pharmaphorum

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.

FDA 115

FDA Food and Drug Administration Patients Food 115

Pharmaceutical Technology

JUNE 15, 2023

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

Food and Drug Administration 52

Food and Drug Administration Side effects Recruitment Safety 52

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.

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Marketing Pharma Food and Drug Administration Media 40

Pharma Leaders

MAY 8, 2023

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. Nexus Pharmaceuticals stated that the regulatory approval process validates facilities’ compliance with stringent quality and safety standards.

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Manufacturing Food and Drug Administration FDA Pharmaceutical manufacturing 52

Pharmaceutical Technology

SEPTEMBER 15, 2022

Valeo Pharma and Veru have signed a commercial services agreement in Canada for sabizabulin as a treatment for Covid-19. Due to clear clinical efficacy without any safety concerns, the Independent Data Monitoring Committee stopped the trial. The proportion of mortality by day 60 was the trial’s primary endpoint.

Food and Drug Administration 52

Food and Drug Administration Food Pharma Safety 52

European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 5) monitoring access to biosimilars. Senate Bill 562 (S.

Food and Drug Administration 52

Food and Drug Administration Pharma Prescription Manufacturing 52

European Pharmaceutical Review

NOVEMBER 15, 2022

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 85

Manufacturing Pharma Food and Drug Administration Safety 85

European Pharmaceutical Review

JUNE 27, 2023

For World Microbiome Day on 27 June 2023, EPR put questions to Hervé Affagard, CEO and co-founder of MaaT Pharma and Jeffrey Silber, Chief Medical Officer of Vedanta Biosciences, to find out how the field is progressing and what innovations could transform future microbiome-based therapies.

Food and Drug Administration 98

Food and Drug Administration Manufacturing Medicine Pharma 98

Clarivate

NOVEMBER 13, 2023

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them.

Patients 52

Patients Food and Drug Administration FDA Safety 52

Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. The list, designed to serve as a reference point for prioritized drug review and evaluation policies, included 121 rare diseases. [8]. 10] [11] [12].

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Patients Food and Drug Administration Marketing Pharma 52

Clarivate

NOVEMBER 10, 2022

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them.

Patients 52

Patients Food and Drug Administration FDA Safety 52

Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors. However, there is still some use of remote patient monitoring technologies.

Food and Drug Administration 52

Food and Drug Administration Electronics Healthcare Healthcare 52

Clarivate

MARCH 17, 2022

Drug developers often face a Catch-22 regarding clinical trials and pregnancy. How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? Panelists were asked to discuss the potential use of the drug during pregnancy.

Food and Drug Administration 10

Food and Drug Administration Safety FDA Ethics 10

Pharmaceutical Technology

MARCH 22, 2023

Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. In recent times, suppliers have also chosen other systems that rely on blockchain and sensors to track drug supply and reduce the influx of counterfeit drugs.

Food and Drug Administration 105

Food and Drug Administration Electronics Pharma FDA 105

World of DTC Marketing

JUNE 8, 2021

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company. standards for approving new drugs”.

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FDA Food and Drug Administration Patients Biopharma 207

Evolve Your Success

MAY 17, 2022

You know when they are trying to push a drug and white-knuckling it. You ask the hospital administrators to figure out the financial aspects of that side of it. We are going to be the change for healthcare because we are the boots on the ground and so are you. What drugs are we using? You do not even have to say it.

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Medical sales Medical Sales Patients 52

Impetus Digital

NOVEMBER 14, 2022

It is no secret that Pharma (still) has a major diversity problem. We know from real-world evidence that drug efficacy and safety can differ based on age, sex, race, and ethnicity; these discrepancies may jeopardize treatment outcomes in undertested groups. Mobile health technologies and remote monitoring.

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Pharma Recruitment Food and Drug Administration Patients 90

Clarify Health

NOVEMBER 9, 2022

However, some communities have historically been underrepresented in clinical research due to barriers like a lack of access, awareness, and trust in drug development processes. Pharma companies have accelerated to address diversity, ethnicity, and inclusion (DE&I) in their clinical trials. Current FDA guidance.

Pharma 40

Pharma Food and Drug Administration Medicine Patients 40

Clarify Health

NOVEMBER 9, 2022

However, some communities have historically been underrepresented in clinical research due to barriers like a lack of access, awareness, and trust in drug development processes. Pharma companies have accelerated to address diversity, ethnicity, and inclusion (DE&I) in their clinical trials.

Pharma 40

Pharma Food and Drug Administration Patients Medicine 40

Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug. Proteus’s profile grew considerably; it was soon valued at $1.5

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Food and Drug Administration FDA Medicine Patients 122

Pharmaceutical Technology

APRIL 12, 2023

However, according to the US Food and Drug Administration (FDA), non-human primates are still the most scientifically relevant large model to test biologic drugs for safety. This is to ensure patient safety, as outlined in The Medicines for Human Use (Clinical Trials) Regulations 2004.

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Pharma Food and Drug Administration Safety Medicine 98

World of DTC Marketing

OCTOBER 7, 2020

HEY NOW: The number of people who said that they would get a COVID vaccine is dropping rapidly because they don’t trust the FDA, drug companies, or the government to approve fully tested medications. Simple, they don’t trust the current administration to approve a vaccine without thorough testing.

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Healthcare Healthcare Food and Drug Administration Media 233

Pharmaceutical Technology

APRIL 26, 2023

Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The role of primary packaging has extended beyond the primary objectives of sterility, physical and chemical protection, and security.

Manufacturing 52

Manufacturing Medical Food and Drug Administration Pharmaceutical 52

World of DTC Marketing

SEPTEMBER 22, 2020

Under no circumstances can ANY pharma company allow this administration to fastback a COVID vaccine for political purposes. To do so would derail our drug safety and lead to patients and HCP’s to question all prescription drug data. Pharma has to fight with everything in their arsenal.

Food and Drug Administration 181

Food and Drug Administration Pharma Food Insurance 181