pharmacy mentor

MAY 30, 2025

Wegovy was first approved in the US in 2021 and reached the UK market in early 2023. Mounjaro was approved by the FDA in 2022, and by mid-2023 it was already widely used off-label for weight loss in the US. Wegovy was released even earlier than Mounjaro, receiving approval in the US in 2021.

Labelling

PharmExec

AUGUST 1, 2025

The label update refines language and streamlines the safety section by removing certain adverse events, aligning with placebo group occurrence rates. SHOW MORE The updated label no longer requires Leqvio (inclisiran) to be used in combination with statins for low-density lipoprotein cholesterol management.

Labelling

Putting Patients First Blog

JUNE 26, 2025

This step would ensure that real-world considerations, such as off-label uses and quality-of-life impacts, are factored into revised pricing decisions. A minimum 60-day window for public input should be established, with outreach to affected patient groups. 15 Inflation Reduction Act of 2022 , Pub.

Drug Pricing

Pharmacy Times

JUNE 30, 2025

It was originally approved in 2021 for the treatment of polycythemia vera and the manufacturer, as of January 2025, is seeking to expand the agent’s indication to the treatment of essential thrombocytopenia based on data from the SURPASS-ET trial (NCT04285086). November 12, 2021. Accessed June 20, 2025. Updated November 30, 2023.

Pharmacy Technician

Pharmacy Times

JUNE 9, 2025

3 neoCARHP was a multicenter, open-label, randomized, noninferiority phase 3 trial (NCT04858529) that compared the efficacy and safety of TCbHP with THP in the neoadjuvant setting. If caught early, the cancer can often be treated and cured, according to Cleveland Clinic. Gao HF, Li W, Wu Z, et al. J Clin Oncol. doi:10.1200/JCO.2025.43.17_suppl.LBA500

Pharmacy Technician

Pharmaceutical Technology

JULY 29, 2025

Find out more Skytrofa was previously approved by the FDA in 2021 to treat children and paediatric patients aged one year or above weighing at least 11.5kg and are experiencing growth failure due to inadequate secretion of endogenous growth hormone (GH). GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate?

Packaging

Express Pharma

FEBRUARY 10, 2025

Rezurock was approved by the United States Food and Drug Administration (US FDA) in 2021 and by the Central Drugs Standard Control Organisation (CDSCO) in India in 2024.

Labelling

Pharmaceutical Technology

JUNE 6, 2025

Originally approved for children in 2021, the FDA updated the drug’s label in January this year to include adults. A drug with a recent approval extension in the US, though not the UK, was Supernus Pharmaceuticals’ Qelbree (viloxazine extended-release capsules). ADHD treatments were in the political crosshairs in the US recently.

Communication

The Thyroid Pharmacist

MAY 15, 2025

Published 2021 Feb 9. link] Ding Y, Wang H, Pu S, Huang S, Niu S. Resistance Trends of Klebsiella pneumoniae Causing Urinary Tract Infections in Chongqing, 2011-2019. Infect Drug Resist. 2021;14:475-481. doi:10.2147/IDR.S295870 [3] Risnen LK, Kriinen SE, Sund R, Engberg E, Viljakainen HT, Kolho KL.

Immunization

pharmaphorum

JULY 7, 2025

Skip to main content Monday 7 July 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

Insurance Coverage and Processing

Express Pharma

APRIL 21, 2025

2021; 10.1056/NEJMoa2035807. About Urothelial Cancer Urothelial cancer is the most common type of bladder cancer (90 per cent of cases) and can also be found in the renal pelvis (where urine collects inside the kidney), ureter (tube that connects the kidneys to the bladder) and urethra 1. Bladder cancer: introduction (5-2019). N Engl J Med.

Chemotherapy

pharmaphorum

AUGUST 14, 2025

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Diabetes

The Thyroid Pharmacist

MARCH 7, 2025

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 16] Even more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! From indoor pollutants like formaldehyde (yes, really!),

Health and Personal Care Stores

pharmaphorum

JULY 2, 2025

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Diabetes

FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

Provided that a brief device description, clear intended use, and list or picture of all labeling claims are made, FDA aims to review the information and provide a response generally within 7 days. According to the latest MDUFA performance report , only 25% of 513(g)s in fiscal year 2023 met the 60-day statutory time frame.

Documentation

pharmaphorum

JULY 7, 2025

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Diabetes

EMCrit Project

JULY 23, 2025

Subscribe Login Notify of new follow-up comments new replies to my comments Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* intensivist, CCRN, etc.) Δ Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* Your Job (i.e. Your Job (i.e.

Labelling

pharmaphorum

JUNE 30, 2025

Skip to main content Monday 30 June 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

Vaccines

InCrowd

JULY 16, 2025

2021 was a year marked by significant changes for me: a divorce and a new job. I saw firsthand how women are treated by our health care system, gaslighted and ignored, and labeled as anxious if we made someone accountable or asked questions. The surgery happened in August 2021. During the journey, I became a better doctor.

