European Pharmaceutical Review

AUGUST 23, 2023

2019], the USP Microbiology Expert Committee proposed the inclusion of recombinant factors for endotoxin testing in chapter <85> Bacterial Endotoxins Test. This revision proposal will include methods for recombinant Factor C (rFC) and recombinant cascade reagents (rCR). In a recent publication in the Pharmacopeial Forum 45(5) [Sep.-Oct.

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Packaging 98

European Pharmaceutical Review

AUGUST 23, 2022

On- or in-dose authentication means that a security measure or anticounterfeit feature is integrated with the dosage form itself, offering product verification and traceability embedded into each medicine, rather than on the secondary package” WHO estimates that >50 percent of the drugs for sale on the internet are fake. References.

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Packaging Dosage Pharmaceutical Companies Pharmaceutical Companies 98

Fuld

APRIL 15, 2021

In just three years, Amazon has put together a package of leading-edge services that have the potential to revolutionize the US healthcare market. Five months later in June, it announced the $753 million acquisition of PillPack and its move into the drug supply chain with mail order pouch packaging services. .

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Health and Personal Care Stores Cerner Packaging Customer Service 96

pharmaphorum

DECEMBER 10, 2021

Intercept first filed for approval of OCA in the EU and US in 2019, but the FDA finally turned down the US application in June 2020 after twice extending what should have been a swift six-month review of the drug. Shares in Intercept slipped around 15% after it announced the news.

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Packaging FDA 98

pharmaphorum

APRIL 21, 2021

Advair lost US patent protection in 2010 and exclusivity on the Diskus inhaler went in 2016 – but it took until February 2019 for the FDA to approve a generic from Mylan, now part of Viatris. The amendment was required because of enhanced packaging controls to meet new industry standards adopted since the filing.

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Packaging FDA 59

Pharmaceutical Technology

JULY 26, 2022

A complete analytical, preclinical and clinical data package is part of the BLA and MAA submissions. In 2019, Sandoz and Polpharma Biologics signed an international commercialisation agreement for natalizumab. This indication is already approved by the regulatory agency for Tysabri.

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FDA Packaging 64

pharmaphorum

OCTOBER 13, 2020

Launched in February 2019, Numan claims to help men take action with their health and wellbeing. Shah headed up NHSX , the government agency digitising the UK’s health service, from March to October 2019. Novator partner Birgir Már Ragnarsson will also join Numan’s board as part of the funding package.

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Packaging 52

STAT

NOVEMBER 4, 2022

By 2019, his brother had assembled a team of scientists at Charles River Laboratories, UMass Chan Medical School, Yale University, and other institutions to help design a bespoke therapy for Terry. Like many gene therapy companies, Cure Rare Disease packaged the therapy in adeno-associated viruses.

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Medical Schools Packaging 100

European Pharmaceutical Review

APRIL 21, 2023

The leaked draft of the European pharmaceutical package is promising on this point as it states that marketing authorisation may be refused if the ERA is not completed or risk mitigation measures are insufficient, and that an ERA programme should be set up for medicines that were authorised before the introduction of the ERA. cited 23Apr].

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Pharmaceutical Companies Pharmaceutical Companies Packaging 98

Pharmaceutical Technology

JUNE 19, 2023

It is critical to understand the supply chain, plan your packaging, storage and distribution lanes, then test the entire process before patient shipments go live. Products are stored and packaged in a dedicated suite by a dedicated team,” explains MacNeir. The requirements When handling personalised medicines, time is of the essence.

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Pharma Times

DECEMBER 21, 2023

First introduced in April 2019, every two years, the faecal immunochemical test (FIT) will be automatically sent to an additional 830,000 people in England, aged 54 years, to check for blood in a small stool sample, which can be a sign of bowel cancer. Recent data has shown a national uptake increase of the kit from 59.2%

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Packaging Vaccines 46

European Pharmaceutical Review

SEPTEMBER 26, 2023

Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics in 2019. The regulatory package submitted to the EC included evidence derived extensive analytical characterisation. Sandoz has the rights to commercialise and distribute it in all markets under the deal.

