FDA tightens heart tox warnings on mRNA COVID vaccines
pharmaphorum
MAY 22, 2025
The FDA has instructed Pfizer and Moderna to add stronger warnings to the labels of their COVID-19 vaccines about the risk of cardiotoxicity
FDA rejects label expansion for Dynavax’s hepatitis B vaccine
Pharmaceutical Technology
MAY 15, 2024
The US agency rejected the expanded use of Dynavax’s vaccine for adults on haemodialysis, citing insufficient efficacy and safety data.
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EMA panel probes heart inflammation with Pfizer/BioNTech COVID vaccine
pharmaphorum
MAY 10, 2021
A review of side effects reported with coronavirus vaccines by the EMA’s safety committee has uncovered cases of inflammation of the heart in people receiving the Pfizer/BioNTech Comirnaty shot. . It is also asking for similar data from Moderna, which manufacture a COVID-19 vaccine that like Comirnaty is based on mRNA.
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Cancer vaccines: providing the edge in oncology
pharmaphorum
FEBRUARY 9, 2022
In this article, Ben Hargreaves looks into the promise of cancer vaccines and how this treatment modality may offer advantages over existing immunotherapies in the oncology sector. One area that is gathering increasing levels of interest is the development of cancer vaccines. A broad front.
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E.U. Regulator Argues to Continue J&J Vaccine With a Warning Label
NY Times
APRIL 20, 2021
The European Union’s drug regulator said that the Johnson and Johnson vaccine should carry a warning of potential risk for rare blood clots on the label, but did not recommend stopping the vaccine, saying the benefits of the vaccine outweighed the risks.
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How advanced technology can streamline the COVID-19 vaccine rollout
pharmaphorum
MARCH 2, 2021
Zebra Technologies healthcare lead Chris Sullivan discusses the COVID-19 vaccine rollout and how technology can streamline the process to combat new variants. . While the rollout of the COVID-19 vaccine has signified the first signs of light at the end of the tunnel, the reality is that this public health crisis is still far from over.
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Merck raises pressure on Pfizer in pneumococcal vaccine tussle
pharmaphorum
AUGUST 25, 2021
Just a month after getting approval for its new pneumococcal vaccine Vaxneuvance in adults, Merck & Co has reported positive trial results in children that will ramp up the pressure on Pfizer and its market-leading Prevnar franchise.
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TechInvention launches Euvichol-Plus, oral cholera vaccine in India
Express Pharma
MAY 11, 2023
TechInvention Lifecare India, has partnered with Eubiologics Co, South Korea, to launch Euvichol-Plus, a oral cholera vaccine (OCV), in a low-density polyethylene (LDPE) unidose pack in India. The post TechInvention launches Euvichol-Plus, oral cholera vaccine in India appeared first on Express Pharma.
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The Pandemic Treaty and the opportunity to end ‘vaccine apartheid’
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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Bavarian eyes Mpox vaccine label expansion to include toddlers, kickstarts Phase II trial
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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Health Canada consults on transition of interim order drugs, vaccines, and medical devices to permanent approval pathways
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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Moderna’s mRNA vaccine along with Keytruda obtains PRIME designation
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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EU regulators ‘worried’ member states undermined AZ vaccine
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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EC extends marketing authorisation for Bavarian Nordic’s smallpox vaccine
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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UK’s MHRA Grants Marketing Authorization for Chikungunya Vaccine
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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WHO Prequalifies Bavarian Nordic’s MVA-BN as First Vaccine Against Mpox
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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Covid-19 vaccine success bolsters nanoparticle drug delivery research
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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Leading API biologics (cell, gene, vaccine and virus) companies in contract marketing
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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FDA approves label expansion of AbbVie hepatitis C therapy
Pharmaceutical Technology
JUNE 13, 2025
The US Food and Drug Administration (FDA) has approved the label expansion of AbbVie’s Mavyret (glecaprevir/pibrentasvir) for treating adults and paediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection. Credit: © AbbVie Inc. All rights reserved.
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GMP rules to keep pharmaceutical warehouse in perfect condition
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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Africa’s growing vaccine capacity
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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Resourceful or risky? The UK’s controversial COVID-19 vaccine strategy
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.
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Resourceful or risky? The UK’s controversial COVID-19 vaccine strategy
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.
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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program
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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RxSource optimizes clinical labeling process with PRISYM 360 cloud-based solution
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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Belgium halts dosing of J&J COVID vaccine in under 41s after death
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-Approved Labeling: Is Enough Enough?
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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Trends in pharma packaging
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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Nuclear Pharmacist by Day, DJ by Night
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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The MAHA Assessment’s Implications: Drugs (Part One)
FDA Law Blog: Biosimilars
JUNE 4, 2025
There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns.
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Trends in pharma packaging
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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Pharma supply chain: From fragile to agile
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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3 ways pharma marketers can draw inspiration from digitally-native brands
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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Transforming India’s pharma sector: Opportunities and Innovations under Modi 3.0
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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10th edition of PharmaLytica held in Hyderabad
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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PHARMAP 2024 held in Amsterdam, marks its fourth edition
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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Disrupted medical conferences: Lessons learnt
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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Drug advertising: Updated guidance from Health Canada on the distinction between advertising and other activities for health products
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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Valuable virtual tools to keep HCPs informed
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.
Tech and policy evolution of India’s pharma supply chain
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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Analytical platform could advance mRNA medicine QC
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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Drug Repurposing: Unlocking access to rare solutions
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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FDA accepts to review ImmunityBio’s BLA for bladder cancer treatment
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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Mitigating fill, finish and CCI challenges for injectables
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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