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On 24 October, American vaccine developer Vaxcyte shared positive topline data from a Phase I/II study of its multivalent conjugate pneumococcal vaccine VAX-24 , bringing the 24-valent pneumococcal jab one step closer to market. This is in addition to its long-available pneumococcal polysaccharide vaccine PPSV23.
For example, rising ambient temperatures and ingress of mould from items entering cleanrooms, has resulted in some vaccine and pharmaceutical companies in Europe experiencing increased contamination. The authors also shared: “in the last three years [since 2023], the US FDA has recalled several drugs due to fungal contamination.”
Governments do not have to look hard to find ample opportunity for their health systems to accelerate biosimilar adoption practices and drive huge healthcare savings while still delivering excellent high quality patient care, as noted openly by the FDA during the last 18 months. Unpleasant truth: let’s embrace it and take action.
In 1990, the US Food and Drug Administration (FDA) requested Astra to change Losec’s brand name to Prilosec, to avoid confusion with Sanofi-Aventis’ diuretic, Lasix (furosemide). In June 2007, AstraZeneca completed the acquisition of vaccine maker MedImmune, buying its drug-development pipeline for $15.2 Pascal Soriot.
In Aug’21, the US FDA cleared QSam’s IND application for CycloSam. In Jun’21, the company initiated the evaluation of FAP-2286 in a P-I/II clinical trial (LuMIERE) following the US FDA’s IND clearance. In Sep’21, the US FDA granted DUNP19 an ODD for Osteosarcoma.
Within the emerging innovation stage, cell therapy for ocular disorders, coronavirus vaccine components, and DNA polymerase compositions are disruptive technologies that are in the early stages of application and should be tracked closely.
Total Revenue: $35.48B Founded Year: 2000 Total Employees: ~69,400 Headquarters: London, United Kingdom Market Cap: $77.61B Stock Exchange: LON GSK is a multinational healthcare company indulged in discovering and developing therapeutic products under its business segments, including General Medicines, Specialty Medicines, and Vaccines.
Dr. Blumberg discovered the hepatitis B virus in 1967 and 2 years later developed the first hepatitis B vaccine. Plasma-derived vaccine approval by FDA for Hepatitis use in the humans . 1986. Vaccines improvement through genetic engineering for the treatment and control of Hepatitis. . May 2010.
MyoVista wavECG is the company’s first FDA-cleared product which is designed to provide diagnostic information related to cardiac dysfunction in addition to being a resting 12-lead ECG. LP-310, another lead asset of the company received FDA Type-B Pre-IND guidance recently for Oral Lichen Planus. Founded Year: 2010 No.
Identification and Analysis of Contamination Trends Three major recall databases—those of the US FDA, the United Kingdom’s Medicine and Healthcare Products Regulatory Agency (UK MHRA), and Australia’s Therapeutic Goods Administration (TGA)—were searched to assess contamination trends in the past five years.
Pharmaceutical companies have been working on developing vaccines and other prophylactics for respiratory syncytial virus (RSV) since its discovery in 1956. Despite strong efforts and scientific advances, a safe and effective vaccine for RSV has yet to be approved for any patient population.
In the US, the FDA responded by creating guidance that excluded women of childbearing age from participating in phase 1 and phase 2 trials. The COVID-19 pandemic has further highlighted the complex ethics of including pregnant women in vaccine clinical trials. were women.
By 2010, about 2000 isolated human genes had been patented in the U.S. In 2010, the Association for Molecular Pathology (AMP), among other organizations, brought suit against Myriad Genetics, challenging the validity of the company’s patents on the BRCA 1/2 genes.
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