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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Vaccination Vaccine Pharma Companies Medicine 111

pharmaphorum

FEBRUARY 24, 2021

The FDA has issued guidelines allowing for faster development of updated coronavirus vaccines, based on previously approved shots that have been tweaked to combat emerging variants of the SARS-CoV-2 virus. If vaccines need updating, the FDA expects that manufacturing information will remain generally the same.

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Vaccination Vaccine Immune Response Regulation 59

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. There are already rules that dictate how countries should react against public health events that have the potential to traverse country borders, through the International Health Regulations.

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Vaccination Vaccine Production Licensing 86

BioPharma Reporter

JANUARY 12, 2021

The European Commission had held discussions with French pharma company, Valneva, with a view to securing up to 60 million doses of its inactivated virus COVID-19 vaccine, VLA2001.

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Vaccination Vaccine Pharma Companies Regulation 64

pharmaphorum

MARCH 18, 2021

The World Health Organization has backed the safety of the Oxford University/AstraZeneca vaccine ahead of a key announcement from European safety experts later today. Several major European countries including Germany, Italy and France have temporarily suspended use of the vaccine amid fears that it could be linked to blood clots.

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Vaccination Vaccine Regulation Pharma Companies 52

BioPharma Reporter

JUNE 20, 2022

Following the adoption of a critical list of COVID-19 vaccines and treatments, European Union member states and pharma companies will communicate to ensure sufficient supply to meet evolving demand.

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Pharma Companies Vaccination Vaccine Regulation 105

pharmaphorum

MARCH 2, 2022

Pfizer’s vaccine for Clostridium difficile (C. The pharma company was quick to point out however that the CLOVER trial of PF-06425090 was undermined by a lower-than expected rate of C. With no approved vaccines to date, C. As it stands, PF-06425090 is still leading the field among candidate vaccines for C.

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Vaccination Vaccine Trials Bacterium 52

World of DTC Marketing

FEBRUARY 16, 2022

What is pharma’s responsibility? Pharma provides medications to treat everything from severe cardiac issues to depression but should America’s pharma companies go beyond just providing a treatment? People accuse pharma of keeping people sick to make money. Pha a fails in this. That’s a rumor.

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Pharma Companies Regulation Vaccination Vaccine 178

pharmaphorum

AUGUST 21, 2020

New insights into smell and taste loss symptoms, artificial intelligence and further encouraging data from a vaccine candidate hit the headlines this week as the COVID-19 coronavirus pandemic continues. The post Coronavirus pharma news round-up 21/08/20 appeared first on.

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Vaccination Vaccine Regulation Manufacturing 105

World of DTC Marketing

FEBRUARY 4, 2021

I asked her why some reviews of working at the company are so positive, to which she replied, “these are people who are worker bees and don’t dare do anything innovative because they will be seen a not being a team player.” Misuse Federal Data to Falsely Claim COVID Vaccines Are Dangerous. ” Ouch.

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Vaccination Vaccine HR Packaging 180

pharmaphorum

FEBRUARY 18, 2021

The South African coronavirus variant may cut the effectiveness of Pfizer/BioNTech’s vaccine by around two thirds, according to a laboratory study. In a response statement Pfizer and BioNTech noted that the COVID-19 vaccine did still provide protection in the lab study.

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Immune Response Genetic Engineering Vaccination Vaccine 52

pharmaphorum

NOVEMBER 16, 2020

EMA executive director Guido Rasi has ended his second term at the helm of the EU medicines regulator, with Emer Cooke taking the wheel and becoming the first women in the role. Cooke is returning to the EMA after a four-year period as head of medicines regulation at the World Health Organization (WHO). Emer Cooke.

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Regulation Medicine Vaccination Vaccine 64

World of DTC Marketing

MARCH 26, 2021

Pharma cannot afford to let good people leave without so much as an exit interview to try and retain them. A colleague recently decided to leave her organization to join another pharma company. To me, it’s the continuing loss of talented people who understand how to work in a regulated industry and excel.

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Pharma Companies Production Regulation Vaccination 156

pharmaphorum

DECEMBER 21, 2020

Moderna and BioNTech, two rising stars in biotech, were in the limelight this year with their pioneering mRNA vaccines against COVID-19. Just who are these companies and who is behind them, asks Richard Staines. A year ago, the names Moderna and BioNTech were known mainly to those who followed biotech and pharma dealings.

