pharmaphorum

MARCH 1, 2021

In the latest of a suite of features looking at the biggest markets in Europe, Leela Barham takes stock of what 2021 could bring for market access in France. Compassionate access is for off-label treatments that aren’t in development for an indication. Yet there are still challenges to be worked through in 2021.

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Labelling 78

Pharmaceutical Technology

APRIL 11, 2023

This label expansion makes Orkambi the only disease-modifying CF medication available to patients of this age in Canada. This label expansion follows a similar label change in the US in September 2022. Health Canada is granting this new label expansion based on recent results from a Phase III study.

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Labelling Communication 98

Express Pharma

MARCH 20, 2025

Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Lancet 2021; 398(10295): 143-155. Abstract 100-OR. Rosenstock, J, et. 2021;398(10295):143-155. 2021;398(10300):583-598.

Diabetes 101

Diabetes Labelling Communication 101

Pharmaceutical Business Review

JULY 11, 2023

The label update reinforces the safety and effectiveness data of Leqvio generated by the VictORION clinical trial programme, claimed the company. Leqvio was initially approved by the FDA in December 2021. Among the other updates to the label include the removal of the Limitations of Use statement.

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Labelling 75

Eye on FDA

JULY 19, 2021

But here is what we see looking at the first 6 months 2021, and comparing it to mid-years past. It has been a regular feature of the blog to give a read on what FDA has been talking about, at least through the form of press releases. Of the 153, only 33 of them were translated into Spanish.

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Labelling Communication Vaccines 93

pharmaphorum

APRIL 28, 2021

exploring ‘validation ready’ global labeling systems . ? . A group of industry experts is set to explore how medical device, clinical trial and pharmaceutical companies can proactively manage labeling risk. The post Experts to come together for compliance event ‘validation ready’ global labeling systems appeared first on.

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Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

Express Pharma

JANUARY 17, 2025

In addition, the nutra market boom in APAC that began during the COVID-19 pandemic continues to accelerate looking for green-label, plant-based capsules for encapsulation. We also see a growing emphasis on sustainable practices in manufacturing and packaging, aligning with global trends in reducing carbon footprint and waste.

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Labelling Packaging 104

pharmaphorum

FEBRUARY 4, 2021

It comes as PRISYM ID announces five new business wins for the start of 2021, with new accounts spanning clinical trials, pharmaceutical and medical device sectors and with significant growth of the company’s flagship PRISYM 360 platform in the Cloud.

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Labelling 52

pharmaphorum

JANUARY 12, 2021

Boehringer and Lilly are waiting for the results of the EMPEROR-Preserved later in 2021, while AZ should also Farxiga in the DELIVER trial in HFpEF, with additional data on both HFrEF and HFpEF due from the DETERMINE study, before year-end.

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Labelling Diabetes 76

RX Note

JULY 29, 2023

In fact, off-label drug uses can become widely entrenched in clinical practice and become predominant treatments for a given clinical condition. In a study published in JAMA Internal Medicine , off-label use lacking strong scientific evidence had a higher adverse drug event rate compared with on-label use.

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Labelling Dosage Immunization Immunity 40

pharmaphorum

SEPTEMBER 23, 2022

The full approval also extends the Retevmo label to include patients with locally advanced as well as metastatic disease. ” Sales of Retevmo have been gathering momentum since its first approval in 2020, coming in at $87 million in the first half of the year, double the same period of 2021.

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Labelling 59

European Pharmaceutical Review

JANUARY 16, 2023

Rykindo ® was approved for marketing in China in 2021 for the treatment of schizophrenia. An open-label pharmacokinetic and safety study of LY03004 evaluated an escalating single intramuscular injection in stable patients with schizophrenia or schizoaffective disorder. Clinical trials of the FDA approved Rykindo ®.

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Labelling Drug Development 122

Safe Biologics

DECEMBER 19, 2023

The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. On November 17th, ASBM submitted comments to the Food and Drug Administration (FDA) on draft guidance released in September by the FDA.

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Biosimilars Labelling Packaging 100

Pharma in Brief

JANUARY 9, 2022

In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2021. In 2021, governments advanced major policy initiatives aimed at the COVID-19 pandemic and broader health priorities. The courts also had a busy year in 2021. Introduction. c) Other policy developments.

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Documentation Labelling Vaccines Packaging 52

pharmaphorum

MAY 10, 2021

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. — Ursula von der Leyen (@vonderleyen) May 8, 2021. Other contracts and other vaccine technologies will follow.

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Vaccines Labelling Immunization Immunity 122

Pharmaceutical Technology

JANUARY 23, 2023

However, the 2021 approval of AstraZeneca’s Saphnelo in the US will mean increasing competition for Benlysta in the coming years. Furthermore, similar to GSK’s strategy with Benlysta, AstraZeneca initiated the Phase III TULIP subcutaneous (SC) trial in SLE using subcutaneous delivery of Saphnelo in June 2021.

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Labelling Immunization Immunity 111

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. All labeler codes that are covered by Discount Program agreements will be distributed to PDP sponsors and posted on the CMS website. of the total expenditures for all Part D drugs in 2021.

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Labelling Drug Pricing Compounding Payment Processing 105

European Pharmaceutical Review

NOVEMBER 22, 2022

The application is supported by results from the LBCL cohort of the EPCORE NHL-1 open-label, multi-centre Phase I/II trial evaluating the safety and preliminary efficacy of epcoritamab in adults with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL). EPCORE NHL-1 Trial of epcoritamab .

