XTalks

JUNE 29, 2021

Prescription digital medicine company Akili Interactive is set to launch a digital campaign for its FDA-approved video game for the treatment of attention deficit hyperactivity disorder (ADHD). The video game is called EndeavorRx and is the first and only FDA-backed therapy delivered through a video game experience.

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XTalks

JANUARY 29, 2025

This translates to an average weight loss of 21%, which was demonstrated in clinical trials (over a period of 72 weeks) that supported Zepbounds FDA approval. Zepbound was approved in 2023 as the obesity counterpart of Eli Lillys GLP-1 blockbuster Mounjaro. Its changing how much weight I lose, up to 48 lbs, he says.

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XTalks

DECEMBER 18, 2024

It also received the FDAs rare pediatric disease priority review voucher along with the approval, which will help expedite the agencys assessment of another application. The company said Crenessity will be available through specialty pharmacy PANTHERx Rare in order to centralize and simplify fulfillment of prescriptions for the drug.

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XTalks

MARCH 28, 2024

The US Food and Drug Administration (FDA) has given the nod to Winrevair (sotatercept-csrk injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve WHO (World Health Organization) functional class (FC) and reduce the risk of clinical worsening events.

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XTalks

SEPTEMBER 21, 2023

Among the companies Lilly has accused of selling non-US Food and Drug Administration (FDA) approved compounded products “fraudulently claiming to be Mounjaro” are medical spas, wellness centers and compounding pharmacies. Mounjaro, a dual GLP-1/GIP agonist was approved in May 2022 for type 2 diabetes.

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XTalks

SEPTEMBER 10, 2024

Amneal Pharmaceuticals and Shilpa Medicare have announced US Food and Drug Administration (FDA) approval of Boruzu, a ready-to-use formulation of bortezomib for subcutaneous or intravenous (IV) administration.

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XTalks

OCTOBER 29, 2024

It also marks the first US approval for an oral penem antibiotic (a class of beta-lactam antibiotics with wide-ranging antibacterial activity). Orlynvah is also only the second uUTI treatment approved in the past two decades. uUTIs affect millions in the US each year and primarily affect women.

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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

OCTOBER 29, 2024

It also marks the first US approval for an oral penem antibiotic (a class of beta-lactam antibiotics with wide-ranging antibacterial activity). Orlynvah is also only the second uUTI treatment approved in the past two decades. uUTIs affect millions in the US each year and primarily affect women.

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XTalks

SEPTEMBER 25, 2024

However, it still requires a prescription, and those choosing the self-administration option will complete a screening process through an online pharmacy before receiving the vaccine. The FDA’s approval came after comprehensive studies, which included human factors and usability evaluations.

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XTalks

FEBRUARY 25, 2025

With an increasing number of employees looking to maintain overall health and wellness, the medications are now viewed as a desirable benefit one that can potentially lower long-term health risks while enhancing quality of life. Moreover, the high demand for GLP-1 drugs also led to shortages of the drugs over the past couple of years.

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XTalks

JULY 19, 2024

Compounded GLP-1 medications, created by specialized pharmacies under a special US Food and Drug Administration (FDA) allowance due to ongoing shortage, have become increasingly popular for weight loss. The report also shows a rapid rise in compounding pharmacies.

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XTalks

MARCH 10, 2025

Pricing data indicate that the price of TNKase is around $8,672 for a 50 mg IV injection for cash-paying customers, though prices can vary based on pharmacy and location. XTALKS WEBINAR: Rethinking Recruitment and Retention with Empathy and Innovation: What if Patients Chose You?

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Medicine Trials Pharmacy Clinical Trials 59

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

NOVEMBER 1, 2024

Why it sold so well: Botox is FDA-approved for the treatment of chronic migraines and that is currently the only chronic condition for which it has received approval. mL, depending on the pharmacy. Related: Top 30 Drugs to Watch in 2024: Insights from 2023 Sales Data 1. mL) is around $620 for a supply of 0.25

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FDA Approval Drugs Botox Sales 85

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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XTalks

JULY 3, 2024

Verona Pharma has received US Food and Drug Administration (FDA) approval for Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disorder (COPD). COPD is a progressive lung disease that results in breathing problems, chronic coughs and fatigue. It includes conditions like emphysema and chronic bronchitis.

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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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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.

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XTalks

MAY 17, 2024

The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products.

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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

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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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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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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Research Hormones Protein Regulation 98

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

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

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.

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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.

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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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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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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

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.

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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.

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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.

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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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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.

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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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