Pharmaceutical Technology

OCTOBER 13, 2023

The Phase IIb SurVaxM vaccine study will enrol 265 patients and has an estimated completion date in Q2 2024.

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Fierce Pharma

OCTOBER 24, 2023

On the market for two decades, AstraZeneca’s nasal spray flu vaccine, FluMist, may become available for self-administration as soon as next year. | On the market for two decades, AstraZeneca’s nasal spray flu vaccine, FluMist, may become available for self-administration as soon as next year.

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Pharmaceutical Technology

OCTOBER 4, 2023

The US FDA has amended the EUA of Novavax’s adjuvanted Covid-19 vaccine (NVX-CoV2601) to incorporate the 2023-2024 formula.

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European Pharmaceutical Review

JANUARY 5, 2023

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has accepted the Biologics License Application (BLA) for nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in all infants. The FDA has indicated they will work to expedite their review.

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Pharmaceutical Technology

FEBRUARY 14, 2023

The US Department of Health and Human Services (HHS) and the Department of Defense have modified their existing agreement with Novavax to secure additional doses of the Covid-19 vaccine, Adjuvanted (NVX-CoV2373). million additional doses of its Covid-19 vaccine. Under the modified deal, Novavax will deliver up to 1.5

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Pharmafile

MAY 13, 2024

Moderna has announced that the US Food and Drug Administration (FDA) has shared that it will not complete its review of the Biologics License Agreement (BLA) for mRNA-1345 by its Prescription Drug User Fee Act (PDUFA) date of 12 May 2024. The post Moderna shares update on RSV vaccine appeared first on Pharmafile.

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PharmExec

DECEMBER 19, 2023

Merck’s Biologics License Application for V116, a novel 21-valent pneumococcal conjugate vaccine has been given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024.

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Pharmaceutical Commerce

DECEMBER 19, 2023

Merck’s Biologics License Application for V116, a 21-valent pneumococcal conjugate vaccine, was given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024.

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European Pharmaceutical Review

NOVEMBER 10, 2023

The US Food and Drug Administration (FDA) has approved Valneva SE’s IXCHIQ ® , the first chikungunya vaccine to be authorised in the world. The single-dose, live-attenuated vaccine is indicated for preventing chikungunya virus disease in individuals over 18 years old who are at increased risk of contracting the virus.

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Pharmaceutical Technology

JUNE 8, 2023

The European Commission (EC) has granted marketing authorisation for GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, for adults aged 60 years and above. The vaccine is indicated for active immunisation to prevent RSV-related lower respiratory tract disease (LRTD) in older adults.

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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.

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PharmaShots

FEBRUARY 20, 2023

Shots: The USPTO issued the company a patent for its transformative technology to produce orally delivered animal vaccines by the number Patent US-11566255-B2, "Expression of PEDV Sequences in Plants and Plant Produced Vaccine for Same" on the 31st of Jan 2023 The patent covers foundational technology for the company’s first vaccine (..)

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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.

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pharmaphorum

SEPTEMBER 16, 2021

Takeda has had a run of bad luck with its Wave1 pipeline of new drug candidates of late, but can now celebrate a vestry after getting FDA approval for first-in-class lung cancer therapy Exkivity. The post Takeda gets a win for its Wave1 pipeline, as Exkivity nabs FDA approval appeared first on.

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European Pharmaceutical Review

JUNE 13, 2024

In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa. In December 2023, the FDA granted OCU400 Regenerative Medicine Advanced Therapy (RMAT) designation. What’s the latest and what’s next?

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European Pharmaceutical Review

JANUARY 29, 2024

During August 2023 the FDA also updated its guidance for NDSRIs 7 and it was closely aligned (but not identical) to EMA’s evolving guidance. 3 Differences include that potency category 1 in FDA’s CPCA approach is 26.5 FDA has also published the AIs of some 265 NDSRIs. ng/day, compared to EMA which is 18 ng/day.

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Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). The company aims to then increase supplies in 2024.

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Drug Topics

NOVEMBER 23, 2023

The federal agencies said that they will continue to work closely with manufacturers to maintain the availability of the vaccines through the end of 2023 and early 2024 to meet the demand during the RSV season.

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The FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

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The Checkup by Singlecare

JULY 8, 2024

Medicare Part B also covers a limited number of prescription drugs , but these covered drugs are generally ones that you would not typically give to yourself, such as infusions that you get in a doctor’s office, flu shots , and vaccines. Medicare Part D plans will cover Dupixent if it is prescribed for an FDA-approved indication.

