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

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. Following similar decisions by the American and European regulators, Swissmedic approved Pfizer/BioNTech’s bivalent Comirnaty booster.

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Pharmaceutical Technology

MARCH 10, 2023

Pharmaceutical and biotechnology industries widely use freeze-drying systems to protect vaccines, antibodies, antibiotics such as penicillin, blood plasma, proteins, enzymes, hormones, viruses, and bacteria from heat and minimise their biological activity. The process eliminates the disadvantages of conventional drying methods or freezing.

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The Pharma Data

NOVEMBER 22, 2020

As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. There were no serious adverse safety events.

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The Pharma Data

AUGUST 24, 2020

China is set to move ahead with human testing of a potential coronavirus vaccine that has been created using insect cells. It is hoped that using insect cells to grow proteins for the vaccine could speed up large-scale production. These were primarily border officials and health workers. Conor Kavanagh. Source link.

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Pfizer

APRIL 26, 2023

Albert Bourla Every day, I am asked about how Pfizer and our partners at BioNTech will distribute our COVID-19 vaccine now that it has begun to be authorized by regulators in different countries. But the underlying question is always the same: How will Pfizer and BioNTech ensure a seamless distribution of our vaccine?

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pharmaphorum

NOVEMBER 16, 2020

EMA executive director Guido Rasi has ended his second term at the helm of the EU medicines regulator, with Emer Cooke taking the wheel and becoming the first women in the role. Cooke is returning to the EMA after a four-year period as head of medicines regulation at the World Health Organization (WHO). Emer Cooke.

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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. Assays to support mRNA-based Covid-19 vaccines. However, messenger RNA (mRNA) based vaccines present particular analytical challenges.

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The Pharma Data

JANUARY 6, 2021

6 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunisation of adults.

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Pharmaceutical Technology

FEBRUARY 3, 2023

With scientists fervently developing mRNA vaccines, nucleic acid therapeutics, and viral vector-based gene therapies, clinicians are set to have a growing number of tools available to treat a wide range of conditions, from infectious diseases to genetic disorders and more. Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus.

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The Pharma Data

MARCH 25, 2021

European Medicines Agency to Conduct First-Ever Parallel Assessment of a Medicinal Product, Takeda’s Dengue Vaccine Candidate (TAK-003), for use in the EU; Countries Outside of the EU through the EU-M4all (Previously Article 58) Procedure.

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pharmaphorum

MAY 27, 2022

Once stakeholders are confident that technologies are adequately validated, selection based on scientific and ethical considerations can be presented to regulators in accordance with applicable legal and regulatory frameworks. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines.

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pharmaphorum

JANUARY 28, 2021

The Covid-19 pandemic has put further pressure on clinical trial suppliers to be fleet of foot in getting products dispatched when a new patient is recruited, as studies for vaccines have been set up and run at unprecedented speed. . To find out more about the webinar and to register, visit [link] .

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Roots Analysis

OCTOBER 30, 2023

These RNA based therapeutics play a crucial role in protein production and regulation of gene functions. 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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The Pharma Data

DECEMBER 30, 2020

Becomes First Country to Approve Covid-19 Vaccine From Oxford-AstraZeneca. Britain became the first country to give authorization to the coronavirus vaccine developed by AstraZeneca and the University of Oxford, The New York Times reported Wednesday.

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The Pharma Data

FEBRUARY 19, 2022

Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. This alert covers FDA-regulated products purchased from Family Dollar stores in those six states from Jan. Today, the U.S. We will continue to work to protect consumers.”. 1, 2021, through the present.

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pharmaphorum

APRIL 11, 2022

Medicines and vaccines are among the most powerful interventions that can help improve quality of life for people across the world. At Janssen, we strive to improve access to our innovative medicines and vaccines and achieve the best possible outcomes for patients across the world.

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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

OCTOBER 12, 2022

Regulation of transdermal delivery systems will be another key theme addressed, in combination with clinical trial optimization. Other key areas will be microneedle vaccines and transdermal patches for management of chronic disease. Primary Packaging Material Designers. Secondary Packagers. Microneedle Device Developers.

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The Pharma Data

OCTOBER 14, 2020

Study May Lead to Biomarkers for Tailoring COVID-19 Vaccines and Therapeutics. Such aptamers have the potential to identify biomarkers for protective CoV-2 immunity and may lead to accelerated precision medicine-driven vaccines designed to protect against COVID-19. CHATHAM, N.J., About TNX-1800. 1 Noyce RS, et al.

