Camargo

MARCH 9, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The FDA revealed that pharma companies are not forthcoming when they publicly disclose the reasons behind a refuse-to-file (RTF) letter from the Agency.

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Development Manufacturing Drugs Production 146

Outsourcing Pharma

DECEMBER 12, 2023

Clinical-stage pharma company, PharmaKure which develops precision medicine for Alzheimerâs Disease and other neurological diseases has announced a collaboration agreement with one of the largest comprehensive universities in Malaysia.

Pharma Companies 89

Pharma Companies Medicine Development Regulation 89

Drug Discovery World

APRIL 20, 2023

Dr Paula Moran, Dr Kiri Granger, Dr J Mark Treherne , and Dr Jenny Barnett explore the effects of long Covid-19 symptoms and what the opportunities are for drug developers working to treat post-Covid-19 cognitive impairment. developed dementia over the subsequent two years (vs. Notably, among over-65s who had had Covid-19, 4.5%

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Development Drugs Clinical Trials Clinical Trials 98

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? They believe developing new medications is enough while rake in billions for shareholders.

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Pharma Companies Regulation Vaccination Vaccine 178

Pharma Marketing Network

OCTOBER 12, 2023

Benefits of VR & AR in Pharma Advertising VR and AR offer a unique opportunity for pharma companies to engage with customers in a more immersive and interactive way. For example, by using VR and AR, a pharma company could create an interactive 3D environment that allows customers to explore the product in detail.

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Pharma Companies Production Compliance Regulation 52

pharmaphorum

DECEMBER 21, 2021

During the course of the webinar, Keefer explained how specialty sites, with deep knowledge on one or certain groups of Rare Diseases, are crucial for further progress in drug development to progress the number of treatments available to Rare Disease patients and to provide support to those individuals. Headway being made.

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BioPharma Reporter

SEPTEMBER 19, 2023

The big pharma company Bristol Myers Squibb (BMS) has recruited contract manufacturing and development organization (CDMO) Samsung Biologics to manufacture a commercial antibody cancer treatment until 2030.

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Manufacturing Contract Manufacturing Pharma Companies Antibody 59

Pharma Marketing Network

OCTOBER 28, 2023

It is a shift from a traditional focus on drug development and marketing to a focus on the patient’s needs. This shift is being driven by advances in digital communication, which are allowing companies to better understand and meet the needs of their patients. What is Patient-Centricity?

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World of DTC Marketing

FEBRUARY 28, 2021

SUMMARY: Pharma companies, like J&J, have received criticism for engaging in illegal activities, such as providing kickbacks and bribes, knowingly shipping adulterated or contaminated drugs to pharmacies, and marketing drugs for unapproved uses. So should we forget all that because they developed a COVID vaccine?

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pharmaphorum

SEPTEMBER 30, 2021

The new guidance is the first of a series that have been promised by the US regulator to develop a framework for regulating RWD, which is increasingly being used by pharma companies to investigate how their medicines perform beyond the controlled environment of clinical trials.

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pharmaphorum

AUGUST 21, 2020

Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. Could AI prevent future pandemics by developing an armoury of drugs that work against all coronaviruses?

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Vaccination Vaccine Regulation Manufacturing 105

Pharmaceutical Technology

JANUARY 31, 2023

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. That leaves three years for pharma companies to prepare. asked panel chair Ipsita Smolinski, MD of consultancy Capitol Street. It’s much needed. It’s a hot area.”

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Drugs Regulation Gene Therapy Insulin 130

pharmaphorum

DECEMBER 21, 2021

Novartis has joined the ranks of big pharma companies developing TIGIT-targeted drugs for cancer, and found its candidate in an existing partner, Chinese biotech BeiGene. Pharma companies are looking at whether blocking TIGIT as well as PD-1/PD-L1 can improve the efficacy of cancer immunotherapy.

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Drugs Antibody Pharma Companies Development 98

Pharmaceutical Technology

DECEMBER 21, 2022

But as the field grows in leaps and bounds, many authorities have prioritised the release of new guidelines, frameworks, and regulations to keep pace with these advances. According to a cross-sectorial survey by the consulting firm Mckinsey & Company , 52% of respondents reported investing in AI this year compared to 40% in 2018.

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Regulation Pharma Companies Medicine Clinical Trials 351

pharmaphorum

FEBRUARY 14, 2022

The pandemic also saw a reduction in the overall development cycle of a product, which has been growing in recent years. In 2020, the development cycle averaged 7.14 This can be understood through the accelerated development cycles experienced on COVID-19 treatments and vaccines. years, which was reduced during 2021 to 6.9

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pharmaphorum

JULY 8, 2022

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. We have also seen the regulators actively support the use of these hybrid decentralised research approaches. New sensor technology revolutionising data collection. Novel digital endpoints.

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Clinical Trials Clinical Trials Trials Regulation 92

pharmaphorum

DECEMBER 15, 2022

When capturing medical and field insights you have to comply with numerous regulations relevant to the world of data privacy – a challenge often compounded by the many different variables that govern the process of insight capture and analysis. Business Development Account Manager. Capturing Medical Insights With Zero-Risk.

