The Pharma Data

JULY 28, 2021

Teva Pharmaceutical Industries Ltd. On behalf of clients, MGA conducts original data analysis, constructs economic models, conducts research, writes white papers and expert reports and offers strategic advice. Teva saved the United States $28.8 billion in 2020, $4.2 Source link: [link].

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The Pharma Data

DECEMBER 28, 2020

Our new directors are well-recognized for their leadership and accomplishments in the biopharmaceutical, biotechnology and pharmaceutical industries, as well as in public capital markets and corporate governance.” Hofstein completed his postdoctoral training and research in the Department of Neurobiology at Harvard Medical School.

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The Pharma Data

JANUARY 7, 2021

The pharmaceutical product landscape is rapidly and fundamentally changing with profound impact on research and development strategy and technology needs. Emerging Technology Needs and Value Proposition for Strategic Partnerships with Contract Development and Manufacturing Organizations (CDMOs).

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The Pharma Data

MARCH 20, 2021

The Kluyver Center for Genomics of Industrial Fermentation in Delft, Holland, is a consortium of several different Universities and Research Centres. Fermentation is used in the production of renewable feedstocks for food products and ingredients, beverages, pharmaceutical compounds, nutraceuticals, through to fine and bulk chemicals.

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Conversations in Drug Development Trends

APRIL 4, 2024

Developing pharmaceuticals is a complex process, requiring stringent bioanalytical method validation guidelines to ensure drug safety and efficacy. To help integrate these various regulatory standards, the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use was founded in 2016.

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Agency IQ

NOVEMBER 10, 2023

BY ALEXANDER GAFFNEY, MS, RAC | NOV 9, 2023 6:35 PM CST Background on CDER’s Office of Pharmaceutical Quality (OPQ) CDER’s Office of Pharmaceutical Quality became operational in January 2015, making it a still relatively recent addition to the agency. Read AgencyIQ’s analysis of FDA’s QMM White Paper here.]

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PPD

DECEMBER 19, 2023

According to industry figures, the use of FSP models grew from 28% to 41% in just three years (2018-2021); by 2022, our internal research shows that nearly two-thirds of outsourcing budgets were allocated to FSP or hybrid FSP/FSO models. Read our white paper to learn the keys to successfully implementing functional service partnerships.

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PPD

JULY 9, 2024

A unique flex hub model that delivers global solutions at scale At the PPD clinical research business of Thermo Fisher Scientific , a typical FSP RA engagement designates a single team to provide oversight across a client’s many products and throughout all their markets. Let’s connect.

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Eye on FDA

NOVEMBER 18, 2021

Media coverage regarding the nomination has been largely focused on concerns expressed by some about Dr. Califf’s past work with pharmaceutical companies in clinical research. Secondly, one actually wants someone who knows research and understands the industry to be the head of FDA.

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The Pharma Data

MARCH 20, 2021

Medicine in Oxford, Biogazelle, a biotechnology company in Ghent, and the Centre For Proteome Research at the University of Liverpool. Vandesompele is a research. the Emmott Lab in the Centre for Proteome Research at Liverpool University. research efforts in further understanding viral-host. In the examples below, we.

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FDA Law Blog: Biosimilars

JANUARY 24, 2024

Fast-forward to March 2023, when The White House OSTP issued a document per Executive Order 14081, titled “ Bold Goals for U.S. Biotechnology and Biomanufacturing; Harnessing Research and Development to Further Societal Goals.” generic pharmaceutical industry, resulting in low profit-margins. bioeconomy.”

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Agency IQ

FEBRUARY 21, 2024

As other health authorities started to require data standards, some, such as Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and China’s National Medical Products Administration (NMPA) decided to opt for CDISC for regulatory submissions. CMS in the United States ).

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Drug & Device Law

JULY 31, 2023

It’s an interesting topic; Eric recently wrote a paper on it , and Bexis is putting together a “white paper” for the Product Liability Advisory Council on the same subject. Medicis Pharmaceutical Corp. , vs. Ortho-McNeil-Janssen Pharmaceuticals , 2013 WL 2917651 (Pa. Paddock Pool Construction Co. , Accord Kreves v.

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