Quality Matters

MAY 24, 2023

World Vaccine Congress 2023: Spotlight shines on mRNA and viral vectored technology platforms Interest in innovative vaccines that use messenger ribonucleic acid (mRNA) and viral vectored technologies was among the key draws at this year’s World Vaccine Congress (WVC) on April 3-6 in Washington, D.C.

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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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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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Pharma in Brief

JANUARY 9, 2022

In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2021. In 2021, governments advanced major policy initiatives aimed at the COVID-19 pandemic and broader health priorities. The courts also had a busy year in 2021. Introduction. c) Other policy developments.

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pharmaphorum

JULY 6, 2021

Oxford Nanopore is also building up to an initial public offering (IPO) later this year that could reinforce 2021’s position as the best-ever year for UK financing, well ahead of last year’s total tally of £2.81 Globally, the biotech sector raised just over £9.4 billion from venture and private sources, up from £7.6

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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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Putting Patients First Blog

APRIL 30, 2024

Key Points of Support Conciseness and Focus of Key Information The NHC supports the FDA’s emphasis on beginning the informed consent document with concise, focused presentations of key information. The importance of using plain language in health communications is well-documented in literature.

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FDA Law Blog: Biosimilars

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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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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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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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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Amber

AUGUST 11, 2022

According to a 2021 survey, 1/3 of Americans take on additional roles outside of their full-time jobs. Medical Transcriptionist Transcribing medical documents is work you can do from anywhere at hours convenient for you. Medical assistants need training to administer vaccines.

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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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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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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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Pharma in Brief

OCTOBER 25, 2020

On Friday, October 23, the Patented Medicine Prices Review Board ( PMPRB ) released final Guidelines that are intended to take effect on January 1, 2021, together with the scheduled coming-into-force of amendments to the Patented Medicines Regulations (the Amendments ).

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National Association of Boards of Pharmacy

JULY 22, 2022

Many pharmacists can now administer diagnostic tests and vaccines, as well as dispense treatments for coronavirus disease 2019 (COVID-19). State and federal governments relaxed certain requirements and restrictions related to pharmacist and pharmacy technician licensing and scope of practice.

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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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Quality Matters

JUNE 14, 2023

Beyond addressing proper documentation, storage, and transportation, GDPs incorporate appropriate mitigation strategies to control the foreseeable risks. According to the Pharmaceutical Security Institute, incidents of counterfeiting, illegal diversion and theft of medicines totaled over 5,900 in 2021.

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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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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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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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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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FDA Law Blog: Biosimilars

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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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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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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Pharma in Brief

APRIL 13, 2021

The Food and Drug Regulations ( FDR ) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance ( NOC ) under the FDR. We reported on the IO and the government’s consultation regarding its transition plan last year.

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pharmaphorum

OCTOBER 18, 2021

The development of COVID-19 vaccines required levels of cooperation and pioneering science comparable to the Apollo space programme. Within 12 months of the outbreak, vaccines were being deployed to prevent severe infections, hospitalisation, and death. billion people have been fully vaccinated. Last accessed: October 2021.

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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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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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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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LifeProNow

APRIL 19, 2023

The primary endpoint evaluated in this study is progression-free survival, defined as time from randomization to the first documentation of progressive disease or death due to any cause, whichever occurs first. The safety of immunization with live viral vaccines during or after ABECMA treatment has not been studied.

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Quality Matters

JUNE 21, 2023

In 2022 alone, six countries achieved ML3/ML4 for medicines and vaccines regulatory systems, leading to a call for increased adoption of risk-based approaches to post-marketing surveillance. To address the issue during the pandemic, USP produced a suite of resources targeting SF vaccines and treatments.

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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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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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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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Putting Patients First Blog

SEPTEMBER 9, 2024

These codes facilitate proper documentation and reimbursement, ensuring that health care providers are fairly compensated for the critical services they offer. Preventive Services The expansion of preventive services, including hepatitis B vaccinations and colorectal cancer screenings, is a positive development for public health.

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