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. 2021 [cited May 2022].

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Vaccines Documentation 98

pharmaphorum

DECEMBER 16, 2020

Moderna looks odds on to claim emergency use authorisation from the FDA for its COVID-19 vaccine this week, after the regulator published a report endorsing its safety and rating its efficacy at 94.5%. Both vaccines will be provided free of charge to recipients.

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FDA Vaccines Documentation 98

pharmaphorum

JUNE 2, 2021

The first batch of EU countries have started recognising the vaccination status of travellers using digital vaccine certificates as the bloc moves towards freeing up travel ahead of the summer period. — Ursula von der Leyen (@vonderleyen) May 31, 2021. Europeans should enjoy a safe and relaxing summer.

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Vaccines Documentation 96

European Pharmaceutical Review

NOVEMBER 9, 2022

Within recent years this situation has been further exacerbated by the COVID-19 pandemic: both directly, through viral vaccine manufacture; and indirectly, through instability in global supply chains. Those available commercially include adenoviral-based vaccines by AstraZeneca and Johnson & Johnson. 2021 [Cited 16 September 2022].

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Vaccines Documentation Communication Hospitals 115

European Pharmaceutical Review

JUNE 27, 2022

A guidance document has been released to support these activities. This is in line with the targets set by both the United Nation (UN)’s Sustainable Development Goal 3 on NTDs and the World Health Organization (WHO)’s Neglected Tropical Disease Roadmap (2021-2030). Did you know, 1.7

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Vaccines Communication Documentation Compounding 110

The FDA Law Blog

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

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FDA Documentation Vaccines 108

pharmaphorum

NOVEMBER 10, 2020

The UK’s NHS is ready to start rolling out a coronavirus vaccine, likely beginning in the new year, according to health secretary Matt Hancock. In an interview with the BBC Hancock said that the vaccine could be available by Christmas, but he expected a mass roll out “in the first part of the new year”.

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Vaccines Documentation 59

pharmaphorum

NOVEMBER 24, 2021

The pandemic has propelled issues for the pharmaceutical industry to the top of the political and public agenda, from clinical trial recruitment to the journey required for medicines or vaccines to reach patients. Getting the UK’s COVID vaccine and treatments programme ahead of schedule. Why is this important for the UK?

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Vaccines Documentation 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). “Economists in 2021 estimated the pandemic cost the world over $11 trillion.

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Documentation Vaccines 118

STAT

NOVEMBER 18, 2022

The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world.

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FDA Documentation Compounding Pharmaceutical Companies 98

pharmaphorum

APRIL 8, 2021

COVID-19 has been a trial-by-fire showing just how quickly drugs and vaccines can be developed under the right circumstances – but there is much to do to ensure this progress is not lost, said speakers at WIRED Health 2021, including the CEOs of BioNTech and BenevolentAI. .

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Vaccines Documentation Communication 93

pharmaphorum

APRIL 7, 2021

Oxford University has suspended a clinical trial of its AstraZeneca-partnered COVID-19 vaccine in children and adolescents while a possible link to rare cases of blood clotting is investigated by the UK drugs regulator. . MHRA Chief Executive Dr June Raine reminds everyone to report side effects of Covid-19 vaccine to the #YellowCard scheme.

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Vaccines Documentation Hospitals 52

pharmaphorum

JANUARY 27, 2023

“We’ve almost got an opportunity to take it to the next level now, because we saw this with the collaboration with the COVID vaccine development and roll-out of the vaccination programme. As an overall term, ‘patient centricity’ itself has undergone a transformation, as well. It really enables the smooth running of studies.”

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Pharmaceutical Companies Pharmaceutical Companies Vaccines Documentation 111

pharmaphorum

JANUARY 9, 2023

1 Kenya, for example, entered the pandemic with no human vaccines manufacturing facility and established the BioVax institute for local vaccine manufacture with a major plant investment starting in 2023. For pharma, the impact in critical areas such as the performance of newly marketed innovation has already been documented.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 98

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.,

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Documentation FDA Communication Packaging 52

pharmaphorum

APRIL 16, 2021

IQVIA’s Sarah Rickwood reviews the launch of innovative medicines in 2020 and outlines three key pillars of activity for companies to focus on and address in 2021. Even with the vaccine roll-out, further waves of COVID infection and lockdowns mean these vital drivers of launch performance remain impacted in 2021, and even beyond.

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Pharmaceutical Companies Pharmaceutical Companies Documentation Vaccines 95

pharmaphorum

OCTOBER 1, 2021

It also won a £113 million contract to provide rapid saliva-based COVID-19 testing services to the NHS, although that was ended early by the UK government in the summer as demand fell due to vaccinations. It may also use the cash injection for “in-licensing opportunities and potential acquisitions”, according to the document.

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Documentation Vaccines 52

pharmaphorum

APRIL 6, 2021

. — Digital Health and Care Wales (@DHCWales) April 1, 2021. ” There is however much more to do, he added. “We are at a watershed where new technologies can truly transform the way healthcare is delivered, and the new SHA will ensure Wales is at the forefront of this revolution.”

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Documentation Vaccines 59

PQA

AUGUST 8, 2022

Between 2019 and 2021, PQS has significantly contributed to the industry’s further understanding of how to utilize pharmacy as a clinical practice by helping to bring awareness of the impact pharmacy staff can have on their communities. 2021, October 13). Sheer et al., References Sheer, R., McCullough, J., Pickering, M.,

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Independent Pharmacies Community Pharmacies Patient Care Vaccines 52

Digital Pharmacist

NOVEMBER 21, 2022

Food and Drug Administration (FDA) announced its approval of the Boostrix vaccine, commonly known as Tdap (combination of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis) for immunization administration during the third trimester of pregnancy to prevent pertussis in infants younger than two months of age.

