pharmaphorum

JUNE 6, 2023

ASCO: Enhertu data sets up tumour-agnostic label bid Phil.Taylor Tue, 06/06/2023 - 08:26 Bookmark this

Labelling 97

Labelling 97

Drug Store News

JULY 6, 2023

Several beauty trends will be revealed at PLMA’s 2023 annual Private Label Trade Show, Nov. 12-14 in Chicago.

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Labelling 98

Fierce Pharma

MAY 15, 2023

UPDATED: After Supreme Court rejection, Teva mulls options in GSK 'skinny label' feud fkansteiner Mon, 05/15/2023 - 10:59

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Labelling 92

Fierce Pharma

JANUARY 4, 2023

Particulates, label issues prompt separate recalls for Pfizer's Hospira and Accord. Wed, 01/04/2023 - 11:35.

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Labelling 87

Drug Store News

MARCH 23, 2023

The award recognizes the men and women who have significantly contributed to the growth and development of the global private brand industry.

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Labelling 98

Pharmaceutical Technology

MARCH 22, 2023

In the US Drug Quality and Security Act (DSCSA), the FDA mandates that manufacturers and trading partners should have full interoperable electronic track and trace systems in place by November 2023. RFID is an important facet of smart labelling and its evolution, but not the only one.

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Labelling Data Entry Communication FDA 105

Fierce Pharma

MARCH 20, 2023

Novo Nordisk, Eli Lilly replenish Type 2 diabetes stars Ozempic, Mounjaro after off-label weight-loss boom fkansteiner Mon, 03/20/2023 - 10:09

Labelling 87

Labelling 87

NF2 BioSolutions

JANUARY 4, 2023

Print our cake labels, bunting and flyers to make your event a great success. The post 2023 Fundraising Challenges appeared first on NF2 BioSolutions. You can set up a personal fundraiser on Peoples fundraising or simply choose the existing NBS UK fundraiser. Buy, bake or ask for donations of cakes.

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Labelling 96

Pharmacy Times

MAY 13, 2024

Antihemophilic factor (recombinant) Fc-VWF-XTEN fusion protein-ehtl was initally approved in February 2023 for adults and children with hemophilia A for prophylaxis and on-demand treatment to control bleeding.

Labelling 115

Labelling FDA 115

OctariusRx

AUGUST 28, 2023

The 2023 version of the OctariusRx medication safety quiz is about to be released. What does the Medication Safety Quiz 2023 cover and how do you get one? The quiz focuses on some of the most commonly encountered situations, including allergies, labeling medications and controlled substances. How are you assessing your staff?

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Controlled Substances Labelling 88

The Checkup by Singlecare

DECEMBER 6, 2023

In 2023, the top medications with SingleCare customers included vitamin D supplements, inhalers, and anti-inflammatory drugs. It’s also often prescribed off-label—that is, for a use other than what it’s been approved for—as a treatment for fibromyalgia. Read on to see if any of your prescriptions made the list. Levothyroxine 1.

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Dosage Prescription Filling Labelling 105

Fierce Pharma

MARCH 31, 2023

In Teva vs. GSK skinny label feud, Biden admin urges Supreme Court to weigh in fkansteiner Fri, 03/31/2023 - 09:11

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Labelling 65

The FDA Law Blog

DECEMBER 8, 2022

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g.,

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Documentation Labelling FDA Packaging 59

European Pharmaceutical Review

OCTOBER 24, 2023

Europe’s pharmaceutical packaging and labelling market is projected to reach $35.78 billion in 2022, the pharmaceutical packaging and labelling market in Europe is expected to expand at a compound annual growth rate (CAGR) of 4.78 percent between the forecast period: 2023 and 2028. percent between the forecast period 2023-2028.

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Packaging Compounding Labelling Pharmaceutical Companies 118

European Pharmaceutical Review

AUGUST 30, 2023

The Windsor Framework, announced on 9 June 2023 by the Medicines and Healthcare products Regulatory Agency (MHRA), provides a long-term solution for the supply of medicines into Northern Ireland. The agreement stipulates that certain conditions must be met in the labelling and packaging of these medicinal products.

