pharmaphorum

JUNE 14, 2022

The approval comes despite scrutiny of the safety of the JAK inhibitor class by the FDA, with the risk of heart-related issues leading to warnings being applied to the labels of Olumiant and other drugs in the class including Pfizer’s Xeljanz (tofacitinib) and AbbVie’s Rinvoq (upadacitinib).

Labelling

Express Pharma

JULY 28, 2024

Several US KOLs have acknowledged that they utilise Nuzyra off-label for the treatment of NTM-PD caused by the species Mycobacterium abscessus and M. According to GlobalData estimates, Nuzyra for the treatment of NTM-PD is expected to launch in the US in 2029 and in the EU in 2030. avium complex (MAC).

Labelling

Pharmaceutical Technology

APRIL 28, 2023

In 2022, US sales of Ozempic contributed to 65% of global sales; this is expected to continue, with the US market forecast to continue capturing the majority of sales, generating $71bn between 2023–2029. It is forecast that Ozempic will sustain its sales growth over the next five years, with an expected annual sales figure of $17bn in 2029.

Diabetes

Express Pharma

NOVEMBER 14, 2024

Most of the drugs currently used to treat NTM infections are used off-label, which leaves a critical unmet need for new therapeutic options with improved efficacy, specifically approved for the use of NTM infections.” Several US KOLs have acknowledged that they utilise omadacycline off-label for the treatment of NTM-PD caused by MABc and M.

Labelling

Pharmaceutical Technology

JANUARY 10, 2023

billion in 2029, with drug sales almost doubling at a compound annual growth rate (CAGR) of 11.5%. Specifically, across all the major classes there are significant developments, label updates, and biosimilar launches that are driving their growth. billion in 2029, although its sales growth is likely to continue beyond 2029.

Biosimilars

pharmaphorum

FEBRUARY 23, 2022

It also includes data from a long-term, open-label study that focused on the safety and tolerability of the drug over 26 weeks. Analysts at GlobalData are predicting peak sales of $383 million for the drug in 2029. Vraylar is now one of AbbVie’s fastest-growing products with sales expected to reach around $2.2

Labelling

pharmaphorum

NOVEMBER 24, 2022

Spravato has been approved since 2019 for TRD, with its label extended the following year as a rescue therapy for adults with major depressive disorder (MDD) who were at risk of self-harm or suicide. Both drugs were given on top of standard antidepressants to patients wo had failed a least two earlier treatments.

Labelling

Putting Patients First Blog

DECEMBER 5, 2024

Real-world case studies demonstrating how PPI has influenced decisions, such as targeted approvals or label modifications, would clarify its practical utility. 20 Specialized patient labeling should describe patient preferences for specific benefits and risks, tailored to the population most likely to use the device. 1 (2009): 2029.

Labelling

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. All labeler codes that are covered by Discount Program agreements will be distributed to PDP sponsors and posted on the CMS website. had Part D expenditures on or before August 16, 2022).

Labelling

Express Pharma

JUNE 25, 2024

The Breakthrough Therapy designation is supported by data from the Phase I/II, open-label, multi-centre, first-in-human study to evaluate the safety, pharmacokinetics, and preliminary efficacy of BAY2927088 as second-line therapy in adult patients with advanced NSCLC harbouring HER2 and EGFR mutations.

Labelling

pharmaphorum

OCTOBER 26, 2022

billion a 25% gain in the prior year and fuelled in part by extensions to its label to include other progressive ILDs. Ofev is, however, heading for patent expiry in 2029, and Boehringer is looking to BI 1015550 to maintain the franchise beyond that date, and also to improve the treatment of IPF, which remains incurable.

Labelling

Pharmaceutical Technology

JULY 8, 2025

By GlobalData Learn more about Strategic Intelligence “Efimosfermin is a key growth opportunity for GSK with multiple development options and potential first launch in 2029. Stay proactive with real-time data and expert analysis. We look forward to unlocking the potential of this medicine for patients.”

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