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.

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Clinical Trials Clinical Trials Regulation Trials 64

pharmaphorum

OCTOBER 28, 2020

Data defines modern therapeutics, but this is almost uniquely confined to the clinical trial stages of drug development. Identifying, recruiting, retaining and monitoring patients during this part of the cycle is estimated to cost pharma US$19 billion a year as companies seek to harvest patient experiences. The way back.

Medicine 118

Medicine Pharma Companies Vaccination Vaccine 118

pharmaphorum

DECEMBER 16, 2022

Further, with a pandemic treaty in development, there are reasons to believe that many countries and the WHO want to see a more equitable distribution of medical products for future pandemics. The industry has so far resisted demands for the sharing of intellectual property (IP) around products developed to counter the pandemic.

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Vaccination Vaccine Production Licensing 75

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

pharmaphorum

JANUARY 7, 2021

The California-based company has signed a non-exclusive license with Pfizer to supply its 89Zr CD8 Immuno-PET agent, which can be used to image CD8 T cells in cancer patients.

Doctors 53

Doctors Doctor Immune Response Pharma Companies 53

pharmaphorum

NOVEMBER 30, 2022

The biggest gathering of pharma companies in Europe right now on the commercial side, the Veeva Systems Summit permits the sharing of best practices and of new ideas. Facts that they gleaned included: Across Europe, only 52% of HCPs will accept a visit from a pharma company (i.e.

Life Science 90

Life Science Pharma Companies Sales Marketing 90

Drug Discovery World

MAY 6, 2024

In this article, DDW’s Diana Spencer highlights several prominent hotspots that are taking the lead on advancing European drug discovery and development. The oldest, still active pharmaceutical company worldwide, Merck, started life in 1668 in Darmstadt, Germany. The CDD will sponsor and manage KWF-supported trials.

Drugs 59

Drugs Life Science Gene Editing Gene 59

pharmaphorum

DECEMBER 21, 2020

A year ago, the names Moderna and BioNTech were known mainly to those who followed biotech and pharma dealings. But the tragic events of 2020 have meant these companies have become household names as their trailblazing mRNA vaccines became the first to be approved by regulators against the COVID-19 scourge.

Vaccination 86

Vaccination Vaccine Doctors Doctor 86

pharmaphorum

MAY 14, 2021

Merck KGaA had been developing the drug with partner Avillion and van Amstel’s team got in touch as soon as they heard the German pharma was considering selling it as part of a pipeline rethink. Licensed in from Ablynx in 2013 five years before a merger with Sanofi, German Merck recognised its potential.

Licensing 59

Licensing Licensing Drugs Marketing 59

pharmaphorum

MAY 14, 2021

Long headquartered in London, the EU drug regulator is now severed from the country both physically and systematically, with its base now in Amsterdam and the UK now assessing drugs through its own regulatory agency, MHRA. The post How will NICE fare in a post-Brexit world? appeared first on.

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Marketing Regulation Medicine Life Science 59

Drug Discovery World

MARCH 29, 2023

Antibiotic development According to Politico, the European Medicines Agency is investigating a chronic shortage in antibiotics across Europe, where almost every country is reporting gaps in supplies – 25 out of the 27 EU countries have reported local shortages, the agency’s Chief Medical Officer, Steffen Thirstrup, told a press briefing 6.

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

pharmaphorum

APRIL 1, 2021

We speak to the company’s CEO and co-founder, Szabolcs Nagy, to find out why moving beyond traditional biotech drug development is a good fit for the country’s ecosystem. It’s incredibly exciting to see what can be done with the right data and digital expertise combined with experienced drug developers. This is very liberating.

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Bioinformatics Drugs Development Scientist 97

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

Advarra

JULY 19, 2022

Also consider quality agreements for key vendors, such as contract development and manufacturing organizations (CDMO) and CROs. The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. A: For FDA 1572 is a Statement of Investigator under US Regulations/Laws.

Packaging 52

Packaging Packaging Drugs Containment 52

XTalks

SEPTEMBER 5, 2023

Vaccines have been an integral piece of the global public health toolbox for over 200 years, but the COVID-19 pandemic brought about a new era in vaccine development with renewed interest in mRNA technology and unprecedented accelerated regulatory approvals. What are the major challenges you’re facing right now in vaccine development?