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Packaging Labelling 105

Pharmaceutical Technology

DECEMBER 4, 2022

Humira is indicated for 10 adult and pediatric conditions, including Crohn’s disease, rheumatoid arthritis, and ulcerative colitis, as per its label. Indeed, Amgen’s biosimilar was approved in September 2016, but the company was not able to launch it until January 2023 in the US. Temporary first-to-market advantage.

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Labelling Communication Hospitals FDA 104

Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration. The FDA’s approval was granted in January 2020.

Labelling 52

Labelling FDA 52

Fierce Pharma

FEBRUARY 2, 2023

Merck's recent Keytruda label expansion in NSCLC is more of a 'long-term' opportunity, CEO says kdunleavy Thu, 02/02/2023 - 10:43

Labelling 52

Labelling 52

Hospital Pharmacy Europe

MARCH 26, 2024

It is likely to be safe for penicillin allergy labels (PALs) to be removed for most patients, a study from the University of Birmingham has found. Some 97% of participants labelled with PALs were shown to have no allergy. However, a large body of evidence suggests that 90-95% of PALs are inaccurate.

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Labelling Hospitals 52

The Checkup by Singlecare

DECEMBER 6, 2023

In 2023, medications like Ozempic , Mounjaro , and Wegovy soared in popularity—so much so that many pharmacies faced a shortage. Read on to see what readers cared about the most in 2023. Whether you’re taking Ozempic for diabetes or off-label for weight loss, you might be curious if it’s safe to mix it with alcohol.

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Labelling Hospitals FDA 81

Fierce Pharma

FEBRUARY 6, 2024

billion in sales, bringing its 2023 haul to $8.9 On a day when Vertex revealed trial data that indicate | On a day when Vertex revealed trial data that indicate its next-generation cystic fibrosis (CF) treatment will soon be ready to grab the baton, the Boston company also presented figures that show Trikafta remains formidable.

Labelling 75

Labelling 75

European Pharmaceutical Review

JULY 4, 2023

The International Organization for Standardization (ISO) has published its new standard Sterilization of health care products — Microbiological methods — Part 3 Bacterial endotoxin testing ( ISO 11737-3:2023). This includes products that must be non-pyrogenic based on either intended use or non-pyrogenic label claim, or both.

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Documentation Labelling 111

pharmaphorum

MAY 10, 2021

billion doses through 2023. Happy to announce that @EU_Commission has just approved a contract for guaranteed 900 million doses (+900 million options) with @BioNTech_Group @Pfizer for 2021-2023. The meeting did however recommend a change to the label for Comirnaty to include a risk of facial swelling with the jab.

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Vaccines Labelling Immunization 122

The FDA Law Blog

JANUARY 2, 2023

Labeling in the drug and biologics approval process. FDA Boot Camp is taking place virtually from March 22-23, 2023, visit [link] to learn more! Clinical trials for drugs and biologics. cGMPs and other manufacturing concerns relative to products liability. Proactive adverse events monitoring and signal detection.

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FDA Labelling 59

STAT

JANUARY 25, 2024

 One person also experienced hypoglycemia in 2023 after injecting a compounded version of Ozempic, said the organization, which represents 55 regional poison centers across the country and works with the U.S. Ozempic and similar diabetes medicines have been increasingly used off label for weight loss.

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Labelling Compounding FDA 107

Pharmaceutical Technology

APRIL 17, 2023

On 14 April 2023, experts from the US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) voted largely in favour of the potential approval of Otsuka’ s and Lundbeck Pharmaceuticals’ Rexulti for the treatment of agitation associated with Alzheimer’s dementia (AAD). Rexulti is an atypical antipsychotic.

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FDA Medical Schools Labelling Communication 96

BioPharm

OCTOBER 3, 2023

The new customized system is designed for fully automated and integrated labeling, orientation, and palletization, and it is expected to streamline the current manual processes, according to the press release.

