pharmaphorum

NOVEMBER 20, 2020

Pfizer and BioNTech have filed for emergency use of their COVID-19 vaccine candidate in the US, paving the way for a launch before year-end. On the efficacy side, the filing will highlight a vaccine efficacy rate of 95% in a phase 3 study testing patients with and without previous infection with SARS-CoV-2.

Vaccines 96

Vaccines Documentation FDA 96

Pharmaceutical Technology

JANUARY 31, 2023

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Moderna ’s investigational mRNA vaccine candidate, mRNA-1345, for respiratory syncytial virus (RSV) in adult patients. vaccine efficacy (VE) against RSV-LRTD, defined by two or more symptoms and 82.4% The findings showed 83.7%

Vaccines 72

Vaccines FDA Communication 72

The Checkup by Singlecare

SEPTEMBER 12, 2023

Luckily, there’s a shot to help prevent it: Shingrix, the shingles vaccine. The Shingrix vaccine triggers the immune system to respond to the varicella virus and suppress the outbreak of shingles,” says David Cutler , MD, a family medicine physician at Providence Saint John’s Health Center in Santa Monica, California.

Vaccines 105

Vaccines Immunization Pharmacy Program Director Chemotherapy 105

pharmaphorum

JUNE 6, 2022

With vaccine hesitancy leading to a rise in measles cases, the FDA’s approval of GlaxoSmithKline’s venerable vaccine Priorix for sale in the US looks timely. The post FDA clears GSK’s Priorix, first new MMR vaccine in 50 years appeared first on.

Vaccines 59

Vaccines FDA 59

Pharma Times

NOVEMBER 26, 2021

The Food and Drug Administration (FDA) granted approval for emergency use of the Comirnaty vaccine in children in October 2021.

Vaccines 58

Vaccines FDA 58

Pharmaceutical Technology

MAY 4, 2023

After a winter marked by a rise in hospitalisations due to the RSV, the FDA has granted its first approval for an Respiratory Syncytial Virus (RSV) vaccine to GSK’s Arexvy for adults ages 60 years and above. This vaccine specifically prevents RSV-related lower respiratory tract disease (LRTD).

Vaccines 64

Vaccines FDA Communication Immunization 64

pharmaphorum

SEPTEMBER 1, 2022

Dr. B was founded in 2021 to connect providers with leftover COVID vaccines to the patients seeking to receive them. at the height of the COVID crisis to save lives by getting vaccines to people who needed them. The post Dr. B: Expanding the business model from COVID vaccines to antiviral medications appeared first on.

Vaccines 98

Vaccines FDA Insurance Patient Care 98

Pharmaceutical Technology

OCTOBER 9, 2023

The FDA decision follows a similar designation for the vaccine UV1 against malignant melanoma in December 2021.

Vaccines 52

Vaccines FDA 52

Pharmaceutical Technology

OCTOBER 28, 2022

On 24 October, American vaccine developer Vaxcyte shared positive topline data from a Phase I/II study of its multivalent conjugate pneumococcal vaccine VAX-24 , bringing the 24-valent pneumococcal jab one step closer to market. This is in addition to its long-available pneumococcal polysaccharide vaccine PPSV23.

Vaccines 64

Vaccines FDA Immunization 64

Pharmaceutical Technology

MAY 30, 2023

Valneva has submitted a regulatory application to Health Canada, seeking marketing approval for its chikungunya vaccine candidate, VLA1553. The vaccine is designed to be administered as a single shot and is intended for individuals aged 18 years and older. Valneva plans to make further regulatory submissions.

Vaccines 52

Vaccines FDA 52

The Checkup by Singlecare

SEPTEMBER 17, 2024

Its most common use is for the treatment of severe eczema (atopic dermatitis) in adults and children 6 months and older, but it’s also approved by the Food and Drug Administration (FDA) to treat asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, and eosinophilic esophagitis (EoE) in certain people.