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The Pharma Data

OCTOBER 19, 2020

Testing Therapies, Antivirals and Vaccines. There has been some discussion of running challenge trials for COVID-19 vaccines. In a challenge trial, people are given a vaccine then intentionally dosed with the virus or bacteria that causes the disease. The race for a COVID-19 vaccine continues to heat up as case numbers rise.

Vaccination 52

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pharmaphorum

JANUARY 17, 2022

Discuss the impact on UK parallel trade following Brexit, through the eyes of regulators, the pharmaceutical industry and academics. Develop further understanding of the rules and regulation changes over the past 12 months, Parallel Trade, where are we now? Engage in interactive sessions about case law with a focus on packaging.

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Pharma in Brief

JANUARY 9, 2022

These policy initiatives included reforms to the Patented Medicine Prices Review Board ( PMPRB ), the Patented Medicines (Notice of Compliance Regulations) ( PM(NOC) Regulations ), the Patent Rules , and other regulatory matters at Health Canada. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.

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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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Pfizer

AUGUST 15, 2022

I am grateful to have received four doses of the Pfizer-BioNTech vaccine and I am feeling well while experiencing very mild symptoms. I am incredibly grateful for the tireless efforts of my Pfizer colleagues who worked to make vaccines and treatments available for me and people around the world. COVID-19, Vaccines. 07.19.2022.

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pharmaphorum

JANUARY 27, 2023

The same goes for many commodities used in the production process for key medicines, from solvents through to packaging. The recent reversal of China’s “zero Covid” policy, at a time when the country still lacks optimal vaccine coverage, has also created another unknown, in terms of global supply and demand forecasting.

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The Pharma Data

NOVEMBER 10, 2020

coli O157:H7 strain found by Michigan Department of Agriculture and Rural Development (MDARD) in Tanimura & Antle brand packaged single head romaine lettuce. brand packaged single head romaine lettuce with a pack date of Oct. recalled packaged single head romaine lettuce with a pack date of Oct. SILVER SPRING, Md. ,

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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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FDA Law Blog

JANUARY 3, 2024

Specifically, CVM ensures that animal drugs are safe and effective, properly made, and adequately labeled and packaged; food-producing animals only take drugs that would be safe for humans to consume; pet foods and additives are safe; and educates the public, monitors the market, and encourages development of new animal health products.

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Drugs Production Containment Licensing 59

Pfizer

DECEMBER 13, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. Research Vaccines. COVID-19 Research Vaccines.

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XTalks

AUGUST 2, 2023

With each passing year, pharmaceutical companies around the globe strive to deliver cutting-edge medicines, therapies and vaccines that impact the lives of millions. Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. billion in 2022. for a pediatric dose.

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Cloudbyz

AUGUST 15, 2024

This includes forecasting, manufacturing, packaging, labeling, storage, distribution, and inventory management to ensure that the right supplies are available at the right time and place. How do RTSM systems handle multi-center trials with varying regulations across regions? What are the considerations for using RTSM in vaccine trials?

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Clinical Trials Clinical Trials Trials Compliance 52

The Pharma Data

MAY 14, 2021

When you drink, the liver has to work to remove the alcohol from the blood instead of regulating blood sugar. I’ve set up a discounted package system of 6 bottles of GlucoFlow for you, for only 49 dollars a bottle, for a total of 294 bucks which is being offered TODAYâ?¦for CLICK NOW TO SECURE YOUR PACKAGE WHILE SUPPLIES LAST!

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The Pharma Data

FEBRUARY 13, 2022

The FDA took a critical step to help reduce sodium through a recently released guidance that establishes voluntary sodium reduction targets in processed, packaged and prepared foods. One of the FDA’s signature efforts to improve our nation’s nutrition is focused on reducing the level of sodium in the food supply. Source link: [link].

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The Pharma Data

DECEMBER 14, 2020

The IND package is based upon the favorable safety profile of Rabeximod shown in previous Phase 1 and Phase 2a studies. This contains such information that Cyxone AB is required to make public under the EU’s Market Abuse Regulation. “Filing an IND with the FDA is an important step in the clinical development of Rabeximod.

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The Pharma Data

OCTOBER 26, 2020

For 20 years, Novasep has acquired experience in developing and manufacturing a wide range of viral vectors through its sites in Belgium: AAV, Adenovirus, Lentivirus, HSV, VEEV, VSV…, for cell & gene therapy, immunotherapy, vaccination and other therapies from process development to cGMP production. Source link.

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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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