Labelling

BioPharma Dive

JULY 9, 2025

In 2021, Merck agreed to pay $11.5 Merck CEO Rob Davis has been on the lookout for acquisitions in the $10 billion to $15 billion range as he prepares the company to lose patent protection on its top-selling Keytruda cancer drug. billion for Acceleron Pharma. In 2023, the New Jersey-based company scooped up Prometheus Biosciences for $10.8

Drug Pricing

STAT

APRIL 30, 2024

A controversial provision of a federal law designed to speed copycat drugs to market and foster competition saved Medicare Part D nearly $15 billion from 2015 to 2021 on just 15 medicines during that period, according to a new analysis. In short, this is a so-called carve-out.

Labelling

STAT

JANUARY 8, 2024

Cure Ventures , a Boston-based venture capital firm founded in 2021 by a trio of veteran biotech investors, has brought in two former executives from Sage Therapeutics to prepare them for investing in neuroscience startups. Continue to STAT+ to read the full story…

Labelling

STAT

JUNE 29, 2023

He allegedly worked with several other individuals and pharmacies between 2017 and 2021 as part of the scheme. Reconfiguring bottles and labels for distributing medicines is known as misbranding or diverting legitimate prescription drugs. Steven Diamantstein, who runs Scripts Wholesale in Brooklyn, N.Y.,

Labelling

STAT

OCTOBER 4, 2023

Lumakras received an accelerated — or conditional — approval in May 2021, making it the first KRAS drug on the market. The treatment, which is called Lumakras and made by Amgen, is designed to treat lung cancer caused by a specific genetic mutation to a protein called KRAS. Now, Amgen needs to prove it works.

Diabetes

pharmaphorum

MARCH 1, 2021

In the latest of a suite of features looking at the biggest markets in Europe, Leela Barham takes stock of what 2021 could bring for market access in France. Compassionate access is for off-label treatments that aren’t in development for an indication. Yet there are still challenges to be worked through in 2021.

Labelling

Pharmaceutical Technology

APRIL 11, 2023

This label expansion makes Orkambi the only disease-modifying CF medication available to patients of this age in Canada. This label expansion follows a similar label change in the US in September 2022. Health Canada is granting this new label expansion based on recent results from a Phase III study.

Labelling

Pharmaceutical Business Review

JULY 11, 2023

The label update reinforces the safety and effectiveness data of Leqvio generated by the VictORION clinical trial programme, claimed the company. Leqvio was initially approved by the FDA in December 2021. Among the other updates to the label include the removal of the Limitations of Use statement.

Labelling

pharmaphorum

APRIL 28, 2021

exploring ‘validation ready’ global labeling systems . ? . A group of industry experts is set to explore how medical device, clinical trial and pharmaceutical companies can proactively manage labeling risk. The post Experts to come together for compliance event ‘validation ready’ global labeling systems appeared first on.

Labelling

pharmaphorum

FEBRUARY 4, 2021

It comes as PRISYM ID announces five new business wins for the start of 2021, with new accounts spanning clinical trials, pharmaceutical and medical device sectors and with significant growth of the company’s flagship PRISYM 360 platform in the Cloud.

Labelling

pharmaphorum

JULY 9, 2021

The updated label for Aduhelm (aducanumab) says it should only be used in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia, according to an update from the drug’s developers. Katie Porter (@RepKatiePorter) July 6, 2021. Now, it has backtracked on that decision.

Labelling

European Pharmaceutical Review

JANUARY 16, 2023

Rykindo ® was approved for marketing in China in 2021 for the treatment of schizophrenia. An open-label pharmacokinetic and safety study of LY03004 evaluated an escalating single intramuscular injection in stable patients with schizophrenia or schizoaffective disorder. Clinical trials of the FDA approved Rykindo ®.

Labelling

pharmaphorum

SEPTEMBER 23, 2022

The full approval also extends the Retevmo label to include patients with locally advanced as well as metastatic disease. ” Sales of Retevmo have been gathering momentum since its first approval in 2020, coming in at $87 million in the first half of the year, double the same period of 2021.

Labelling

RX Note

JULY 29, 2023

In fact, off-label drug uses can become widely entrenched in clinical practice and become predominant treatments for a given clinical condition. In a study published in JAMA Internal Medicine , off-label use lacking strong scientific evidence had a higher adverse drug event rate compared with on-label use.

Labelling

pharmaphorum

MAY 10, 2021

Happy to announce that @EU_Commission has just approved a contract for guaranteed 900 million doses (+900 million options) with @BioNTech_Group @Pfizer for 2021-2023. — Ursula von der Leyen (@vonderleyen) May 8, 2021. Other contracts and other vaccine technologies will follow.

Vaccines

Pharmaceutical Technology

JANUARY 23, 2023

However, the 2021 approval of AstraZeneca’s Saphnelo in the US will mean increasing competition for Benlysta in the coming years. Furthermore, similar to GSK’s strategy with Benlysta, AstraZeneca initiated the Phase III TULIP subcutaneous (SC) trial in SLE using subcutaneous delivery of Saphnelo in June 2021.

Labelling

Safe Biologics

DECEMBER 19, 2023

The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. On November 17th, ASBM submitted comments to the Food and Drug Administration (FDA) on draft guidance released in September by the FDA.

Biosimilars

European Pharmaceutical Review

NOVEMBER 22, 2022

The application is supported by results from the LBCL cohort of the EPCORE NHL-1 open-label, multi-centre Phase I/II trial evaluating the safety and preliminary efficacy of epcoritamab in adults with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL). EPCORE NHL-1 Trial of epcoritamab .

Labelling