pharmaphorum

DECEMBER 16, 2022

Ben Hargreaves discovers why some have referred to the distribution of COVID-19 vaccines and treatments as a form of apartheid. Vaccine access for a price. Tendayi Achium, labelled the response by the global community as a form of “vaccine apartheid,” a suggestion echoed by the organisation’s director general.

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Pharmaceutical Technology

OCTOBER 29, 2024

The registrational trial is expected to support the approval for Bavarian’s mpox/smallpox vaccine use in children 2-11 years of age.

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Pharma in Brief

DECEMBER 3, 2020

Any authorization for drugs, vaccines, and medical devices issued pursuant to the interim orders are also set to terminate when the respective interim order expires or is withdrawn. Drugs and Vaccines. Both interim orders are set to expire 1 year after they were issued, or sooner if withdrawn by the Minister.

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Pharmaceutical Technology

APRIL 6, 2023

Moderna has announced that its cancer vaccine mRNA-4157/V940 along with Keytruda secured the European Medicines Agency (EMA) Priority Medicines (PRIME) scheme designation for the adjuvant treatment of high-risk stage III/IV melanoma patients after complete resection.

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pharmaphorum

MARCH 17, 2021

European regulators are “worried” that national regulators may have undermined trust in the Oxford University/AstraZeneca vaccine by temporarily suspending its use, despite central guidance to keep using it until a safety review has concluded later this week. . Politically motivated?

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Pharmaceutical Technology

JULY 25, 2022

The European Commission (EC) has extended Bavarian Nordic ’s smallpox vaccine Imvanex (MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic) marketing authorisation to offer protection from monkeypox. A non-replicating smallpox vaccine, Imvanex was developed in partnership with the US Government.

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Big Molecule Watch

FEBRUARY 17, 2025

On February 5, 2025 Valneva SE (Valneva) announced that the United Kingdoms Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Valnevas chikungunya vaccine, IXCHIQ. The post UKs MHRA Grants Marketing Authorization for Chikungunya Vaccine appeared first on Big Molecule Watch.

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Big Molecule Watch

SEPTEMBER 17, 2024

On September 13, 2024, the World Health Organization (WHO) announced that it added the first vaccine against monkeypox (mpox) to its prequalification list. The vaccine, MVA-BN, is manufactured by Bavarian Nordic A/S. Prequalification is a mechanism “used to evaluate quality, safety and efficacy of medical products, such as vaccines.

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Pharmaceutical Technology

APRIL 24, 2023

Since then, the field of nanomedicine has steadily progressed to reach high points such as the successful use of nanotechnology to deliver messenger RNA (mRNA)-based Covid-19 vaccines. In the case of most mRNA vaccines, a lipid nanoparticle-based approach was chosen due to its ability to protect the mRNA in the body and prevent degradation.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

The list includes providers of development services, biologics management supply chain solutions, clinical trial services, commercial and logistics services, as well as packaging, labelling and distributing services for biologics.

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GMPSOP

APRIL 3, 2024

A pharmaceutical warehouse is responsible for receiving, storing, and releasing incoming goods (including labeling and packaging) and distributing finished products. Materials and products may not need physical status labels or be stored in separate areas if computers are used. All these goods will be issued with unique lot numbers.

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Labelling Packaging Documentation Inventory Control 52

Quality Matters

FEBRUARY 9, 2023

Africa’s growing vaccine capacity Manufacturing products locally for more equitable pandemic responses Every year, vaccines prevent nearly 5 million deaths around the globe. Yet, Africa produces less than 1 percent of the vaccines it needs to protect patients and communities across the continent.

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pharmaphorum

JANUARY 8, 2021

As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses. When the UK announced the approval of the Pfizer-BioNTech and Oxford-AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.

Vaccines 59

Vaccines Immunity Immunization Medical Schools 59

pharmaphorum

JANUARY 8, 2021

As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses. When the UK announced the approval of the Pfizer-BioNTech and Oxford/AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.

Vaccines 59

Vaccines Immunity Immunization Medical Schools 59

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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Labelling Packaging Vaccines 52

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. All labeler codes that are covered by Discount Program agreements will be distributed to PDP sponsors and posted on the CMS website. covered insulin product or vaccine). state pharmaceutical assistance programs).

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pharmaphorum

MAY 26, 2021

Belgium’s Ministry of Health has paused dosing of people under the age of 41 with Johnson & Johnson’s one-shot COVID-19 vaccine, following the death of a woman from what appeared to be a blood clot-related condition. . Last month, the EU regulator concluded that the benefits of the vaccine still outweigh any risks.

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. A recent state law failure-to-warn case in the SDNY makes that very point.

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Express Pharma

MARCH 23, 2023

Here are the comments from the leaders: Responsible manufacturing is our key focus: UFlex Chemicals While speaking to Rajesh Bhasin, Joint President – Chemical Business from UFlex Chemicals division at PlastIndia 2023, we learned about their plans of introducing inks for the pharma foils and narrow web labelling for pharma products.

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Pharmacy Is Right For Me

OCTOBER 21, 2022

My evenings involve music production, radio show production, podcast production, reviewing new music sent by labels/music promoters, and preparing for gigs. When the monkeypox outbreak was happening here in NYC, I used my platform to be a source of information about vaccines and TPOXX treatments.

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Hospitals Labelling Vaccines Drug Development 130

Express Pharma

MARCH 23, 2023

Here are the comments from the leaders: Responsible manufacturing is our key focus: UFlex Chemicals While speaking to Rajesh Bhasin, Joint President – Chemical Business from UFlex Chemicals division at PlastIndia 2023, we learned about their plans of introducing inks for the pharma foils and narrow web labelling for pharma products.