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Packaging Labelling 52

Pharmaceutical Technology

APRIL 28, 2023

Novo Nordisk’s leading drug Ozempic (semaglutide) is forecast to demonstrate a sales growth of 23% in 2023. Ozempic’s forecast 2023 sales of $12.5bn consolidate its position as the dominant market leader, with projected sales in 2023 54% greater than closest competitor Trulicity (dulaglutide) by Eli Lilly, which anticipates sales of $8bn.

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Compounding Dosage Labelling FDA 52

Hospital Pharmacy Europe

JANUARY 4, 2024

The alert supersedes previous guidance issued in July 2023 instructing prescribers not to initiate any new patients on GLP-1 RAs for the duration of the shortage, which was then predicted to continue until at least mid-2024. And it warned prescribers not to prescribe GLP-1 RAs licensed for type 2 diabetes for off-label indications.

Labelling 105

Labelling Hospitals 105

Pharmaceutical Technology

DECEMBER 11, 2023

Novartis is seeking approval for Kisqali as a treatment of early breast cancer, with an FDA application planned by the end of 2023.

Labelling 52

Labelling FDA 52

The Checkup by Singlecare

DECEMBER 1, 2023

Department of Agriculture (USDA) requires it to be labeled “farmed” or” wild-caught.” Check the nutrition facts label to find the amount of vitamin D and other nutrients contained in individual products. As of January 2023, an increase of up to 560 IU of vitamin D per 100 g of cereal is allowed. mcg or 100–144 IU per cup.

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Labelling Mayo Clinic FDA Immunization 93

European Pharmaceutical Review

OCTOBER 19, 2023

According to the European Medicines Agency (EMA), pre-filled pens falsely labelled as the type 2 diabetes medicine Ozempic ( semaglutide , 1mg, solution for injection) have been identified at wholesalers in the EU and the UK. The pens, with labels in German, originated from wholesalers in Austria and Germany.

Labelling 105

Labelling 105

European Pharmaceutical Review

MARCH 8, 2023

A placebo-controlled, Phase IIa, proof-of-concept, social anxiety clinical trial is expected to begin in the first half of 2023. The results are anticipated by the end of 2023. An open-label, Phase IIa, proof-of-concept clinical trial in women with PPD is expected to initiate in the second half of 2023.

Labelling 98

Labelling 98

European Pharmaceutical Review

OCTOBER 18, 2023

Further to the three Phase III trials for XPHOZAH, Ardelyx also declared that it has completed two open-label clinical trials (OPTIMIZE and NORMALIZE) to evaluate different options for integrating the treatment into clinical practice. XPHOZAH is expected to be available to eligible patients in the US in November 2023.

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FDA Adverse Reactions Labelling 119

PharmaShots

MAY 25, 2023

AbbVie’s Rinvoq (upadacitinib) Receives EC’s Approval for the Treatment of Moderately to Severely Active Crohn's Disease Rinvoq Active ingredient: upadacitinib Approved: April 17, 2023 Company: AbbVie Disease: Active Crohn's Disease The approval was based on 3 P-III trials incl. (U-EXCEED and (15 & 30mg) @52wks.

Labelling 56

Labelling FDA 56

European Pharmaceutical Review

APRIL 19, 2023

percent from 2023, according to the data. This is driving the adoption of item-level smart labelling , the report noted. A market report has identified that global demand for electronic smart packaging will reach $2.6 billion in 2033. This represents a compound annual growth rate (CAGR) of 15.4

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Packaging Labelling Compounding 97

PharmaShots

APRIL 5, 2023

The results are expected at the end of 2023 Additionally, MiGenTra and Minapharm will be sharing responsibilities to file, launch and commercialize Adessia in Africa and the Middle East. The company's main goal is to advance the most diverse pipelines in neuroscience, which will revolutionize patient care in a no.

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FDA Packaging Labelling Patient Care 49