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Vaccination Vaccine Doctors Doctor 90

pharmaphorum

OCTOBER 28, 2020

That narrative, for many patients, is that pharma companies just don’t care”. Pharma is swimming against the tide and can’t pretend that the democratisation of medicines data doesn’t exist — because it’s already here. 72% do not feel listened to by pharmaceutical companies. Yet it is widely mistrusted. The way back.

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Medicine Pharma Companies Vaccination Vaccine 119

pharmaphorum

FEBRUARY 14, 2022

The easy answer as to why this has happened can be quickly linked to the COVID-19 pandemic, where sales of vaccines and treatments led to a large increase in return on investment and sales projections. This can be understood through the accelerated development cycles experienced on COVID-19 treatments and vaccines.

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Production Clinical Trials Clinical Trials Sales 97

XTalks

NOVEMBER 9, 2023

XTALKS WEBINAR: Impacts of the New IVD Regulation (IVDR) for Manufacturers and Users Live and On-Demand: Tuesday, January 9, 2024, at 10am EST (4pm CET/EU-Central) Register for this free webinar to learn about the specific compliance requirements, risk assessments and quality management changes mandated by the IVDR.

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FDA Approval HR Genotype Life Science 64

pharmaphorum

JULY 5, 2021

Parexel has been a champion of the concept for years, but while adoption was fairly slow pre-COVID, it has accelerated at a fast pace since the crisis, aided by the increasing willingness of regulators to accept decentralised trial data in marketing applications.

Clinical Trials 64

Clinical Trials Clinical Trials Regulation Trials 64

pharmaphorum

FEBRUARY 25, 2022

Pharma companies are now household names, having been thrust into the public’s consciousness after dominating the headlines through the pandemic. These efforts, as Nadhim Zahawi rightly said when he was Vaccines Minister, have led to the life sciences and pharma industry becoming a UK national treasure.

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Life Science Vaccination Vaccine Pharmacy 96

pharmaphorum

APRIL 30, 2021

Not only has COVID forced companies, governments and healthcare systems to work towards approving drugs and vaccines in record times, the sector is also facing an influx of digital therapeutics and advanced drugs that don’t fit neatly into existing access frameworks. AI meets RWE: The future of drug assessment?

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Marketing Sales Regulation Drugs 91

pharmaphorum

DECEMBER 16, 2020

Increased levels of collaboration and joint working – both between the industry and the wider sector and between different pharma companies – have been something of a silver lining from the pandemic, and Torbett says this is happening at many different levels. The road to a vaccine. A collaborative future.

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Vaccination Vaccine Life Science In-Vitro 122

pharmaphorum

NOVEMBER 23, 2020

Pharma companies, healthcare providers and governments share a well-established common purpose: the desire to make disease a thing of the past. I saw a statistic in a Health Europe article, published in September this year, which reported that 81% of patients do not feel listened to by pharma companies.

Pharma Companies 128

Pharma Companies Regulation Development Compliance 128

pharmaphorum

MAY 27, 2022

Once stakeholders are confident that technologies are adequately validated, selection based on scientific and ethical considerations can be presented to regulators in accordance with applicable legal and regulatory frameworks. There is a huge opportunity for pharma companies to capitalise on by focusing on increased DEI in clinical trials.

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Clinical Trials Clinical Trials Trials Packaging 80

XTalks

MARCH 22, 2023

While not a record-breaking deal at $17 billion, the buyout strengthened Pfizer’s injectables business unit with the company reporting an 11 percent increase in revenue the following year. Pfizer is also the co-developer of what is arguably the most successful COVID-19 vaccine rollout.

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Life Science Drugs FDA Approval Vaccination 97

pharmaphorum

JULY 28, 2022

And while there are occasional discussions about pharma companies re-shoring API production facilities, the process would be extremely expensive and complex. Companies could benefit from talking to third party experts such as NSF to ensure that they are in compliance.

