Pharmaceutical Technology

JANUARY 23, 2023

in revenue across seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan) in 2018, and also was the first approved biologic therapy for LN in the US, having gained approval in 2020. in 2018 across the 7MM despite being an off-label therapy for lupus.

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Labelling Immunization Immunity 111

European Pharmaceutical Review

JANUARY 18, 2023

The first good manufacturing practice (GMP) registration of a UK pharmaceutical facility for high Δ9-tetrahydrocannabinol (THC) cannabis active pharmaceutical ingredient (API) has been granted since the legalisation of medical cannabis in 2018. The firm’s medicinal cannabis product will be supplied in oil form as an API.

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Labelling Pharmaceutical Companies Pharmaceutical Companies 119

ALiEM - Pharm Pearls

MARCH 7, 2024

Longitudinal view of the right kidney: Left – Probe placement in right mid-axillary line; Right – Unlabeled and labeled ultrasound view Video 1. Acad Emerg Med , 2018 [11] Systematic review & Meta-analysis, Multicenter, 2005 Through April 2016 N=1,773, Adults POCUS has modest diagnostic accuracy in adults for nephrolithiasis.

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Labelling Communication 177

The Guardian - Pharmaceutical Industry

DECEMBER 5, 2023

Then came Orkambi in 2015 and Symkevi in 2018 – both two-drug combinations. Kaftrio is the latest to be labelled unaffordable for a cash-strapped NHS. The drugs that have caused such a stir are made by the US biotech company Vertex. Since 2020, there has been Kaftrio, which is a triple combination. Continue reading.

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Labelling 83

pharmaphorum

AUGUST 4, 2021

The withdrawals – while voluntary – come as the FDA has been taking a closer look at accelerated approvals of cancer drugs, focusing mainly on checkpoint inhibitors that have seen new uses added to their labels at breakneck speed since being launched onto the market.

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Chemotherapy Labelling 98

pharmaphorum

MARCH 9, 2022

billion takeover of Bioverativ in 2018 – is extended in the body by fusing it with von Willebrand factor (vWF), a protein that binds to factor VIII in the blood and makes it more stable, protecting it from degradation. The half life of the new drug – one of the main draws for Sanofi’s $11.6

Labelling 98

Labelling 98

Express Pharma

JULY 28, 2024

“The results of this Phase III post-marketing commitment study are consistent with those of the pivotal Phase III study, which supported the approval of Nuzyra by the FDA in 2018 and demonstrate the drug’s continued clinical success. avium complex (MAC).

Labelling 98

Labelling 98

Express Pharma

MAY 22, 2023

The US Food and Drug Administration (FDA) has granted Fast Track designation for the drug in January 2018. This ASP-1929-301 study is currently underway in several countries such as the US and Taiwan, and will enroll 275 patients globally including Indian patients.

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Labelling Drug Development 98

European Pharmaceutical Review

JUNE 12, 2024

Since 2018, biotech company Mikrobiomik has been researching, development and producing innovative biological medicines based on the human microbiome. This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. Clin Infect Dis 2018; 66: 987–94. 2018; 66(5): 645–50.

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Documentation Labelling Hospitals 111

pharmaphorum

AUGUST 4, 2022

Keytruda has struggled to make an impact in prostate cancer, and the disease does not feature on the drug’s very long list of approved indications, despite considerable clinical testing on Merck’s part, or indeed on the label’ of other drugs in the PD-1/PD-L1 inhibitor class like Bristol-Myers Squibb’s Opdivo (nivolumab).

Chemotherapy 105

Chemotherapy Labelling 105

pharmaphorum

JUNE 11, 2021

takeover of Bioverativ in 2018, is designed to block the complement pathway of the immune response, which becomes activated in CAD. At the moment CAD is managed using off-label therapies, including rituximab and corticosteroid drugs. Sutimlimab, which Sanofi acquired via its $11.6

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Immunity Immunization Labelling 96

pharmaphorum

MARCH 16, 2022

The Belgian biotech, which was spun out from the Vrije Universiteit Brussel in 2014, is developing a pipeline of radio-labelled, single-chain antibodies led by CAM-H2, currently in a phase 1/2 study in patients with HER2-positive metastatic breast and gastric cancers.

