Pharmaceutical Technology

MAY 2, 2023

The pharmaceutical industry is constantly striving for better, cleaner, safer manufacturing, especially when it comes to injectable medicines. Datwyler is a leading provider of parenteral packaging components and is helping the industry put quality first through the invention of the FirstLine® manufacturing standard.

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Pharmaceutical Technology

APRIL 3, 2023

Hyrimoz has been approved for use in all the indications covered by the reference medicine Humira, including plaque psoriasis, rheumatic diseases, ulcerative colitis, Crohn’s disease, uveitis and hidradenitis suppurativa. Its reference medicine, Humira, initially received approval with an adalimumab 50 mg/mL concentration.

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Pharma Packaging Solutions

OCTOBER 29, 2024

As a premier provider of medical device packaging solutions, we recognize the prime importance of adhering to global regulations while creating packaging solutions that protect both products and patients. Essential Packaging Requirements Examining the arena of packaging requirements reveals many considerations.

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XTalks

DECEMBER 14, 2020

AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. According to AvKARE, the error occurred at a third-party bottle filling facility.

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Pharma Packaging Solutions

AUGUST 2, 2022

If you have ever taken any kind of medication, be it prescription or over the counter (and you almost certainly have), then you’re probably familiar with blister packaging. Blister packaging is extremely common in the pharmaceutical industry, thanks to its many benefits. Another benefit of blister packaging is convenience.

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Pharmaceutical Technology

JULY 26, 2022

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) of Novartis subsidiary Sandoz for natalizumab, a proposed first-ever multiple sclerosis (MS) biosimilar to reference medicine Tysabri. A complete analytical, preclinical and clinical data package is part of the BLA and MAA submissions.

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Medical Xpress

APRIL 5, 2023

There's no package insert listing ingredients or dosage instructions. What if you've just tried to treat your headache with counterfeit medicine? So you buy painkillers from the street vendor, and take two. But how do you know what those pills really are? The vendor isn't a pharmacy.

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Medical Xpress

DECEMBER 30, 2022

Ira Katz bustles at his pharmacy in Atlanta's Little Five Points neighborhood this cough season, serving patients who need medicine for respiratory viruses like COVID-19. He dispenses occasional packages of Paxlovid, a drug designed to nip COVID in the bud. But there aren't as many of those Paxlovid prescriptions as there might be.

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Pharma Packaging Solutions

SEPTEMBER 15, 2022

Pharmaceutical packaging companies play a critical role in the pharmaceutical industry. Thus, choosing a packaging company to partner with is a very important decision. When evaluating a pharmaceutical packaging company, your first order of business should be determining whether it has the capabilities to meet your specific needs.

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Pharmaceutical Technology

JANUARY 31, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for Sandoz’s citrate-free high-concentration formulation (HCF) of Hyrimoz (adalimumab) biosimilar.

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Scienmag

FEBRUARY 7, 2021

Disconnects between the front labels and ingredient lists of packaging containing fruits and vegetables make it more difficult for parents to understand what kind of food they are buying for their children, according to the Journal of Nutrition Education Credit: Journal of Nutrition Education and Behavior Philadelphia, February 8, 2021 – Early (..)

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Scienmag

MARCH 9, 2022

RIVERSIDE, Calif. — Each simple RNA virus has a genome, its “native RNA.” This genome dictates how the virus replicates in cells to eventually cause disease. The genome also has the code for making a capsid, the protein shell of a virus that encapsulates the genome and protects it like a nanocontainer. Credit: Zandi lab, […].

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical wholesalers act as intermediaries between pharmaceutical manufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. Worldwide sourcing and drop-ship of orphan medicines, and. GDP and GMP advisory. Temperature control facilities and supply solutions.

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Pharmaceutical Technology

MAY 26, 2023

The European Medicines Agency (EMA) has accepted two marketing authorisation applications (MAA) from Sandoz for the proposed biosimilar denosumab. The MAAs include all indications covered by the Xgeva (denosumab) and Prolia (denosumab) reference medicines to treat conditions such as osteoporosis in postmenopausal women.

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Pharmaceutical Technology

JUNE 19, 2023

Pharmaceutical companies are putting their trust in the immense potential this new generation of medicine has for treating individuals with rare genetic diseases, which currently affect an estimated 280 million patients worldwide. The requirements When handling personalised medicines, time is of the essence.

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Camargo

MAY 2, 2021

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Note: Some medicines are in more than one category.

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STAT News

SEPTEMBER 19, 2022

WASHINGTON — One of Washington’s most prominent drug pricing patient groups is tapping an advocate who has fought for access to medicines for nearly two decades as its new leader.

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Pharmaceutical Technology

APRIL 14, 2023

No concerns related to the clinical data package, safety or the medicine label. Mirikizumab also obtained a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use. The regulator has issued a complete response letter.

