Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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Pharmaceutical Technology

JULY 14, 2022

This analysis covers late April to May and is based on a list of CMOs impacted by regulatory decisions by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and reimbursement authorities like the UK’s National Institute of Health and Care Excellence (NICE). Covid-19 vaccines stay in the spotlight.

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Pharmaceutical Technology

AUGUST 30, 2022

Brazilian pharma production sites are involved in Covid-19 vaccine and therapy manufacture. Oswaldo Cruz Foundation will package the drug in its facility in Rio de Janeiro before supplying it to the Brazilian public health system; the company is also involved in clinical trials for the drug’s possible use as Covid-19 prophylaxis.

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Pharmaceutical Technology

AUGUST 16, 2022

Even giant pharma companies with large internal production capabilities are leaning on outsourcing to meet market demand for huge numbers of injectables, including high-value biologics and Covid-19 vaccines, according to a GlobalData analysis. Outsourcing may also be pursued if it is more favourable in terms of time and/or cost.

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Packaging Vaccines FDA 64

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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European Pharmaceutical Review

MAY 29, 2023

Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. Nanoparticle HIV vaccine shows potential in trial Nanomedicines generally require aseptic processing. Yet in 2021, 100 nanomedicines had been marketed. Tanzini et al. Significance of Annex 1–2022 for implementing Pharma 4.0

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Process Improvement Packaging Vaccines FDA 95

ISPE

NOVEMBER 2, 2022

He shared Pfizer’s approach to reinventing to be able to develop medicines and vaccines faster, an approach that is helping pave the way to future development. Pfizer “cleared runway to allow for large-scale vaccine manufacturing before we had a product!” while clinical trials were still underway, he said.

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pharmaphorum

JUNE 17, 2022

It has now been over six months since the FDA authorized Paxlovid in December 2021 “for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing who are also at high risk for progression to severe COVID-19.” .

Hospitals 105

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Pharmaceutical Technology

NOVEMBER 30, 2022

These contracts involve the manufacturing of biological and small molecule active pharmaceutical ingredients (APIs), parenteral manufacturing and packaging, and other manufacturing-related tasks. Also in September, the US FDA expanded Sanofi / Regeneron Pharmaceuticals’ Dupixent (dupilumab) label to include prurigo nodularis.

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Pharmaceutical Technology

NOVEMBER 22, 2022

Advanced biologic production involving cell and gene therapies is currently limited but concentrated in Eastern China in provinces such as Shanghai, Zhejiang and Jiangsu for US FDA-approved sites. Guangdong is based in the south and has a comparatively strong number of manufacturing relationships producing innovative FDA and EMA drugs.

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The FDA Law Blog

JANUARY 3, 2024

Enter the FDA’s Center for Veterinary Medicine (“CVM”). A longstanding component of the FDA and its predecessor, CVM, in its initial form as part of the Department of Health, Education, and Welfare, was established in 1965 and evolved in CVM by 1984. And CVM certainly exercises that authority.

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pharmaphorum

NOVEMBER 16, 2020

In his final message as head of the EMA, Rasi said the number of COVID-19 drugs and vaccines being developed by pharma companies is “encouraging,” and pointing to the agency’s pivotal role “in reviewing the available data packages to ensure that our usual high standards of safety, efficacy and quality are achieved and upheld.”.

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The Checkup by Singlecare

JULY 11, 2024

Food and Drug Administration ( FDA ), some common side effects include: Headache Nausea Increased appetite Trouble sleeping Weight gain Fatigue Fluid retention Acne Prednisone may also cause certain serious side effects. Prednisone might treat some of gout’s most frustrating symptoms, but it might also cause some minor side effects.

Dosage 94

Dosage Packaging Immunization FDA 94

pharmaphorum

AUGUST 16, 2021

Nearly every element of the clinical trial design, data collection, analysis and approvals has been shortened and this helped ensure the swift rollout of safe and effective vaccines.”. To this end, ryze has been used extensively in several COVID-19 vaccine trials, to reduce the lag time for SDTM conversions. About the interviewee.