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Labelling 59

Pharmaceutical Technology

JULY 29, 2022

While the prevalence was 1 in 150 children in 2000, it reached the rate of 1 in 44 in 2018, in the US, according to the Centers for Disease Control and Prevention. Off-label medication options. The rate at which children are being identified with autism spectrum disorder (ASD) has tripled in the past two decades.

Communication 105

Communication Labelling Hospitals 105

pharmaphorum

NOVEMBER 9, 2022

The FDA is due to deliver a decision on the marketing application in the first half of next year, with AZ going after a broad label that would include all patients aged four and over. AZ is developing PT027 with UK partner Avillion under the terms of an agreement first signed in 2018.

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Labelling 59

Big Molecule Watch

NOVEMBER 21, 2023

Genentech previously sued Sandoz on December 21, 2017 and Celltrion and Teva on January 12, 2018. Both cases were dismissed in December 2018, after the parties filed stipulations of dismissal stating that they had entered into settlement agreements.

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Biosimilars Labelling 49

pharmaphorum

JULY 8, 2021

If approved, TSLP inhibitor tezepelumab could reach the market with a broader label than currently-used asthma antibodies, which are approved to treat patient with severe asthma characterised by high levels of eosinophils – a type of white blood cell.

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Labelling 52

pharmaphorum

JANUARY 5, 2021

Main rival Keytruda however retains one advantage – a label that include the treatment of patients with low levels of the biomarker – which means that it can be used without chemotherapy in nearly all the first-line NSCLC population.

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Chemotherapy Immunity Immunization Labelling 52

European Pharmaceutical Review

OCTOBER 19, 2023

The development of novel radiotherapeutics ushered in a new era in targeted treatment 1 for cancer, with two separate radiotherapeutic approvals in Europe and the US, in 2018 and 2022. Recent advancements for radiopharmaceuticals in oncology include a $1.4

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Chemotherapy Compounding Immunization Immunity 105

pharmaphorum

MAY 25, 2022

Vtama (tapinarof) – originally developed by GlaxoSmithKline – is a first-in-class, once-daily topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA) and has been approved by the US regulator with a broad label spanning mild, moderate, and severe psoriasis and an unlimited duration of use. Otezla – which Amgen acquired for $13.4

Labelling 52

Labelling Biosimilars 52

pharmaphorum

MARCH 3, 2021

The court case stems from October 2018, when AstraZeneca began litigation against Mylan and subsequently against 3M Company (3M) asserting infringement of various US patents covering Symbicort. Symbicort was first FDA-approved in 2006 as a treatment for asthma, followed by an extension to its label covering COPD in 2009.

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Labelling 52

Pharmaceutical Technology

MARCH 7, 2023

As per one 2018 study , perimenopause is associated with an increased risk of experiencing greater symptoms of depression. However, as per the 2018 guidelines, data on estrogen plus progestin is “sparse and inconclusive”. Zulresso contains brexanolone, which is chemically identical to allopregnanolone, as per the drug’s label.

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Labelling Hospitals 52

RX Note

JUNE 9, 2023

FDA Pregnancy and Lactation Labelling Final Rule, 2015 In the past, FDA Pregnancy Categories was used in US. To address this, on 13 December 2014, the FDA published the Pregnancy and Lactation Labelling Rule” (PLLR). Labelling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.

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Labelling Adverse Reactions 52

RX Note

JUNE 8, 2023

This book received highly recommended recognition in Obstetrics and Gynaecology at the British Medical Association (BMA) Medical Book Awards in 2018 and selected as a Doody's Core Title for 2022 and 2023. In the past, package inserts were not always reliable sources of information regarding medication safety during lactation.

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Labelling Packaging 40

pharmaphorum

FEBRUARY 25, 2021

The NHS genomic medicine service, launched in 2018, is leading the drive for more personalised treatment, making genomic sequencing a routine part of diagnosis and treatment, and giving all patients the chance to participate in research. “We now know that 80% of rare diseases have a genetic origin.

