2029 and Labelling - Pharmacist Digest

Intra-Cellular Therapies acquisition will expand J&J’s presence in neurology space, says GlobalData

Express Pharma

JANUARY 17, 2025

GlobalData forecasts that Caplyta could generate sales of $640 million in MDD by 2029 in the 7MM. Opdenakker continues, The addition of Caplyta could be particularly significant, given its versatility as a proven treatment for schizophrenia and bipolar disorder, as well as a potential label expansion into MDD.

Labelling

BMS expands Krazati’s FDA label to include colorectal cancer

Pharmaceutical Technology

JUNE 24, 2024

The KRAS inhibitor, Krazati, is expected to generate $1.3bn in global sales in 2029, as per GlobalData’s analysis.

Labelling

Daiichi Sankyo poised to add another ADC blockbuster with datopotamab deruxtecan for non-squamous NSCLC: GlobalData

Express Pharma

FEBRUARY 21, 2024

billion by 2029. “ Gilead’s Trodelvy (sacituzumab govetican), marketed for advanced breast and bladder cancer, is seeking a label expansion for first-line NSCLC in combination with Keytruda. billion in 2023, and GlobalData projects it to surpass $14 billion by 2029. GlobalData estimates the drug to earn $3.12

Chemotherapy

Chemotherapy Labelling Immunity Immunization

J&J’s Akeega FDA approval to heat up PARP battle with dual-action treatment for prostate cancer: GlobalData

Express Pharma

AUGUST 29, 2023

Akeega’s current predicted sales will experience only a slight increase as a result of its narrow label and fierce competition with other recently approved poly(ADP-ribose) polymerase (PARP) inhibitors, according to GlobalData. billion by 2029. However, the combination presents with potentially higher efficacy than Akeega.

Labelling

Lilly’s Olumiant okayed in alopecia, with Pfizer, Concert in hot pursuit

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

Phase III post-marketing commitment study data paves way for usage of Paratek’s Nuzyra in other indications: GlobalData

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

Seeking Ofev successor, Boehringer takes PDE4B drug into phase 3

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

Novo Nordisk blockbuster Ozempic boasts 23% sales surge in 2023

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

Diabetes Dosage Compounding Labelling

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

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

Labelling Drug Pricing Compounding Payment Processing

Bayer’s BAY2927088 to face competition in EGFR-mutant but limited competition in HER2-exon 20 mutant NSCLC market in China: GlobalData

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

Paratek Phase IIb data shows omadacycline’s potential to address unmet needs in NTM treatment, says GlobalData

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

T2D market growth driven by novel GLP-1RAs and once-weekly basal insulin therapies

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.

AbbVie files Vraylar as add-on therapy for depression in US

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

J&J builds case for antidepressant Spravato with head-to-head trial

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

Labelling Hospitals

NHC Submits Comments on FDA’s Draft Guidance for Voluntary Incorporation of Patient Preference Information

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

Labelling Communication Mayo Clinic

Pharmacist Digest

Intra-Cellular Therapies acquisition will expand J&J’s presence in neurology space, says GlobalData

BMS expands Krazati’s FDA label to include colorectal cancer

Trending Sources

Daiichi Sankyo poised to add another ADC blockbuster with datopotamab deruxtecan for non-squamous NSCLC: GlobalData

J&J’s Akeega FDA approval to heat up PARP battle with dual-action treatment for prostate cancer: GlobalData

Lilly’s Olumiant okayed in alopecia, with Pfizer, Concert in hot pursuit

Phase III post-marketing commitment study data paves way for usage of Paratek’s Nuzyra in other indications: GlobalData

Seeking Ofev successor, Boehringer takes PDE4B drug into phase 3

Novo Nordisk blockbuster Ozempic boasts 23% sales surge in 2023

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

Bayer’s BAY2927088 to face competition in EGFR-mutant but limited competition in HER2-exon 20 mutant NSCLC market in China: GlobalData

Paratek Phase IIb data shows omadacycline’s potential to address unmet needs in NTM treatment, says GlobalData

T2D market growth driven by novel GLP-1RAs and once-weekly basal insulin therapies

AbbVie files Vraylar as add-on therapy for depression in US

J&J builds case for antidepressant Spravato with head-to-head trial

NHC Submits Comments on FDA’s Draft Guidance for Voluntary Incorporation of Patient Preference Information

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