Express Pharma

JANUARY 19, 2025

This study consists of a 36-week treatment phase, followed by a 16-week open-label extension. 2024 Jul 27;1842:149129. This study will enrol 210 ALS patients and study doses of 50 mg and 75 mg Usnoflast versus placebo. DOI: 10.1002/cpdd.1162 DOI: 10.1002/cpdd.1318. DOI: 10.1016/j.brainres.2024.149129. 2024.149129.

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Clinical Pharmacology Labelling Medical Schools Drug Development 111

LifeProNow

JANUARY 18, 2025

Data collected through the second quarter of 2024 and presented at the European Society for Medical Oncology (ESMO) 2024 Congress as alate-breaking oral presentationshowed an 83.5

Packaging 100

Packaging Labelling 100

Pharmaceutical Technology

NOVEMBER 18, 2024

At AHA 2024, clinical trial results were presented from the ongoing open-label extension trial, LIBERATE-OLE, involving lerodalciep.

Labelling 52

Labelling 52

European Pharmaceutical Review

MARCH 5, 2024

International participation and trending topics With over 900 exhibitors, analytica 2024 promises an impressive lineup. Digitalisation also relieves laboratory personnel through optimised inventory management with online inventory maintenance and automatic label printing, enhancing efficiency and occupational safety.

Labelling 98

Labelling 98

Safe Biologics

JUNE 6, 2024

ASCO 2024: ASBM Releases Resource Guide for Cancer Patients on IRA’s Impact on R&D, Access From May 31st – June 4th, the American Society of Clinical Oncology (ASCO) held its Annual Meeting in Chicago, IL. Read more about the FDA approvals here.

Biosimilars 100

Biosimilars Labelling 100

Express Pharma

DECEMBER 15, 2024

According to IQVIA sales data for the 12-month period ending October 2024, the market for Vimpat Oral Solution, 10 mg/mL, recorded annual sales of approximately $57 million. The Lacosamide Oral Solution, 10 mg/mL, is approved only for the indications listed in Glenmarks approved label.

Labelling 98

Labelling 98

Express Pharma

MARCH 20, 2025

Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Accessed February 20, 2024. 2021;398(10300):583-598. 2022;327(6):534-545. doi:10.1001/jama.2022.0078 Hypertension.

Diabetes 101

Diabetes Labelling Communication 101

Drug Channels

AUGUST 16, 2024

Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. The findings shed light on payers' view of biosimilar conpetition, contracting challenges, and other issues. Click here to learn more about MMIT’s Custom Market Research offering for biosimilar manufacturers. Read on for Benjamin’s insights.

Labelling 78

Labelling Biosimilars 78

Express Pharma

MARCH 20, 2024

Material Sourcing (Strategic & Plant), Global Supply Chain Management, Dr Reddy’s Laboratories (Moderator) + Chandi Prasad Ravipati, Head-Packaging Development, Aurobindo Pharma + Santanu Chowdhury, Sr GM – Packaging Development, Sun Pharmaceutical Industries + Prabir Das, Pharma Expert + Dr Sajeev Chandran, VP – Pharma R&D, (..)

Packaging 52

Packaging Labelling 52

European Pharmaceutical Review

JUNE 4, 2024

Meeting the Divisions at ACHEMA 2024 IMA Active The ideal partner for each solid dose processing phase: granulation, tableting, capsule filling and banding, weight checking, coating, handling and washing. customers will have the opportunity to experience first hand various digital solutions aimed at reducing maintenance costs and downtime.

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Packaging Customer Service Labelling Dosage 95

Express Pharma

JULY 16, 2024

According to IQVIA sales data for the 12-month period ending May 2024, the Topamax Capsules, 15 mg and 25 mg market ( 3) achieved annual sales of approximately $21.9 References: 1 Glenmark’s Topiramate Capsules USP, 15 mg and 25 mg is only approved for the indication(s) listed in Glenmark’s approved label.

