STAT

AUGUST 21, 2023

In a landmark study published in the New England Journal of Medicine in 2021, Intellia revealed data from six patients in its trial for a transthyretin amyloidosis therapy — showing for the first time that it was possible to precisely alter the DNA of particular cells within the human body to treat disease with a one-time infusion of CRISPR.

Packaging 240

Packaging 240

Pharma in Brief

JANUARY 9, 2022

In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2021. In 2021, governments advanced major policy initiatives aimed at the COVID-19 pandemic and broader health priorities. The courts also had a busy year in 2021. Introduction. c) Other policy developments.

Documentation 52

Documentation Labelling Vaccines Packaging 52

European Pharmaceutical Review

JANUARY 10, 2023

In 2024, Pharmapack Europe, the two-day exhibition and conference for pharma’s drug delivery and packaging industry will introduce two brand new zones to the flagship event. Bio packaging zone . Pharmapack’s bio packaging zone builds on its long history of being at the forefront of innovations in biological drug delivery.

Packaging 71

Packaging Biosimilars 71

pharmaphorum

SEPTEMBER 4, 2020

SMi Reports: Registration is open for SMi Group’s 13 th annual conference and exhibition taking place in January 2021. 13 th – 14 th January 2021. The post Registration opens for Pre-filled Syringes & Injectable Devices Conference 2021 appeared first on. The pre-filled syringes industry is growing at an exponential rate.

Packaging 52

Packaging 52

Safe Biologics

DECEMBER 19, 2023

The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. On November 17th, ASBM submitted comments to the Food and Drug Administration (FDA) on draft guidance released in September by the FDA.

Biosimilars 100

Biosimilars Labelling Packaging 100

European Pharmaceutical Review

AUGUST 19, 2022

percent between 2021 and 2026 (the forecast period). billion in 2021. According to the report, the packaging segment of the market will be worth $15.6 billion by 2026, as contract manufacturing organisations increasingly adopt newer and efficient ways to package products, increasing demand for new machinery. percent CAGR.

Packaging 88

Packaging Compounding 88

Pharmaceutical Technology

AUGUST 16, 2022

Large (market cap $10–100bn) and mega-cap (market cap >$100bn) sponsors also require contract manufacturers and packagers with specialist injectable capabilities in the case of cell and gene therapies, as shown in the report titled Contract Injectable Packaging Trends in the Bio/Pharma Industry (August 2022).

Packaging 64

Packaging Vaccines 64

Pharmaceutical Business Review

MAY 8, 2023

The Pleasant Prairie facility was opened in 2021, with an estimated investment of $100m. It comprises manufacturing space, packaging capabilities, warehousing, as well as analytical, environmental, and microbial testing.

Pharmaceutical Manufacturing 96

Pharmaceutical Manufacturing Packaging Hospitals 96

Express Pharma

MARCH 7, 2024

For instance, in November 2021, Encube Ethicals, which was Sanofi’s contract manufacturer for Soframycin Skin Cream for more than 20 years, acquired some of these brands — Soframycin and other legacy associated brands Sofradex, Sofracort, Soframycin-Tulle for India and Sri Lanka markets.

Drug Development 103

Drug Development Packaging Vaccines 103

Putting Patients First Blog

OCTOBER 31, 2023

However, in 2020, this statistic rose to 68,630 deaths and to 80,411 deaths in 2021. Of the 106,000 total overdose deaths in 2021, 70,601 could be attributed to fentanyl. 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

pharmaphorum

JANUARY 27, 2021

A plant in Wales manufacturing the AstraZeneca COVID-19 vaccine was evacuated on the advice of the authorities today after it was sent a suspicious package. Wockhardt UK in Wrexham this morning received a suspicious package. — WockhardtUK (@WockhardtUk) January 27, 2021.

Vaccines 98

Vaccines Packaging Hospitals 98

European Pharmaceutical Review

MARCH 11, 2024

Additionally, this can be caused by “poor handling, repackaging, and nonadherence to good manufacturing practices [GMP] during dispensing and packaging have resulted in the microbiological contamination of non-sterile pharmaceutical products.” One case of drug contamination from 2021 was highlighted in the paper. Ahmed et al.