Vaccines 52

Vaccines Immunization Adverse Reactions FDA 52

pharmaphorum

MAY 31, 2022

billion takeover of US biotech Affinivax, buying a pneumococcal vaccine candidate that is aiming to break into a market that for years has been dominated by Pfizer’s Prevnar franchise. The post GSK bolsters vaccines division with $3.3bn swoop on Affinivax appeared first on. GlaxoSmithKline has agreed a $3.3

Vaccines 52

Vaccines Immunization FDA 52

Pharmaceutical Technology

APRIL 24, 2023

Since then, the field of nanomedicine has steadily progressed to reach high points such as the successful use of nanotechnology to deliver messenger RNA (mRNA)-based Covid-19 vaccines. In the case of most mRNA vaccines, a lipid nanoparticle-based approach was chosen due to its ability to protect the mRNA in the body and prevent degradation.

Vaccines 59

Vaccines Immunization Medical Schools FDA 59

European Pharmaceutical Review

FEBRUARY 14, 2023

Recently there have been several key advances in the clinical development of messenger RNA (mRNA) vaccines, including vaccines for RSV and a personalised cancer vaccine. Progress on mRNA vaccines for RSV Moderna’s mRNA vaccine mRNA-1345 demonstrated vaccine efficacy of 83.7

Vaccines 105

Vaccines Immunization FDA 105

pharmaphorum

DECEMBER 21, 2020

As expected, the FDA has moved swiftly ahead with emergency approval of Moderna’s COVID-19 vaccine after a positive assessment at its vaccines advisory committee. The biotech now expects to have between 100 and 125 million doses available in the first quarter of 2021, of which 85 to 100 million have been claimed by the US.

Vaccines 89

Vaccines FDA 89

European Pharmaceutical Review

APRIL 25, 2023

The R21/Matrix-M malaria vaccine, developed by the University of Oxford , has been approved for use in Ghana (13 April 2023) and was authorised for use in Nigeria on 17 April. Granted full national licensure by the country’s Food and Drugs Authority (FDA Ghana), it is authorised for children aged 5 to 36 months.

Vaccines 111

Vaccines Immunization FDA 111

Digital Pharmacist

OCTOBER 26, 2022

Food and Drug Administration (FDA) announced its approval of the Boostrix vaccine, commonly known as Tdap (combination of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis) for immunization administration during the third trimester of pregnancy to prevent pertussis in infants younger than two months of age.

Vaccines 98

Vaccines FDA Hospitals Immunization 98

pharmaphorum

OCTOBER 26, 2020

Moderna is close to completing its phase 3 trial of COVID-19 vaccine candidate mRNA-1273 after completing recruitment of the 30,000 subjects in the trial. Moderna shared demographic data from the study at an FDA committee meeting today which showed that it included some of the groups most at risk from COVID-19.

Vaccines 111

Vaccines FDA 111

pharmaphorum

FEBRUARY 28, 2021

The FDA has approved emergency use of a third COVID-19 vaccine from Johnson & Johnson’s Janssen Biotech unit, the day after an advisory committee concluded it was safe and effective. Today, FDA issued an emergency use authorization (EUA) for the third vaccine for the prevention of #COVID19 caused by SARS-CoV-2.

Vaccines 59

Vaccines FDA Immunization 59

pharmaphorum

DECEMBER 2, 2020

Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world to approve it. Pfizer and BioNTech have an agreement to supply the UK with 40 million doses of the vaccine, which is called BNT162b2 and was shown to be 95% effective in a phase 3 trial.

Vaccines 87

Vaccines FDA 87

Pharmaceutical Technology

APRIL 14, 2023

Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. Children between the ages of five and 36 months are at highest risk of death from malaria.

Vaccines 111

Vaccines Immunization FDA 111

pharmaphorum

OCTOBER 30, 2020

Moderna is still preparing for the launch of its COVID-19 vaccine mRNA-1273 – assuming phase 3 trials go to plan – but has already received $1.1 That is the basis for filing for emergency use authorisation (EUA) of the vaccine in the US, according to criteria set out by the FDA. billion in deposits for the shot.

Vaccines 100

Vaccines Immunization FDA 100

pharmaphorum

JANUARY 27, 2023

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. and other XBB subvariants, said the FDA in an update. Evusheld is also ineffective against the BQ.1,

FDA 135

FDA Chemotherapy Immunization Vaccines 135

Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. This is a significant increase compared to the 2021–20 season when the rate was 28.3 per 100,000.

Vaccines 64

Vaccines Pharmaceutical Companies Pharmaceutical Companies FDA 64

pharmaphorum

JANUARY 8, 2021

The UK has approved the Moderna coronavirus vaccine, hard on the heels of its go-ahead in Europe, although supplies are not expected to arrive for several weeks. The UK government has ordered 17 million doses of the new vaccine, but none will be available before March, when Moderna is able to bring new production capacity online.

