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.

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Labelling 98

STAT

JULY 26, 2024

On July 6, 2024, Sonya Massey, 36, called 911 to report a potential home intruder at her home in Springfield, Ill. After the shooting, Grayson labeled her as “crazy” and not deserving of first aid. “Don’t hurt me,” were her first words to the two officers who responded. You called us.”

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Labelling 306

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.

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Biosimilars Labelling 100

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.

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Biosimilars Labelling 52

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.

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Packaging Pharmaceutical Manufacturing Labelling 105

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 57

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.

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Biosimilars Labelling 52

STAT

SEPTEMBER 13, 2023

The Boston-based company will continue offering its pediatric treatment, EndeavorRx, by prescription until it can convert it to over-the-counter labeling — it plans to submit data to FDA in 2024. In its second-quarter results reported in August, Akili said it earned just $114,000 on $15.3 million in expenses.

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Labelling 336

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.

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Labelling Biosimilars 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.

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Labelling 69

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.

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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.

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Labelling Adverse Reactions Dosage 57

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

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.

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Labelling 52

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.

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Labelling 89

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.

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Labelling 105

Big Molecule Watch

OCTOBER 31, 2024

On October 22, 2024, Alvotech and Teva announced that SELARSDI (ustekinumab-aekn) received FDA approval for a new presentation, 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion. We previously reported that SELARSDI was approved by the FDA for 45 mg/0.5 Thomas Rainey, Senior Vice President, U.S.

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Biosimilars Labelling 62

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.

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Labelling 110

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 101

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.

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Labelling 57

Big Molecule Watch

NOVEMBER 19, 2024

On November 8, 2024 Autolus, Inc. (“Autolus”) announced that the FDA has approved AUCATZYL (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“ALL”).

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Chemotherapy Labelling 62

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 94

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 57

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.

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Labelling Vaccines 52

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.

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Labelling 52

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.

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Labelling 97

FDA Law Blog: Biosimilars

AUGUST 7, 2024

But recently, a new challenge was filed in the District Court for the District of Columbia questioning whether modifications to labeling as a result of patent protections—beyond the mere omission of language—are permissible under the section viii carve-out requirements. FDA and intervenor MSN vehemently defend FDA’s approval here.

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Labelling Hospitals 57

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.

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Packaging Labelling 105

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.

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Labelling 130

Big Molecule Watch

MAY 3, 2024

The 60-day comment period for this revised draft guidance ends on 6/24/2024. Topics the FDA addresses include correctly identifying products, presenting comparative study data, and avoiding any suggestion that a biosimilar product may be less safe or effective, to highlight a few.

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Biosimilars Communication Labelling Documentation 62

Pharmaceutical Business Review

JULY 15, 2024

The deal, which was announced in May 2024, includes an upfront cash payment of $1.3bn and $1.7bn in milestone payments on meeting developmental, regulatory and commercial goals. Under the deal terms, Merck, through a subsidiary, has acquired all the outstanding shares of the UK-based biotech.

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Research Laboratories Diabetes Labelling 59

Express Pharma

NOVEMBER 13, 2024

They will debut as a late-breaking abstract at the upcoming American College of Rheumatology (ACR) 2024 congress, which will take place from November 14 to 19, 2024. The findings of this trial constitute a significant milestone for the companies.

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Labelling Immunity Immunization 101

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.

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Biosimilars Labelling 68

GMPSOP

MARCH 30, 2024

Proper line segregation involves physically separating different lots of starting materials, labeling components, and printing matters, many of which look similar. Before filling and labeling, you should thoroughly examine the filling line using a standard operating procedure. Please look at the labeling operation in the picture below.

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Labelling Packaging Documentation Pharmaceutical Manufacturing 52

Express Pharma

AUGUST 2, 2024

Refer label for a detailed indication. Nelarabine Injection, 250 mg/50 mL has an estimated market size of US$ 23 million for twelve months ending March 2024 according to IQVIA. Alembic has a cumulative total of 211 ANDA approvals (183 final approvals and 28 tentative approvals) from USFDA.

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Chemotherapy Labelling 52

Pharmaceutical Business Review

SEPTEMBER 19, 2024

Azitra CEO Francisco Salva said: “Many cancer patients receive EGFR inhibitors, which often have significant side effects, resulting in rashes that require off-label treatment with antibiotics, steroids or other medications, or discontinuation of EGFRi therapy. This topical therapy is aimed at treating moderate to severe skin rash.

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Labelling 59

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 52

Labelling 52