PharmaTech

APRIL 1, 2025

William Wainwright, business development manager at Iwata Label USA, discusses the practical security benefits of functional labels at INTERPHEX 2025.

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Labelling 52

Express Pharma

DECEMBER 2, 2024

The company’s Phase III product Rybelsus, already FDA approved for cardiovascular risk factors and type 2 diabetes, is being positioned for a label expansion to include obesity.

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Labelling Diabetes Drug Development 126

Express Pharma

APRIL 16, 2025

The notification, dated 15 April 2025, was issued under Section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), citing the potential risk of using the said FDC in children under four and the availability of safer alternatives. Subsequently, the Drugs Technical Advisory Board (DTAB) also reviewed the safety of the combination.

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Packaging Labelling 90

FDA Law Blog: Biosimilars

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. RUO-labeled reagents and materials are often used in LDTs in clinical laboratories. By Steven J. Gonzalez & Allyson B. The Warning Letter seems to echo this point.

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Labelling 59

ID Stewardship

APRIL 16, 2025

In this article an infectious diseases pharmacist discusses someof many learning tidbitsfrom ESCMID Global 2025, the largest international meeting of clinical microbiologists and infectious diseases specialists. Each bottle was labeled with the data point and the year. Authored By: Timothy P. Gauthier, Pharm.D.,

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Labelling Communication 52

pharmaphorum

AUGUST 24, 2022

The biotech has confirmed it will not launch the biosimilar until March 2025 however, honouring the terms of its 2020 agreement with Alexion that resolved litigation over the validity of patents covering Soliris (eculizumab) in the US.

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Biosimilars Labelling 98

Express Pharma

FEBRUARY 18, 2025

million in 2025 to $111.9 per cent (2025-2030), driven by the anticipated launch of two high-priced targeted therapies for FXS in 2027, according to GlobalData. There are currently no approved therapies available for FXS; prescribed treatment consists exclusively of off-label drugs that target individual symptoms of the disease.

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Labelling 99

Drug Channels

MARCH 4, 2025

Fein, president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCIs new live video webinar: PBM Industry Update: Trends, Challenges, and What's Ahead This event will be broadcast live on Friday, April 4, 2025, from 12:00 p.m. This event is part of The Drug Channels 2025 Video Webinar Series.

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Specialty Pharmacies Drug Pricing Labelling 98

Express Pharma

JANUARY 17, 2025

Caplyta is currently under FDA review for major depressive disorder (MDD), with a decision anticipated in the first half of 2025. Opdenakker continues, The addition of Caplyta could be particularly significant, given its versatility as a proven treatment for schizophrenia and bipolar disorder, as well as a potential label expansion into MDD.

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Labelling 105

Express Pharma

APRIL 14, 2025

At the recently held 2025 American Academy of Neurology (AAN) meeting, Remegen presented positive Phase III results for telitacicept in patients with AChR+ or MuSK+ generalised myasthenia gravis (gMG). Furthermore, there are also highly effective treatments for MuSK+ patients that are currently used off-label.

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Biosimilars Labelling 95

Pharmafile

JANUARY 23, 2025

Award winners by category DELIVERY AND DEVICE INNOVATION SHL Medical for Elexy reusable electromechanical autoinjector ECO-DESIGN WINNER Huhtamaki for Omnilock Ultra PAPER PACKAGING INNOVATION WINNER Mitsubishi Gas Chemical Company for new OXYCAPT Multilayer Plastic Vial PATIENT-CENTRIC DESIGN WINNER UCB Pharma for Bimzelx 160mg 2ml autoinjectors product (..)

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Packaging Labelling 59

FDA Law Blog: Biosimilars

MARCH 23, 2025

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. Originally, the Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) final rule was to become effective January 27, 2025. By Deborah L.

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Labelling 59

European Pharmaceutical Review

AUGUST 30, 2023

The agreement stipulates that certain conditions must be met in the labelling and packaging of these medicinal products. The following new measures are set to be introduced on 1 January 2025. After this date: Under the framework, medicines can have the same packaging and labelling across the UK.

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Packaging Labelling 105

Pharma Marketing Network

APRIL 20, 2025

Introduction Is Big Pharma a villainous label or a misunderstood brand? For marketers in 2025, understanding the implications of this term is more important than ever. This article explores the nuances of how this label affects pharmaceutical marketing and what brands can do to respond strategically. Its central.

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Labelling Communication Drug Pricing 52

Pharmaceutical Commerce

FEBRUARY 21, 2025

In the final part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Laura Johnson, senior director of sales, life sciences, Loftware, comments on other concepts that are powering the companys 2025 Supply Chain Trends Report, and how they could possibly change in 2026.

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Labelling 52

Pharmaceutical Technology

NOVEMBER 15, 2024

The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.

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Labelling 52

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. Express Scripts’ 2025 strategy will also drive biosimilar adoption, although its pricing strategy is more problematic.

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Biosimilars Labelling 52

European Pharmaceutical Review

NOVEMBER 1, 2024

billion in 2025 to approximately $174.45 Otherwise, advanced technological features such as “Advanced Recycling PET or Carbon Capture PET” as well as “labelling and sensory tracking systems” offer opportunities too, Towards Packaging asserted. billion by 2033, according to a study published by Towards Packaging.

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Packaging Dosage Labelling Pharmaceutical Companies 52

Big Molecule Watch

APRIL 29, 2025

On April 18, 2025, Regeneron Pharmaceuticals announced that the U.S. The FDA disagreed with Regenerons proposal to add additional extended dosage intervals of greater than every 16 weeks, which is the maximum dosing interval on the currently approved label. Regeneron has not yet responded to the letter.

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Dosage Diabetes Labelling 40

European Pharmaceutical Review

AUGUST 17, 2022

The second facility for WuXi STA in the US, Phase I of the new campus will provide formulation development, clinical and commercial drug product manufacturing services for a variety of oral and injectable dosage forms, as well as packaging, labelling, storage and distribution services for clinical trial materials and commercial drug products.

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Pharmaceutical Manufacturing Dosage Packaging Labelling 96

European Pharmaceutical Review

OCTOBER 31, 2023

Galapagos also agreed to pay up to €40 million by June 2025 to Alfasigma for development activities.

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Labelling 105

pharmaphorum

SEPTEMBER 21, 2022

After its US approval, analysts at Piper Sandler predicted sales would reach $500 million in 2023, and top $1 billion by 2025, while Jefferies is reckoning on peak sales of $1.5 billion or more.

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Labelling 111

Express Pharma

APRIL 9, 2025

At the recently held American Academy of Neurology (AAN) 2025 annual meeting, Axsome Therapeutics presented promising data for AXS-05 (bupropion + dextromethorphan) in treating agitation associated with Alzheimers disease (AD).

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Labelling 66

Pharmaceutical Technology

JUNE 7, 2023

Mounjaro’s approval in 2022 for T2D has already led to many prescribers providing the therapy off-label to their patients to help them lose weight. Lilly is currently in the midst of initiating a head-to-head Phase IIIb trial for Mounjaro in comparison to Wegovy, which the company expects to conclude in early 2025.

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Pharmaceutical Companies Pharmaceutical Companies Labelling Diabetes 98

The Thyroid Pharmacist

NOVEMBER 29, 2023

This is because I had learned about various adulterants found in supplements, how some supplement manufacturers don’t actually put the products that are on the label in the bottle, or that the dosages listed on the label may be completely different from what’s in the products. We have 270 expiring in March 2025.)

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Health and Personal Care Stores Immunity Immunization Labelling 81

pharmaphorum

JUNE 6, 2022

It will, however, add to BMS’ earnings potential from 2025 – when the company will start to bear the brunt of patent expiries on key drugs, including $12.8 billion product, mainly from first-line use, if it can claim FDA approval for a broad label covering any ROS1-positive cancer.

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Chemotherapy Labelling 98

Pharmaceutical Business Review

JUNE 10, 2024

A decision on the approval under the Prescription Drug User Fee Act (PDUFA) is anticipated on 25 January 2025. The sBLA is based on the modelling of observed data from a Phase II trial, Study 201, and its open-label extension (OLE) part as well as the Clarity AD study (Study 301) and its OLE study.

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Labelling 59

Big Molecule Watch

FEBRUARY 17, 2025

On February 5, 2025 Valneva SE (Valneva) announced that the United Kingdoms Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Valnevas chikungunya vaccine, IXCHIQ. IXCHIQ is currently approved for adults 18 years of age and older.

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Vaccines Immunity Immunization Labelling 45

pharmaphorum

DECEMBER 29, 2021

Dupixent’s label currently calls for dosing every two weeks for all patients. The company has put tralokinumab at the heart of plans to significantly expand its product sales, R&D pipeline and global presence by 2025. after a lead-in period of dosing every other week. billion in 2020. with #AtopicDermatitis.

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Labelling 111

The Thyroid Pharmacist

MAY 15, 2025

Accessed May 7, 2025. Accessed May 8, 2025. Published 2025 Feb 26. Ther Adv Urol. 2019;11:1756287219832172. Published 2019 May 2. doi:10.1177/1756287219832172 [2] Orenstein R, Wong ES. Urinary tract infections in adults. American Family Physician. March 1, 1999. link] Ding Y, Wang H, Pu S, Huang S, Niu S. Infect Drug Resist.

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pharmacy mentor

MAY 30, 2025

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. It’s currently in late-stage trials and could receive FDA approval in 2025, with European and UK authorisation likely to follow soon after.

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PhRMA

FEBRUARY 13, 2025

Currently, AOMs are excluded from Medicare Part D coverage and optional in state Medicaid programs, when used specifically for the treatment of obesity, because they’re labeled as “agents used for weight loss.”

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Labelling 52

European Pharmaceutical Review

MARCH 27, 2025

Equalise: making UK immigration costs competitive The UKs visa fees have been labelled as national self-harm by the House of Lords. The country could follow the lead of the EU and Nordic countries by offering alternative pathways for workers to prove their skills. Available from: [link] 2. Internet] UK Parliament.

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Pharmaceutical Companies Pharmaceutical Companies Labelling 52

pharmaphorum

SEPTEMBER 11, 2022

Analysts at Mizuho have suggested that competition from BMS’ drug could trim Otezla’s 2025 sales from $3 billion to $2 billion, although Amgen is attempting to defend its product by expanded the label of the drug to include mild psoriasis. Otezla was acquired by Amgen for $13.4

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Labelling Immunity Immunization 52

Putting Patients First Blog

APRIL 8, 2025

NHC Submits Comments on FDA Draft Guidance for AI/ML-Enabled Medical Devices (PDF) April 7, 2025 Dockets Management Staff U.S. 9 Labeling materials should describe how the technology works, its intended use, known limitations, and the circumstances under which human oversight is recommended.

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Documentation Labelling Communication 52

Big Molecule Watch

SEPTEMBER 17, 2024

WHO’s announcement added that the “vaccine may be used ‘off-label’ in infants, children and adolescents, and in pregnant and immunocompromised people.” It further added that it “could supply up to 13 million MVA-BN doses by the end of 2025, including 2 million in 2024.”

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Vaccines Labelling 49

European Pharmaceutical Review

MARCH 14, 2024

Furthermore, participants who switched from placebo to atacicept in the open-label extension had similar results at 72 weeks as those initially randomised to atacicept in the first 36 weeks. The safety profile in the open-label extension was consistent with the randomised period and with the overall population of patients with IgAN.

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Diabetes Labelling Immunity Immunization 98