Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. FDA continues to approve the most NASs. Changes in company strategy.

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Medicine Food and Drug Administration FDA Healthcare 98

PM360

OCTOBER 25, 2023

Between May 1, 2016, and May 31, 2021, 42% of all U.S. Food and Drug Administration (FDA) oncology approvals were for drugs used in combination. When 1+1 ≠ 2 In theory, combining two or more branded agents can lead to a price that exceeds SoC monotherapy. References: 1. Benjamin, Alexander Xu, Mark P.

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Food and Drug Administration Manufacturing Marketing Pharmaceutical manufacturing 105

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.

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Patients Food and Drug Administration Side effects Safety 82

European Pharmaceutical Review

NOVEMBER 4, 2022

Nevertheless, chemotherapy’s disadvantages, including substantial toxicities, combined with inconvenient hospital-based intravenous (IV) administration, impede patients’ ability to stay on treatment and their quality of life. tumour effects. The importance of taxanes in oncology.

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Food and Drug Administration FDA Pharmaceutical Patients 80

European Pharmaceutical Review

AUGUST 17, 2022

million of these, 2 meaning drug-resistant infections killed more people than HIV/AIDS (864,000 deaths) or malaria (643,000 deaths). Steve Brooks, Manufacturing Lead at the AMR Industry Alliance (Advisor to the Alliance): AMR is multifaceted; there are many potential causes, including environmental ones.

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Manufacturing Food and Drug Administration Management Pharmaceutical manufacturing 85

PM360

AUGUST 9, 2022

EPA Administrator Michael Regan said the agency will take more aggressive action against PFAS. Since 2016, the EPA put health advisories on PFAS levels of more than 70 parts per trillion, but now the EPA warns that the chemicals are in fact dangerous even at levels near zero. Drug Approvals. FDA Update.

Healthcare 52

Healthcare Healthcare Food and Drug Administration FDA 52

PM360

OCTOBER 25, 2023

Drug Enforcement Administration (DEA) that cannabis be moved from a Schedule I Controlled Substance to a Schedule III Controlled Substance under the federal Controlled Substances Act. On August 30, the U.S. Department of Health and Human Services (HHS) made a recommendation to the U.S. What’s Next if Rescheduling is Approved?

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Food and Drug Administration FDA Insurance Medical 119

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics.

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Food and Drug Administration Manufacturing Safety Pharmaceutical 87

European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline.

Food and Drug Administration 76

Food and Drug Administration Safety Patients Leads 76

Clarify Health

MAY 27, 2022

The US Food and Drug Administration (FDA) recently announced new draft guidance for life science companies on increasing diversity and inclusion in clinical trials to improve enrollments of underrepresented racial and ethnic populations.

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FDA Food and Drug Administration Recruitment Transportation 52

Clarify Health

MAY 27, 2022

The US Food and Drug Administration (FDA) recently announced new draft guidance for life science companies on increasing diversity and inclusion in clinical trials to improve enrollments of underrepresented racial and ethnic populations.

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FDA Food and Drug Administration Recruitment Transportation 52

Pharmaceutical Technology

MAY 17, 2023

The US Food and Drug Administration (FDA) has awarded an orphan drug designation to Intercept Pharmaceuticals’ fixed-dose combination of obeticholic acid and bezafibrate for the treatment of primary biliary cholangitis. This results in bile buildup in the liver and can lead to scarring. billion in 2029.

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Food and Drug Administration FDA Pharmaceutical Prospecting 52

Pharmaceutical Technology

APRIL 6, 2023

Verismo Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its investigational new drug, SynKIR-110. The investigational drug has been developed for treating patients with mesothelioma, a rare type of cancer that impacts abdominal cavities or the chest lining.

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FDA Food and Drug Administration Medical Food 52

World of DTC Marketing

APRIL 7, 2022

The seventh leading cause of death in the United States, diabetes costs $327 billion in medical costs and lost work and wages. Launch prices of new cancer drugs in the U.S. Food and Drug Administration (FDA). billion estimated cumulative spending on the new oral targeted cancer drugs by the end of 2018.

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Healthcare Healthcare Food and Drug Administration Government 215