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 […]
May 5, 2023
Via: Drugs.comResearchers 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 […]
May 3, 2023
Via: Drugs.comThe 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, Industry, Regulations, Vaccines
April 28, 2023
Via: Biopharma DiveWhile vaccines for the bacterial infection are widely available, thousands of cases still lead to hospitalization and death in the U.S. each year. In response, Pfizer, Merck and others have worked to develop new shots that offer better protection, particularly […]
April 21, 2023
Via: Drugs.comWhile 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 […]
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 […]
April 18, 2023
Via: Biopharma DiveA 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 […]
March 29, 2023
Via: Drugs.comNew 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
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 […]
March 15, 2023
Via: PMLiVEWith 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 […]
Industry, Mergers and Acquisitions, Vaccines
March 9, 2023
Via: PMLiVEThe partnership will see both companies advance MDX-2201 to an Investigational New Drug application filing, after which Merck will be responsible for clinical and regulatory activities, as well as product commercialisation. In exchange, Opko will receive an upfront payment of […]
FDA, Industry, Regulations, Vaccines
March 7, 2023
Via: PMLiVEDespite having a long history in the US, the vaccines have previously only been administered via subcutaneous injection, which is given into the fatty tissue just under the skin. Now, healthcare professionals will have the option to choose to administer […]
March 2, 2023
Via: Drugs.comAllergic reactions to the Pfizer or Moderna COVID vaccines are very rare, and a new study questions whether many of those that do occur are even real. In a small new study of 16 people who said they’d experienced an […]
March 1, 2023
Via: PMLiVENational vaccine regulatory agencies and pharmaceutical companies will now use this guidance to develop, produce and license influenza vaccines for the following season. WHO organises consultations with an advisory group of experts twice a year to analyse influenza virus surveillance […]
FDA, Industry, Regulations, Vaccines
February 28, 2023
Via: Biopharm InternationalModerna and Merck announced on Feb. 22, 2023 that their investigational personalized messenger RNA (mRNA) cancer vaccine, mRNA-4157/V940, in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, has been granted Breakthrough Therapy Designation by FDA for the adjuvant treatment of patients with […]
FDA, Industry, Regulations, Vaccines
February 24, 2023
Via: PMLiVEThe vaccine, mRNA-4157/V940, is designed to stimulate an immune response by generating specific T-cell responses based on the unique mutational signature of a patient’s tumour, while Keytruda increases the ability of the body’s immune system to help detect and fight […]
February 17, 2023
Via: Contract PharmaBavarian Nordic announced has entered into an agreement with Emergent BioSolutions, to acquire two marketed travel vaccines, Vivotif for the prevention of typhoid fever and Vaxchora against cholera as well as a Phase 3 vaccine candidate for the prevention of […]
February 16, 2023
Via: Drugs.comAmerican adults who have no health insurance or those who are underinsured will still be able to get free COVID vaccines from Moderna, even after government-purchased supplies run out, the company announced Monday. “Moderna’s COVID-19 vaccines will continue to be […]