Pharmacy Times

JUNE 20, 2025

There are too many drug approvals, label updates, and new data published for even the most skilled and experienced oncology pharmacist to keep up with, let alone those still building their baseline knowledge. December 13, 2018. Oncology pharmacy practice changes at a rapid pace. American Oncology Network. August 8, 2024. Desimone R.

Pharmacy Technician

Pharmaceutical Commerce

JULY 16, 2025

This has driven a staggering surge in prescriptions, with some reports indicating growth of over 5,000% since 2018 in the United States. Existing policies often feature explicit exclusions for non-FDA approved products or harm from off-label use.

Compounding

BioPharma Dive

JULY 16, 2025

On Wednesday, Sarepta shared that the FDA is adding a black box warning about the risk of liver failure or injury to Elevidys’ label, which Sarepta said should resolve any agency concerns with the therapy’s use in that group. Track how they’re performing. By Ben Fidler and Gwendolyn Wu • Updated June 19, 2025 Keep up with the story.

Drug Pricing

RX Note

DECEMBER 25, 2024

Strategies for sodium reduction include Make reading food labels a habit. The KDIGO guidelines recommend a sodium intake of <2 g (90 mmol/day) for patients with chronic kidney disease not on dialysis. When available, buy low-sodium, reduced-sodium or no-sodium versions of foods (e.g. breakfast cereals, canned or frozen foods).

Community Pharmacies

pharmaphorum

JULY 7, 2025

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Insurance Coverage and Processing

pharmaphorum

JULY 2, 2025

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Diabetes

pharmaphorum

JULY 7, 2025

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Diabetes

pharmaphorum

JUNE 30, 2025

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Vaccines

InCrowd

JULY 16, 2025

I developed an interest in rare diseases due to the academic stimulation of learning something new, which prompted me to study young lung cancer, a rare condition back in 2018, but now a more common phenomenon. I learned firsthand how the healthcare system labels women as anxious almost immediately.

Labelling

STAT

NOVEMBER 30, 2023

Even before the Covid pandemic, a 2018 paper reported that new genetic tests, many of them for increasingly rare conditions, were being released at the rate of 10 a day. You can now avail yourself of noninvasive diagnostics that claim to screen for rare birth defects, cancer-associated mutations, and even Alzheimer’s.

Labelling

BioPharma Dive

SEPTEMBER 6, 2024

New trial results could offer support for an expansion of Nucala’s label after U.S. regulators rejected GSK’s submission in 2018.

Labelling

PharmaShots

JUNE 13, 2023

Eisai's and Merck Announces EU's Marketing Approval of Lenvima (lenvatinib mesylate) for Hepatocellular Carcinoma Published: 23 Aug,2018 | Tags: Eisai, Merck, Approval, Lenvima, HCC, 2. Pfizer to co-promote Exact Sciences Cologuard Published: 22 Aug,2018 | Tags: Exact, Pfizer, Agreement, Promote, Cologuard 7.

Labelling

Big Molecule Watch

SEPTEMBER 25, 2023

Last week, 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.” The fictitious example provided in the 2023 Draft Guidance is “replicamab-cznm.”

Labelling

pharmaphorum

NOVEMBER 27, 2020

The new EU approval comes after the FDA approved the expanded label last year, and provides the first treatment option that tackles the underlying cause of CF in patients aged six to 11 with these mutations. Together these drugs cover the CFTR mutations seen in around half of all CF patients.

Labelling

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.

Labelling

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.

Labelling

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.

Labelling

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.

Labelling

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.

Chemotherapy

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

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

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.

Labelling

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

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

Immunity

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.

Documentation

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

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.

Labelling

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.

Labelling

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.

Biosimilars

BioPharma Dive

JULY 22, 2025

Vicebio was formed by European life sciences investment firm Medicxi in 2018. IPO activity has been depressed for years now, but the first half of the year brought only seven pricings, the lowest total BioPharma Dive has tracked since 2018 for the period. The University of Queensland remains an investor. Track how they’re performing.

Vaccines

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

Chemotherapy

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.

Labelling

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.

Chemotherapy

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

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.

Labelling

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.

Labelling

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.

Documentation