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.” Ahmed et al.

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Pharmaceutical Technology

DECEMBER 12, 2022

Pharmaceutical companies often outsource different parts of the manufacturing process, including the production of small molecule active pharmaceutical ingredients (APIs) and parenteral packaging, to contract manufacturing organizations (CMOs). Iomab-B met the durable complete remission endpoint.

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Roots Analysis

OCTOBER 30, 2023

The next generation RNA therapeutics and RNA vaccines pipeline currently features the presence of more than 20 circular RNA therapeutics and vaccines, being developed across initial stages of drug development (discovery and preclinical).

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European Pharmaceutical Review

DECEMBER 26, 2023

Advanced inducible systems to better regulate the expression of certain genes will improve the generation of packaging and producer cell clones, giving companies more control over gene expression for improved safety as well as efficiency. Scientific American; 2022 [cited 2023 Jun]. 2023 [cited 2023 Jun]. Bhatkhande S.

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The FDA Law Blog

JANUARY 3, 2024

CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA). Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous.

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Roots Analysis

JANUARY 27, 2025

It is important to note that, for the purpose of subcutaneous biologics market analysis, the biologics were segregated into antibodies , nucleotides, proteins and vaccines. The below figure presents the distribution of subcutaneous biologics based on initial approval year and type of biologic.

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ISPE

OCTOBER 26, 2022

It seems like yesterday, and now the 2022 ISPE Annual Meeting & Expo in Orlando, Florida, has come and gone, and Mike Rutherford is the 2022–2023 Chair. This interaction was used to further improve the ISPE Charter, and the proposed changes will be implemented into the 2023 version. One ISPE and Strategic Plan Refresh.

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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.

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Roots Analysis

OCTOBER 5, 2023

Presently, polymers are employed in various fields, including agricultural, aircraft, automotive, consumer science, medicine, packaging, and sports. Vaccine Adjuvants: Polymers often serve as carriers for releasing the antigen and thereby regulating the immunological responses.

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The FDA Law Blog

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price.

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The Checkup by Singlecare

JANUARY 18, 2024

Access free preventive care services, including vaccinations, screenings, and certain checkups, before meeting your deductible. Employer-sponsored health health coverage is offered to employees and qualified members of their immediate family, as part of their benefits package for employment. Sources U.S.

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PharmaShots

APRIL 25, 2023

The company strives to discover and develop therapeutic products under its business segments, including General Medicines, Specialty Medicines, and Vaccines. R&D Expenditure: $6.6B Founded Year: 2000 Total Employees: ~69,400 Headquarters: London, United Kingdom Market Cap: $75.3B R&D Expenditure: $14.6B

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European Pharmaceutical Review

SEPTEMBER 4, 2023

Included in Issue 4 of European Pharmaceutical Review : FOREWORD Dissolution testing – a dual role David Elder, David P Elder Consultancy REGULATORY INSIGHT EU packaging reform: a prescription for change?

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ISPE

NOVEMBER 29, 2022

The 2023 ISPE Aseptic Conference will devote one entire day to case studies related to aseptic manufacturing projects. What they have in common is that they lead the way for the future: How to introduce a lifesaving vaccine as fast as possible by finding the appropriate approach through all the stages of manufacturing. Trudy Patterson.

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Pharmaceutical Technology

JUNE 9, 2023

The FDA accepted nirsevimab’s biologics license application (BLA) in January, with a PDUFA date penned for Q3 2023. After a long period without any new approvals, in May, the FDA approved GSK’s vaccine Arexvy for the prevention of LRTD caused by RSV in individuals 60 and older.

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ISPE

SEPTEMBER 11, 2023

Considerations for a Decentralized Manufacturing Paradigm Trudy Patterson Mon, 09/11/2023 - 06:47 Features September / October 2023 Considerations for a Decentralized Manufacturing Paradigm Marquerita Algorri, PhD Ting Wang, PhD Jocelyn X. McQueen Nina S.

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ISPE

JANUARY 10, 2023

Rapid Filter or Resin Change Strategies for Biomanufacturing Trudy Patterson Tue, 01/10/2023 - 14:05 Technical January / February 2023 Rapid Filter or Resin Change Strategies for Biomanufacturing Amy C. Four proposed data packages and submission strategies follow. Dowd, PhD Rob Deitcher Brian Kelley Nina S.

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Pharmaceutical Technology

JULY 4, 2022

US President Joe Biden has gained approval from Congress for a new package of aid worth $40bn, and the US government announced last month that it plans to provide an additional $1bn in security assistance to Ukraine. million vaccine doses upon EMA authorisation.

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Pharmaceutical Technology

MARCH 21, 2023

Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

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Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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Pharmaceutical Technology

MARCH 22, 2023

The European Commission plans to launch its revised EU pharmaceutical package in Q1 2023 to ease drug shortages,” she says. Among other things, supply chain optimisation, maintaining access to affordable vaccines, and supporting innovation for unmet clinical needs will be the discussion topics, she adds.

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BuzzRx

AUGUST 30, 2022

This law includes a broad package of provisions concerning healthcare, taxes, and climate change. With these provisions due to take effect starting in 2023, I examine their potential impact on prescription drug costs for Medicare beneficiaries. million who received the shingles vaccine. or more price increase.

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