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 104

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.

Dosage 98

Dosage Packaging Pharmaceutical Companies Pharmaceutical Companies 98

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.

FDA 64

FDA Packaging 64

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.

Packaging 59

Packaging Dosage FDA 59

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%

Packaging 36

Packaging Vaccines 36

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

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 FDA 59

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.

Packaging 138

Packaging Compounding Insurance Patient Care 138

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. .

Health and Personal Care Stores 96

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.

Packaging 98

Packaging FDA 98

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?

Packaging 52

Packaging Dosage 52

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.

Controlled Substances 40

Controlled Substances Omnicell Hospitals Packaging 40

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 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).

Labelling 62

Labelling Packaging FDA 62

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

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

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.

Packaging 40

Packaging Hospitals FDA 40

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.

Medical Schools 100

Medical Schools Packaging 100

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

Packaging 52

Packaging Immunization 52

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

Packaging 52

Packaging Documentation Communication Data Entry 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.

Compounding 105

Compounding FDA Packaging 105

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.

FDA 75

FDA Documentation Packaging Communication 75

Pharmaceutical Technology

MARCH 10, 2023

Based on the further deteriorating economic situation, the MoH provided a pricing resolution that reduced subsidies on a range of raw materials used for local production and packaging of medicines.

Insurance 52

Insurance Packaging 52

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.

Packaging 59

Packaging Pharmaceutical Companies Pharmaceutical Companies 59

ISPE

MARCH 8, 2023

The cases covered the same types of contaminants and impurities noted in Table 1: microbial contaminants, process-related im-purities, metal contaminants, packaging-related contaminants, drug cross-contamination, and an “unknown” category encompassing other contaminants associated with the manufacturing process, including those from cell culturing.

Compounding 52

Compounding Compounding Pharmacies Packaging FDA 52

The Checkup by Singlecare

DECEMBER 26, 2023

A supplement package may claim it contains lion’s mane mushroom, but it may not specify what part of the mushroom it’s made from. In this form, you generally get a very low-potency product that may or may not work.” Dr. Cooperman explains.

Immunization 52

Immunization Dosage Packaging FDA 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.

Packaging 52

Packaging Dosage Pharmaceutical Companies Pharmaceutical Companies 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.

Packaging 97

Packaging Chemotherapy 97

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.

Packaging 105

Packaging Vaccines 105

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.

Immunization 105

Immunization Packaging 105

Roots Analysis

OCTOBER 30, 2023

Notably, since 2019, more than USD 380 million has been raised / invested by companies engaged in the development of circular RNA, reflecting significant funding activity for circular RNA-based therapies in this domain. Many stakeholders are undertaking initiatives to forge alliances with other industry / non-industry players.

Vaccines 40

Vaccines Immunization Packaging Pharmaceutical Companies 40

The Checkup by Singlecare

JANUARY 9, 2024

Because celery is often packaged in plastic, the gas becomes trapped and accelerates this process. Department of Agriculture (2019) The post 9 health benefits of celery appeared first on The Checkup.

Mayo Clinic 69

Mayo Clinic Packaging Compounding 69

The FDA Law Blog

NOVEMBER 22, 2022

Reported illnesses began just three days before Thanksgiving in 2017, but due to the unknown source of the turkey at the center of the outbreak, the Centers for Disease Control and Prevention (CDC) did not conclude the outbreak investigation until April 2019. Two days before Thanksgiving the following year, the CDC warned U.S.

FDA 52

FDA Packaging Hospitals 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.

Immunization 105

Immunization Packaging Labelling FDA 105

Pharmacy Friday Pearls

MARCH 28, 2022

Epinephrine [package insert] Lake Forest, IL: Hospira, Inc.; 2019. • (poster) Kim et al. . • Micromedex [Electronic version].Greenwood Greenwood Village, CO: Truven Health Analytics. Accessed 2022, March 15. • [link]. Callaway C. Epinephrine for cardiac arrest. Current Opinion in Cardiology. 2013;28(1):36-42. Mion Get al.

Dosage 40

Dosage Hospitals Packaging 40

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.

Pharmaceutical Companies 115

Pharmaceutical Companies Pharmaceutical Companies Vaccines Packaging 115

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.

Packaging 66

Packaging Labelling FDA 66