Sterile Compounds 82

Sterile Compounds Compounding Packaging Pharmaceutical Companies 82

Pharma Mirror

SEPTEMBER 27, 2021

New York/USA, At Interphex 2021 in New York, Syntegon (formerly Bosch Packaging Technology) presents new solutions for lab-scale and small batch filling of solid and liquid pharmaceuticals. The need for smaller quantities of highly potent drugs is rising continuously.

Packaging 52

Packaging 52

Pharmacy Joe

OCTOBER 25, 2023

The removal appears to be in response to the publication of a 2021 article in the International Journal of Pharmaceutical Compounding. .” How is this possible when we all have referred to this list as the “ISMP’s Do Not Crush List” for over a decade?

Dosage 111

Dosage Inpatient Packaging Documentation 111

Safe Biologics

DECEMBER 6, 2023

A 2021 survey of 401 U.S REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. and worldwide.”

Biosimilars 130

Biosimilars Packaging Labelling Drug Development 130

Pharmaceutical Technology

MAY 26, 2023

M&A activity for pharma CMOs reached a peak in 2021, with 2022 seeing a slight decline in the number of deals. Top valuations were also higher in 2021, although there were high-value deals in 2022, such as Merck KGaA (Hessen, Germany) acquiring the injectables manufacturer Exelead Inc. Catalent Inc.

Packaging 52

Packaging 52

European Pharmaceutical Review

AUGUST 4, 2023

Life sciences sector to receive £650 million funding This new funding to support development of sustainable inhalers and thus environmental targets in the drug delivery sector follows on from a £650 million funding boost as part of the ‘Life Sci for Growth’ package, announced by the UK Chancellor in May 2023.

Packaging 80

Packaging Pharmaceutical Companies Pharmaceutical Companies 80

Big Molecule Watch

JANUARY 5, 2024

Three utility patents and five design patents alleged to be infringed by SB15 packaging and syringe cap: U.S. In its counts for infringement of certain patents, Regeneron has alleged that “between August 29, 2021 and March 28, 2023, Samsung imported 17 shipments of SB15 into the United States. Patent Nos. Design Patent Nos.

Packaging 62

Packaging Biosimilars Documentation 62

Pharma Leaders

MAY 8, 2023

The Pleasant Prairie facility was opened in 2021, with an estimated investment of $100m. It comprises manufacturing space, packaging capabilities, warehousing, as well as analytical, environmental, and microbial testing.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Packaging Hospitals 52

Safe Biologics

NOVEMBER 12, 2023

6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. However, S.6 This would inappropriately limit the FDA’s authority to determine what data is scientifically appropriate for a particular biosimilar to provide in order to receive the designation.

Biosimilars 130

Biosimilars Drug Pricing Packaging Labelling 130

European Pharmaceutical Review

OCTOBER 17, 2022

Historically, the 50-year-old site produced oral solids, sterile liquids, packaged products and offered retesting services to the Japanese and Asian markets. Both parties said they intend to use the facility as a platform for future growth and to ensure the site provides a reliable supply of affordable products.

Pharmaceutical Manufacturing 83

Pharmaceutical Manufacturing Packaging Diabetes Pharmaceutical Companies 83

European Pharmaceutical Review

AUGUST 10, 2023

on 11 May 2023 , the company’s investigations were found to lack “sufficient root cause determinations, CAPA, and assessment of all potentially affected batches” regarding multiple deviations for numerous broken tablets caused by the company’s packaging equipment between 20 October 2021 and 8 November 2021.

Pharmaceutical Manufacturing 83

Pharmaceutical Manufacturing Packaging 83

pharmaphorum

APRIL 21, 2021

Hikma had to start a whole new trial to answer the FDA’s questions following a rejection in 2017 and then had to put its launch on hold this year while the regulator reviewed a packaging update. The amendment was required because of enhanced packaging controls to meet new industry standards adopted since the filing.

Packaging 52

Packaging 52

European Pharmaceutical Review

DECEMBER 15, 2022

In 2021, the World Health Organization (WHO) established the Global Diabetes Compact, a global initiative to support countries in implementing effective programmes for the prevention and management of diabetes. “This initiative will empower local manufacturing, finishing and distribution of quality insulin in Africa.”.

Diabetes 75

Diabetes Packaging Communication 75

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. 2021 RCT, (n=113) Fixed dose 4F-PCC 1500 units vs variable-based dosing • Reversal success to goal INR ?1.5 References.

