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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Manufacturing Production Containment Antibody 147

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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Vaccination Vaccine Protein Genetics 52

Pharmaceutical Technology

NOVEMBER 1, 2022

The medicines regulators in Europe have a strategy for 2025 where the second pillar is data and digitalisation, so we are trying to transform medicines regulation to be data-driven,” says Peter Arlett, Head of Data Analytics and Methods Task Force at EMA. Arlett explains that Darwin EU is playing a collaborative role in this goal.

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Big Data Regulation Medicine Research 278

World of DTC Marketing

FEBRUARY 4, 2021

Amgen CEO Bob Bradway racked up a 2018 pay package of $18.6 regulators knew about reports of suicidal behavior in men taking the anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label. million while the company’s pipe line falters.

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Vaccination Vaccine HR Packaging 180

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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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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Manufacturing Marketing Pharma Companies Vaccination 195

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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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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Vaccination Vaccine Medicine Trials 52

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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Regulation Medicine Vaccination Vaccine 64

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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Drug Delivery Drugs Packaging Packaging 40

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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Packaging Packaging Clinical Trials Clinical Trials 52

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

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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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Drugs Manufacturing Regulation Production 57

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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Contamination Vaccination Vaccine Pharmacy 52

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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Vaccination Vaccine Development Medicine 40

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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Packaging Packaging Marketing Regulation 52

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.

Drugs 57

Drugs Production Containment Licensing 57

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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Drug Delivery Production Drug Delivery Systems Packaging 52

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.

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Vaccination Vaccine Trials Clinical Trials 52

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

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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Contamination Packaging Packaging Production 52

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

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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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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Clinical Trials Clinical Trials Trials Compliance 98

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.

Medicine 115

Medicine Clinical Trials Clinical Trials Development 115

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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Drugs Vaccination Vaccine In-Vitro 99

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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Manufacturing Drug Delivery Systems Drug Delivery Packaging 40

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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Cosmetics Production Packaging Packaging 40

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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Medicine Production Marketing Packaging 105

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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Production Packaging Packaging Insulin 52

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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Clinical Trials Clinical Trials Clinical Development Drugs 52

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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Gene Therapy Gene Manufacturing Production 52

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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Drugs Licensing Licensing Production 110

The Pharma Data

JULY 6, 2021

At its Investor Update, GSK announced a package of new financial outlooks and ambitions. Profit growth is expected to be underpinned by a combination of strong revenue growth from new vaccines and specialty medicines, improving operational performance and benefits from the transformation.

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Sales Vaccination Vaccine Production 52

The Pharma Data

MAY 16, 2021

able to download in this package. can be effective in regulating the production of stomach acids. your copy of this package simply click on the button. physical crystals or minerals are required for this technique to work. but you can use them if you want to. Beware: This Could Be The ONLY. Serpentine. within the body.

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Production Hormones Packaging Packaging 52

The Pharma Data

MAY 15, 2021

Page 51 – 75 percent of all adverse reactions from all food additives reported to the FDA are due to this one common food additive found in most pre-packaged foods. Learn a simple method to test your body’s PH level and how you can easily keep it within safe levels. You are going to be shocked to know what it is.

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Doctors Doctor Containment Allergies 52