Express Pharma

MAY 22, 2024

PharmaLytica Expo, the flagship event within South India’s pharmaceutical industry, is scheduled from May 30 to June, 2024, at HITEX, Hyderabad. The two-day conference, PharmaLytica 2024, with a theme of “Optimising Pharmaceutical Quality and Compliance.”It

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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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Express Pharma

MAY 6, 2024

The event brought together over 330 professionals from across the industry’s value chain Pharmaceutical Manufacturing and Packaging Congress (PHARMAP 2024) was held in Amsterdam, Netherlands on April 22-23, 2024. According to its statement, PHARMAP 2024 brought together over 330 professionals from across the industry’s value chain.

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Packaging Pharmaceutical Manufacturing Labelling Pharmaceutical Companies 105

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 307

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

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 329

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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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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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

JUNE 4, 2024

PharmaLytica 2024 offered a unique platform for stakeholders to engage in discussions covering the full spectrum of pharma machinery and packaging, lab analytical and cleanroom solutions, and pharmaceutical ingredients. billion worth of drugs in the financial year 2024, achieving a 9.6 We exported USD 27.8

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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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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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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

Pharmaceutical Technology

MARCH 30, 2023

Table 1: Medical product (drugs, devices, and diagnostics) safety budget, 2023 vs. 2024 Source: FDA; GlobalData © GlobalData Whether the proposal passes, and with what alterations, will depend on US Congress. This is made up of $2.1bn in direct funding and $2.4bn in user fees.

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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

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 100

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 111

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

Express Pharma

AUGUST 6, 2024

The falsified product was detected in the unregulated supply chain in Finland and reported to WHO in July 2024 by the Finnish Medicines Agency (FIMEA). To identify this falsified product check for the following: The falsified version label does not have a barcode on the bottle. The falsified version is labelled 40mg.

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Labelling 105

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

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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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

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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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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Express Pharma

JULY 9, 2024

With the FDA’s approval, label restrictions that were included when the medicine was granted accelerated approval in the US in December 2012 are removed. Results confirmed that a bedaquiline-containing regimen offered a significant improvement in treatment outcomes compared to injectable-containing regimens.

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Labelling 98

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 104

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