness and death. Divided from the components of the vaccine and the types of preventive viruses, the influenza vaccines currently available in China include trivalent influenza vaccine and tetravalent influenza vaccine. Trivalent influenza vaccine mainly prevents H1N1 and H3N2 subtypes of Influenza A, as well as Influenza B Victoria lineage viruses, while tetravalent influenza vaccine is based on trivalent influenza vaccine, with added prevention against Influenza B Yamagata lineage viruses. OLYMVAX’s quadrivalent influenza virus lysate vaccine (MDCK cells) has been approved by the State Drug Administration for the issuance of the Notice ...
- Source: drugdu
- 123
- July 9, 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
- 99
- 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
- 92
- July 5, 2024
Moderna Awarded $176 Million from the Biomedical Advanced Research and Development Authority to Expedite Development of mRNA-Based Influenza Vaccines

By Don Tracy, Associate Editor Funding from the Biomedical Advanced Research and Development Authority (BARDA) is expected to support the late-stage development and licensure of a pre-pandemic vaccine targeting the H5 influenza virus. The Biomedical Advanced Research and Development Authority (BARDA) has granted Moderna a $176 million project award under the Rapid Response Partnership Vehicle (RRPV) Consortium, with the goal of expediting the development of mRNA-based pandemic influenza vaccines. Reportedly, the award is expected to support the late-stage development and licensure of a pre-pandemic vaccine targeting the H5 influenza virus, a subtype known for causing severe avian influenza and posing a potential risk to humans.1 “mRNA vaccine technology offers advantages in efficacy, speed of development, and production scalability and reliability in addressing infectious disease outbreaks, as demonstrated during the COVID-19 pandemic,” said Stéphane Bancel, CEO, Moderna, in a press release. “We are pleased to continue our collaboration with BARDA to ...
- Source: drugdu
- 136
- July 5, 2024
Europe contributes over €750m to African Vaccines Manufacturing Accelerator

The EU, its Member States and European financial institutions have announced a more than €750m contribution to the newly launched African Vaccines Manufacturing Accelerator (AVMA) as part of the EU’s Global Gateway strategy. Over the next decade, the AVMA aims to purchase more than 800 million vaccine doses produced in Africa, making more than €1bn available to manufacturers to offset high start-up costs while providing assurance of demand. Developed by Gavi, the Vaccine Alliance and the Africa Centres for Disease Control and Prevention, the AVMA has the potential to improve African pandemics, outbreaks, preparedness and responses, as well as to support global health security. It aims to enhance the predictability of demand for vaccines made in Africa, support the growth of its manufacturing base and achieve its ambition to produce most vaccines required by African countries on the continent while also helping to diversify a set of global vaccine suppliers ...
- Source: drugdu
- 87
- June 27, 2024

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