pharmaphorum

FEBRUARY 17, 2025

GSK joins arch-rival Pfizer in the market for five-in-one meningococcal vaccines with FDA approval for Penmenvy, a top launch prospect for 2025.

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Vaccines FDA 72

European Pharmaceutical Review

MARCH 6, 2023

” Post-construction, the facility “will harness mRNA science that aims to develop and deliver innovative vaccines to the UK public that address emerging threats from respiratory viruses.” The Moderna Innovation and Technology Centre is expected to become operational in 2025.

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pharmaphorum

DECEMBER 1, 2021

Sanofi has added to its vaccine pipeline with an agreement to acquire Austria’s Origimm Biotechnology and its vaccine-based immunotherapy for people with acne. It will highlight vaccines for pneumococcal disease, meningitis, respiratory syncytial virus (RSV), influenza, and chlamydia. Photo by Scott Webb on Unsplash.

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Vaccines FDA 105

Drug Topics

APRIL 17, 2025

The FDA approved Penmenvy in February 2025 for use in patients aged 10 to 25 years.

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Vaccines FDA 484

DiversifyRx

MARCH 4, 2025

And when you set the right goals, 2025 could be the year you finally break free from PBM madness, build a loyal patient base, and boost your pharmacy profits. But that’s setting yourself up for frustrationespecially when outside factors (DIR fees, staffing shortages, FDA, etc.) Better: Hit 750 vaccines by Q4.

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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 The FDA has granted the drug an orphan drug designation, and Phase III trials with eplontersen were completed In June.

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pharmaphorum

JANUARY 13, 2023

Everyone agrees that cell and gene therapies are poised for an explosion, with far more drugs in the pipeline than are currently approved, and the FDA predicts it will clear 10 to 20 per year by 2025. Ups and downs of government – FDA. On the other hand, the executive branch in the form of the FDA receives a more mixed review.

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The FDA Law Blog

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year. covered insulin product or vaccine).

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PharmaShots

MAY 23, 2023

Propelled by constant innovatory winds, the Cell and Gene therapy market is anticipated to grow by 20 percent year-over-year through 2025. The company first received the US FDA approval for its gene therapy Zynteglo in Aug 2022 for treating adult and pediatric patients with ß-thalassemia.

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pharmaphorum

FEBRUARY 23, 2022

The global health crisis caused spending on healthcare to increase , due to the funding provided to the development and purchases of vaccines and treatments, as well as support provided for the associated infrastructure. billion in 2020.

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Vaccines FDA 98

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. Lets take a look at these letters: Back in January 2025, CVM issued a Warning Letter to animal drug sponsor Elanco Animal Health.

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Pharmaceutical Technology

NOVEMBER 22, 2022

The Chinese government announced its ten-year 'Made in China 2025' strategic plan in 2015, which aimed to make the country a global leader in several high-tech industries. Guangdong is based in the south and has a comparatively strong number of manufacturing relationships producing innovative FDA and EMA drugs.

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Pharma Marketing Network

JANUARY 7, 2025

This article explores top strategies that can help you lead with confidence and achieve executive success in 2025. For instance, oncology drugs may require unique outreach compared to vaccines like Pfizers Comirnaty. On the other, strict regulations from the FDA and other governing bodies place limits on what you can say or do.

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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. There have been several biosimilars approved, including Wezlana , Selarsdi, and Pyzchiva, but they are not expected to be available until early 2025. What is a biosimilar?

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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. I see the market picking back up towards the end of 2024 or early 2025. It’s a three-year project and we have already developed a benchtop version of the platform.

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Vaccines FDA 97

pharmaphorum

JANUARY 31, 2022

Regeneron’s rival antibody product was approved by the FDA to treat a genetic form of elevated cholesterol – homozygous familial hypercholesterolemia (HoFH) – and is also testing it in other, more common forms of dyslipidaemia and in acute pancreatitis prevention.

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ISPE

SEPTEMBER 11, 2023

Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” www.fiercepharma.com/manufacturing/sanofi-pumps-554m-into-new-vaccine-manufacturing-facility-eastern-france 41 Boccard. New Project: Evolutive Vaccines Facility for Sanofi.” www.boccard.com/evolutive-vaccines-facility-for-sanofi/ 42 Amgen.