Labelling 100

Labelling 100

Pharmaceutical Technology

JANUARY 22, 2024

Processa announced plans to begin a Phase II breast cancer study for its capecitabine combination therapy in Q3 2024.

Labelling 69

Labelling 69

Drug Channels

SEPTEMBER 24, 2024

Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. There’s still time to request an invite to the inaugural Drug Channels Leadership Forum. Attendance will be highly limited. We have already begun extending invitations, so apply now to be considered. Click here to view the full agenda.

Biosimilars 52

Biosimilars Labelling 52

Express Pharma

MAY 17, 2024

According to IQVIA sales data for the 12-month period ending March 2024, the Combigan Ophthalmic Solution, 0.2%|0.5% is only approved for the indication(s) listed in Glenmark’s approved label. Glenmark’s Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%|0.5% appeared first on Express Pharma.

Labelling 98

Labelling 98

FDA Law Blog: Biosimilars

MARCH 5, 2024

Many individual states have pursued some type of legislation to restrict the use of traditional meat terminology for the labeling of APPs. Many states have proposed but failed to enact legislation regulating the labeling of APPs, in some cases due to concerns of potential legal challenges based on federal preemption claims.

Labelling 59

Labelling 59

Express Pharma

OCTOBER 3, 2024

Refer label for a detailed indication. Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg have an estimated market size of $ 163 million for twelve months ending June 2024 according to IQVIA. Alembic has a cumulative total of 216 ANDA approvals (188 final approvals and 28 tentative approvals) from USFDA.

Labelling 111

Labelling 111

Express Pharma

MAY 5, 2024

These data were featured in an Oral Presentation Session (Abstract #PD48-02) 1 at the 2024 American Urological Association (AUA) Annual Meeting taking place 3-6 May, 2024, in San Antonio, Texas. 2,3 At the data cutoff of March 22, 2024, 64 patients had been treated with TAR-210 across the two cohorts.

Labelling 104

Labelling 104

Express Pharma

SEPTEMBER 27, 2024

Further details on the indications are available on the product label. mg, 3 mg, 6 mg, and 9 mg, is estimated at US$ 48 million for the twelve months ending June 2024. It is also indicated for the treatment of schizoaffective disorder, either as monotherapy or as an adjunct to mood stabilisers and antidepressants.

Labelling 105

Labelling 105

Express Pharma

OCTOBER 20, 2024

The label provides a detailed indication. million for the twelve months ending June 2024, according to IQVIA. It is also indicated for the management of chronic stable angina. Diltiazem Hydrochloride Extended-Release Capsules USP in the 120 mg, 180 mg, and 240 mg dosages have an estimated market size of US$ 28.2

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Dosage Labelling 105

Drug Channels

SEPTEMBER 24, 2024

Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. There’s still time to request an invite to the inaugural Drug Channels Leadership Forum. Attendance will be highly limited. We have already begun extending invitations, so apply now to be considered. Click here to view the full agenda.

Biosimilars 52

Biosimilars Labelling 52

FDA Law Blog: Biosimilars

MARCH 23, 2025

We wrote about the December 26, 2024 publication of the final rule (89 FR 105288) here. Livornese On Friday, March 21, 2025, FDA announced that it was further delaying the effective date for the ACNU final rule until May 27, 2025.

Labelling 59

Labelling 59

Express Pharma

FEBRUARY 12, 2025

billion in 2024 and projected to reach $11.55 On one hand, the Indian government has taken proactive steps to explore bringing nutra products under the purview of the Central Drugs Standard Control Organisation (CDSCO) by setting up a government-constituted panel in February 2024. billion by 2030, according to a GlobeNewsWire report.

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Documentation Labelling 99

Drug Channels

SEPTEMBER 4, 2024

Below, we review the 18 products competing with Humira—including four private-label products marketed by in-house subsidiaries owned by CVS Health and Cigna. Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. All rights reserved. This Feed is for personal non-commercial use only.

