Express Pharma

MAY 7, 2024

Steriline, the European manufacturer of standard and robotic lines for the aseptic processing of injectable drugs, will exhibit at Achema 2024, from June 10 to 14.It References: [1] [link] The post Steriline to exhibit its Robotic Vial Filling Machine at ACHEMA 2024 appeared first on Express Pharma. per cent per year until 2028 1.

Packaging 105

Packaging Pharmaceutical Manufacturing Labelling 105

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

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

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

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

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

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.

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Labelling 59

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.

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Labelling 98

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

Drug Channels

DECEMBER 9, 2024

During Friday's webinar, Ill share some updated thoughts on biosimilars and PBMs private label products. Below, we review the 20 products competing with Humiraincluding four private-label products marketed by in-house subsidiaries owned by CVS Health and Cigna. Click here to see the original post. All rights reserved.

Biosimilars 52

Biosimilars Labelling 52

European Pharmaceutical Review

AUGUST 30, 2023

The agreement stipulates that certain conditions must be met in the labelling and packaging of these medicinal products. After this date: Under the framework, medicines can have the same packaging and labelling across the UK. All medicines on the UK market must be labelled as for sale only within the UK, including in Northern Ireland.

Packaging 105

Packaging 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

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

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

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 52

Labelling Biosimilars 52

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

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

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.

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Labelling Adverse Reactions Dosage 59

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

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.

Biosimilars 59

Biosimilars Labelling Communication 59

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.

Biosimilars 130

Biosimilars Labelling Drug Pricing Packaging 130

LifeProNow

JANUARY 19, 2024

January 08, 2024: “The U.S. The FDA has revised the final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to list VHP as an example of an Established Category A method of sterilization.

Labelling 130

Labelling 130

Quality Matters

MARCH 8, 2024

Further, the proclaimed health benefits found on an unverified supplement’s label are not necessarily true or accurate. FDA of nearly 70 dietary supplements for sale at major online retailers revealed that most of these products included active ingredients that were not listed on the label. A recent test conducted by the U.S.

Labelling 98

Labelling 98

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

European Pharmaceutical Review

NOVEMBER 28, 2023

“We are pleased with the broad label, which includes all progressing adult patients and specifically references improvement in pain, and believe Ogsiveo has the potential to become the new standard of care for people living with these devastating tumours,” Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics commented.

Labelling 104

Labelling 104

European Pharmaceutical Review

SEPTEMBER 26, 2023

Patients who experienced disease progression while having a placebo treatment were offered resminostat in an open label treatment arm. In terms of drug development , the company stated that filing for marketing approval of the oral small molecule treatment in the EU, Switzerland and UK is planned for Q1 2024.

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Labelling Drug Development 110

Pharmaceutical Technology

JULY 17, 2023

The complete data readouts of two-Phase II trials are expected in 2024, with an additional open-label extension study currently in the works.

Labelling 52

Labelling 52

European Pharmaceutical Review

MARCH 8, 2024

Novo Nordisk stated it expects to file for regulatory approvals of a label expansion for Ozempic ® in the US and EU this year. The company added that the detailed results from FLOW will be presented at a scientific conference in 2024.

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Diabetes Labelling 98

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 69

Biosimilars Labelling 69

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 86

Labelling 86

FDA Law Blog: Biosimilars

JULY 23, 2024

The draft guidance (June 2024) defines an EDDO as the “design outputs necessary to ensure delivery of the intended drug dose to the intended delivery site. Comments may be submitted by September 30, 2024. Drug delivery includes successful product preparation and the initiation, progression, and completion of dose delivery.

Labelling 105

Labelling 105