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Camargo

AUGUST 11, 2021

In this two-part blog series, we will explore the regulatory strategy considerations sponsors should bear in mind when working with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), with a focus on the development of drug and biologic products. Meeting Package Due. Meeting Type. Meeting Purpose.

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Pharmaceutical Technology

APRIL 5, 2023

The European Medicines Agency (EMA) has announced plans to expedite scientific advice and support the preparation of regulatory packages under its PRIority Medicines (PRIME) scheme. PRIME is an EMA scheme to support the development of medicines for rare diseases and conditions with high unmet need.

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Pharmaceutical Technology

FEBRUARY 7, 2023

The BLA covers all indications which are covered by Prolia (denosumab) and Xgeva (denosumab) reference medicines. The BLA submission is supported by a comprehensive analytical and clinical data package, including the Phase I/III ROSALIA trial data.

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Pharmaceutical Technology

JANUARY 20, 2023

And delays in the supply chain, even for short periods of time can potentially affect the efficacy of medicines, lead to longer-term supply bottlenecks, and ultimately prevent people from getting access to the critical medicines they need.

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STAT News

DECEMBER 1, 2022

A new venture called Merative — which was formed recently from the ashes of IBM’s Watson Health division — has decided it will no longer provide the media with pricing changes for specific medicines. This includes details such as separate doses and packaging on both current and historical prices.

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STAT News

FEBRUARY 10, 2023

Giving the government such power seemed like an admission that generic medicines don’t do enough to keep costs down. Now that the changes are law, however, industry experts and lobbyists acknowledge the package is more of a mixed bag for generics makers like Teva and Sandoz, not an existential threat.

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Fierce Pharma

APRIL 17, 2024

Riding high on Teva’s success under its recent “Pivot to Growth” strategy, chief executive Richard Francis—in his first year at the helm of the generics and innovative medicines hybrid—has emerged | Riding high on Teva’s success under its recent “Pivot to Growth” strategy, chief executive Richard Francis—in his first year at the helm of the generics (..)

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STAT News

AUGUST 15, 2022

A new report from the National Academies of Sciences, Engineering, and Medicine (NASEM) aims to change that. communities. Although researchers have known about the impact of these chemicals for years, there has been little guidance available for clinicians. Read the rest…

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Scienmag

NOVEMBER 5, 2020

News from the Journal of Marketing Researchers from Illinois State University, North Carolina State University, University of South Carolina, and University of Maryland published a new paper in the Journal of Marketing that examines the impact of moving nutrition labels, typically placed on the back of product packages, to the front.

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pharmaphorum

JUNE 1, 2021

Pharmaceutical companies are accountable for ensuring that their medicine is safe when it comes into the hands of patients. Specific apps could also alert healthcare providers if vulnerable patients are failing to scan their medicine. This technology can also play an important role in supporting virtual clinical trials.

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The Pharma Data

MARCH 15, 2022

Teva is donating medicines valued at over $11M, for acute therapies in support of Ukrainian refugees The donations include over 1 million packages of antibiotics and other essential medicines as well as hygienic products for Ukrainian infants and children. million packs of medicines, valued at over $10.8 About Teva.

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XTalks

DECEMBER 14, 2020

AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. According to AvKARE, the error occurred at a third-party bottle filling facility.

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pharmaphorum

AUGUST 5, 2021

Medicines Discovery Catapult (MDC) today announces the relaunch of radiochemistry at the Wolfson Molecular Imaging Centre (WMIC) in Manchester. Theranostics combines therapeutics and diagnostics in one package for image-guided therapy and could be a step change in defining the outcome of treatment at an early stage.

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The Pharma Data

MARCH 3, 2022

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced an initial donation of essential medicines to Ukraine. At the same time we are ensuring that our critical medicines and diagnostics reach the people who need them both in Ukraine and other countries impacted by the crisis. Roche vehemently condemns the violent invasion of the country.

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Pharmaceutical Technology

AUGUST 17, 2022

These molecules synthesised newly are packaged densely into custom lipid nanoparticles (LNPs), which Orna has made to act on the body’s crucial tissues. By self-circularisation, Orna’s oRNA technology makes circular ribonucleic acids (oRNAs) from linear RNAs.

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pharmaphorum

NOVEMBER 13, 2020

Today , the University of Exeter and Medicines Discovery Catapult (MDC) announce their strategic partnership to accelerate medicines Research & Development (R&D), creating value for the sector and enhancing translational skills.

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FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022.

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Scienmag

NOVEMBER 24, 2020

Glass tuning-fork-shaped tubing gives accurate, continuous measurements of drug dissolution Credit: William Grover When you take a time-release drug, you count on it doing what the package says: release the drug slowly into your bloodstream to provide benefits over the specified period of time.

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pharmaphorum

NOVEMBER 24, 2020

The combined company will cover a broad swathe of the digital health landscape, bringing together population health software, telehealth services, digital pharmacy delivering compounded and manufactured medicines, and tech enabled behavioural health services for people with mental health and substance abuse issues.

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