XTalks

JULY 10, 2023

With the remarkable success of its semaglutide products Wegovy and Ozempic for weight loss and type 2 diabetes, respectively (the latter also for weight loss through off-label prescribing), Novo Nordisk is cracking down on pharmacies making compounded versions of the glucagon-like peptide-1 (GLP-1) receptor agonist drugs.

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XTalks

NOVEMBER 2, 2023

Amgen’s Wezlana (ustekinumab-auub) has received US Food and Drug Administration (FDA) approval as a Stelara biosimilar for the treatment of several inflammatory diseases including Crohn’s disease, ulcerative colitis (UC), plaque psoriasis and psoriatic arthritis. This gives it a significant edge over a simple biosimilar designation.

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XTalks

JUNE 5, 2023

Drug compounding involves combining, mixing or altering ingredients to create customized medications for individual patients; however, compounded drugs are not FDA-approved, and their safety and efficacy are not validated. mg and 1 mg doses will be available to wholesalers for distribution to retail pharmacies. mg and 2.4

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XTalks

FEBRUARY 8, 2024

Diabetes remains a critical global challenge, affecting millions of lives and commanding significant attention from the medical, life sciences and pharmaceutical sectors. Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. mL subcutaneous solution (2 mg/1.5

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XTalks

SEPTEMBER 22, 2023

In time for respiratory virus season this fall and winter, the US Food and Drug Administration (FDA) approved updated COVID vaccines from Pfizer/BioNTech and Moderna last week, followed by an endorsement from the Centers for Disease Control and Prevention (CDC) a day later.

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Vaccination Vaccine FDA Approval Pharmacy 59

XTalks

JANUARY 8, 2024

Initially receiving accelerated approval in December 2021 based on proteinuria as a surrogate marker, Tarpeyo has now achieved the status of being the first treatment for IgAN to receive full FDA approval predicated on evaluations of kidney function.

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XTalks

MARCH 22, 2023

In October 2022, Xtalks celebrated two decades of bringing diverse stakeholders in the life science industry together through first holding physical events, then soon after, hosting exclusively online events. Just last year, the FDA approved a one-time gene therapy treatment for hemophilia B priced at $3.5

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Life Science Drugs FDA Approval Vaccination 97

pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

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FDA Approval Manufacturing Clinical Trials Clinical Trials 85

XTalks

NOVEMBER 9, 2023

Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDA approved Zepbound for chronic weight management in adults with obesity.

FDA Approval 59

FDA Approval Manufacturing Drugs Pharmacy 59

XTalks

MARCH 14, 2023

Pfizer recently announced that their novel migraine nasal spray Zavzpret (zavegepant), received US Food and Drug Administration (FDA) approval for the acute treatment of migraines (with or without aura) in adults. Zavzpret will be available in pharmacies in July 2023.

FDA Approval 98

FDA Approval Pharmacy Drugs Gene 98

XTalks

MARCH 8, 2024

The biosimilar injections, Jubbonti (denosumab-bddz) and Wyost (denosumab-bddz), are approved as interchangeable biosimilars to Prolia and Xgeva, respectively. This means they can be substituted for the reference product at a pharmacy without the need for instruction from a prescriber.

Drugs 59

Drugs FDA Approval Production Immune Response 59

XTalks

APRIL 26, 2024

Wegovy nabbed a second US Food and Drug Administration (FDA) approval in March for reducing the risk of cardiovascular death, heart attack and stroke in adult patients with cardiovascular disease who have obesity or are overweight. The company received FDA approval for Ozempic in 2017 followed by Wegovy’s approval in 2021.

Drugs 52

Drugs FDA Approval Manufacturing Production 52

XTalks

APRIL 10, 2023

From Prescription to Non-Prescription (Rx-to-OTC) Approval Naloxone was originally approved by the FDA in 1971, and it has been widely used for decades to treat opioid overdoses. Narcan shares the same formulation, principle, intended use and prescription strength (4 mg) as the initially prescribed naloxone spray.

