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 20, 2023

Following a tumultuous development cycle, DBV Technologies will now have to conduct an additional safety study of its peanut allergy Viaskin patch in toddlers ages 1–3 years, based on written correspondence from the US Food and Drug Administration (FDA).

Food and Drug Administration 52

Food and Drug Administration FDA Safety Prospecting 52

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. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects. New hope for stomach cancer patients.

Patients 104

Patients Food and Drug Administration Side effects Safety 104

European Pharmaceutical Review

OCTOBER 21, 2022

At week 28, the study assessed the vaccine’s safety and levels of anti-HBV surface antibodies (HBsAbs). A two-dose version of the vaccine was approved by the US Food and Drug Administration (FDA) in 2017. Volunteers were administered with additional doses four weeks and 24 weeks into the study.

Patients 96

Patients Food and Drug Administration Side effects Food 96

Clarivate

OCTOBER 7, 2024

Food and Administration (FDA) approval, a change long sought by animal welfare organizations. Drugs can be now cleared for human trials using non-animal technologies developed over the last 10-15 years. Since then, animal-based testing has been the gold standard for establishing a drug’s safety and efficacy.

Food and Drug Administration 52

Food and Drug Administration Pharmacology Food Engineering 52

European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

Pharmaceutical 111

Pharmaceutical Food and Drug Administration Medicine FDA 111

Pharmaceutical Technology

APRIL 18, 2023

Members of the FDA’s Antimicrobial Drugs AdCom voted 12-0 for the drug’s potential approval based on a positive benefit-risk assessment. The agency accepted the drug’s new drug application (NDA) for priority review in November 2022. The application’s PDUFA date was set to 29 May 2023. Entasis is a subsidiary of Innoviva.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Food 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

Food and Drug Administration 122

Food and Drug Administration FDA Medicine Patients 122

European Pharmaceutical Review

JUNE 8, 2023

2 The US Food and Drug Administration (FDA) has recently announced that it will control the quality of tobacco products, particularly e-cigarettes, more closely, to prevent avoidable contamination and help address “inconsistencies between product labelling and actual concentrations” in these products, potentially misleading customers.

Food and Drug Administration 59

Food and Drug Administration FDA Manufacturing Law & Regulation 59

Pharmaceutical Technology

JUNE 9, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of AstraZeneca’s and Sanofi’s respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) prophylactic nirsevimab for use in newborns and infants entering their first RSV season.

FDA 59

FDA Food and Drug Administration Patients Food 59