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.

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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. Patient focused drug development in alopecia areata clinical trials.

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Patients Food and Drug Administration FDA Safety 52

pharmaphorum

JUNE 27, 2022

7008), which allows manufacturers to share vital information with healthcare payers and plans while treatments are pending Food and Drug Administration (FDA) approval, was passed by the House of Representatives and is awaiting approval in the Senate. The AMCP backed bill (H.R. The history of PIE.

Food and Drug Administration 76

Food and Drug Administration Medical Patients FDA 76

European Pharmaceutical Review

MAY 4, 2023

Martin Vogel, Janssen’s Therapeutic Area Lead Oncology for the Europe, Middle-East and Africa (EMEA) region shared with EPR what makes the BsMAb promising for treating this indication. Why are bispecific monoclonal antibody drugs such as amivantamab promising for this indication? 2017; 8(43): 75712–26. Nan X, Xie C, Yu X, Liu J.

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Food and Drug Administration Safety Medicine Patients 92

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 85

Patients Food and Drug Administration Side effects Safety 85

European Pharmaceutical Review

APRIL 21, 2023

In addition, the number of active substances detected in the environment has been increasing with unknown consequences for ecosystems and the accumulation of substances in food chains. Therefore, another question is how we can obtain reliable, transparent information on older drugs.

Pharma 83

Pharma Food and Drug Administration Medicine Pharmaceutical 83

World of DTC Marketing

MARCH 17, 2022

In recent years, early detection and treatment improvements have helped boost the 3-year survival rate for lung cancer from 21% in 2004 to 31% in 2015 through 2017. But it’s’ still the leading cause of cancer deaths. The Food and Drug Administration approved them, an analysis JAMA Internal Medicine found.

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Food and Drug Administration Medical Ethics Patients 255

Pharmaceutical Technology

MAY 15, 2023

Nirsevimab is still undergoing regulatory review in the US, with the US Food and Drug Administration (FDA) accepting the Biologics License Application (BLA) for nirsevimab in January 2023. Nirsevimab is a long-acting antibody being jointly developed by Sanofi and AstraZeneca as per an agreement made in 2017.

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European Pharmaceutical Review

OCTOBER 19, 2023

One of the aspects of radiopharmaceuticals that is often overlooked is how complicated it is to develop a new agent, in terms of the complexity of drug design to realise a therapeutic candidate and the implementation of the clinical evaluations. Can you share an update on the clinical trial for your lead candidate?

Food and Drug Administration 90

Food and Drug Administration Side effects Manufacturing Doctors 90

Legacy MEDSearch

FEBRUARY 21, 2023

Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable endotherapy device for endoscopic mucosal resections (EMR) and difficult colonoscopies. Since 2017, clinicians in the U.S., Connecticut-based medical device innovator Lumendi, LLC announced that it has received U.S.

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European Pharmaceutical Review

JUNE 28, 2022

According to the World Health Organization (WHO), CVDs are the leading cause of death worldwide accounting for 32 percent of global deaths in 2019 (approximately 17.9 This theory has been supported by the clinical results of drugs such as empagliflozin, the SGLT2 inhibitor, across several of these conditions. 2021 [cited 8 June 2022].

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Food and Drug Administration Medicine Patients FDA 93

Pharmaceutical Technology

JUNE 30, 2022

This will put up a barrier to the traditional system where the drugs are shipped on a direct-to-site basis straight away from the manufacturing facilities to a Georgia storage facility within the location.”. Bolkvadze predicts that another challenge may be found in the increased volume of operations, leading to a capacity shortage.

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Food and Drug Administration Distribution Recruitment Transportation 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

Evolve Your Success

FEBRUARY 7, 2023

In a sense, although I started a surgery center company from scratch in 2017 and we sold that. The foods are put on the trays, then go up to the person who has a diabetic diet. It’s the first drug-eluting heart stent in the world. Do you want to go into healthcare administration? It went up in 2017 or something like that.

Medical 52

Medical Sales Medical sales Doctors 52