Biosimilars 52

Biosimilars Labelling 52

LifeProNow

MARCH 8, 2024

March 06, 2024: “The U.S. Consumers can find lot codes listed on the product’s label. The agency sent a letter to all cinnamon manufacturers, processors, distributors and facility operators in the U.S., The FDA is working with the firms listed below to voluntarily recall the products, with the exception of the MTCI cinnamon.

Labelling 130

Labelling 130

Pharmaceutical Technology

JUNE 17, 2024

If Calquence receives FDA label expansion in MCL, it will achieve a unique position in the treatment-naive MCL market share.

Labelling 52

Labelling 52

Big Molecule Watch

JANUARY 10, 2025

Here are some of the top regulatory developments from 2024. FDA Approvals in 2024 There were 17 FDA approvals of Biologic License Applications (BLAs), including for Autolus Inc.’s There were also 18 FDA approvals of biosimilar products , including 6 ustekinumab biosimilars and 5 aflibercept biosimilars in 2024 alone.

Biosimilars 45

Biosimilars Drug Pricing Labelling Communication 45

Pharmacy Times

APRIL 9, 2024

In March 2024, the label for bempedoic acid was expanded to reduce cardiovascular risk and expand the low-density lipoprotein-C (LDL-C) lowering in both primary and secondary prevention patients.

Labelling 57

Labelling 57

Pharmaceutical Commerce

SEPTEMBER 6, 2024

Bernstein, President of Bernstein Rx Solutions, LLC, comments on industry’s preparedness for DSCSA compliance and provides an update as to where pharma is in terms of RFID label adoption. In the final part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G.

Labelling 52

Labelling 52

FDA Law Blog: Biosimilars

SEPTEMBER 17, 2024

By Sarah Wicks & Dara Katcher Levy — FDA’s Office of Prescription Drug Promotion (OPDP) has issued its fourth Untitled Letter of 2024 – this one to AbbVie, Inc. The approved labeling for UBRELVY includes a warning and precaution regarding hypersensitivity reactions, with the most common adverse reactions being nausea and somnolence.

Labelling 59

Labelling Adverse Reactions Dosage 59

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 52

Labelling 52

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

Labelling 105

Labelling Drug Pricing Compounding Payment Processing 105

FDA Law Blog: Biosimilars

APRIL 25, 2024

Promotional labeling is generally any labeling other than FDA-required labeling that is devised for the promotion of a product, as well as other functions, and can include printed, audio, or visual matter that describes the product. Comments to the revised draft guidance are due to the docket by June 25, 2024.

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Biosimilars Labelling Communication 59

Drug Channels

DECEMBER 11, 2023

This week, I’m rerunning some popular posts while I prepare for Friday’s Drug Channels Outlook 2024 live video webinar. Click here to see the original post from September 2023. Here’s the press release: CVS Health Launches Cordavis.

Biosimilars 75

Biosimilars Labelling 75

Express Pharma

JUNE 10, 2024

Sara Reci, MSc, Managing Pharma Analyst at GlobalData, commented, “The results of both studies are embellishing additions to the successful start that Roche’s Vabysmo has had to 2024. Edits Made by EP News Bureau The post Roche’s Vabysmo showcases stronghold across wAMD and DME spaces : GlobalData appeared first on Express Pharma.

Diabetes 105

Diabetes Labelling 105

Safe Biologics

DECEMBER 3, 2023

The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. They may be submitted here and are due by January 5, 2024 Read the full statement here. state law, only interchangeable biosimilars may be substituted by a pharmacist without contacting the prescriber.

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Biosimilars Labelling Drug Pricing Packaging 130

European Pharmaceutical Review

DECEMBER 13, 2024

This authorises a novel CE-labelled needle for intravitreal injection. Subsequently, Vabysmo PFS was granted first approval for the conditions by the US Food and Drug Administration (FDA) in July 2024, Roche shared.

Diabetes 97

Diabetes Labelling Hospitals 97

Pharmaceutical Technology

OCTOBER 26, 2023

GSK plans to submit the data to regulatory agencies to support label expansion for Arexvy in the younger adult patient population in 2024.

Labelling 52

Labelling Vaccines 52