pharmaphorum

DECEMBER 4, 2020

Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. The big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of 100 million doses.

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Vaccines Documentation FDA 125

pharmaphorum

DECEMBER 9, 2020

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. The post FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel appeared first on.

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Vaccines FDA Adverse Reactions Documentation 111

pharmaphorum

DECEMBER 10, 2020

The European Medicines Agency (EMA) says it suffered a cyberattack, with documents relating to a Pfizer and BioNTech’s COVID-19 vaccine accessed. Shortly after however BioNTech confirmed that documents submitted as part of its marketing application for coronavirus vaccine BNT-162b had been accessed by the hackers.

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Vaccines Documentation 111

pharmaphorum

DECEMBER 10, 2020

The US government’s coronavirus vaccine chief has said that Pfizer/BioNTech’s vaccine could carry a warning that it should be avoided by people who are prone to serious allergic reactions. Both recovered after appropriate treatment. Both are recovering well.”.

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Vaccines Documentation FDA 103

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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Vaccines Adverse Reactions Documentation Labelling 119

pharmaphorum

SEPTEMBER 17, 2020

US medical experts are reportedly concerned that a neurological side effect picked up in AstraZeneca’s closely-watched COVID-19 vaccine trial could compromise the whole project, as the FDA weighs whether to give the go ahead for US studies to resume. The post US experts stress over safety of AZ’s COVID-19 vaccine appeared first on.

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Vaccines FDA Documentation Immunization 105

European Pharmaceutical Review

NOVEMBER 18, 2022

The World Health Organization (WHO)’s Global Vaccine Market Report 2022 , the first report to examine the impact of COVID-19 on the global vaccine market, shows that inequitable distribution is not unique to COVID-19 vaccines, with poorer countries consistently fighting to access vaccines in demand by wealthier countries.

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Vaccines Immunization Documentation 98

pharmaphorum

NOVEMBER 20, 2020

Pfizer and BioNTech have filed for emergency use of their COVID-19 vaccine candidate in the US, paving the way for a launch before year-end. On the efficacy side, the filing will highlight a vaccine efficacy rate of 95% in a phase 3 study testing patients with and without previous infection with SARS-CoV-2.

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Vaccines Documentation FDA 96

pharmaphorum

JANUARY 13, 2021

Hackers posted stolen confidential information about Pfizer/BioNTech’s COVID-19 vaccine online, the European Medicines Agency has said in an update. The EMA last month revealed that documents relating to the Pfizer/BioNTech vaccine were stolen in a cyber-attack on its records.

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Vaccines Documentation 82

Pharmaceutical Technology

SEPTEMBER 15, 2022

Last year was a positive year for biopharmaceutical companies, particularly those with Covid-19 vaccines. As a result of huge global sales of mRNA Covid-19 vaccines, the split in profits between Pfizer and BioNTech’s Comirnaty contributed towards revenues of $81.3bn and $22.4bn last year, respectively. YoY revenue growth.

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Vaccines Documentation Compounding FDA 108

Pharmafile

MAY 9, 2024

UK-based pharmaceutical company AstraZeneca has announced that is it voluntarily withdrawing its COVID-19 vaccine Vaxzevria due to a drop in global demand. The withdrawal also comes after AstraZeneca admitted in court documents that the vaccine can cause thrombosis with thrombocytopenia syndrome (TTS).

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Vaccines Documentation Pharmaceutical Companies Pharmaceutical Companies 59

Fierce Pharma

DECEMBER 1, 2023

Less than two weeks after documents were unsealed showing that Texas has accused Pfizer and manufacturer Tris Pharma of providing a compromised ADHD medicine to the state, Paxton has sued Pfizer for “unlawfully misrepresenting the effectiveness” of the company’s COVID-19 vaccine.

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Vaccines Documentation 78

European Pharmaceutical Review

JUNE 29, 2022

As the healthcare sector grows, there is a clear trend towards the expansion of biologic therapeutic drugs and vaccines like the one developed by Novavax. To summarise, bioproduction hurdles include the necessity to be fast, agile and, not to be understated, able to deliver safe and effective vaccines worldwide. _4W2cWlEb439CWlu?startTime=1632749714000

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Vaccines Documentation 98

pharmaphorum

JANUARY 28, 2022

The failure of the European Commission to locate text messages between its president Ursula von der Leyen and Pfizer chief executive Albert Bourla on procurement of COVID-19 vaccine has earned a rebuke from the EU Ombudsman. billion doses of Pfizer and BioNTech’s vaccine. billion doses of Pfizer and BioNTech’s vaccine.

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Vaccines Documentation 64

BioPharm

OCTOBER 24, 2023

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.

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Vaccines Documentation FDA 52

Pharma Times

JULY 27, 2023

New HSCC document deems the UK’s vaccination position to be at risk - News - PharmaTimes

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Vaccines Documentation 49

pharmaphorum

FEBRUARY 24, 2021

AstraZeneca has said it will be able to meet a target to deliver 180 million COVID-19 vaccines to the EU in the second quarter, by topping up the supply from its global production network. However there is hope that vaccine production will be stepped up later on in the year, according to Reuters.

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Vaccines Documentation 64

DiversifyRx

MAY 9, 2024

Are you finally thinking of starting a vaccine program in your independent pharmacy? Adding vaccine administration to your list of pharmacy services is a great way to serve and protect your community while increasing your pharmacy’s visibility, revenue, and profit. Additional revenue Vaccinations can be a profitable service.

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Vaccines Health and Personal Care Stores Immunization Independent Pharmacies 52

Omnicell

JANUARY 10, 2023

Howard Montgomery, MS, RPh Director, Clinical Consulting, Omnicell The biggest vaccination campaign in history is now underway and scaling fast. The vaccine rollout brings unique logistical challenges, especially for health system pharmacy as they need to manage inventory across multiple, diverse locations.