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Regulation Compliance Pharma Companies Business Development 52

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 regulators are okay with immunogenicity studies we aim to start vaccinating (with updated version) in the autumn,” he added.

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pharmaphorum

JANUARY 8, 2021

The global pandemic has caused pharma companies to invest in digital marketing, as healthcare systems across the world adapt to strict lockdown rules. Healthcare companies have been in the vanguard of this change, with an enormous rise in the use of telehealth and all forms of digital communications. Will we go back to that?

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Marketing Doctors Doctor Pharma Companies 86

pharmaphorum

DECEMBER 22, 2021

Gyroscope Therapeutics and its gene therapy for the sight-robbing disease geographic atrophy (GA) has been acquired by a big pharma company – but likely not the one you would expect. CFI regulates the activity of the complement immune system which is over-activated in GA. It has been fast-tracked by the FDA.

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Gene Therapy Gene Licensing Licensing 105

pharmaphorum

FEBRUARY 1, 2021

Biogen filed aducanumab with the FDA in July last year and the regulator granted a faster six-month Priority Review in August lasty year. Development of aducanumab has been far from straight forward. With the extension the FDA is now due to make a decision on aducanumab by 7 June.

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Pharma Companies Drugs Regulation Development 85

pharmaphorum

DECEMBER 9, 2022

The PharmaStars accelerator was set up last year to help bridge the gap between digital health start-ups and potential pharma partners, which can be instrumental in making sure their technologies meet their potential – and help them to navigate the challenges of developing them in the highly regulated healthcare environment.

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pharmaphorum

JUNE 16, 2022

There are already more than 30 DiGAs that have approved for use by the BfArM medical regulator and are covered by the national GKV health insurance system. Germany recorded almost 70,000 new cases of breast cancer in 2020, according to World Health Organization (WHO) figures, accounting for 11% of all forms of cancer.

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Hormones Pharma Companies Regulation Drugs 99

pharmaphorum

JANUARY 6, 2021

The regulator said it wanted more long-term safety and efficacy data from the REGENERATE study before making a final decision on the drug, which had been expected to be the first entrant into a likely multi-billion dollar market niche. The post High hopes as Inventiva takes NASH contender into phase 3 appeared first on.

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Gene Silencing Regulation Pharma Companies Doctors 52

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

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

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

pharmaphorum

JUNE 14, 2021

Rebecca Sanders from Lipodystrophy UK tells us how the patient voice helped convince NICE to approve a much-needed drug for this rare disease, and explores how regulators and pharma companies can help make patient involvement in HTA more impactful. This article appears in our free digital magazine Deep Dive: Market Access 2021.

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Drugs Pharma Companies Licensing Licensing 100

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.

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Medicine Pharma Companies Vaccination Vaccine 119

pharmaphorum

FEBRUARY 18, 2021

“Pfizer and BioNTech are taking the necessary steps, making the right investments, and engaging in the appropriate conversations with regulators to be in a position to develop and seek authorisation for an updated mRNA vaccine or booster once a strain that significantly reduces the protection from the vaccine is identified.”

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pharmaphorum

JANUARY 24, 2022

“The cost of developing a new drug is extortionately high,” said Landray, adding that a very large proportion of those costs is in phase 3, and that means many promising therapies may never be taken forward by pharma companies.

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Drug Discovery World

DECEMBER 27, 2023

Developing. Ng is working on critical challenges in clinical trials, specifically in planning and recruitment, and has been building innovative solutions designed to benefit patients and researchers – with a focus on efficiency, transparency and diversity in clinical development. DDW Highlights Innovative. Listen here. Listen here.

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Clinical Trials Clinical Trials Drugs Development 69

World of DTC Marketing

JUNE 24, 2021

Safety pages on Pharma product websites continue to have high utility. As we have seen over the past few years, Pharma companies are a business, a regulated business, but still a business. Only requirement in TV ads should be for “boxed” products.

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pharmaphorum

APRIL 22, 2021

Biosensor firm physIQ has licensed its technology to Johnson & Johnson’s Janssen pharma unit in a multi-year deal, to investigate use of wearable sensors in virtual clinical trials. The pharma company will use the technology known as accelerateIQ to collect data across its clinical studies through a variety of wearable biosensors.

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Drug Discovery World

FEBRUARY 6, 2024

From finding potential active substances and identifying novel targets, to simulating how drugs will function in the human body and optimising laboratory workflows, digital technologies are having a significant impact on drug discovery and development.

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Marketing Medicine Genome Genomics 69

XTalks

MARCH 28, 2024

The FDA’s approval of Duvyzat for DMD, based on our robust and successful clinical development program, reflects Italfarmaco’s commitment to providing a safe and proven-effective therapy that can have a meaningful impact for people living with DMD,” said Paolo Bettica, MD, PhD, chief medical officer at Italfarmaco Group in a press release.

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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.

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