pharmaphorum

APRIL 11, 2022

Dudley Tabakin, CEO of VivoSense, describes how this financing is set to accelerate the development of novel digital biomarkers and improve digital clinical outcome assessments. How can this data be incorporated into clinical trials?”. How can this data be incorporated into clinical trials?”. Tabakin agrees. “In

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Pharmaceutical Technology

JUNE 19, 2023

Pharmaceutical companies are putting their trust in the immense potential this new generation of medicine has for treating individuals with rare genetic diseases, which currently affect an estimated 280 million patients worldwide. Cell and gene therapies are not your typical clinical supply chain.

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The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.

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pharmaphorum

APRIL 11, 2022

Janssen’s Catherine Taylor, vice-president, EMEA medical affairs, therapy area strategy, discusses the importance of systemic innovation across the healthcare system to realise the full value of medicines. Medicines and vaccines are among the most powerful interventions that can help improve quality of life for people across the world.

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Pharmaceutical Technology

DECEMBER 12, 2022

Pharmaceutical companies often outsource different parts of the manufacturing process, including the production of small molecule active pharmaceutical ingredients (APIs) and parenteral packaging, to contract manufacturing organizations (CMOs). Regulatory decisions and clinical trial news.

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Sciensano

MARCH 27, 2024

In 2021, a total of 12 529 counterfeit ivermectin tablets originating from postal packages were seized. These tablets are regularly found in postal packages to this day. It is also being promoted as a low-cost medicine via social media, but there is no clinical evidence to confirm that ivermectin is an effective treatment of COVID -19.

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The Pharma Data

MARCH 3, 2022

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced an initial donation of essential medicines to Ukraine. At the same time we are ensuring that our critical medicines and diagnostics reach the people who need them both in Ukraine and other countries impacted by the crisis. Roche vehemently condemns the violent invasion of the country.

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pharmaphorum

JUNE 1, 2021

Pharmaceutical companies are accountable for ensuring that their medicine is safe when it comes into the hands of patients. Specific apps could also alert healthcare providers if vulnerable patients are failing to scan their medicine. This technology can also play an important role in supporting virtual clinical trials.

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The Pharma Data

JANUARY 13, 2021

. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. MindMed is a psychedelic medicine biotech company that discovers, develops and deploys psychedelic inspired medicines and therapies to address addiction and mental illness.

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pharmaphorum

JANUARY 28, 2021

The Covid-19 pandemic has put further pressure on clinical trial suppliers to be fleet of foot in getting products dispatched when a new patient is recruited, as studies for vaccines have been set up and run at unprecedented speed. . To find out more about the webinar and to register, visit [link] .

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Drug Discovery World

APRIL 27, 2023

BioGenCell has partnered with the University of California San Francisco (UCSF) as part of the company’s Phase II clinical trials. This is part of a worldwide multi-site placebo-controlled trial in dozens of patients across North America, Europe and Asia. This results in grave pain in the feet or toes, even while resting.

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Camargo

MAY 2, 2021

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Note: Some medicines are in more than one category. Product selection.

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Cloudbyz

JUNE 21, 2023

In the world of clinical research, Electronic Data Capture (EDC) systems play a pivotal role in efficiently collecting, managing, and analyzing clinical trial data. The Study Data Tabulation Model (SDTM) is a widely accepted format that ensures consistency and interoperability of clinical trial data.

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Drug Discovery World

MAY 1, 2023

The EC says the revisions will make the system more agile, flexible, and adapted to the needs of citizens and businesses across the EU, as well as making medicines more available, accessible and affordable. High prices for innovative treatments and shortages of medicines remain an important concern for patients and healthcare systems.

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The Pharma Data

MAY 26, 2023

The expansion forms part of Catalent’s ongoing global strategy to increase its ability to handle, store and manage advanced therapies for clinical supply, and follows investments at its facilities in Philadelphia, Singapore, and Shanghai, China, in specialized, ultra-low temperature storage capabilities. With sites in the U.S.,

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Camargo

AUGUST 11, 2021

In this two-part blog series, we will explore the regulatory strategy considerations sponsors should bear in mind when working with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), with a focus on the development of drug and biologic products. Meeting Package Due. Meeting Type. Meeting Purpose.

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Pharmaceutical Technology

SEPTEMBER 26, 2022

Clinical trials were thrown into turmoil on the morning of 24 February 2022, along with every aspect of life in Ukraine. In July, approximately a third of companies had paused a trial in the country. By August, 28 foreign-sponsored, multi-country trials were affected, almost half with sites in Ukraine and Russia. [1].

