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Commissioner Makary Charts a New Course for FDA at FDLI Annual Conference

FDA Law Blog: Biosimilars

Many of the Commissioners comments were familiar to those who have followed his podcasts and book rounds: he firmly believes the FDAs regulatory model needs disruption. Its a brandthe greatest in the world, he saidand he thinks that change is needed to live up to that lofty reputation.

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Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA.

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Pharma groups slam US decision to support COVID-19 vaccine patent waivers

The Pharma Data

Pharmaceutical industry groups in the US and the EU lambasted a recent decision by the Biden Administration to support a proposal pending in the World Trade Organization (WTO) that would waive intellectual property patents for coronavirus vaccines, charging that the waiver is a bad idea that would compromise vaccine efficacy and safety.

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Sanofi delivered close to double-digit Q4 2020

The Pharma Data

Vaccines up 14.6%, driven by record demand for differentiated influenza vaccines and continued growth of PPH. to €36,041 million, driven by Dupixent ® (€3,534 million, up 73,9%) and Vaccines. We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks.

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Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER

The Pharma Data

Vaccines up 14.6%, driven by record demand for differentiated influenza vaccines and continued growth of PPH. to €36,041 million, driven by Dupixent ® (€3,534 million, up 73,9%) and Vaccines. We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks.

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PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

The Pharma Data

This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

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FDA accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI

The Pharma Data

Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma. Am Soc Clin Oncol Educ Book. Updated November 17, 2022. Accessed February 2, 2023. 2019;39:207-215.

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