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Vaccines Omnicell Documentation Compounding 52

pharmaphorum

JUNE 29, 2022

Future booster campaigns against COVID-19 should include vaccines with a component targeting the Omicron variant of SARS-CoV-2, according to the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). They are however both based on the original BA.1 1 will be “already somewhat outdated.”

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Vaccines FDA Immunization Documentation 52

Omnicell

SEPTEMBER 5, 2022

” Job one for the incoming administration will be the efficient distribution and administration of COVID-19 vaccines – as underscored by President-elect Joe Biden’s stated goal of administering 100 million doses in the first 100 days of his administration. In addition, Biden has advocated a $3.4

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Vaccines Omnicell Documentation Immunization 52

Omnicell

SEPTEMBER 5, 2022

Danny Sanchez VP and General Manager, EnlivenHealth® As news emerged about the positive COVID-19 vaccine trial results from Pfizer and its German partner BioNTech, the attention turned to how the vaccine would be distributed and administered to 330 million Americans.

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Vaccines Documentation Communication 52

Pharmaceutical Technology

DECEMBER 13, 2022

To develop a vaccine and then get as many people vaccinated as quickly as possible. Advanced monitoring and analysis technology has enabled more than 13 billion COVID-19 vaccinations to be distributed worldwide to date. Before the COVID-19 pandemic, 25-50% of vaccines were wasted due to cold chain issues.

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Vaccines Communication Documentation 52

Pharmaceutical Technology

SEPTEMBER 8, 2022

The information contained within the download document is designed for pharmaceutical executives, developers, research scientists and associates, regulatory solutions consultants, and any other individual involved in API biologics production in the pharmaceutical industry.

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Vaccines Packaging Documentation Labelling 40

Drug Topics

NOVEMBER 8, 2023

In a recent Morbidity and Mortality Weekly Report (MMWR), the results of a study showed 63% of those who died from HAV had at least 1 documented preexisting indication for vaccination.

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Vaccines Documentation 247

European Pharmaceutical Review

DECEMBER 19, 2023

Many of today’s vaccines are produced in ready-to-inject liquid formulations that must be kept cold to maintain stability. However, this greatly complicates both the worldwide distribution and stockpiling of vaccines and other drugs. A requisite cold chain has been designed and implemented to be uninterrupted from factory to patient.

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Vaccines Communication Immunization Documentation 111

pharmaphorum

JANUARY 29, 2021

The EMA has approved AstraZeneca’s COVID-19 vaccine for use in the EU in all adults aged over 18, despite assertions in Germany this week that it shouldn’t be used in elderly people. That’s in line with the conclusions of the MHRA, which approved the vaccine at the end of last year. Janssen shot 66% effective.

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Vaccines Documentation FDA 64

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. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Accessed 7 September 2021.

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Documentation FDA Communication Packaging 52

The Checkup by Singlecare

FEBRUARY 15, 2024

However, simply having a qualifying disability typically isn’t sufficient; the person also needs documentation from a medical professional that indicates that the service animal could improve or support his or her condition. To be eligible for a service dog , individuals must meet the ADA criteria for a mental or physical disability.

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Health and Personal Care Stores Documentation Grocery Stores Hospitals 98

pharmaphorum

MAY 16, 2022

In 2020, USAID launched two policy documents to guide how the agency invests in digital infrastructure as part of its development and humanitarian assistance programmes: Digital Strategy and Vision for Action in Digital Health (aka Digital Health Vision).

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Documentation Vaccines 118

pharmaphorum

JULY 12, 2022

Researchers in the US have started a clinical trial of a vaccine against Nipah virus, a serious infection caught from animals that has a fatality rate of between 40% and 70%, developed by mRNA specialist Moderna. “The need for a preventive Nipah virus vaccine is significant,” he added.

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Vaccines Documentation Immunization 52

pharmaphorum

MARCH 19, 2021

The chip is loaded with binding agents produced by Avacta and Aptamer that detect Spike proteins found on the surface of the virus, which are also the targets for many of the vaccines available and under development.

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Documentation Vaccines 145

pharmaphorum

JULY 6, 2021

” Life Sciences Minister Nadhim Zahawi said late last month that the Vision document is due to be published over the summer and will form part of the treasury’s Plan for Growth agenda, published at the budget in March. Globally, the biotech sector raised just over £9.4 billion from venture and private sources, up from £7.6

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Documentation Vaccines 141

Viseven

DECEMBER 4, 2024

It also requires documenting the entire process, from raw material sourcing to product launch. This type of validation is particularly useful for fast product launches (think the COVID-19 vaccine) when there is no time for prospective validation. Process design should be based on solid evidence and include thorough documentation.

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Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 52

STAT

JULY 18, 2024

Europe’s second-highest court criticized the European Commission for a lack of transparency over Covid-19 vaccine contracts four years ago , Reuters writes. The EC says she did not keep the messages. Continue to STAT+ to read the full story…

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Documentation Vaccines 98

European Pharmaceutical Review

NOVEMBER 16, 2022

As the emphasis of new drug development gravitates towards new, ground-breaking therapies and vaccines, the requirements of manufacturing sites, equipment and processes need to be appropriate for this new environment.

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Documentation Vaccines 119

IDStewardship

MAY 12, 2023

Review your schedule, elective options, and documentation responsibilities We have to start with the basics in order to adequately orient to future expectations. To help support our future pharmacy specialists, the following five tips for for incoming PGY2 residents are provided… 1.

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Communication Documentation Vaccines 130