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Drug Topics

FEBRUARY 8, 2024

June 7, 2024 is the target PDUFA date for the additional indication of GSK's respiratory syncytial virus vaccine Arexvy.

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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.

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European Pharmaceutical Review

FEBRUARY 14, 2025

percent between 2024 and 2033. This includes the EUs Horizon Programme aimed at investing in research, and the US Food & Drug Administration (FDA) providing regulatory guidelines for producing and using water in drug manufacturing. A report by Cervicorn Consulting forecasts that the pharmaceutical water market will value $96.25

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Pharmaceutical Technology

JANUARY 6, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca ’s nirsevimab biologics licence application (BLA) for review to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in children aged up to 24 months.

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The FDA Law Blog

APRIL 7, 2025

Koblitz & Dara Katcher Levy Promotional claims do not receive the most attention with respect to FDA enforcement these days, and veterinary promotion is no exception. Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination.

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European Pharmaceutical Review

APRIL 30, 2024

On the other side, if you look at the nucleic acid space, that’s where the market has truly taken off, especially after the success of the mRNA-based COVID vaccines. Sticking to the cell and gene therapy space, what’s your main prediction for 2024? I see the market picking back up towards the end of 2024 or early 2025.

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The Checkup by Singlecare

JULY 12, 2024

Beyond that overlap, Xolair is approved by the Food and Drug Administration (FDA) to treat chronic spontaneous urticaria (CSU)—previously referred to as chronic idiopathic urticaria (CIU)—the medical term for hives with no cause. In 2024, the FDA also approved Xolair for accidental exposure in people with food allergies.

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The Checkup by Singlecare

APRIL 15, 2024

In January 2024, it became the first and only treatment approved by the Food and Drug Administration (FDA) for eosinophilic esophagitis (EoE) in children ages 1 and older. The injectable medication was originally FDA approved in May 2022 for EoE treatment in adults and children ages 12 years and older.

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The Checkup by Singlecare

SEPTEMBER 10, 2024

It is approved by the Food and Drug Administration (FDA) to treat plaque psoriasis , psoriatic arthritis , Crohn’s disease , and ulcerative colitis. According to the FDA , biological products are complex medicines made from living cells, like those from plants or animals. Wezlana (ustekinumab-auub) was FDA approved on Oct.

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Pharmaceutical Technology

MAY 30, 2023

At the height of the pandemic, Catalent’s Bloomington site won contracts to produce Moderna’s (Cambridge, MA, US) and Johnson & Johnson’s (New Brunswick, NJ, US) Covid-19 vaccines, and Regeneron’s (Tarrytown, NY, US) Covid-19 monoclonal antibody Regen-Cov. The CEO, who took over in July 2022, will remain in place.

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STAT

DECEMBER 18, 2023

Illumina will either sell Grail to another company or list it on capital markets, consistent with an order from the European Commission, and aims to finalize the terms of the deal by the end of the second quarter of 2024. The decision opens what should be the final chapter in one of the most disastrous attempted mergers in biotech history.

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European Pharmaceutical Review

MAY 7, 2024

percent compound annual growth rate (CAGR) between 2024 to 2029. Injectable vaccines activate the immune system to help to prevent infectious conditions such as influenza. A new report by MarketsandMarkets has predicted that the injectable drug delivery market will reach an 8.6 The market is anticipated to value $1139.4

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pharmaphorum

AUGUST 23, 2024

The FDA has approved new versions of Pfizer/BioNTech's Comirnaty and Moderna's Spikevax COVID-19 vaccines that target the Omicron KP.2

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European Pharmaceutical Review

OCTOBER 3, 2024

The post <em>European Pharmaceutical Review </em> Issue 4 2024 appeared first on European Pharmaceutical Review. Preparing for the impact of EU GMP Annex 1 on primary packaging Niamh Bissett and Dr Ana Kuschel West Pharmaceutical Services, Inc. Login or create an account to download your copy of our Issue now!

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STAT

JULY 6, 2023

agency and Colombian authorities of problems at the Caucaseco Scientific Research Center and the Malaria Vaccine Development Center. Moderna started the application process to get an approval for its respiratory syncytial virus (RSV) vaccine in older adults with regulators in the United States, Australia, and Europe , Reuters notes.

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The FDA Law Blog

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. The most noteworthy are the following: 1.

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European Pharmaceutical Review

JULY 21, 2023

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year. Recommendations were also published earlier this year for all stakeholders in the pharma supply chain.

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