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Labelling 98

FDA Law Blog: Biosimilars

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. Part 117, and the Food Allergy Safety, Treatment, Education and Research Act (2021).

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Labelling 45

Eye on FDA

JANUARY 9, 2022

In that respect, 2021 was not a banner year. One of them involved the more serious Warning Letter action, possibly because the product associated with that communication had a Boxed Warning in its label. The Numbers: Looking first at the quantity of enforcement, the numbers were low.

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Communication Documentation Labelling Pharmaceutical Companies 64

European Pharmaceutical Review

FEBRUARY 8, 2023

Research from data and analytics company GlobalData shows that the use of CD19 chimeric antigen receptor T-cell (CAR-T) agents for blood cancer is set to significantly increase between 2021-2031. GlobalData predicts Bristol-Myers Squibb’s Breyanzi and Gilead’s Yescarta are set to have high annual sales in the forecast period.

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. A recent state law failure-to-warn case in the SDNY makes that very point.

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Labelling Vaccines Communication 40

Pharma Marketing Network

APRIL 15, 2021

Download this infographic and learn which 6 digital tools are at the center of digitalization and how the will influence the future of Pharma marketing in 2021 and beyond. Company Email *.

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Labelling 98

Pharmaceutical Technology

MAY 12, 2023

According to the FDA update, current labels for these drugs do not have up-to-date warnings about the risks of drug misuse and abuse and fail to mention that most individuals who misuse prescription stimulants source drugs from other family members or peers. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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Labelling Patient Counseling Communication 59

Express Pharma

FEBRUARY 10, 2025

Rezurock was approved by the United States Food and Drug Administration (US FDA) in 2021 and by the Central Drugs Standard Control Organisation (CDSCO) in India in 2024.

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Labelling 52

Express Pharma

NOVEMBER 8, 2023

Due to their novel mechanisms of action, and positive efficacy and safety profiles, these therapies are expected to improve treatment rates and drive growth within the class II-V MG market*, especially within the treatment refractory segment, in which patients fail to respond to two or more off-label treatments.

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Labelling Compounding 105

European Pharmaceutical Review

NOVEMBER 10, 2022

Medicines Discovery Catapult (MDC) released a report 2 on complex medicines in 2021, proposing narrowing the definition to: ‘medicines requiring the application of novel technologies for their delivery and targeting of drugs, through the modification of an active pharmaceutical ingredient (API) or formulation, or a novel delivery route’.

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Pharma in Brief

MARCH 18, 2021

Health Canada is seeking input from industry stakeholders on a new draft guidance document that discusses the use of electronic media in prescription drug labelling. Consultation on the draft guidance document is open until May 7, 2021. Consultation on the draft guidance document is open until May 7, 2021. Background and scope.

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Labelling Documentation Packaging 40

European Pharmaceutical Review

JANUARY 18, 2023

In 2021, Peter Kohut, Director of Drug Safety at Arriello shared with EPR how European medical cannabis market lacks a common regulatory framework. “… there is a lack of standardisation in the manufacturing of medical cannabis products , their ingredients and labelling.”.

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Labelling Pharmaceutical Companies Pharmaceutical Companies 119

Pharmaceutical Technology

JULY 20, 2022

While the label expansion will likely increase avenues for patients to access the antiviral, Ganio adds one caveat: due to burnout and turnover seen across the healthcare field, including pharmacy staff, there are going to be sites that just don't have the resources to dedicate a pharmacist to do some of this work.

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Labelling Community Pharmacies Medical Records Communication 111

pharmaphorum

JANUARY 3, 2023

The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more than six months. in the evenamide group.

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Labelling Drug Development 105

Safe Biologics

DECEMBER 3, 2023

The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. A 2021 survey of 401 U.S state law, only interchangeable biosimilars may be substituted by a pharmacist without contacting the prescriber. It is also opposed by the majority of physicians, in the U.S.

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Biosimilars Labelling Drug Pricing Packaging 130

Pharma in Brief

DECEMBER 3, 2020

continue to exclude COVID-19 drugs from brand-name assessments, including a look-alike/sound-alike assessment and labeling mock-ups, at the time of submitting an NDS. This interim order will expire on March 18, 2021 as will any device authorizations issued under the interim order.

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Vaccines Labelling Biosimilars Packaging 98

pharmaphorum

SEPTEMBER 2, 2020

These include handling of decentralised and mutual recognition procedures, how variations to labels will be handled and new assessment routes from 1 January. Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. “If

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Documentation Labelling 124

Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. The amendments contemplate labelling flexibilities for special containers. Public Comments.

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Labelling Packaging Biosimilars 98

European Pharmaceutical Review

NOVEMBER 1, 2022

The Phase III open-label, randomised trial ( NCT03682536 ) evaluated the efficacy and safety of Reblozyl versus epoetin alfa. in November 2021. The primary endpoint assessed in this study was RBC-TI for 12 weeks, with a mean haemoglobin increase ? The company will also discuss results with health authorities.

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Labelling 105

Drug Channels

OCTOBER 3, 2023

CVS Health launched Cordavis, a new subsidiary that will market a private label, low-list-price version of Sandoz’ Hyrimoz. Boehringer-Ingelheim launched an unbranded, low WAC version of its interchangeable biosimilar. The Humira biosimilar market has arrived! This month, nine biosimilar versions of adalimumab launched in the U.S.

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Biosimilars Drug Pricing Labelling 98