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Packaging Dosage FDA 59

European Pharmaceutical Review

DECEMBER 13, 2022

Tamper‑evident packaging is also recommended to prevent adulteration or contamination of the excipient. In India alone, where the cough syrup was manufactured, there have been five serious incidences involving 84 fatalities over the last 50 years; most recently in 2019.

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Compounding FDA Packaging 105

ISPE

MARCH 7, 2023

As such there’s a growing question of how the industry will improve the sustainability profile of its existing medicines and ensure that sustainability is designed into new medicines, such as products, with a reduced environmental risk, greener manufacturing technologies, and recyclable delivery systems and packaging. 9 December 2021.

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Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

Druggist

MARCH 11, 2021

HAp+ Dry Mouth Drops - 16 Strawberry & Rhubarb Flavoured Lozenges - Mouth Watering, Vegan, and Sugar Free - Maintains Healthy Teeth - Blister Pack - New Packaging (Strawberry & Rhubarb). Sci Rep 9, 17648 (2019). Published 2019 Jun 29. The Breath Co Dry Mouth lozenges Mandarin Mint 100 Pieces. ysik et al., £4.95.

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Packaging Chemotherapy 97

The FDA Law Blog

FEBRUARY 16, 2023

With the Rx-to-OTC switch objective in mind, FDA took the “ unprecedented ” step of developing and testing a model drug facts label (DFL) for OTC naloxone and published a label comprehension study and model DFLs for naloxone administered via nasal spray and auto-injector in 2019. including a QR code that links to additional training).

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Labelling Packaging FDA 64

pharmaphorum

JULY 21, 2021

According to the AP, around 40 states have now signed up to the national settlement package, which could be announced later today. From 1999–2019, nearly 500,000 people died from an overdose involving any opioid, including prescription and illicit opioids, according to figures from the US Centre for Disease Control and Prevention (CDC).

Packaging 52

Packaging 52

pharmaphorum

APRIL 11, 2022

If we are to move towards a value-based healthcare system, then we must utilise the power of both clinical trials data and real-world evidence, to produce the best possible data package for regulatory submissions. Between 2016-2019, she was the medical affairs therapeutic area lead in haematology for Janssen Oncology across the EMEA region.

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Pharmaceutical Companies Pharmaceutical Companies Vaccines Packaging 115

pharmaphorum

JANUARY 27, 2023

The same goes for many commodities used in the production process for key medicines, from solvents through to packaging. About the author Richard Saynor was appointed CEO of Sandoz in 2019, a Novartis generics and biosimilars division. However, as with hope, they can never replace a sound strategy.

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Packaging Vaccines 105

Hospital Pharmacy Europe

JANUARY 18, 2023

In practice, moving from BCT to intervention package “requires a balance between science and creativity” said Professor Hughes. The study was started in August 2019 but had to be suspended during the coronavirus pandemic. The use of drugs in the elderly population in Italy, National Report – 2019. References. Barzilai N et al.

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Pharmaceutical Technology

MARCH 30, 2023

While the drug was granted accelerated approval in June 2019, it did not deliver on a key overall survival (OS) endpoint as part of its post-marketing data package.

Chemotherapy 52

Chemotherapy Packaging FDA Documentation 52

The Checkup by Singlecare

SEPTEMBER 26, 2023

You’ve probably heard fruit referred to as “nature’s candy,” thanks to its innate sweetness—but blueberries are almost like nature’s candy and nature’s medicine all in one tiny blue package. In other words, blueberries could help protect the arteries from damage.

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Immunization Packaging 105

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. The payload is packaged inside a dissolvable needle, loaded within a microsyringe that is attached to a folded, self-inflating balloon. 2019 [cited 2023Feb]. the enteric coating and the capsule dissolve.

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Immunization Packaging Labelling FDA 105

Druggist

OCTOBER 8, 2020

The h2-receptor antagonist can be useful in reducing stomach acid production; however, PPIs such as omeprazole or lansoprazole are more effective. In 2019 and 2020, ranitidine was subject to a number of recalls due to the potential of being carcinogenic. Buy on Amazon Price incl.