Vaccines 64

Vaccines FDA 64

Pharmaceutical Technology

MAY 1, 2023

After a long period of inactivity in RSV vaccine development , two pharmaceutical companies are now approaching regulatory decisions for their RSV vaccines. Both Pfizer and GSK have major approval decisions regarding the use of their RSV vaccines for older adults this May. What incentivises a country to cover a vaccine?

Vaccines 52

Vaccines Nursing Homes Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

JANUARY 8, 2021

As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses. When the UK announced the approval of the Pfizer-BioNTech and Oxford/AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.

Vaccines 59

Vaccines Immunization Medical Schools FDA 59

Pharmaceutical Technology

SEPTEMBER 5, 2022

Following AstraZeneca’s success in vaccine development during the Covid-19 pandemic , the pharmaceutical giant is now looking to expand its scope through acquisitions across a range of indications, says CEO Pascal Soriot. “We Prior to this, the FDA had granted Enhertu regulatory approval for breast cancer treatment.

FDA 114

FDA Vaccines 114

ISPE

AUGUST 29, 2022

In May 2021, the US Food and Drug Administration (FDA) published a draft industry guidance, ICH Q12: Implementation Considerations for FDA-Regulated Products. In July 2021, Health Canada (HC) released an updated draft guidance for its Post-Notice of Compliance (NOC) Changes and solicited public comments. 2021.09.046.

Documentation 52

Documentation FDA Communication Packaging 52

PharmaShots

MAY 23, 2023

Stock Exchange: TYO With focus areas extending to the discovery and development of biopharma products, AnGes is dedicated to developing genetic medicines and therapeutic vaccines for intractable or rare diseases. In November 2021, bluebird bio spun off its Oncology business into a separate company named 2seventy Bio.

FDA 58

FDA Pharmaceutical Companies Pharmaceutical Companies Immunization 58

pharmaphorum

FEBRUARY 11, 2021

AstraZeneca is aiming to get a next-generation vaccine targeting emerging variants approved and into the arms of patients by the autumn, company representatives said in a press conference. While the vaccine is approved in Europe, the UK and several other countries, FDA approval hangs on a study in the US.

Vaccines 78

Vaccines FDA 78

pharmaphorum

JANUARY 8, 2021

As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses. When the UK announced the approval of the Pfizer-BioNTech and Oxford-AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.

Vaccines 57

Vaccines Immunization Medical Schools FDA 57

STAT

NOVEMBER 18, 2022

The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world. The first therapy that delays the onset of type 1 diabetes received approval from the U.S.

FDA 98

FDA Documentation Compounding Pharmaceutical Companies 98

The FDA Law Blog

DECEMBER 3, 2023

Manufacturers must also ensure that all electronic FDA listings and all NDC listings with the electronic database vendors used to process pharmacy claims, including information about discontinued drugs, are up to date for all applicable drug and selected drug NDCs. covered insulin product or vaccine).

Labelling 105

Labelling Compounding Payment Processing Vaccines 105

European Pharmaceutical Review

JUNE 27, 2023

Of note, the US Food and Drug Administration (FDA) and ANSM (French regulatory authorities) have established themselves as early leaders to develop guidelines. Since these fresh FDA approvals for microbiome-based therapies, regulatory pathways are becoming clearer and opening new perspectives for companies. Science, 2021.

Chemotherapy 105

Chemotherapy Immunization FDA Vaccines 105

pharmaphorum

DECEMBER 23, 2020

It has been a year dominated by the pandemic and many life sciences research projects were put on hold as big pharma turned its attention to vaccines and therapies. The FDA has gone on to grant a fast review of the results ahead of a regulatory decision on the new lung cancer indication next year. months, compared with 6.7

FDA 93

FDA Chemotherapy Compounding Vaccines 93

The FDA Law Blog

SEPTEMBER 10, 2023

This finalized a draft guidance issued in December 2021, largely similar in substance. For example, as the guidance states, “FDA must be confident. Even though the draft guidance was issued in 2021 after the onset of the COVID-19 pandemic, the Agency’s thinking now appears to be more reflective of this recent experience.

FDA 108

FDA Documentation Vaccines 108