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pharmaphorum

SEPTEMBER 21, 2021

.” Ireland is the third-largest exporter of pharmaceuticals globally, according to IDA Ireland, with 50 FDA-approved manufacturing facilities generating annual exports of around €80 billion. The post After Alexion buy, AZ plans $360m investment in Irish facilities appeared first on.

Packaging 59

Packaging Compounding Vaccines FDA 59

pharmaphorum

JANUARY 18, 2022

The past year has seen significant developments in the injectables landscape with the rapid introduction and development of vaccines in response to the pandemic, updates in regulations including the EU MDR and FDA guidance on bridging studies, and increasing industry acceptance of connectivity to aid the user experience.

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Packaging FDA Documentation Vaccines 52

Pharmaceutical Technology

DECEMBER 9, 2022

Solvias has extensive experience with analytical method development and testing for mRNA-based vaccines as well as monograph testing of excipients and APIs according to Ph Eur or USP. All our equipment is in line with the latest European Medicines Agency (EMA) and FDA methods. Assays to support mRNA-based Covid-19 vaccines.

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ISPE

MARCH 8, 2023

Identification and Analysis of Contamination Trends Three major recall databases—those of the US FDA, the United Kingdom’s Medicine and Healthcare Products Regulatory Agency (UK MHRA), and Australia’s Therapeutic Goods Administration (TGA)—were searched to assess contamination trends in the past five years.

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The FDA Law Blog

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease.

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Vaccines Packaging FDA Documentation 59

ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). These new operating models can help enable and accelerate the efforts of Pharma 4.0™

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

Pharmacy Friday Pearls

MARCH 4, 2022

1 risk factor for progression to severe disease a No prior COVID-19 vaccine or infectionStandard of care treatment allowed but primary analysis population was limited to subjects who did NOT receive COVID-19 monoclonal antibodies COVID-19 related hospitalizations/death through day 28: 0.8% link] Molnupiravir [package insert].

HIV Treatment and Prevention Agents 40

HIV Treatment and Prevention Agents Hospitals Packaging Immunization 40

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. ICH Q12: Implementation Considerations for FDA-Regulated Products Guidance for Industry.” Draft Guidance for Industry.

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PharmaShots

MARCH 9, 2023

Other Affiliations: Angela is an active Board of Director member of the Pfizer Foundation (a charitable organization addressing global health challenges), European Federation of Pharmaceutical Industries and Associations (EFPIA), and UPS (the global leader in package delivery and supply chain logistics). LinkedIn Total experience: 26 yrs.

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FDA Pharmaceutical Companies Pharmaceutical Companies Immunization 40

ISPE

AUGUST 30, 2022

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Finally, the DP is packaged in a suitable container to ensure continued quality. It is considered a moderate change by the FDA (CBE30) and NMPA.

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pharmaphorum

MAY 26, 2022

The race to produce a vaccine which could protect the world against COVID-19 brought the topic of diversity in clinical trials, or lack of it, into sharp focus. Vaccines approved for public use require comprehensive RCTs to establish their safety and efficacy. The pandemic brought imbalances into sharp focus. About the authors.

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Pharmaceutical Technology

JULY 4, 2022

Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on the domestic market.

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ISPE

JANUARY 10, 2023

Both the development of COVID-19 vaccines and monoclonal antibody therapies and supply chain shortages related to the pandemic have affected sup-ply of the essential filters and chromatography resins used in the manufacture of biological products. Four proposed data packages and submission strategies follow.

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Packaging FDA Communication Vaccines 52

pharmaphorum

JANUARY 18, 2021

A promise by president-elect Joe Biden to carry out 100 million coronavirus vaccinations in his first 100 days in power is “absolutely doable”, according to the US leading infectious diseases expert Dr Anthony Fauci. So far only 12 million people have received vaccines in the US. That can be done.”.

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Vaccines Packaging FDA 52

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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