Vaccination 96

Vaccination Vaccine Development Clinical Trials 96

pharmaphorum

DECEMBER 7, 2020

Bureaucracy, political upheaval, and lack of regulations continue to make Latin America a difficult market for European and North American pharma to enter – and COVID-19 has only worsened these issues. Developing market specialist Dr Zulf Masters OBE takes us through the nuances of being successful in this region.

Marketing 82

Marketing Regulation Production Medicine 82

pharmaphorum

SEPTEMBER 1, 2020

Whilst the scientific revolution of the 17th century had spread ideas of rationalism and experimentation, and the industrial revolution had transformed the production of goods in the late 18th century, the marrying of the two concepts for the benefit of human health was a comparatively late development.

Medicine 145

Medicine Insulin Pharmacy Drugs 145

pharmaphorum

MAY 26, 2022

Within pharma and healthcare, where greater representation has been proven to lead to better health outcomes for all patients and the pharmaceutical companies developing medicines, change is also happening. In recent years this has seen diversity, equity, and inclusion (DEI) become a big focus for industries to get right.

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Clinical Trials Clinical Trials Trials Medicine 128

pharmaphorum

DECEMBER 8, 2020

AbCellera is a specialist in applying artificial intelligence to drug discovery, specifically to sift through immune system data to find antibodies that can be developed as drugs. Its approach involves licensing rights to the antibodies to other pharma companies, rather than bringing its own candidates through development.

Drugs 99

Drugs Antibody FDA Approval Pharma Companies 99

The Pharma Data

NOVEMBER 5, 2020

The demand for an effective drug for nail fungus is high and MOB-015 can achieve a unique market position through its high antifungal effect,” says Anna Ljung, CEO of Moberg Pharma. The information was submitted for publication, through the agency of the contact persons set out above, at 8.00 CET on November 6, 2020.

Marketing 40

Marketing Production Regulation Containment 40

pharmaphorum

AUGUST 4, 2020

Shares in Redx Pharma were soaring this morning after it licensed its preclinical fibrotic disease drug RXC006 to AstraZeneca. The company’s shares were valued as high as 95p on the London Stock Exchange following the announcement, the highest they had been since 2015.

Drugs 87

Drugs Clinical Trials Clinical Trials Pharma Companies 87

pharmaphorum

MAY 21, 2021

It builds on the company’s four partnership projects: two with the generics and biosimilars firm Hikma, one with US biotech Inhibrix and another with an unnamed biosimilars partner. There is still a need for faster acting insulins, we are using technology to develop superior best in class versions.”.

Insulin 52

Insulin Drugs Production Marketing 52

XTalks

MARCH 22, 2023

Our webinars have become a key vendor-selection tool for decision-makers across the drug development pipeline — from discovery to commercialization — which is why all ten of the top ten contract research organizations (CROs) have worked with Xtalks. Click on the infographic to explore the data.

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

The Pharma Data

DECEMBER 30, 2020

The reason for this is still not understood and many regulators may want it to be explained before authorizing it for broader use. and European COVID-19 vaccine development, announced their Phase III ENSEMBLE trial was fully enrolled with about 45,000 participants. Johnson & Johnson’s COVID-19 vaccine. Venture Capital.

Vaccination 52

Vaccination Vaccine Gene Therapy Trials 52

The Pharma Data

DECEMBER 16, 2020

AstraZeneca has seen a few setbacks with the COVID-19 vaccine it has developed with Oxford University, including a confusing efficacy outcome that resulted from the inclusion of a half-dose. Despite those setbacks, the company anticipates its vaccine could be available for use in the United Kingdom within the next several weeks.

Vaccination 52

Vaccination Vaccine DNA Antibody 52

XTalks

FEBRUARY 15, 2024

US Senator Bernie Sanders, who chairs the Health, Education, Labor, and Pensions (HELP) Committee, managed to bring CEOs of major American pharma companies to a committee hearing to discuss exorbitant US drug pricing. These are the guys developing cures.”

Drugs 52

Drugs Pharma Companies Pharmacy Regulation 52