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PharmaShots

FEBRUARY 19, 2023

The clinical trials remain ongoing as Pfizer continues to enroll new patients at those sites VLA15 is a Lyme disease vaccine candidate that blocks the outer surface protein A (OspA) of the bacteria causing Lyme disease, Borrelia burgdorferi, thereby inhibiting its ability to leave the tick & infect humans.

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Vaccines FDA 40

BioPharm

AUGUST 22, 2024

The approvals and authorizations come amid a late summer surge in the virus that is tracking a bit earlier than the early fall wave in the US in 2023.

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Vaccines FDA 59

Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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pharmaphorum

JANUARY 10, 2022

The arrival of COVID-19 brought precious few positives, but one that emerged for the pharmaceutical industry was the emergence and validation of mRNA vaccine technology to prevent disease. Pfizer already has a head start on competitors in the field, having achieved the first US FDA approval for an mRNA vaccine, alongside BioNTech.

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Pharmaceutical Technology

JANUARY 20, 2023

In 2020, Moderna made a net loss of $747 million while its investigational mRNA vaccines were under development. However, during the Covid-19 pandemic, the US-based biotech rose to prominence as it was one of the first companies to develop Covid-19 vaccines with its mRNA technology. billion in Covid-19 vaccine sales.

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Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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The FDA Law Blog

AUGUST 14, 2022

Medicare Part D redesign: The IRA changes Medicare Part D starting in 2025 by lowering the patient out-of-pocket (“OOP”) limit to $2,000, adjusted annually in subsequent years. The same will be required under state Medicaid and CHIP programs by October 1, 2023.

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The Checkup by Singlecare

JUNE 7, 2024

While you are on Stelara, you should not receive live vaccines , including MMR, varicella, rotavirus, nasal flu vaccine, or the Bacillus Calmette–Guérin (BCG) vaccine , which is used to prevent TB in high-risk people in some countries. The way brand name drugs have generic equivalents, biologic drugs may have biosimilars.

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The Checkup by Singlecare

JUNE 6, 2024

Farxiga (dapagliflozin) is a brand-name prescription medication that has been approved by the Food & Drug Administration (FDA) for several indications. Under the new law, there will also be a Part D out-of-pocket price cap of $2,000 starting in 2025.

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The Checkup by Singlecare

JUNE 6, 2024

Jardiance is a brand-name drug that was initially approved by the Food and Drug Administration (FDA) to control blood sugar in adults with Type 2 diabetes. It has since achieved additional approvals, including the treatment of children 10 years and older with Type 2 diabetes when combined with diet and exercise.

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Insurance Hospitals Vaccines Pharmaceutical Companies 52

European Pharmaceutical Review

MARCH 4, 2025

Four medicines were recommended for approval at the EMAs human medicines committee (CHMP)s February 2025 meeting. The US Food and Drug Administration (FDA) granted approval of the gene therapy in May 2023. The group recommended authorisation of two medicines for oncology indications.

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European Pharmaceutical Review

JANUARY 10, 2025

Eleven medicines, covering key areas such as gene therapy, as well as drugs for obesity and oncology, are anticipated to attain blockbuster status or be therapeutic game-changers globally within five years to 2030, according to the 2025 edition of the Drugs to Watch report.

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Vaccines FDA 59

European Pharmaceutical Review

JANUARY 2, 2025

The RNA therapeutics industry stands poised for a transformative 2025, driven by breakthroughs in technology, expanding clinical applications, and a rapidly growing pipeline of innovative therapies. Innovation in base modification could be transformative for differing profiles of future RNA vaccines.

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Vaccines FDA 69

The FDA Law Blog

FEBRUARY 4, 2025

Koblitz Last December, Congress narrowly avoided a shutdown by significantly paring down the originally proposed 2025 Appropriations bill, slashing away hundreds of programs and laws. As of the start of 2025, tropical PRVs represent less than 20% of all the PRVs granted. By Faraz Siddiqui & Sara W. See Table 1.

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Vaccines FDA 52

STAT

DECEMBER 31, 2024

The Food and Drug Administration’s leadership and agenda is about to change, making 2025 a critical year for the agency.  Kennedy has floated loosening regulation on raw milk, more harshly scrutinizing the safety of vaccines, and cracking down on ultra-processed foods and additives. Kennedy Jr.

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STAT

NOVEMBER 24, 2024

That the FDA doesn’t place enough emphasis on recommendations from its expert advisory panels. Further, he’s not a fan of remote work and wants to see more active monitoring of adverse events caused by vaccines.    Continue to STAT+ to read the full story…

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