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Packaging 98

Druggist

JULY 20, 2020

Evorel patches have been subject to shortages since 2019. Theramex bought Evorel range of products from Janssen Pharmaceutical Companies (Johnson & Johnson) in October 2019. Theramex committed to increase manufacturing of Evorel products by investing in an additional manufacturer and additional packaging equipment.

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Packaging Pharmaceutical Companies Pharmaceutical Companies 59

pharmaphorum

DECEMBER 31, 2021

The complaint against Teva was brought in 2019, and accused the company of aggressively marketing opioid painkillers across New York and misleading the public about the harmful effects of the drugs. New York was also one of the states that is holding out against a proposed $4.5

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Packaging Immunization 52

The FDA Law Blog

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Whether a firm used the 10-day call and/or an SIR, it should include any prior feedback from those interactions with FDA in the AI response and describe how and where in the AI response package the prior feedback was addressed.

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FDA Documentation Packaging Communication 75

Omnicell

JANUARY 10, 2023

In 2019, more than 148 million doses of medicine were lost , endangering both patients and employees. And according to the 2019 Drug Diversion Digest , 47.2 The new cassettes for the Omnicell CSD will accommodate MicroVault® packaging for a variety of low-dose narcotic medications, including morphine, hydromorphone, and fentanyl.

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Controlled Substances Omnicell Hospitals Packaging 40

European Pharmaceutical Review

FEBRUARY 6, 2024

Update January 2019: This Q&A has been superseded by the Guideline on The Sterilisation of the medicinal product, active substance, excipient and primary container. These are discussed in EU GMP guide annexes: Supplementary requirements: Annex 1: Manufacture of sterile medicinal products. What is the maximum bioburden level?

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Pharmaceutical Technology

MARCH 30, 2023

The overdose death rate in the US increased more than 250% from 1999 to 2019, as per a Canada-US joint white paper on substance use and harms. According to Emergent , the delay is due to manufacturing changes that will need to be made to support nonprescription packaging, and supply chain modifications.

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FDA Packaging 52

pharmaphorum

AUGUST 16, 2021

In 2019, Formedix collaborated with a UK-based consortium interested in observing early safety data. These are now used by several regulatory bodies, including the Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for submission packages.

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Documentation Vaccines Packaging Pharmaceutical Companies 98

pharmaphorum

NOVEMBER 29, 2021

iii] It’s no longer just about the company, compensation package and secondary benefits (e.g., He joined the company in 2015, moving to the position of head of HR medical devices North America in 2019, before taking up his current role in 2021. gym membership).

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Communication Packaging Pharmaceutical Companies Pharmaceutical Companies 98

Pharmacy Friday Pearls

SEPTEMBER 23, 2022

The package insert for Kcentra® indicates dosing is to be based on both INR and weight, resulting in possible confusion and delayed time to administration of Kcentra®. Dosing According to Package Insert. Kcentra (prothrombin complex concentrate [Human]) [package insert]. Am J Emerg Med 2019;X(XX):1-4. References.

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Packaging Hospitals FDA 40

The Checkup by Singlecare

OCTOBER 7, 2024

For the most part, this means moderating your intake of cake and candy, sodas and fruit juices, and other pre-packaged treats, but not necessarily fruits that contain natural sugars, like bananas and grapes. Varughese, making Januvia less effective at stabilizing your glucose.

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Packaging Labelling FDA 99

The Checkup by Singlecare

FEBRUARY 5, 2024

Saturated fat is found in red meat, dairy products, and processed or packaged foods. If saturated fat consumption has led to high cholesterol, reducing the amount of saturated fat you eat can help decrease your levels. If you have any of the above risk factors, getting a regular cholesterol blood test is a good idea—at least every five years.

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Packaging 105

ISPE

MAY 11, 2023

The goal is to break down complex processes into easy-to-grasp packages, including data privacy and information technology (IT) security. Pharmaceutical Engineering (May/June 2019). In the fourth and last step, the defined work packages are executed. The characteristics of transition from Industry 3.0 to Industry 4.0

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Packaging Documentation Communication Data Entry 52

pharmaphorum

JUNE 1, 2021

Many countries have introduced serialisation legislation which requires product identifiers to be affixed to each package to provide traceability throughout the distribution supply chain. However, traceability and security measures focused on the packaging level may not be enough to protect patients.

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