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Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union. Keep thorough records of approvals for future reference.

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Cloudbyz

AUGUST 9, 2023

Let’s delve into why this method is paramount for the transformation of clinical research management. Unified Data Management Clinical trials generate vast amounts of data, from patient records to lab results and monitoring findings. Flexibility and Customization Not all clinical trials are the same.

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World of DTC Marketing

MARCH 17, 2021

Recently, the opioid epidemic and high charges for both new and old medicines have further alienated the public. collected a pay package worth more than $21 million. They need to be extensively tested in long and expensive clinical trials. Political pressure was mounting in the US, the most profitable market.

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pharmaphorum

JULY 22, 2021

In addition to time pressures, the pandemic exacerbated some of the challenges associated with conducting global clinical trials, including patient recruitment and retention, social distancing measures causing restrictions on patients’ ability to visit trial sites and many more. “We

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Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”.

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Pharmaceutical Technology

NOVEMBER 21, 2022

A lower number of clinical trials and regulatory filings were other important influences behind the decision. In terms of the influence caused by negative changes in international investment in Japan, the pharmaceutical companies that decided to lower their business priority in Japan reported lower pharmaceutical sales.

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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. While many pharma companies are actively working on initiatives to improve diversity in clinical trials, we still have a long way to go.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. ,

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Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union. Keep thorough records of approvals for future reference.

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pharmaphorum

NOVEMBER 22, 2022

Ut comes just as FogPharma is preparing to start clinical trials of alpha-helical polypeptide candidate FOG-001. The Helicons are taken into cells using endocytic trafficking, a process which sees the compounds packaged into folds in the plasma membrane, forming vesicles that are then internalised.

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Drug Discovery World

MARCH 29, 2023

An example of the current disparity, drawn from data from the European Federation of Pharmaceutical Industries and Associations (EFPIA), can be seen in Romania, Poland or Bulgaria, where a recently approved medicine will take more than 800 days on average before it becomes publicly available compared with Germany, where that figure is 133 days 3.

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pharmaphorum

MARCH 3, 2022

The UK biopharma industry has welcomed a new tranche of funding from the government aimed at bolstering manufacturing of medicinal products and developing the national health data infrastructure.

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Pharmaceutical Technology

NOVEMBER 21, 2022

A lower number of clinical trials and regulatory filings were other important influences behind the decision. In terms of the influence caused by negative changes in international investment in Japan, the pharmaceutical companies that decided to lower their business priority in Japan reported lower pharmaceutical sales.

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The Pharma Data

OCTOBER 23, 2020

The results of a new clinical trial, published today in the New England Journal of Medicine , show that dexamethasone—a glucocorticoid used to treat many conditions, including rheumatic problems and severe COVID-19— can boost survival of premature babies when given to pregnant women at risk of preterm birth in low-resource settings.

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pharmaphorum

JUNE 11, 2021

Ocugen is the first company to be affected by the FDA’s recent decision to raise the bar on emergency use authorisations for COVID-19 medicines, and will have to file for full approval of its vaccine candidate. It was given the go-ahead in January, well before Bharat reported phase 3 data suggesting a protective efficacy of 78%.

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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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pharmaphorum

FEBRUARY 10, 2021

It will develop 11 solutions using state-of-the-art computational technologies to test the safety and/or the efficacy of medical devices, medicinal products, and even advanced therapy medicinal products such as tissue engineering constructs for regenerative medicine.

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Drug Discovery World

AUGUST 4, 2022

The growing hospital-to-home trend has motivated drugmakers to convert intravenous medicines into subcutaneous formulations that patients can self-administer. The development of easy to use, intuitive home administration devices, including wearable devices, that can deliver medicines to patients on demand is expanding. Never too early.

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Drug Discovery World

SEPTEMBER 26, 2022

Indeed, having a safety profile already established could entice patients to enter clinical trials more readily than with ‘unknown’ compounds. . Remote trials, wearable devices and advancements in genomic sequencing means that clinical data is now more abundant than ever and is only set to grow. .

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XTalks

FEBRUARY 10, 2023

According to a recent review published in Nature , as of April 2022 almost 1,800 active cell therapy clinical trials were listed in ClinicalTrials.gov, a 33 percent increase from 2021. In a recent webinar, Dr. Vassallo discussed the operational considerations for complex cell therapy clinical trials.

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