BioPharma Reporter

FEBRUARY 21, 2023

The US Food and Drug Administration (FDA) has accepted Pfizerâs Biologics License Application (BLA) for its maternal RSV vaccine under priority review. If approved, the vaccine will become the first RSV vaccine for pregnant women to protect against RSV in infants.

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STAT News

AUGUST 9, 2022

heath secretary recently declared monkeypox as a public health emergency , paving the way for emergency use authorizations of additional vaccines or vaccine regimens to fight the disease. The same day, Food and Drug Administration Commissioner Robert Califf said that the U.S. — by changing the way it is given.

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Pharmaceutical Technology

AUGUST 14, 2022

Novavax and its partner SK bioscience have obtained a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety (KMFDS) for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), to be used in adolescents of the age 12 to 17 years. It enrolled 2,247 adolescents across 73 US sites.

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pharmaphorum

NOVEMBER 23, 2021

Sanofi has bolstered its push into mRNA-based therapies with a new licensing deal – but not as might be expected with some up-and-coming biotech company. Sanofi is the first pharma company to partner with Baidu on its LinearDesign AI platform, which has been developed specifically to optimise the sequence of mRNA-based vaccines and drugs.

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BioPharma Reporter

DECEMBER 8, 2022

The US Food and Drug Administration (FDA) has accepted Pfizerâs RSV vaccine Biologics License Application (BLA) for priority review: with a decision expected in May.

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Drug Discovery World

NOVEMBER 24, 2023

The University of Queensland’s re-engineered clamp platform has produced a vaccine that is equally safe and virus-neutralising as an approved Covid vaccine considered among the best in its class. He said: “CEPI is striving towards vaccines being developed within 100 days of a new virus emerging: a goal known as the 100 Days Mission.

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Fierce Pharma

MAY 17, 2024

Takeda put down $100 million upfront for an option to license an anti-amyloid vaccine from AC Immune. Following a reportedly bullish assessment from Medicare, Eisai has projected a significant sales increase for Leqembi. Eisai has projected a significant sales increase for Leqembi. And more.

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BioTech 365

AUGUST 25, 2021

Moderna Completes Submission of Biologics License Application to the U.S. Food and Drug Administration for its COVID-19 Vaccine Moderna Completes Submission of Biologics License Application to the U.S. Food and Drug Administration for its COVID-19 Vaccine Final blinded analysis of … Continue reading →

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NY Times

AUGUST 20, 2021

Federal regulators are winding down the process of licensing Pfizer’s two-dose coronavirus vaccine, setting up an approval possibly by Monday and possibly kicking off a wave of new mandates.

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Drug Discovery World

JANUARY 16, 2024

A new study will compare whether giving tuberculosis vaccine by inhalation is better at protecting against tuberculosis (TB) than injection into the skin. The Jenner Institute at the University of Oxford is conducting the study using Bacille Calmette-Guérin (BCG), the current licensed vaccine against TB.

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Drug Discovery World

FEBRUARY 20, 2024

A five-year contract totalling up to $31 million including programme options has been awarded to Ginkgo Bioworks to discover and develop next-generation vaccine adjuvants. Licensing for human use Adjuvants are components of vaccines that help to enhance the magnitude, breadth, and duration of the immune response to vaccination.

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Pharmaceutical Technology

AUGUST 23, 2022

Pfizer and BioNTech have filed an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a booster dosage of an Omicron BA.4/BA.5-adapted 5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. 1-adapted vaccine. 5-adapted bivalent vaccine.

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Pharmaceutical Technology

AUGUST 26, 2022

Amid a shortage of monkeypox vaccine doses, the WHO and FDA have declared public health emergencies, and the FDA has granted its first Emergency Use Authorization (EUA) to a monkeypox vaccine and opened the door for more. On the same day, the FDA granted a EUA to Bavarian Nordic’s (Copenhagen, Denmark) Jynneos vaccine.

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BioPharma Reporter

JULY 19, 2021

The US Food and Drug Administration (FDA) has granted priority review designation for Pfizer and BioNTechâs COVID-19 vaccine Biologics License Application (BLA).

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XTalks

MAY 28, 2024

In a move signaling a major shift in influenza prevention strategies, CSL Seqirus, a global leader in flu vaccines, has transitioned from quadrivalent to trivalent formulations for the upcoming 2024/25 flu season in the US.

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Drug Discovery World

MARCH 27, 2024

The vaccines currently in late-stage development hold promise in tackling the disease burden of tuberculosis (TB), says data and analytics company GlobalData on World Tuberculosis Day 2024. According to GlobalData, there are 11 vaccines in late-stage development for TB globally. TB remains a global pandemic, with 1.8

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Drug Discovery World

JANUARY 8, 2024

UK-based Barinthus Biotherapeutics, the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford are working together to fast-track the development of a vaccine candidate for the prevention of Middle East Respiratory Syndrome (MERS).

