Pharmaceutical Technology

FEBRUARY 24, 2023

The EU is planning a sweeping revision of its pharma legislation in March, the largest change in 20 years. The overhaul will address drug marketing exclusivity length, pricing, patient access, innovation incentives, antimicrobial resistance, clinical trials, supply chain security and shortages, and environmental impact.

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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. Involving patients in discussions.

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XTalks

MAY 6, 2022

In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinical trials. Data security: The clinical trial data is backed-up and secure.

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XTalks

MAY 11, 2023

Clinical trials are essential for the development of new treatments for rare diseases, but they can be complex and challenging to execute. Patient input is a crucial component of rare disease clinical trials, as it can provide valuable insights into the patient experience and inform decisions about study design and implementation.

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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. Take us back to May 2020.

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World of DTC Marketing

FEBRUARY 7, 2022

At 99% of pharma companies, that's a huge no-no. On top of this, “the company also revealed that the Federal Trade Commission and the Securities and Exchange Commission had opened two new, separate investigations into the troubled biotech. At 99% of pharma companies, that’s a huge no-no.

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Pharmaceutical Technology

MARCH 30, 2023

The US FDA has revealed its detailed budget proposal for FY2024, which would require pharma companies to name their active pharmaceutical ingredient (API) suppliers, restart President Biden’s Cancer Moonshot, inject cash into amyotrophic lateral sclerosis (ALS) research, and enforce stricter rules around manufacturing, recalls, and shortages.

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Pharmaceutical Technology

OCTOBER 28, 2022

Designed to explain either the risk management plan (RMP) or clinical trial results (CTR) in a way that a child can understand, lay summaries are now a required document for all clinical trials in the European Union (EU) following changes to EU Clinical Trials Regulations (EU-CTR) regulations earlier this year.

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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

JANUARY 14, 2021

Healthcare technology firm Seqster has introduced a new version of its service that aims to help pharma companies work with patients’ data while on virtual clinical trials. What Seqster does for pharma clinical trials is it brings together in real time a health record for participants.

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Find Me Cure

SEPTEMBER 2, 2020

As part of our patient advocacy efforts, at FindMeCure we are dedicated to creating a bridge between patients and the world of clinical research. This includes spreading clinical trial awareness, connecting patients to the trials they are interested in but also speaking up about the issues in the clinical research industry. .

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Clinical Research Research Clinical Trials Clinical Trials 97

pharmaphorum

JANUARY 24, 2022

” Those trials also need to be large, involve a diverse range of individuals, and able to be run at reduced cost, said Landray. Protas will design and run smart clinical trials through collaborations with charities, foundations, academic research teams and industry partners, and will take on both repurposed and experimental drugs.

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pharmaphorum

JANUARY 26, 2023

Guidance on the way pharma companies communicate about prescription medicines has been updated in the UK to cover use of social media channels for the first time. It has drawn up the guidance with the help of the companies, the ABPI, and UK regulator the MHRA.

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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. It concluded that the clinical efficacy and use of the approach should be further tested, while noting its potential to reduce healthcare costs.

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pharmaphorum

JULY 5, 2021

The handover comes four years after Pamplona Capital Management bought the company for around $5 billion, and just a few weeks after lab tech company Thermo Fisher Scientific agreed to acquire another CRO – PPD – in a deal valued at $17.4

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pharmaphorum

AUGUST 31, 2021

However, if history is any indication, pharma companies have been risk-averse when it comes to fully immersing itself into the expanded use of RWE in our development efforts. The industry has looked to regulators for guidance, and the Food and Drug Administration (FDA) has been quick to respond.

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Clinical Trials Clinical Trials Life Science Trials 89

pharmaphorum

FEBRUARY 14, 2022

A spokesperson for BenchSci, a company focused on developing machine learning applications for medicine development, which provides its technology to 16 of the top 20 pharma companies, spoke to pharmaphorum about where the industry is facing difficulties and the ways in which machine learning could provide a solution.

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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

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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Drug Discovery World

DECEMBER 27, 2023

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. Listen here. Listen here. Listen here.

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Clinical Trials Clinical Trials Drugs Development 69

Pharmaceutical Technology

MAY 24, 2023

By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.

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Camargo

NOVEMBER 11, 2020

In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

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Development Bioequivalency Generic Drugs Production 242

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 63

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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pharmaphorum

MAY 26, 2022

Racial disparities are still commonplace in many clinical trials with white-ethnic groups often overrepresented amongst trial participants. Inadequate clinical trial representations of all populations can therefore leave underrepresented groups vulnerable due to the lack of subgroup-specific data.

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Clinical Trials Clinical Trials Trials Medicine 143

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. Enhancing the clinical trials process.

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Drug Discovery World

MAY 6, 2024

billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1. The city is host to many innovative biotech companies, including relative newcomers Orexa, a company that recently launched its first Phase II clinical trial.

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pharmaphorum

JANUARY 29, 2021

California-based Sangamo Therapeutics is one such company that believes in the powerful potential of in vivo genome editing and regulation, together known as genome engineering, and has built up a sizable preclinical pipeline of genome regulation treatments for diseases such as Huntington’s disease and Amyotrophic lateral sclerosis (ALS).

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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. “As

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Roots Analysis

FEBRUARY 23, 2023

Moreover, in order to be at par with the conventional medicines, several organizations have taken the initiative of validating their product in clinical trials for its safety and efficacy. In fact, the term “digital pills” has been coined due to its ability to compete against the conventional medicines/drugs.

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Drug Discovery World

MARCH 29, 2023

Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care). What are the rNPV effects of forcing pharma companies to pursue new indications requested by third parties, and of opening up the authorisation process to third parties?

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Clinical Trials Clinical Trials Production Medicine 52

Drug Discovery World

FEBRUARY 6, 2024

As AI-designed drugs start to enter large-scale clinical trials, DDW’s Diana Spencer investigates how new digital tools are reinventing and reshaping drug discovery for the future. The company’s platform evaluated more than 11.4

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Marketing Medicine Genome Genomics 69

pharmaphorum

NOVEMBER 4, 2020

Since then the story of Alzheimer’s research has been one of expensive failures as experimental drugs, mainly targeting the amyloid plaques found in the brains of people with the disease, failed to stop or slow cognitive decline in clinical trials.

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Drug Discovery World

APRIL 20, 2023

Regulators are therefore used to seeing cognitive data as primary or secondary outcomes in clinical trials, and are familiar with the instruments and methodological nuances of such data. However, to invest in drug development for this condition, a number of methodological issues will need to be addressed. depression).

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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. According to Hampleton Patners’ latest Healthtech M&A market report2, digital health companies raised a total of $57.2

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pharmaphorum

APRIL 28, 2022

Although they have, by definition, small addressable markets, the treatments cost just as many resources to develop as therapies for more common diseases – sometimes more, because of the added difficulty of finding sufficiently large patient populations for trials and finding disease experts to run them. How big pharma tackles rare diseases.

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pharmaphorum

JANUARY 26, 2021

Clinical trials get more and more digitalised. And with the support of remote sampling, and growing tools for gathering real world evidence about improved quality of life, the clinical trials of the future can be done faster, with lower costs and on a more decentralised basis. Aging in place’ becomes more commonplace.

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