Search Results for “vaccine” – Page 8 – media

Merck expects $20B+ in new cancer sales thanks to Daiichi ADC deal, Moderna vaccine

While some Merck & Co. investors may still get the heebie-jeebies when thinking about Keytruda’s patent cliff in 2028, but the company’s CEO Rob Davis now thinks “it’s just another year.” Make no mistake, given Keytruda’s size, an overall business decline will likely still hit. But Merck is focused on making “the hill to dip as small as possible and the return to growth as fast as possible,” Davis said Monday at the 2024 annual J.P. Morgan Healthcare Conference. Davis and Merck Research Laboratories President Dean Li, M.D., Ph.D., pointed to the breadth of Merck’s portfolio across oncology, infectious disease, cardiometabolic, immunology and neuroscience to explain Merck’s potential for growth. “I know that the conversation continues to be about Keytruda and 2028,” Davis said. “But increasingly, we’re not focused on 2028. 2028, it’s just another year, it’s just another point. We’re focused on 2030 to 2040.” At last year’s J.P. ...
- Source: drugdu
- 100
- January 11, 2024
MSD’s Nine-Valent Human Papillomavirus Vaccine, Gardasil®9, Receives Approval from China’s State Drug Administration for a New Two-Dose Vaccination Program for Females 9 to 14 Years of Age

SHANGHAI, China, January 9, 2024 – MSD announced that it has received approval from the State Drug Administration of China (SDA) for a new two-dose vaccination program (0, June to December) for females aged 9 to 14 years for its nine-valent human papillomavirus vaccine (brewer’s yeast) (trade name: Gardasil®9). This approval means that Gardasil®9 will be added to the previous three-dose vaccination program for women aged 9~45 years old, providing more economical and convenient health protection for more women of the appropriate age group, and helping them to stay away from cervical cancer and cervical lesions associated with HPV infection. Gardasil®9 is indicated for the prevention of cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58; cervical intraepithelial neoplasia (CIN grades 1/2/3) and adenocarcinoma in situ (AIS) of the cervix caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58; and ...
- Source: drugdu
- 167
- January 11, 2024
Kanghua Biologicals Signs License Agreement with HilleVax for Recombinant Hexavalent Norovirus Vaccine

Recently, Chengdu Kanghua Biological Products Company Limited (“Kanghua Biological” or the “Company”) signed an Exclusive License Agreement with HilleVax.INC (“HilleVax”). INC (“HilleVax”). Kanghua Biologicals licensed HilleVax to develop, manufacture and commercialize Recombinant Hexavalent Norovirus Vaccine and its derivatives in areas other than China (including Hong Kong, Macao and Taiwan). Kanghua Biologicals will receive an initial payment of US$15 million for this transaction and is expected to receive milestone payments of US$255.5 million upon the achievement of certain development and sales milestones, and Kanghua Biologicals is also entitled to a single-digit percentage sales commission on net sales in territories other than China (including Hong Kong, Macao and Taiwan). Using genetic engineering technology, Kanghua Biologicals has constructed a recombinant hexavalent norovirus vaccine based on Virus-Like Particles (VLPs), which encompasses the six major prevalent genotypes of norovirus, and theoretically protects against more than 90% of norovirus infections and acute gastroenteritis caused by norovirus, ...
- Source: drugdu
- 76
- January 10, 2024
China Biological Wuhan Institute of Biological Products Receives Another International Registration Certificate for Influenza Vaccine

On January 3, 2024, the quadrivalent influenza virus lysate vaccine independently developed by Wuhan Institute of Biological Products of China Biologicals (WIBP) was granted a certificate of drug registration by the Ministry of Health and Prevention (MOHAP) of the United Arab Emirates (UAE). This is another international registration certificate obtained after the Kenyan registration certificate in 2023, marking the steady progress of the internationalization strategy of Wuhan Bioproducts Research Institute and the gradual opening of a new channel for exporting vaccine products to the Middle East. Influenza is an acute respiratory infectious disease caused by influenza virus. According to WHO’s estimation, about 600 million people are infected with influenza virus globally every year, and as many as 250,000 to 500,000 cases of death. Influenza vaccination is the most cost-effective preventive measure. Influenza vaccine of Wuhan Institute of Biological Products is prepared by a patented process without antibiotics and preservatives. It ...
- Source: drugdu
- 76
- January 9, 2024
Tsinghua University, in collaboration with Minhai Biotechnology, discovers a novel immunoprotective mechanism for vaccine clearance of pathogenic bacteria

Vaccine immunization has dramatically reduced the morbidity and mortality of invasive bacterial infectious diseases such as bloodstream infections. Although a large number of studies have demonstrated that immune protection requires vaccine-induced antibody production, human beings still lack a clear understanding of the cellular and molecular mechanisms of how vaccines provide immune protection. The current international consensus is that vaccines provide immune protection by activating phagocytes in the spleen and blood circulation to remove pathogens that invade the bloodstream. Recently, Jingren Zhang’s group and Linqi Zhang’s group at Tsinghua University School of Medicine, together with Haifa Zheng’s group at Beijing Minhai Biotechnology Co., Ltd, published a paper in Science Translational Medicine titled “Liver macrophages and sinusoidal endothelial cells The research paper, entitled Liver macrophages and sinusoidal endothelial cells execute vaccine-elicited capture of invasive bacteria, reveals that the liver is the main organ that executes vaccine-elicited immunoprotection, and elucidates the molecular mechanism ...
- Source: drugdu
- 127
- January 4, 2024
World Health Organization adds second malaria vaccine to prequalification list