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XTalks

JULY 25, 2023

Emergent BioSolutions, a multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland, has achieved a significant milestone with the approval of its Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted) vaccine by the US Food and Drug Administration (FDA). How Does Cyfendus Work?

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022.

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Fierce Pharma

OCTOBER 12, 2023

BioNTech in-licensed a HER3 antibody-drug conjugate from Chinese company MediLink Therapeutics. | BioNTech in-licensed a HER3 antibody-drug conjugate from Chinese company MediLink Therapeutics. GSK has tapped Chongqing Zhifei to distribute Shingrix in China. GSK has tapped Chongqing Zhifei to distribute Shingrix in China.

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Drug Discovery World

OCTOBER 3, 2023

The R21/Matrix-M malaria vaccine has been recommended for use by the World Health Organization’s Strategic Advisory Group of Experts (SAGE) and the Malaria Policy Advisory Group (MPAG). The developers expect additional regulatory approvals will follow shortly and R21/Matrix-M vaccine doses could be ready to begin wider roll-out next year.

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Outsourcing Pharma

NOVEMBER 16, 2021

The pact between the drug firm and the group is aimed at giving equitable access to treatments and vaccines for people in disadvantaged parts of the world.

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NY Times

SEPTEMBER 22, 2021

billion in taxpayer money to develop its Covid-19 vaccine. and overseas are having trouble persuading the company to license its technology. Moderna accepted $2.5 But officials in the U.S.

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Drug Discovery World

FEBRUARY 3, 2023

A research group from the National Institutes of Health has successfully developed a vaccine against Sudan virus (SUDV) based on the licensed Ebola virus (EBOV) vaccine. SUDV, identified in 1976, is one of the four viruses known to cause human Ebolavirus disease.

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XTalks

JULY 19, 2022

The US Food and Drug Administration (FDA) has given emergency use authorization (EUA) to Novavax’s COVID-19 vaccine, making it the fourth authorized vaccine in the US against COVID-19. The vaccine is branded as Nuvaxovid outside the US with approvals/authorizations in Canada, the EU, UK, Australia and South Korea.

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BioSpace

JANUARY 12, 2021

Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for V114, its 15-valent pneumococcal conjugate vaccine, for Priority Review. Merck announced the U.S.

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XTalks

SEPTEMBER 5, 2023

Vaccines have been an integral piece of the global public health toolbox for over 200 years, but the COVID-19 pandemic brought about a new era in vaccine development with renewed interest in mRNA technology and unprecedented accelerated regulatory approvals. What are the major challenges you’re facing right now in vaccine development?

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Drug Discovery World

OCTOBER 27, 2023

HB-400, a novel arenaviral therapeutic vaccine developed by HOOKIPA Pharma and Gilead Sciences, has been shown to generate robust T cell responses specific to hepatitis B virus with high antibody levels in a preclinical setting. A Phase I clinical trial to evaluate the safety and tolerability of HB‑400 in humans is ongoing.

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pharmaphorum

DECEMBER 6, 2022

Pfizer and partner BioNTech have launched a countersuit against Moderna in a patent despite centring on their mRNA-based vaccines for COVID-19. It also waived its rights to bring the lawsuit when it pledged not to sure other COVID-19 vaccine producers during the pandemic, according to Reuters.

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Roots Analysis

FEBRUARY 26, 2024

Biologics constitute a majority of the top selling drugs and represent one of the fastest growing segments of the overall pharmaceutical industry. Our Social Media Platform Web: [link] LinkedIn: [link] Twitter: [link] The post Subcutaneous Medications and Drug Delivery Systems appeared first on Blog.

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XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.

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XTalks

NOVEMBER 4, 2022

Pfizer announced positive top-line data from a Phase III trial evaluating its respiratory syncytial virus (RSV) prefusion vaccine candidate, RSVpreF (or PF-06928316) for pregnant individuals to help protect their infants from RSV disease after birth. The efficacy against severe MA-LRTI was 81.8

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XTalks

DECEMBER 20, 2021

The World Health Organization (WHO) has backed Novavax’s COVID-19 vaccine, Covovax (NVX-CoV2373), by granting it an emergency use listing (EUL). The company is awaiting on authorization of its vaccine from regulatory health bodies around the world, including the US Food and Drug Administration (FDA) and Health Canada.

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BioPharma Reporter

SEPTEMBER 15, 2022

Pfizer will submit a Biologics License Application (BLA) for its investigational pentavalent meningococcal vaccine (MenABCWY) to the US Food and Drug Administration (FDA) later this year, following positive top-line results from a Phase 3 trial.

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S.

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World of DTC Marketing

AUGUST 22, 2020

QUICK READ: Today Trump suggested that the FDA is part of a “deep state” conspiracy to delay a COVID-19 vaccine until after the election. The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” the president wrote.

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XTalks

OCTOBER 25, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s supplemental biologics license application (sBLA) for a self-administered option of its nasal influenza vaccine FluMist Quadrivalent. FluMist has been in the market since 2003 and is the only intranasal spray vaccine option against flu.

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