Top

Tag: COVID-19


FDA, Regulations

FDA Publishes Guidance on Container Closure Systems for COVID-19

November 9, 2023

Via: Biopharm International

On 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 […]


Industry, Vaccines

A New Era of Vaccines Leaves Old Questions About Prices Unanswered

October 27, 2023

Via: Kaiser Health News

The 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 […]


Industry, Vaccines

University of Oxford launches new trial to enhance flu and COVID-19 vaccines

October 27, 2023

Via: PMLiVE

Funded 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 […]


Industry, Vaccines

‘Project NextGen’ picks new mRNA, intranasal COVID vaccines for funding

October 13, 2023

Via: Biopharma Dive

The 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 […]


Industry, Vaccines

NHS bookings for COVID-19 vaccinations open as winter programme starts early

September 18, 2023

Via: PMLiVE

Millions 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 […]


Industry, Vaccines

US government awards $1.4bn for development of COVID-19 vaccines and therapeutics

August 24, 2023

Via: Biopharm International

Royalty 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 […]


Editorial

Why Vaccine Research and Development Is Important in 2023

June 20, 2023

Via: Natalie Dunn

The 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 […]


Industry, Vaccines

FDA advisory committee backs updated COVID-19 vaccines targeting XBB variants

June 19, 2023

Via: PMLiVE

The 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 […]


Industry, Vaccines

COVID-19: Pfizer’s Paxlovid approved by FDA and Gilead’s Veklury recommended by CHMP

May 26, 2023

Via: PMLiVE

Pfizer’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. […]


Industry, Vaccines

FDA Grants Full Approval to Paxlovid to Treat COVID-19

May 25, 2023

Via: Drugs.com

Americans 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 […]


Industry, Vaccines

Authorisation for Moderna and Pfizer/BioNTech’s bivalent COVID-19 vaccines simplified by FDA

April 19, 2023

Via: PMLiVE

The 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

BioNTech Revenues Slide with Waning Demand for COVID-19 Vaccines

March 27, 2023

Via: Contract Pharma

4Q 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 […]


Mergers and Acquisitions

GSK and Vir Biotech amend COVID-19 research partnership

February 16, 2023

Via: PMLiVE

The 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 […]


Industry, Vaccines

Two Vaccines May Soon Shield Seniors Against RSV

February 16, 2023

Via: Drugs.com

Older 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

FDA Seeks to Simplify COVID-19 Vaccination Program

January 30, 2023

Via: Biopharm International

A 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

FDA Experts Are Still Puzzled Over Who Should Get Which Covid Shots and When

January 27, 2023

Via: Kaiser Health News

At 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 […]


News

What Older Americans Need to Know About Taking Paxlovid

January 18, 2023

Via: Kaiser Health News

A 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. […]


Industry, Vaccines

Global Acceptance of COVID-19 Vaccines Is on the Rise

January 11, 2023

Via: Drugs.com

While 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 […]


Industry, Vaccines

GSK and CureVac to advance mRNA COVID-19 and flu vaccine candidates

January 9, 2023

Via: PMLiVE

The 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

RQ Bio-discovered antibody enters clinic as part of AstraZeneca COVID-19 study

January 4, 2023

Via: PMLiVE

The 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 […]