PPD

JUNE 20, 2023

Prior analyses indicate that recessions can affect drug demand for myriad reasons, including lower utilization of patented biologics and branded drugs, as well as an uptick in utilization of biosimilars and generics. Accordingly, make sure your CRO fosters the use of data so that you’re poised for market access early in the game.

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FDA Law Blog: Biosimilars

JANUARY 3, 2024

CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

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The Pharma Data

MAY 6, 2021

Proposals from the Committee on the Environment, Public Health and Food Safety (ENVI) address how medicines are regulated in the European Union and, to a lesser extent, overseas. The rolling review idea is based on the experience of authorizing COVID-19 vaccines. . The report also addresses bolstering the resilience of supply chains.

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Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. An updated Unified Agenda: The Unified Agenda is the U.S.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

covered insulin product or vaccine). CMS also intends to implement a compliance monitoring program through future regulations or guidance. state pharmaceutical assistance programs).

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Agency IQ

JUNE 2, 2023

The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. The content of the PMI : The regulation describes, in broad terms, what must be included in the PMI. Eliminating duplication : The proposed regulations aren’t only intended to be additive.

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The Pharma Data

JANUARY 26, 2021

Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Dr. Reddy’s operates in markets across the globe.

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The Pharma Data

FEBRUARY 8, 2021

IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. 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. 2,3 In the U.S.,

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The Pharma Data

JULY 8, 2021

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. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

The GAO Report further explained that the agency did not have the resources to regulate the estimated 100,000 OTC drugs marketed through the monograph process. Things got so bad that Congress acted to shield vaccine manufacturers from liability in order to ensure sufficient availability of vaccines.

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The Pharma Data

MAY 15, 2023

Before joining Solvias Group, Karen held various senior leadership roles at Novartis, including global head investor relations from 2000 to 2006, head M&A and Executive Committee member, as well as site head for the Vaccines & Diagnostics division between 2006 and 2011.

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Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

MAY 31, 2024

What we expect European regulators to do in June 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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The Pharma Data

MAY 4, 2021

to $3.65, Primarily Reflecting Updates to Anticipated Contributions from BNT162b2 Partially Offset by Additional R&D Expenses for Vaccines to Protect Against COVID-19 as Well as Other mRNA-Based Development Programs and COVID-19 Antivirals. Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 Adjusted Income (2).

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Agency IQ

DECEMBER 1, 2023

What we expect European regulators to do in December 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Regulations Clinical Trials Production Biosimilars 40

The Pharma Data

MAY 3, 2021

Feds rethink vaccination strategy as slowing demand reveals stark divide ( Politico ). US to launch trade talks on COVID-19 vaccine distribution ( AP ) ( CNBC ). Next Generation of Covid-19 Vaccines Could Be Pill or Spray ( WSJ ). In Focus: US. In Focus: International.

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The Pharma Data

MAY 14, 2021

Fully vaccinated people can shed their masks in most places – CDC ( Reuters ) ( STAT ). US diplomats: Send vaccine overseas now or China, Russia will win out ( Politico ). WHO urges rich countries to donate shots instead of vaccinating children ( Reuters ). India’s Dr. .

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The Pharma Data

MAY 17, 2021

Covid-19 Drugmakers Take On Your Favorite TV Shows to Tackle Vaccine Hesitancy ( WSJ ). US Supreme Court denies Sandoz petition to review biosimilar Erelzi case ( Press ). US Supreme Court denies Sandoz petition to review biosimilar Erelzi case ( Press ). In Focus: US.

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FDA Law Blog: Biosimilars

NOVEMBER 18, 2024

Although not altogether surprising, the formality of an official announcement still came as a shock to many of us who work in areas regulated by HHS, as well as to many others in the public health arena. He has equated vaccination to the Holocaust and argued that COVID-19 was “ethnically targeted” to spare Ashkenazi Jews and the Chinese.

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