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.

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Food and Drug Administration Manufacturing Medicine Pharma 98

European Pharmaceutical Review

MAY 29, 2023

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. Tanzini et al.

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Food and Drug Administration Manufacturing Pharma Pharmaceutical 72

European Pharmaceutical Review

JULY 5, 2022

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. Oncoral (Ascelia Pharma) is a novel patented tablet formulation of irinotecan, currently in Phase II clinical development, for daily dosing at home.

Patients 83

Patients Food and Drug Administration Side effects Safety 83

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.

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Patients Food and Drug Administration FDA Safety 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

Lower DCT usage for Phase I studies may be accounted for due to the heavier focus on safety and efficacy, and increased monitoring of trial participants in-person. Metabolic disorders have remained the leading therapy area for DCT adoption for over five years, mainly due to the use of wearables, such as glucometers, and other smart devices.

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Food and Drug Administration Electronics Healthcare Healthcare 52

World of DTC Marketing

DECEMBER 29, 2020

All vaccines go through clinical trials to test safety and effectiveness. For the COVID-19 vaccine, the Food and Drug Administration (FDA) set up rigorous standards for vaccine developers to meet. Let’s also remember that pharma is going to make a LOT of money on these vaccines.

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Pharma Food and Drug Administration Media Food 307

Pharmaceutical Technology

FEBRUARY 1, 2023

The US Food and Drug Administration (FDA) has granted approval for Ellipses Pharma’s investigational new drug (IND) application for EP0042 to treat acute myeloid leukaemia (AML). The post US FDA approves Ellipses Pharma’s IND for AML therapy appeared first on Pharmaceutical Technology.

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Food and Drug Administration FDA Recruitment Food 52

Pharma Leaders

MARCH 21, 2023

The US Food and Drug Administration has granted fast track designation to Prestige Biopharma’s PBP1510 (Ulenistamab) to treat unresectable or metastatic pancreatic adenocarcinoma (PDAC). It will also lead to the development of acquired resistance to chemotherapeutic agents.

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Food and Drug Administration Safety FDA Food 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. Importance of the human aspect.

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Pharma Recruitment Food and Drug Administration Patients 90

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. What drugs are we using? This office or rep prescribed this drug and this is what I want you to know about this drug.”. You do not even have to say it.

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Medical sales Medical Sales Patients 52

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

European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. Being a cellular therapy that involves cell manipulation and molecular transfection – and above all, being a living drug – makes CAR T-cell therapy a somewhat challenging immunotherapy to manufacture in‑house.

Manufacturing 83

Manufacturing Food and Drug Administration Patients Pharma 83

World of DTC Marketing

SEPTEMBER 28, 2020

Will it lead to an early approval with limited testing or will J&J ensure the vaccine goes thru thorough testing? So the question becomes could the current administration try and approve a COVID-19 vaccine without complete testing in order to try and win votes from a public who is scared of COVID? OK, NOW WHAT?

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Food and Drug Administration Pharma Side effects Food 163

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.

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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.

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Food and Drug Administration Pharma Food Insurance 181

Pharmaceutical Technology

FEBRUARY 23, 2023

Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).

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Food and Drug Administration Pharmaceutical Food Side effects 98