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Communication Documentation Immunization Vaccines 98

The Checkup by Singlecare

OCTOBER 17, 2023

Although this infection has been documented with almost all antibiotics, the most frequent offenders include clindamycin , ampicillin, amoxicillin, and cephalosporins. Certain vaccines interact with clindamycin , which can cause a diminished vaccine effect. Antibiotics can increase the risk of an infection called C.

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Vaccines Documentation FDA Dosage 52

Hospital Pharmacy Europe

JANUARY 19, 2023

In 2016, the country’s first National Strategic Plan in Antimicrobial Resistance 2017–2021 was published. By 2021, reductions of 15.2% Accompanying leaflets for patients have been developed and also digital versions of the documentation. Thailand has had a number of projects to promote appropriate use of antimicrobials.

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Community Pharmacies Hospitals Communication Medical Schools 98

The Happy PharmD

SEPTEMBER 15, 2024

Since 2021, pharmacy-related organizations have been addressing stress and burnout in the profession. The stress experienced by community pharmacists compared to those in other settings is well-documented and has been a longstanding issue. Despite this report being from 2021, the issue still hasn’t been resolved.

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Documentation Dosage Communication Insurance 52

ISPE

OCTOBER 28, 2022

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Dr Gouws added that WHO was the only regulatory authority to have performed inspections of Chinese manufacturers of Covid-19 vaccines during the pandemic.

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FDA Vaccines Documentation Dosage 97

Pharmaceutical Technology

APRIL 27, 2023

The successful development and deployment of the mRNA-based COVID-19 vaccines has catalysed the biopharma industry and paved the way to expand this drug modality to new therapeutic areas. Excluding vaccines, there are five mRNA therapeutic products in clinical trial development as of November 2022.

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Vaccines Documentation Communication 52

pharmaphorum

SEPTEMBER 15, 2021

That’s according to the European Federation of Pharmaceutical Industries and Associations (EFPIA), which has detailed the organisation’s 2021 Connecting Healthcare Awards winners in its fourth annual Health Collaboration Guide. Today’s healthcare challenges are complex and require the skills and perspectives of diverse stakeholders.

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Communication Documentation Vaccines 52

ISPE

SEPTEMBER 11, 2023

1 (2021):48. 6540 (2021):341–42. 1 (2021):7200. Summary from Advanced Manufacturing Technology Workshop Held at 6th Accelerating Biopharmaceutical Development Meeting.” PDA Journal of Pharmaceutical Science and Technology 75, no. 3 a b c Algorri, M., Journal of Pharmaceutical Sciences 111, no. 3 (2022):593–607. Discussion paper.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

The FDA Law Blog

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. Remarkably, manufacturers may not dispute a CMS notification.

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Vaccines Packaging FDA Documentation 59

Viseven

SEPTEMBER 14, 2023

Hidden expenses can pile up, spiraling out of control due to many reasons related to supplier performance: the lack of appropriate documentation, storage, wrong dosage forms, and the list goes on. In 2021, in North America alone, pharma companies suffered from 2,440 incidents of medicine counterfeiting.

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Packaging Pharmaceutical Companies Pharmaceutical Companies Pharmacy Procurement 52

ISPE

NOVEMBER 21, 2022

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Dr Gouws added that WHO was the only regulatory authority to have performed inspections of Chinese manufacturers of Covid-19 vaccines during the pandemic.

FDA 52

FDA Vaccines Documentation Dosage 52

ISPE

AUGUST 30, 2022

During the pandemic, the pharmaceutical industry faced challenges in the production of COVID-19 therapeutics and vaccines to meet global demand, as well as mitigation of drug shortages for non-COVID-19-related products, without compromising product quality or patient safety. Additional requirements are described in ICH Q7.

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Documentation FDA Packaging Communication 52

Roots Analysis

FEBRUARY 1, 2024

In the absence of suitable temperature controlled packaging solutions, the products packaged, such as vaccines, biologics, cell and gene therapies might get exposed to extreme ambient temperatures. Additionally, they are equipped with sensors / data loggers to monitor and document the product’s temperature throughout the process.

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Packaging Documentation Vaccines 40

pharmaphorum

SEPTEMBER 16, 2021

Pfizer and Moderna have both reported data that they say backs up the need for booster shots of their COVID-19 vaccines ahead of an FDA advisory committee meeting tomorrow, although the regulator seems less convinced. Administering a third dose restores protective efficacy back up to 95% or more, it said.

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FDA Vaccines Documentation 108

STAT

MARCH 4, 2025

1, 2021, when he’d noticed Stanford health economist Jay Bhattacharya tweeting about a study Abaluck had done on the effects of masking on Covid-19 in Bangladesh. But in a court document filed on Sept. ” In the Tennessee case from 2021, the judge wrote that “the Court is simply unwilling to trust Dr. Bhattacharya.”

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Documentation Vaccines 143

pharmaphorum

APRIL 22, 2021

Emergent BioSolutions’ difficult month has been made worse by an FDA report into its facility in Baltimore, which has been blamed for the wastage of millions of doses of Johnson & Johnson’s COVID-19 vaccine. . AZ’s vaccine meanwhile has yet to be approved in the US. An FDA decision is expected tomorrow.

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Vaccines FDA Documentation 52