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 117

pharmaphorum

NOVEMBER 24, 2020

The blank cheque company or ‘special purpose acquisition company’ (SPAC) that provides funding is GigCapital2, which raised $150 million in its public offering in June 2019. The merger is expected to be completed in the first quarter of 2021, subject to the usual closing conditions.

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Packaging Compounding 138

European Pharmaceutical Review

JULY 25, 2022

These may be mislabelled or produced in fake packaging and, most dangerously, there is no regulation around their manufacture. As a result, the development of advanced packaging-level tokens has led to watermarking techniques; invisible, encoded data that requires specialist verification software. Supply-chain visibility.

Packaging 104

Packaging Pharmaceutical Manufacturing Online Pharmacies 104

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.

Packaging 98

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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Dosage Packaging Online Pharmacies Pharmaceutical Companies 98

Pharma Packaging Solutions

MARCH 19, 2019

We are ready to discuss challenging packaging issues, upcoming serialization and aggregation deadlines, and more. We look forward to 2019 challenges and working on them with you. appeared first on Pharma Packaging Solutions. We are in the Lotte Palace at 455 Madison Avenue in Suite 5009 (same suite as last year).

Packaging 40

Packaging 40

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.

Packaging 98

Packaging 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.

Packaging 59

Packaging 59

ALiEM - Pharm Pearls

FEBRUARY 8, 2023

Because nail glue is often packaged in small containers identical to eye drop bottles, patients can mistake the nail glue for ophthalmic drops — especially those with visual impairment [6]. Characteristics of ocular nail glue exposures reported to the National Electronic Injury Surveillance System during 2000-2019.

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Packaging 130

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.

Packaging 52

Packaging 52

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.

Biosimilars 64

Biosimilars Packaging 64

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].

Pharmaceutical Companies 98

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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Packaging Compounding Communication Pharmaceutical Companies 52

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.

Biosimilars 59

Biosimilars Dosage Packaging 59

Pharmaceutical Business Review

JULY 21, 2023

CYFENDUS vaccine was the subject of a pre-emergency use authorisation package submitted to the US FDA in December 2018. In 2019, the US government commenced procuring this product for national preparedness efforts.

Vaccines 52

Vaccines Immunity Immunization Packaging 52

GMPSOP

MARCH 3, 2024

Cross contamination is dangerous in pharmaceutical industry as it can severely compromise patient safety if the content is not pure and the product package differs from what is written on the label. – In 2019, the FDA publicly reprimanded 21 companies for cross-contamination. Cross contamination data that can make you nervous!

Health and Personal Care Stores 52

Health and Personal Care Stores Packaging Labelling Documentation 52

Putting Patients First Blog

OCTOBER 31, 2023

According to the National Institute of Drug Abuse, drug-involved overdose deaths have risen sharply since 2019. In July 2023, the House of Representatives’ Energy and Commerce Committee unanimously approved a package to reauthorize and strengthen the SUPPORT Act.

Packaging 52

Packaging 52

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 Packaging 105

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).

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Pharmaceutical Manufacturing Packaging 52

RX Note

MARCH 23, 2023

Today, stability information can be obtained from manufacturer’s labelling information (such as in the package insert), the USP compounding monographs, or peer-reviewed articles and references , such as articles in American Journal of Health-System Pharmacy, the International Journal of Pharmaceutical Compounding.

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Compounding Sterile Compounds Packaging Labelling 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 Biosimilars Vaccines 105

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 Documentation 52

National Association of Boards of Pharmacy

DECEMBER 6, 2023

Further, FDA’s Center for Veterinary Medicine and CBP are working to identify xylazine shipments that are packaged and declared other products. According to CDC , nearly 500,000 people died from opioid-involved overdoses from 1999-2019. The ongoing opioid crisis in the US continues to evolve.

Controlled Substances 72

Controlled Substances Packaging 72

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 Immunity Immunization 52

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.

Biosimilars 105

Biosimilars Diabetes Immunity Immunization 105

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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Dosage Packaging 52

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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Packaging 52

FDA Law Blog: Biosimilars

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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Documentation Packaging Communication Labelling 75

RX Note

JUNE 8, 2023

In the past, package inserts were not always reliable sources of information regarding medication safety during lactation. NOTE: LactMed apps for Android and iOS devices were retired on 16 December 2019. Notable exceptions are heparin and insulin which are too large to cross biological membranes.

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Labelling Packaging 40

Pharma in Brief

AUGUST 3, 2023

An updated version of the Distinction Guidance was first circulated for consultation in 2019. Consultation on the draft guidance ran from July 5, 2019 to September 3, 2019. Distinction Guidance Approach The scope of the Distinction Guidance is now broader.

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Labelling Packaging Vaccines 52

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 40

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

Fuld & Company Blog

MAY 15, 2023

Amazon clearly felt its move to acquire PillPack was positive and, in 2019, launched “Amazon Pharmacy”.  This Amazon Care – The Second Attempt Flush with the 2018 success of PillPack, in 2019 Amazon made its second attempt at a full-service healthcare offering with “Amazon Care”. Prime and, of course, One Medical members.

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Health and Personal Care Stores Mail-Order Pharmacies Packaging Medication Delivery 59

Pharma in Brief

SEPTEMBER 1, 2022

These reforms commenced with August 2019 amendments to the Patented Medicines Regulations (the Amendments ) and accompanying changes to the Board’s Guidelines. A reduced package of Amendments comes into force. In this post, we summarize the current status of reforms to the Patented Medicine Prices Review Board ( PMPRB ).

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Packaging 59

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.

Online Pharmacies 52

Online Pharmacies Dosage Packaging Pharmaceutical Companies 52