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Compliance Drugs Manufacturing Generic Drugs 105

pharmaphorum

OCTOBER 7, 2021

Rewind to March of 2020, and pharma companies were facing a communication crisis. Thankfully, many pharma companies had already started on a journey towards digital engagement, and healthcare professionals (HCPs) are embracing the medium more than ever before, thanks in part to newer generations who are increasingly digitally-savvy.

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Pharma Companies Production Clinical Trials Clinical Trials 96

pharmaphorum

SEPTEMBER 15, 2020

Pharma’s go-to-market strategies have tended to be more traditional than those seen in non-regulated sectors, but there are some signs this is changing, with an acceleration in the pace of change forced by the COVID-19 pandemic that is allowing the industry to close its gap with faster, more nimble consumer brands. “The

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Branding Marketing Pharma Companies Life Science 114

pharmaphorum

FEBRUARY 11, 2021

Pharma companies face many challenges when involving patients in the design of clinical trials – but doing so can have huge benefits further down the line, improving the sustainability and quality of research. The NIHR is also embedded in the NHS, perhaps the most trusted institution in the UK.

Clinical Trials 90

Clinical Trials Clinical Trials Trials Clinical Research 90

Drug Discovery World

SEPTEMBER 28, 2022

Its application in pharma, most commonly in drug discovery, has been steadily growing with global partnerships between tech vendors and pharma companies becoming more commonplace. The AI Drug Development Division is focused on AI-guided design and development of individualised neoantigen vaccines in oncology. .

Pharma Companies 52

Pharma Companies Drugs In-Vivo Genetics 52

Delveinsight

AUGUST 25, 2021

The pharmaceutical industry finds, develops, manufactures, and promotes medicines or pharmaceutical drugs for usage as medications that are administered (or self-administered) to patients in order to cure, vaccinate, or relieve symptoms. Pharmaceutical companies may deal in both generic and brand-name drugs as well as medical devices.

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Vaccination Vaccine Sales Drugs 98

Pharmaceutical Technology

AUGUST 30, 2022

Only a limited number of international pharma companies, however, operate manufacturing sites in the country. Brazilian pharma production sites are involved in Covid-19 vaccine and therapy manufacture. Large Brazilian pharma companies already play a major role in distributing Covid-19 vaccines to all of Latin America.

Manufacturing 195

Manufacturing Marketing Pharma Companies Vaccination 195

pharmaphorum

SEPTEMBER 7, 2020

High barriers to entering the sector and high levels of regulation are just two factors that have meant that there has often been an “innovation lag” when it comes to implementing new technologies and embracing technological and digital change in the pharma industry. The need for data in an uncertain world.

Clinical Trials 108

Clinical Trials Clinical Trials Trials Marketing 108

pharmaphorum

MAY 20, 2022

Last year, the company added clinical trials to the list with the launch of CVS Health Clinical Trial Services , an initiative that works with pharma companies on clinical trial recruitment and even hosts trial sites at certain retail locations.

Clinical Trials 90

Clinical Trials Clinical Trials Trials Clinical Research 90

pharmaphorum

OCTOBER 3, 2021

Novartis has joined a growing number of companies insisting that its workforce is double vaccinated against COVID-19 if they want to work at one of its sites. Novartis joins a lengthening list of pharma companies that are mandating full vaccination – at least in some developed countries like the US.

Vaccination 110

Vaccination Vaccine Pharma Companies Regulation 110

Drug Discovery World

MAY 6, 2024

Mazzetti and Schneider give the example of T3 Pharmaceuticals, a University of Basel spin-off that developed a proprietary cancer therapy platform based on regulating and harnessing the natural behaviours of live bacteria. So, in this way there is a cross fertilisation from the bigger companies to newer ones.

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Drugs Life Science Gene Editing Gene 59

pharmaphorum

APRIL 7, 2021

With other drugs in the pipeline too, van de Winkel said the company aims to continue to break new ground with next-generation antibody-based therapies. He notes that it already has 21 partnerships with pharma companies and will aim to keep more product rights than it did in the past. In good shape. We are in a crisis.

Antibody 71

Antibody Life Science Development Regulation 71

XTalks

DECEMBER 29, 2022

In 2022 alone, the US regulator approved four new gene therapies, showing the high interest in getting these therapies to market. It has also been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the US regulator for both SCD and TDT.

Life Science 52

Life Science Gene Therapy Gene Manufacturing 52