Packaging 40

Packaging Hospitals 40

Express Pharma

MAY 9, 2023

Whereas proper disposal of unused medications, as well as initiatives to reduce packaging waste, chemical waste, and improve recycling programmes, will aid in pro-actively addressing this challenge. This may involve the use of eco-friendly raw materials, green manufacturing processes, and eco-friendly packaging.

Packaging 94

Packaging Labelling Pharmaceutical Manufacturing Research Laboratories 94

Safe Biologics

DECEMBER 3, 2023

The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. A 2021 survey of 401 U.S state law, only interchangeable biosimilars may be substituted by a pharmacist without contacting the prescriber. It is also opposed by the majority of physicians, in the U.S.

Biosimilars 130

Biosimilars Labelling Drug Pricing Packaging 130

The Happy PharmD

JUNE 27, 2022

In the survey conducted in 2021, from 657 responses, 22% of pharmacists say they are happy at work, meaning about 78% are not happy at work. The special care package can be accessed here. . However, the numbers appear to have worsened since COVID. In a similar survey done in 2020, 42% of 217 pharmacists said they were happy at work.

Packaging 52

Packaging Pharmacy Management Diabetes Hospitals 52

RX Note

APRIL 21, 2023

for all of KL from May 7, 5 May 2021 180k Sinovac vaccine doses bottled by Pharmaniaga to be ready this week, 10 May 2021 Nationwide MCO 3.0 for all of KL from May 7, 5 May 2021 180k Sinovac vaccine doses bottled by Pharmaniaga to be ready this week, 10 May 2021 Nationwide MCO 3.0

Vaccines 40

Vaccines Health and Personal Care Stores Hospitals Packaging 40

Pharmacy Joe

OCTOBER 25, 2023

The removal appears to be in response to the publication of a 2021 article in the International Journal of Pharmaceutical Compounding. .” How is this possible when we all have referred to this list as the “ISMP’s Do Not Crush List” for over a decade?

Dosage 52

Dosage Inpatient Packaging Documentation 52

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. The announced changes to the PRIME scheme come after a five year analysis of the program in the 2016– 2021 period, following an initial two-year overview.

Drug Development 52

Drug Development Packaging 52

Pharmaceutical Technology

JULY 25, 2022

Digital technologies will be utilized throughout drug development, production, packaging and delivery for increased process efficiency and improved product quality. According to GlobalData, the number of mentions of ‘Artificial Intelligence’ in the company filings of pharmaceutical organizations increased 105% between 2016 and 2021.

Health and Personal Care Stores 114

Health and Personal Care Stores Packaging Drug Development 114

Amber

SEPTEMBER 14, 2023

“The new Vitality program marks our latest advancement in transplant as we strive to support patients and their caregivers during the post-transplant period with a comprehensive package of services and resources to guide them in their recovery journey.” Amber Specialty Pharmacy, a Hy-Vee, Inc.

Specialty Pharmacies 105

Specialty Pharmacies Medication Delivery Dosage Packaging 105

Express Pharma

MAY 26, 2023

Additional highlights from the report include: Scope 2 emissions decreasing by 13 per centin 2022, due to lower direct electricity demand within the office space The company’s packaging audit seeing a 52 per cent increasein the percentage of products packed with at least one fully recyclable component, up from 12 per cent in 2021 to 64 per cent in (..)

Packaging 66

Packaging 66

pharmaphorum

NOVEMBER 24, 2020

The merger is expected to be completed in the first quarter of 2021, subject to the usual closing conditions. The digital pharmacy business will be provided by MedQuest, which is licensed in all 50 states and pre-packages and ships medicines direct to patients, serving a network of 13,000 providers.

Packaging 129

Packaging Compounding 129

European Pharmaceutical Review

MAY 29, 2023

Yet in 2021, 100 nanomedicines had been marketed. described that while robotics is currently already widely used at the secondary packaging stage, the coming years will see large adoption of robots in aseptic manufacturing environments too. Another 563 new nanomedicines were under clinical trial or in other stages of drug development.

Process Improvement 70

Process Improvement Packaging Vaccines Drug Development 70

European Pharmaceutical Review

OCTOBER 5, 2022

For most consumers, product packaging represents their first impression of a brand and its sustainability credentials. But how is this push shaping the pharma packaging market and what are the key changes we can expect to see? For many, aesthetic appeal and user experience top the list of priorities when it comes to packaging design.

Packaging 83

Packaging Dosage Labelling Communication 83