Bio Pharma Dive

JULY 22, 2022

The positive decision comes as governments aim to expand supply and quicken distribution of the vaccine to combat a widening global outbreak. Separately, the EMA backed approvals of 11 other medicines.

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Regulation Vaccination Vaccine Medicine 344

Bio Pharma Dive

OCTOBER 21, 2022

The company is considering charging as much as between $110 and $130 per dose — roughly four times the vaccine’s current price — once sales transition to the private market.

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Vaccination Vaccine Sales Marketing 349

Bio Pharma Dive

FEBRUARY 10, 2023

The pharma and partner BioNTech have kicked off the first human trial of a messenger RNA shot for shingles, believing there’s room to clear the high bar set by GSK’s rival vaccine.

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Vaccination Vaccine RNA Trials 358

Bio Pharma Dive

JANUARY 23, 2023

Agency scientists are proposing to update COVID shots once a year to match circulating coronavirus strains, as well as simplifying current vaccination regimens.

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Vaccination Vaccine Scientist 325

Pharmaceutical Technology

JUNE 25, 2024

1 Covid-19 vaccine, NVX-CoV2705, for people aged 12 years and above. Novavax has sought EMA approval for its updated JN.1

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Vaccination Vaccine 321

Bio Pharma Dive

MAY 24, 2022

began releasing supplies of an approved Bavarian Nordic shot, Moderna said it's beginning development of its own vaccine against the virus. One day after the U.S.

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Vaccination Vaccine Development 345

Pharmaceutical Technology

DECEMBER 12, 2024

Sanofi has announced that its two combination vaccine candidates have received fast track status from the US FDA.

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Vaccination Vaccine 249

Bio Pharma Dive

FEBRUARY 1, 2023

The agency is currently assessing applications filed by the two companies for what they hope will become the first vaccines against the virus in older adults.

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Vaccination Vaccine 357

Bio Pharma Dive

DECEMBER 16, 2021

Days after the FDA strengthened safety warnings for the company's shot, a CDC panel recommended Pfizer's and Moderna's vaccines be "preferred" over J&J's.

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Vaccination Vaccine 334

Bio Pharma Dive

OCTOBER 12, 2022

The drugmaker’s decision to grab rights to the shot deepens its ties with the COVID-19 vaccine developer and comes weeks before a key data release.

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Vaccination Vaccine Licensing Licensing 325

Bio Pharma Dive

MARCH 1, 2024

The expert committee is discussing whether, for certain older adults, to make a universal recommendation for vaccination, rather than the current policy of “shared decisionmaking.”

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Vaccination Vaccine 294

Bio Pharma Dive

JANUARY 5, 2022

The pharma company, already partnered with BioNTech on vaccines for COVID-19 and influenza, will pay $225 million upfront to further expand its work with the German biotech.

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Vaccination Vaccine Pharma Companies 334

Bio Pharma Dive

OCTOBER 23, 2023

The clearance of the pentavalent shot Penbraya adds to Pfizer’s infectious disease portfolio as it adjusts to slumping COVID-19 vaccine sales.

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FDA Approval Vaccination Vaccine Sales 317

Bio Pharma Dive

MAY 1, 2024

Sales of the shingles vaccine Shingrix and the RSV shot Arexvy helped fuel quarterly revenue totals that surpassed analyst expectations, though the company warned momentum could slow in the months ahead.

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Sales Vaccination Vaccine Drugs 298

Bio Pharma Dive

AUGUST 31, 2021

Marion Gruber and Phil Krause, two veteran vaccine reviewers, are unexpectedly leaving the agency at a critical time. The search for their replacements will begin "imminently," division head Peter Marks said in a letter.

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Vaccination Vaccine 363

Pharmaceutical Technology

JANUARY 29, 2024

The rapid sequencing of the SARS-CoV-2 and the subsequent development of mRNA vaccines led to the authorisation of the first of these vaccines in late 2020.

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Vaccination Vaccine Development 278

Pharmaceutical Technology

MAY 10, 2024

The FDA approved WestGene’s mRNA therapeutic cancer vaccine as mRNA cancer vaccine development rises in popularity.

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FDA Approval Vaccination Vaccine Development 279

Bio Pharma Dive

MAY 31, 2023

The shot’s clearance comes several weeks after the regulator made GSK’s Arexvy the first vaccine for RSV in the U.S.

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FDA Approval Vaccination Vaccine Regulation 321

Bio Pharma Dive

OCTOBER 16, 2024

The pharma’s lawsuit focuses on scientific work that helped clear the path for creating mRNA vaccines to fight the COVID-19 pandemic.

