Top

Tag: vaccines


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

Pfizer’s maternal RSV vaccine candidate backed by FDA advisory committee

May 23, 2023

Via: PMLiVE

The 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

FDA advisers back maternal use of Pfizer RSV vaccine

May 19, 2023

Via: Biopharma Dive

The 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. […]


Industry, Vaccines

FDA Panel Backs First RSV Vaccine Given in Pregnancy

May 18, 2023

Via: Drugs.com

The 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 […]


Industry, Vaccines

FDA Approves First RSV Vaccine

May 10, 2023

Via: Biopharm International

FDA 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 […]


Mergers and Acquisitions

Moderna, Novocol Pharma Partner on Fill-Finish Agreement for mRNA Vaccines

May 5, 2023

Via: Contract Pharma

Moderna, Inc., a provider of messenger RNA (mRNA) therapeutics and vaccines, entered into a long-term agreement with Ontario-based Novocol Pharma, a sterile injectable contract development and manufacturing organization (CDMO), to perform aseptic fill-finish, labelling and packaging of mRNA respiratory vaccines […]


Industry, Vaccines

Science Reveals Cause of Rare Heart Trouble in Young Men Who Get COVID Vaccines

May 5, 2023

Via: Drugs.com

Researchers think they’ve figured out why the COVID vaccine causes heart inflammation in an extremely small number of teenage boys — and what might be done to avoid it. The second dose of COVID vaccine appears to promote a severe […]


Industry, Vaccines

FDA Approves First RSV Vaccine, Arexvy

May 3, 2023

Via: Drugs.com

The first vaccine for respiratory syncytial virus (RSV) has been approved by the U.S. Food and Drug Administration for use in seniors aged 60 and older. Arexvy, manufactured by GlaxoSmithKline (GSK), is expected to help prevent lower respiratory tract infections […]


FDA, Regulations

FDA Gives Guidance for Decentralized Clinical Trials for Drugs, Devices

May 2, 2023

Via: Biopharm International

FDA released a new draft guidance that provides recommendations aimed at sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. This specific guidance refers to a DCT as a clinical […]


Industry, Vaccines

Pandemic Saw Rise in Mistrust of Childhood Vaccines Worldwide

April 21, 2023

Via: Drugs.com

While overall support for childhood vaccines remains strong, a new UNICEF report documents a significant decline in the public’s faith in the importance of these vaccines. Confidence in childhood immunizations dropped by up to 44 percentage points in some countries […]


Clinical Trials, Research and Development

Clinical trial begins using CAR T cells to potentially cure HIV

April 20, 2023

Via: World Pharma News

UC Davis Health researchers have dosed the second participant in their clinical trial looking to identify a potential cure for HIV utilizing CAR T-cell therapy. The novel study uses immunotherapy. It involves taking a patient’s own white blood cells, called […]


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 […]


Industry, Vaccines

FDA favors single dose of updated COVID shots in shift to simplify vaccination

April 18, 2023

Via: Biopharma Dive

A single dose of either Pfizer’s or Moderna’s updated COVID-19 vaccines will be recommended in most cases moving forward, after the Food and Drug Administration on Tuesday updated its authorizations of the shots to simplify the recommended regimens. Adults or […]


Manufacturing, Research and Development

Meissner to Invest $250 Million in New Manufacturing Facility in US

April 12, 2023

Via: Biopharm International

Meissner, a company focused on advanced microfiltration and therapeutic manufacturing systems, announced on April 6, 2023 that it will invest nearly $250 million in a new manufacturing facility in Athens-Clarke County, Ga. The new facility will be located at the […]


News

Curevo Vaccine Names Guy De La Rosa Chief Medical Officer

April 11, 2023

Via: Contract Pharma

Curevo Vaccine, a privately held clinical-stage biotechnology company dedicated to reducing the burden of infectious disease by developing safe and highly effective vaccines, announced Guy De La Rosa has joined the company as its new chief medical officer. “The Curevo […]


Industry, Vaccines

WHO Experts Say Healthy Kids, Teens May Not Need More COVID Shots

March 29, 2023

Via: Drugs.com

New advice from the World Health Organization (WHO) says healthy children and teens may not need additional COVID-19 shots, though they may need to catch up on other routine vaccines. “The public health impact of vaccinating healthy children and adolescents […]


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 […]


Cell and Gene Therapy, Industry

Moderna inks second genetic medicine deal in a month

March 23, 2023

Via: Biopharma Dive

Moderna, flush with more than $18 billion in cash at the end of 2022 from revenue generated by its COVID-19 vaccine, has been reinvesting some of that money in search of its next growth engine. This year, the company is […]


Industry, Vaccines

Pfizer/BioNTech’s Omicron-adapted booster approved by FDA for young children

March 15, 2023

Via: PMLiVE

With this latest approval, children aged six months to four years who have completed their primary series with three doses of the companies’ original vaccine will be able to receive a 3µg booster dose of the bivalent vaccine after at […]