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Documentation Labelling 111

pharmaphorum

DECEMBER 8, 2021

Acadia has indicated previously that most patients who completed the LAVENDER trial have entered an open-label extension, which backs up the idea that the side effects are manageable. At 12 weeks, trofinetide-treated patients had a 5.1-point point reduction in the Rett Syndrome Behaviour Questionnaire (RSBQ) scale, compared to a 1.7-point

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Labelling 59

pharmaphorum

SEPTEMBER 16, 2022

Lebrikizumab would be the second biologic Almirall has launched to market, following tildrakizumab’s commercialisation in 2018 for the treatment of moderate to severe plaque psoriasis. About the interviewee. Dr. Thyssen, MD, Ph.D.

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Medical Schools Hospitals Dosage Labelling 100

European Pharmaceutical Review

AUGUST 14, 2023

With 51 patients enrolled in open label, single arm trial, Vicore says the trial data “demonstrates that C21 has the potential to transform the treatment of IPF and restore lung function.” The disease is currently considered to be incurable and inevitably progressive.

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Labelling Immunization Immunity Pharmaceutical Companies 98

Big Molecule Watch

JANUARY 25, 2024

FDA Guidances In September 2023, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”

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Biosimilars Labelling Drug Pricing 45

RX Note

JUNE 4, 2023

Cartons or bulk containers of products/cosmetics should be adequately labelled with at least the product name, batch number and where necessary, expiry data or retest date. External Links Guideline on Good Distribution Practice, 2018 Garis Panduan Pengurusan Farmasi Logistik, 2020

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Documentation Labelling 40

Pharmaceutical Technology

NOVEMBER 30, 2022

A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients.

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Insurance Coverage and Processing Diabetes Labelling Communication 105

Pharmaceutical Technology

MARCH 6, 2023

Tuoyi received marketing authorisation in China for six oncology indications, including NPC, in December 2018. Keytruda has a HNSCC-wide label in combination with platinum and fluorouracil in the first-line setting and is sometimes used in patients with NPC.

Chemotherapy 52

Chemotherapy Labelling Immunity Immunization 52

pharmaphorum

FEBRUARY 2, 2022

Sales of Ruconest have held up fairly well, despite the FDA rejecting a bid to expand its label to include prevention of HAE attacks in 2018, bringing in $146 million in sales in the first nine months of 2021. For comparison, Takeda reported sales of around $415 million in the first six months of the 2021-22 fiscal year.

Immunity 52

Immunity Immunization Labelling 52

pharmaphorum

OCTOBER 12, 2021

Alnylam has been a pioneer in hereditary ATTR amyloidosis, getting approval in 2018 for the first drug to treat the rare disease, and has now launched a digital companion to help patients track their symptoms. Vutrisiran is under regulatory review in Europe and the US, with decisions due in 2022.

Labelling 52

Labelling 52

pharmaphorum

APRIL 23, 2021

While some argued that GSK overpaid for Tesaro in 2018, at least the deal is bringing badly needed new drugs to market for the under-pressure UK pharma and its highly-paid research chief Hal Barron.

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Chemotherapy Labelling Drug Development 52

pharmaphorum

AUGUST 23, 2020

Those results came from an open-label portion of the trial, however, and at the time Novartis said the results couldn’t be considered conclusive. Results released in 2018 showed some signs of efficacy, but also failed to reach statistical significance and on the basis of overall response rates the triple did worse than Tafinlar/Mekinist.

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Labelling 52

RX Note

OCTOBER 5, 2023

Meanwhile, an unnecessary health risk is created in the home whereby the patient or family members may accidentally consume expired medicines or wrong drug (due to unclear or damaged labels). Failure to discard medications properly may also contaminate the environment through poor disposal either via trash or sewer system.

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Medication Dispensing Community Pharmacies Hospitals Labelling 40

RX Note

MARCH 10, 2023

Introduction In August 2018, I started a self-initiative drug database project, named "Rx". Uses and off-label use (with recommended dosage) Oral medication administration Advice to patients and Essential points, such as adverse drug reaction and role in therapy. The information is organised in following sequence (where appropriate).

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Community Pharmacies Hospitals Dosage Labelling 52