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Packaging Labelling Vaccines 98

Express Pharma

MAY 6, 2024

Florent Bouguin, CTO of Optel Group, uncovered how ultra-low temperatures, crucial for cryopreservation, are revolutionising mRNA production for next-generation medical interventions, particularly vaccines and therapies.

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Express Pharma

JANUARY 4, 2024

It meets 50 per cent of the global demand for various vaccines, 40 per cent of the generic demand in the US, and 25 per cent of all medicine in the UK. In addition to meeting strong domestic demand, the Indian pharmaceutical industry is well poised as a robust contributor to the growing global market.

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Packaging Labelling Vaccines 111

Express Pharma

JULY 8, 2024

.” Prime Minister Narendra Modi has launched several groundbreaking programs in healthcare, such as Pradhan Mantri Jan Arogya Yojana, Pradhan Mantri Bhartiya Janaushadhi Pariyojana, and the successful COVID-19 vaccination drive.

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Labelling Hospitals Vaccines 101

pharmaphorum

SEPTEMBER 15, 2020

As part of this, a number of big pharma companies are also racing to develop a safe and effective vaccine for the coronavirus. There was a pressing need to successfully adapt materials at speed for MLR approval – rewriting labels for changing medical needs, adapting and shifting materials to send different messages, and so on.

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Communication Documentation Labelling Vaccines 130

Express Pharma

JUNE 28, 2024

Our leadership in vaccine supply to WHO, coupled with meeting the generics demands of the USA, Britain, and Europe, underscores our pivotal role in healthcare accessibility. Additionally, the conference addressed the industry’s outlook on packaging, labelling, serialisation, and track and trace technologies.

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Packaging Biosimilars Labelling Vaccines 105

pharmaphorum

MARCH 15, 2022

During the first half of 2020, surveys indicated that doctors would be reluctant to attend physical meetings in 2021, indicating preferences based mainly on fear of contracting COVID-19 and availability of vaccines. yes, if vaccines are available; 15.8% The ‘hybrid’ label is confusing. Results from 335 responses were: 47.8%

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Labelling Vaccines Communication 105

Pharma in Brief

AUGUST 3, 2023

The Old Guidance applied only to drugs for use in humans, whereas the Distinction Guidance now applies to drugs (both prescription and non-prescription), medical devices, natural health products, biologics, vaccines, and animal health products. Patient information.

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pharmaphorum

OCTOBER 7, 2021

That is of paramount importance in medical education, “where a lot of the discussions between the KOLs in the sessions are about off-label content.” ” That means providers have to make sure that they exclude HCPs from countries that aren’t allowed to get off-label content directly from a pharma company.

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Express Pharma

MAY 10, 2023

Pharma and healthcare companies often ship products like vaccines, blood products, and medicines, which need to be maintained at certain temperatures to preserve their potency and validity. This can be achieved through temperature-controlled warehousing and transportation, with IoT sensors to continuously monitor the temperature.

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Labelling Vaccines 104

European Pharmaceutical Review

FEBRUARY 13, 2023

This is like antigens which can trigger an immune response and act as a vaccine. Firstly, using liquid chromatography and mass spectrometry, they carry out a systematic comparison of different fragments of a mRNA molecule to be tested with a similarly fragmented reference mRNA labelled with a stable carbon isotope.

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Immunity Immunization Labelling Vaccines 105

Pharmaceutical Technology

JULY 29, 2022

The open-label, three-cohort, multicentre trial analysed intravesical BCG, N-803 combination in BCG-unresponsive high-grade NMIBC patients. In January, ImmunityBio and Amyris have concluded a joint venture (JV) agreement announced previously to accelerate the marketing of a Covid-19 vaccine.

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Labelling Immunity Immunization Vaccines 105

Express Pharma

NOVEMBER 1, 2024

Venkateswaran suggests that India adopt a model similar to its successful vaccine development strategy, relying on public-private partnerships to pool resources. For instance, the CURE ID platform facilitates collaboration by allowing clinicians to share data on off-label uses of existing drugs,” states Pawar. “As

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Express Pharma

MAY 10, 2023

CCI is the ability of a container closure system to maintain the sterility of final pharma, biological and vaccine products throughout their shelf life. These high standards aren’t reachable without serious commitments to Container Closure Integrity (CCI). It is also a regulatory requirement upon which to qualify closure designs.

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Pharma Packaging Solutions

NOVEMBER 8, 2023

Pre-filled Syringe Packaging A lot of biopharmaceutical products—such as insulin, vaccines, and many hormone therapies—are parenterally administered. Vial and Ampoule Labeling Many biologics are available primarily in liquid form. Tjoapack handles crucial secondary packaging jobs like vial and ampoule labeling.

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Packaging Labelling Vaccines 52

pharmaphorum

MAY 17, 2021

Apellis Pharma has secured FDA approval for its complement C3 inhibitor Empaveli as a treatment for paroxysmal nocturnal hemoglobinuria (PNH) – with a label that will allow it to challenge Alexion’s established therapies directly. .

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FADIC

MARCH 22, 2024

Because antipyretics can also be found in many allergy, cold, cough, and flu products, patients should be advised to always read all medication labels prior to administration to avoid therapeutic duplications or possible medication overdose. Vaccination No Vaccine for the common cold Vaccines are available to help prevent the flu.

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