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Vaccination Vaccine 278

Pharmaceutical Technology

OCTOBER 31, 2022

After decades of setbacks, the respiratory syncytial virus (RSV) vaccine field has bounced back with positive Phase III trial results in older adults. There are currently five players in the race, with vaccines in Phase III of development from GlaxoSmithKline (GSK) , Pfizer , Johnson & Johnson , Moderna and Bavarian Nordic.

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Vaccination Vaccine Marketing Trials 338

Bio Pharma Dive

JULY 31, 2024

sales of Shingrix, the shingles vaccine that's become one of the British pharma's top sellers. Several factors are slowing U.S.

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Vaccination Vaccine Sales 289

Pharmaceutical Technology

OCTOBER 23, 2024

A year after the first samRNA vaccine approval, experts say others are likely to face scientific and regulatory hurdles.

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Vaccination Vaccine 279

Pharmaceutical Technology

MAY 30, 2023

SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. The authorisation allows the distribution of the vaccine in Scotland, Wales and England.

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Vaccination Vaccine Protein Medicine 298

Pharmaceutical Technology

MARCH 14, 2023

The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). The vaccine has received approval for preventing dengue disease in people aged four years to 60 years.

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Vaccination Vaccine Clinical Trials Clinical Trials 286

Pharmaceutical Technology

MARCH 28, 2023

Following on from its Covid-19 vaccine programmes, BioNTech has set its sights on a range of infectious diseases for vaccine development. The company saw major successes with its Covid-19 vaccine, developed in collaboration with Pfizer. In response to the lower vaccine sales forecasts, BioNTech shares opened at 3.9%

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Vaccination Vaccine Development Clinical Trials 276

Pharmaceutical Technology

DECEMBER 1, 2024

The HIV vaccine space has seen dwindling research activity as drug manufacturers turn to PrEP therapies for preventive treatment.

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Vaccination Vaccine Manufacturing Drugs 264

Pharmaceutical Technology

NOVEMBER 29, 2023

Japan’s MHLW has approved CSL and Arcturus Therapeutics’ self-amplifying mRNA (sa-mRNA) Covid-19 vaccine, ARCT-154.

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Vaccination Vaccine 312

Bio Pharma Dive

OCTOBER 15, 2021

Agency advisers unanimously supported offering a second dose of J&J's coronavirus vaccine to adults who previously received it, though guidance could change as regulators evaluate mixing boosters.

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Vaccination Vaccine Regulation 331

Pharmaceutical Technology

FEBRUARY 3, 2023

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections.

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Vaccination Vaccine Antibody Trials 293

Pharmaceutical Technology

AUGUST 20, 2024

Supplies of Emergent’s smallpox vaccine ACAM2000 will accompany Bavarian Nordic’s vaccine to African countries.

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Vaccination Vaccine 263

Bio Pharma Dive

JULY 15, 2022

The regulator said there have been “a few” spontaneous severe allergic reactions following administration of the vaccine, which was this week authorized in the U.S.

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Vaccination Vaccine Regulation 312

Bio Pharma Dive

FEBRUARY 8, 2022

The company estimated revenue from its COVID-19 vaccine and antiviral pill Paxlovid will total $54 billion this year. Curiously, its stock fell by more than 5%.

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Vaccination Vaccine Sales 317

Pharmaceutical Technology

SEPTEMBER 27, 2024

Bavarian Nordic has already said it would prioritise mpox vaccine production to fulfil orders this year.

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Vaccination Vaccine Production 264

Pharmaceutical Technology

AUGUST 17, 2022

On August 8, Pfizer and Valneva announced the initiation of a Phase III study with their Lyme disease vaccine , bringing the prospect of an injection to prevent the condition disease one step closer to reality. This means that the vaccine works against multiple serotypes of the disease, she explains. A one-size-fits-all approach.

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Vaccination Vaccine Bacteria Protein 299

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.

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Vaccination Vaccine Manufacturing Containment 279

Pharmaceutical Technology

AUGUST 1, 2022

Moderna has entered a new supply contract with the US Government to deliver 66 million doses of its Covid-19 vaccine booster candidate, mRNA-1273.222. The contract comprises a $1.74bn award to produce and supply these vaccine doses and options to further procure up to 234 million additional doses of the company’s booster candidates.

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Vaccination Vaccine Gene Therapy RNA 289

Pharmaceutical Technology

NOVEMBER 26, 2024

Gilead and Aelix first teamed up in 2018 for a clinical research collaboration agreement to investigate the vaccine.

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Vaccination Vaccine Clinical Research Research 246