The World Health Organization (WHO) has said it has added a new malaria vaccine to its list of prequalified vaccines, marking a “significant milestone” in the prevention of the mosquito-borne disease. R21/Matrix-M, developed by the University of Oxford and the Serum Institute of India, is now the second malaria vaccine to be prequalified by the organisation following its prequalification of the RTS,S/AS01 vaccine in July 2022. Malaria places a particularly high burden on the African Region, where nearly half a million children die from the disease every year. Despite high demand, WHO outlined that the available supply of RTS,S has been limited and expects the addition of R21 to result in sufficient vaccine supply for children living in areas where malaria is a significant public health risk. Dr Kate O’Brien, director of WHO’s department of immunisation, vaccines and biologicals, said the decision marked “a huge stride in global health”. “This ...
- Source: drugdu
- 159
- January 4, 2024
Super Factory with International Standards for AIM Bio’ Vaccines Ready for Launch

AIM Bio is gearing up for the imminent launch of its blockbuster products, the 13-valent Pneumococcal Conjugate Vaccine and the 23-valent Pneumococcal Polysaccharide Vaccine. The production lines are ready and preparations are underway for WHO-PQ certification. These super vaccine factories have been designed and constructed according to WHO-PQ standards, fully preparing for the global market, showcasing Emergent’s forward-looking layout and arrangements in the international market. In Emergent’s super vaccine factories, the vaccine production process is monitored in real-time, and batches of vaccine products undergo online review and release. The entire production process is traceable with data records, minimizing human intervention, ensuring the repeatability and consistency of vaccine production, reducing the risk of human error, and lowering the risks of contamination and cross-contamination. The digitization and intelligence have reached a globally leading level. Represented by the workshop for the 13-valent Pneumococcal Conjugate Vaccine in Ningbo, these super vaccine factories designed and ...
- Source: drugdu
- 113
- January 2, 2024
China’s First Domestic Oral Trivalent Reassortant Rotavirus Attenuated Live Vaccine Approved for Market

On December 28, the first domestically developed oral trivalent reassortant rotavirus attenuated live vaccine (Vero cells) produced by China National Pharmaceutical Group Corporation (Sinopharm) Lanzhou Institute of Biological Products received the approval and issuance certificate from the China Food and Drug Inspection Research Institute. The vaccine has been sent to various regions across the country and is about to commence vaccination. Rotavirus is a major cause of severe acute diarrhea in infants and young children, with almost every child under the age of 5 being infected at least once. If not intervened in a timely manner, it may lead to systemic damage affecting respiratory, circulatory, and central nervous systems, and in severe cases, dehydration, shock, and even death. Both the World Health Organization (WHO) position papers and the ‘Expert Consensus on Immunization Prevention of Rotavirus Gastroenteritis in Children’ released in China in 2020 clearly state that vaccination with rotavirus vaccines ...
- Source: drugdu
- 115
- January 2, 2024
Moderna and Merck’s Novel Cancer Vaccine, Keytruda Combo Cuts Risk of Skin Cancer Death, Recurrence by Half

Pharmaceutical Executive Editorial Staff Adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Merck’s Keytruda lowered the risk of recurrence or death by 49% compared with Keytruda monotherapy. Findings from the KEYNOTE-942/mRNA-4157-P201 clinical trial show that Moderna’s investigational individualized neoantigen therapy plus Merck’s Keytruda (pembrolizumab) lowered the risk of death or relapse by nearly half in patients with resected high-risk melanoma (stage III/IV) following complete resection. A planned analysis of the Phase IIb randomized trial found that at a median follow-up of approximately three years, adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Keytruda continued to show a clinically meaningful improvement in recurrence-free survival (RFS) by lowering the risk of recurrence or death by 49% compared with Keytruda monotherapy. “As we continue to follow participants in the KEYNOTE-942/mRNA-4157-P201 study, we are excited to see such a robust clinical benefit with mRNA-4157 (V940) as adjuvant treatment in combination with Keytruda ...
- Source: drugdu
- 224
- December 27, 2023
Merck’s 21-Valent Pneumococcal Conjugate Vaccine Granted FDA Priority Review

Pharmaceutical Executive Editorial Staff Merck’s Biologics License Application for V116, a novel 21-valent pneumococcal conjugate vaccine has been given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024. The FDA has granted priority review to Merck’s Biologics License Application (BLA) for V116, a novel 21-valent pneumococcal conjugate vaccine developed as a single dose for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. The BLA has been given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024. “Invasive pneumococcal disease poses a greater risk to older adults or those with weakened immune systems, in part due to disease-causing serotypes not covered by currently licensed pneumococcal conjugate vaccines,” Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said in a press release. “If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed ...
- Source: drugdu
- 133
- December 25, 2023

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