November 9, 2023
Via: Biopharm InternationalOn Nov. 7, 2023, FDA issued final guidance that includes recommendations for reporting post-approval changes of some common changes to container closure system (CCS) components consisting of glass vials and stoppers for approved sterile drug products and biologics. The recommendations […]
October 27, 2023
Via: Kaiser Health NewsThe world is entering a new era of vaccines. Following the success of covid-19 mRNA shots, scientists have a far greater capacity to tailor shots to a virus’s structure, putting a host of new vaccines on the horizon. The most […]
October 27, 2023
Via: PMLiVEFunded by the Medical Research Council part of UK Research and Innovation, the LEGACY03 trial will contribute to future vaccine designs to enhance protection for those most vulnerable to diseases. As the immune systems changes with age, the body’s response […]
October 13, 2023
Via: Biopharma DiveThe U.S. government announced Friday the selection of three “next generation” COVID-19 vaccine candidates, awarding millions of dollars to support mid-stage clinical trials of the shots as part of the Project NextGen initiative. Launched in May by the Department of […]
September 18, 2023
Via: PMLiVEMillions of eligible people in England can now book their vaccine via the NHS website, the NHS app, or by calling 119 for free if they do not have access online. From this week, people aged 65 and over, pregnant […]
August 24, 2023
Via: Biopharm InternationalRoyalty Pharma, a company specializing in acquiring pharmaceutical royalties, and Ferring Pharmaceuticals, a biopharmaceutical company with a new gene therapy expected to hit the market, announced that Royalty Pharma had acquired a synthetic royalty on US net sales of Ferring’s […]
June 20, 2023
Via: Natalie DunnThe COVID-19 pandemic has caused significant disruptions worldwide, altering people’s lifestyles and forcing industries to adapt. Despite the fact that the healthcare crisis has ended, its impact continues to reshape various sectors globally. Businesses have recognized the importance of establishing […]
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 […]
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 […]
April 19, 2023
Via: PMLiVEThe current bivalent vaccines, targeting the original and omicron BA.4/BA.5 strains, can now be used for all doses administered to individuals aged six months and older, including for an additional dose or doses for certain populations. Each vaccine now has […]
Clinical Trials, Industry, Research and Development, Vaccines
March 27, 2023
Via: Contract Pharma4Q Revenues: €4.3 billion (-23%) 4Q Earnings: €2.3 billion (-28%) YTD Revenues: €17.3 billion (-9%) YTD Earnings: €9.3 billion (-8%) Comments: Results in the quarter and FY reflect lower demand for COVID-19 vaccines. Approximately 2 billion doses of COMIRNATY invoiced […]
February 16, 2023
Via: PMLiVEThe companies will still continue to work together on their SARS-CoV-2-targeting antibody, sotrovimab, in markets where it is authorised, as well as their experimental COVID-19 antibody, VIR-7832, and a portfolio of other therapies for respiratory diseases such as influenza. Originally […]
February 16, 2023
Via: Drugs.comOlder people have vaccines available to prevent severe influenza and COVID-19, but there’s been nothing to protect against the third respiratory virus that contributed to this season’s wretched “triple-demic.” Until now. Two major pharmaceutical companies published clinical trial results this […]
FDA, Industry, Regulations, Vaccines
January 30, 2023
Via: Biopharm InternationalA more harmonized formula and schedule for administering COVID-19 vaccines gained strong support from FDA’s expert advisory panel last week, with agreement on the need to reduce confusion over which shot to take and when in order to increase vaccination […]
FDA, Industry, Regulations, Vaccines
January 27, 2023
Via: Kaiser Health NewsAt a meeting to simplify the nation’s covid vaccination policy, the FDA’s panel of experts could agree on only one thing: Information is woefully lacking about how often different groups of Americans need to be vaccinated. That data gap has […]
January 18, 2023
Via: Kaiser Health NewsA new coronavirus variant is circulating, the most transmissible one yet. Hospitalizations of infected patients are rising. And older adults represent nearly 90% of U.S. deaths from covid-19 in recent months, the largest portion since the start of the pandemic. […]
January 11, 2023
Via: Drugs.comWhile COVID-19 vaccine acceptance rose around the world between 2021 and 2022, wide gaps remain, according to new research. Teams from the Barcelona Institute for Global Health in Spain (ISGlobal) and City University of New York (CUNY) also noted the […]
January 9, 2023
Via: PMLiVEThe tested vaccine candidates produced promising immunogenicity and reactogenicity profiles in ongoing phase 1 clinical programmes for COVID-19 and seasonal flu, assessing both modified and unmodified mRNA technology. “The positive results from this preliminary data analysis strongly validate the power […]
Clinical Trials, Research and Development
January 4, 2023
Via: PMLiVEThe start of the trial triggers a $5m milestone payment from AZ, which licensed AZD3152 from RQ Bio in May last year, and reinforces the financial position of the UK-based biotech to execute its four scientific programmes focused on viral […]