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. Since its approval in May 2022, Mounjaro sales have hit $1.4

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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. The other interim orders include: Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (signed March 18, 2020).

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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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Drugs FDA Approval Production Immune Response 59

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. The drug generated an estimated $65 million in net sales in 2022. The company expects to launch the drug this month.

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FDA Approval Drugs Sales Trials 98

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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Drugs FDA Approval Manufacturing Production 52

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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Pharmacy FDA Approval Drugs Containment 59

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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Production Marketing Development Pharmacy 98

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. More potential patients equal more prescriptions which equals higher sales and bigger profits.

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Life Science Drugs FDA Approval Vaccination 97

XTalks

JUNE 12, 2023

Abbott Laboratories reported that the sales from its Diagnostics and Medical Device divisions in 2022 surpassed the company’s initial forecast. The remarkable performance in 2022 was driven largely by the sales of COVID-19 testing kits, including the BinaxNOW COVID-19 Ag test and its at-home self-test version. percent from $27.06

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FDA Approval Production Sales In-Vitro 98

XTalks

AUGUST 30, 2022

Global sales of over-the-counter and prescription products related to central nervous system (CNS) disease added up to $86 billion in 2019. Direct CNS administration is also FDA-approved for multiple small molecules and ASOs. All facilities (such as lab, pharmacy, MRI, etc.)

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Trials Drug Delivery Drugs Gene 83

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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Generic Drugs Branding Drugs Production 246