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Production FDA Approval Manufacturing Drugs 98

XTalks

FEBRUARY 2, 2023

Amgen’s Amjevita, the first biosimilar version of AbbVie’s blockbuster arthritis injection Humira (adalimumab), has finally hit the market this week after fetching US Food and Drug Administration (FDA) approval back in 2016. Alvotech’s biosimilar is pending FDA approval. Amjevita Launch: Cost Savings, But for Whom?

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Marketing FDA Approval Branding Drugs 52

XTalks

MARCH 7, 2023

With the FDA approval, it’s become the first and only treatment for the debilitating condition. The vision loss caused by geographic atrophy has a severely negative impact on quality of life. Syfovre is an eye injection designed to slow the progression of the disease that is administered once every 25 to 60 days.

FDA Approval 98

FDA Approval Drugs Sales Trials 98

XTalks

FEBRUARY 14, 2024

They also blamed pharmacy benefit managers (PBMs), third-party companies that serve as pharma middlemen, who select which drugs receive insurance coverage and charge drug companies rebates and fees for covering them. The companies are often integrated with pharmacies and insurers.

Drugs 52

Drugs Insulin Pharmacy Development 52

XTalks

NOVEMBER 26, 2020

As the second wave of the pandemic continues to grip much of the world, the study is part of efforts to identify existing FDA-approved drugs that can be repurposed to treat or prevent COVID-19 as it is the most efficient and inexpensive approach.

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XTalks

JUNE 12, 2023

Additionally, Abbott launched over 125 new products in 2022, in conjunction with a series of FDA approvals. This system is the first and only FDA-approved heart failure monitoring system that enables physicians to track changes in pulmonary artery pressure. The CardioMEMs HF system was another crucial launch for Abbott.

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FDA Approval Production Sales In-Vitro 98

XTalks

NOVEMBER 28, 2023

Samsung Bioepis was the first company to receive FDA approval for both high-concentration and low-concentration formulations of adalimumab biosimilar. However, it is important for all stakeholders to realize that the FDA interchangeability designation is a legal distinction, not a clinical one.

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XTalks

APRIL 24, 2023

The Recent Increase in Cellular and Gene Therapy Product Approvals for Rare Diseases As of December 2022, the FDA’s Office of Tissue and Advanced Therapies (OTAT) has approved 27 cellular and gene therapy products. Last year, the FDA approved five novel cellular and gene therapy products with orphan drug designation.

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Gene Therapy Gene Trials Clinical Trials 95

Pharma in Brief

NOVEMBER 29, 2020

of the US Importation Rule, drugs eligible for importation must have received an NOC and DIN in Canada and meet FDA approval conditions, aside from US labeling. It does not apply to non-DEL holders, such as pharmacies. The US Importation Rule took effect on November 30, 2020. Interim Order Context.

Drugs 52

Drugs Sales FDA Approval Compliance 52

XTalks

AUGUST 30, 2022

Nusinersen was the first FDA-approved treatment for spinal muscular atrophy (SMA), the first approved nucleic-acid therapeutic for a neurologic disease and the first approved drug to correct defective splicing. Direct CNS administration is also FDA-approved for multiple small molecules and ASOs.

Trials 83

Trials Drug Delivery Drugs Gene 83

XTalks

FEBRUARY 3, 2021

COVID-19 vaccines have been a topic of conversation since the outbreak began, and last year’s US Food and Drug Administration (FDA) approval of the Pfizer/BioNTech and Moderna vaccines have given the world hope to defeat the COVID-19 pandemic. Viewpoints from UAE Residents Who Were Given the COVID-19 Vaccine.

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Vaccination Vaccine Immune Response Manufacturing 98

Pharmaceutical Technology

MAY 3, 2023

“According to the FDA, the introduction of generic medicines offers patients “same as brand” drugs at 39% lower-than-average price,” says Surbhi Gupta, an industry analyst within Frost & Sullivan’s healthcare and life sciences practice area.

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