August 3, 2023
Via: Drugs.comWhile both the Moderna and Pfizer COVID-19 vaccines are considered safe and highly effective, new research finds the Moderna shot has been the safest and most effective for seniors. “The results of this study can help public health experts weigh […]
July 31, 2023
Via: PMLiVEThe modelling study, Global and regional burden of attributable and associated bacterial antimicrobial resistance avertable by vaccination, was carried out by the World Health Organization (WHO), the International Vaccine Institute, Korea (IVI) and the London School of Hygiene and Tropical […]
July 25, 2023
Via: Drugs.comMost early childhood vaccines require three or four doses for best protection, but more than 1 in 6 toddlers aren’t getting them all, leaving them vulnerable to potentially deadly infections, a new study finds. There are many reasons that kids […]
July 21, 2023
Via: Biopharma DiveAdults over the age of 60 now have two RSV vaccines to choose from in the U.S. and Europe. A new antibody treatment is available to prevent infants from infections, too. So far, Pfizer is the only drugmaker to reach […]
July 12, 2023
Via: Biopharm InternationalBiosynth announced on July 11, 2023 that it has acquired celares, a leader in the development and manufacture of conjugate vaccines and bioconjugate drugs, activated PEGs, and polymer-based drug delivery excipients, according to a company press release. The acquisition will […]
July 7, 2023
Via: Contract PharmaSanofi is partnering with Saudi drugmakers Arabio and Lifera to increase the production of vaccines in Saudi Arabia. Lifera and Sanofi signed a Memorandum of Understanding (MOU) enabling the two companies to strengthen local manufacturing. With the MOU Sanofi, LIfera […]
June 29, 2023
Via: Drugs.comAmericans ages 60 and up can get their vaccine for respiratory syncytial virus (RSV) this fall, the U.S. Centers for Disease Control and Prevention announced Thursday. On Thursday, Dr. Rochelle Walensky, the outgoing CDC director, gave her signature to a […]
June 19, 2023
Via: PMLiVEThe Vaccines and Related Biological Products advisory committee (VRBPAC) voted 21 to zero in favour of the monovalent XBB-lineage vaccines, and generally agreed that vaccines targeting the XBB.1.5 subvariant would be preferred. XBB.1.5, which is another descendant of the Omicron […]
June 15, 2023
Via: Drugs.comAn advisory panel to the U.S. Food and Drug Administration voted unanimously on Thursday to recommend that COVID booster shots be updated for the fall to protect solely against one of the three XBB variants that have taken hold in […]
June 14, 2023
Via: Drugs.comCOVID-19 boosters may be offered this fall, but first scientists need to determine what strains to target and who should receive the shots. Advisers to the U.S. Food and Drug Administration are slated to meet Thursday to discuss plans for […]
June 9, 2023
Via: Drugs.comA U.S. Food and Drug Administration advisory panel on Thursday recommended that the agency approve an RSV vaccine for infants and some toddlers. The monoclonal antibody shot would protect against respiratory syncytial virus (RSV) in infants born during or entering […]
June 8, 2023
Via: Biopharma DiveThe development of therapeutic vaccines for cancer has met repeated disappointment over the years, as treatments aimed at cancers of the brain, lung and kidney have failed in clinical testing. But now, developers like Moderna, BioNTech and Gritstone Bio are […]
FDA, Industry, Regulations, Vaccines
June 1, 2023
Via: Drugs.comOlder adults may have a second vaccine option for RSV following the U.S. Food and Drug Administration’s approval of a Pfizer vaccine on Wednesday. The other shot for adults 60 and up is made by GSK. It was approved May […]
May 30, 2023
Via: Drugs.comThe U.S. Food and Drug Administration has approved Brixadi (buprenorphine) extended-release injection to treat moderate-to-severe opioid use disorder. Brixadi is approved for both weekly (8 mg, 16 mg, 24 mg, 32 mg) and monthly (64 mg, 96 mg, 128 mg) […]
May 26, 2023
Via: PMLiVEPfizer’s oral antiviral, which has now been granted full approval to treat mild-to-moderate COVID-19 in adults at a high risk for progression to severe disease, has been available in the US since December 2021 under the FDA’s accelerated approval pathway. […]
May 25, 2023
Via: Drugs.comAmericans with COVID-19 have been taking Paxlovid since it was approved under emergency use in late 2021. Today, the U.S. Food and Drug Administration granted full approval to the drug. This approval will allow drugmaker Pfizer to sell the medication […]
May 23, 2023
Via: PMLiVEThe Vaccines and Related Biological Products advisory committee (VRBPAC) voted unanimously that the available data supported the efficacy of RSVpreF in helping to protect against the complications of RSV in infants from birth to six months of age. The committee […]
FDA, Industry, Regulations, Vaccines
May 19, 2023
Via: Biopharma DiveThe vaccine, if approved, would be the first available for protecting infants from a pathogen that each year kills hundreds of young children. It is one of a recent wave of drugmaker successes against the disease after decades of effort. […]
May 18, 2023
Via: Drugs.comThe first vaccine designed to protect infants against respiratory syncytial virus (RSV) by vaccinating their mothers during pregnancy has been backed by a panel of advisers to the U.S. Food and Drug Administration. On Thursday the independent committee of experts […]
May 10, 2023
Via: Biopharm InternationalFDA announced the approval of GSK’s Biologicals’ Arexvy, a respiratory syncytial virus (RSV) vaccine, on May 3, 2023. The vaccine is the first to be approved for prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged […]