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

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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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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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 130

Hospital Pharmacy Europe

JANUARY 4, 2024

And it warned prescribers not to prescribe GLP-1 RAs licensed for type 2 diabetes for off-label indications. In July, Novo Nordisk – the manufacturer of several GLP-1 RAs such as liraglutide and semaglutide – said it envisaged intermittent supply until 2025, despite running factories 24/7 to increase production.

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The Checkup by Singlecare

MARCH 10, 2025

If your healthcare provider prescribes Ozempic for weight management, which is an off-label use, insurance isnt as likely to cover it. Restrictions on off-label use: Insurance plans may not cover a medication prescribed off-label , that is, if its not prescribed for its FDA-approved use. affected by a shortage).

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The FDA Law Blog

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. Final Guidance at 2.

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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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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

The Checkup by Singlecare

MARCH 31, 2025

It is also often prescribed off-label as a weight loss medication, even in patients with normal blood sugars. For example, its not listed as a side effect in the FDAs 2025 prescribing information. Ozempic is a type of medication called a glucagon-like peptide-1 agonist (GLP-1) and is only given by injection.

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pharmaphorum

OCTOBER 26, 2022

The drug was highlighted at Boehringer’s R&D update earlier this year as one of the most promising candidates among 15 new medicines it plans to bring to market by 2025, fuelled by a €25 billion R&D spend. billion a 25% gain in the prior year and fuelled in part by extensions to its label to include other progressive ILDs.

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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 FDA 111

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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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

The Thyroid Pharmacist

MARCH 7, 2025

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 16] Even more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! From indoor pollutants like formaldehyde (yes, really!),

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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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The Checkup by Singlecare

NOVEMBER 3, 2023

The 2020–2025 Dietary Guidelines for Americans recommend that Americans limit the amount of sugar they consume to less than 10% of their daily intake of calories. Read food labels carefully. When buying packaged foods, carefully scan the label and look for added sugars. Experts suggest restricting your intake of added sugars.

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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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The Checkup by Singlecare

JULY 2, 2024

One common side effect of Mounjaro is weight loss, which is why it may sometimes be prescribed off-label (for a non-FDA-approved use) for that purpose. But in 2025, people who have Part D will not have to pay more than $2,000 in out-of-pocket costs. This is thanks to a provision in the Inflation Reduction Act of 2022.

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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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The FDA Law Blog

JULY 7, 2024

The first phaseout milestone is less than a year away; by May 6, 2025 most laboratories will need to demonstrate compliance with Medical Device Reporting (21 C.F.R. § 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R. report certain device malfunctions, and.

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The FDA Law Blog

OCTOBER 5, 2022

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. It is focused on the nutrients in the food product rather than on it overall nutritional “quality.”.

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The FDA Law Blog

OCTOBER 24, 2022

The Federal Register notice states that the Advancing RWE Program “seeks to identify approaches for generating RWE that meet the regulatory requirements in support of labeling for effectiveness ( e.g. , new indications, populations, dosing information) or for meeting post-approval study requirements.”

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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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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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Labelling Immunization FDA 98

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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Hospital Pharmacy Europe

MARCH 13, 2025

Patient safety spotlight: the risks of overprescribing Salbutamol inhalers for asthma [Accessed February 2025]. Accessed February 2025]. Accessed February 2025]. Accessed February 2025]. Accessed February 2025]. Accessed February 2025]. Accessed February 2025]. Accessed February 2025].

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European Pharmaceutical Review

JUNE 12, 2024

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. The study included 92 adult patients with confirmed CDI. Overall, MBK-01 has potential to be an effective, easy-to-administer, low-risk treatment for CDI. References van Prehn J, Reigadas E, Vogelzang EH, et al.

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Hospital Pharmacy Europe

FEBRUARY 20, 2025

They suggested that pharmacy-specific interventions should include targeted messaging and informative displays at the point of care, clearer labelling on medications to highlight their environmental impact and better access to pharmacy return schemes for unwanted medicines. 2025 Jan 20;15(1):e088066. doi: 10.1136/bmjopen-2024-088066.

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pharmaphorum

AUGUST 9, 2022

Tagrisso meanwhile has been FDA-approved as a second-line treatment for EGFR T790M mutation-positive NSCLC since 2015, with its label extended since then to include first-line and adjuvant treatment. It is AZ’s biggest-selling drug, with sales topping $5 billion last year.

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The FDA Law Blog

JULY 6, 2023

In fact, the priority designation for the final rule is labeled as “economically significant.” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), during his remarks at the annual Food Drug and Law Institute (FDLI) conference in May 2023.

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Pharmaceutical Technology

APRIL 21, 2023

While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. The recent setback dents mirikizumab’s chances to be the first among the IL-23 inhibitors to launch in the US for UC.

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pharmaphorum

NOVEMBER 30, 2021

Mizuho’s Salim Syed has previously said that competition from BMS’ drug could trim Otezla’s 2025 sales from $3 billion to $2 billion. Sales of PDE4 inhibitor Otezla grew 13% in the third quarter to $609 million, but analysts have suggested it will come under pressure from deucravacitinib if approved.

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The Checkup by Singlecare

MARCH 21, 2024

The Jardiance drug label lists various warnings about the drug, and certain populations should take it with close oversight from a healthcare professional or avoid taking it altogether. Although there is no generic version of Jardiance available currently, there may be as early as 2025.

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The Checkup by Singlecare

FEBRUARY 10, 2025

As of January 2025, only the Prasco version of dapagliflozin is available in pharmacies. In addition to FDA -approved uses, healthcare providers sometimes prescribe medications for off-label (non- FDA -approved) uses. What are the differences between brand name and generic Farxiga ?

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The FDA Law Blog

OCTOBER 24, 2023

Structure of the eSTAR for De Novos The draft guidance provides a table that offers a high-level overview of the structure of the eSTAR for De Novos, including elements such as the cover letter, device description, proposed indications for use, classification, benefits, risks, mitigation measures, labeling, and supporting data.

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The FDA Law Blog

SEPTEMBER 22, 2024

Stage 1 is scheduled to take effect on May 6, 2025. FDA plans to hold its next webinar on September 24, 2024, which will cover the labeling requirements that go into effect in Stage 2. See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion.

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