H1 Blog

NOVEMBER 15, 2023

Since KOLs play such a critical role, engaging with the right KOLs is a key strategy for pharmaceutical companies to stay ahead of the game. Compliance ensures that interactions between pharmaceutical companies and KOLs are transparent, fair, and free from any undue influence.

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The Pharma Data

JULY 28, 2021

Teva Pharmaceutical Industries Ltd. As one of the largest manufacturers of affordable generic medicines, Teva saves patients and payers around the globe billions of dollars each year in lower prescription-drug costs,” said Alex Brill, CEO of MGA. Teva saved the United States $28.8 billion in 2020, $4.2 Source link: [link].

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Agency IQ

JULY 7, 2023

What is the state of pharmaceutical quality in the U.S.? Call it murky A new report published by the FDA’s Office of Pharmaceutical Quality (OPQ) promises a look at the current “State of Pharmaceutical Quality.” Read AgencyIQ’s analysis of FDA’s QMM White Paper here.]

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The Pharma Data

DECEMBER 28, 2020

Scopus is a biopharmaceutical company whose lead drug candidate is a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers. Russell has extensive leadership experience across diverse disciplines at numerous private and public biopharmaceutical, biotechnology and pharmaceutical companies. NEW YORK , Dec.

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PPD

DECEMBER 19, 2023

While the FSP model is growing in popularity and serves a critical role in pharmaceutical development, getting the most out of this model requires dedicated roles to drive implementation, communications and planning. Ready to fuel more efficient drug development?

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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

DECEMBER 17, 2020

The analysis of metals in pharmaceutical actives (API), raw material, and drug products has changed as well. Today’s technology has not only changed the way we receive information, but has continually adapted and progressed how we acquire information. ICP-MS/OES has emerged as a critical analytical platform for this analysis.

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PPD

JULY 9, 2024

Companies developing new drugs and inventing new medical devices face a wide range of challenges. This requires an expert RA team capable of processing large volumes of routine submissions to support any changes to manufacturing, market expansion, or safety and quality reporting — for every drug or device in the company’s portfolio.

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The Pharma Data

NOVEMBER 16, 2020

To ensure the safety, quality and efficacy of a drug product prior to market roll out, it is critical life sciences companies can uphold the integrity and security of the data generated throughout an entire product’s lifecycle. For further information on how we process and monitor your personal data click here.

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Conversations in Drug Development Trends

MARCH 7, 2024

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

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Agency IQ

FEBRUARY 21, 2024

In 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the “strongly recommended format” for submission of applications to the FDA. The format and organization of the CTD is outlined in the ICH M4 Guideline.

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FDA Law Blog: Biosimilars

JANUARY 24, 2024

We identify R&D opportunities to promote the development of innovative biomanufacturing pathways that could address supply chain bottlenecks for critical drugs, chemicals, and other materials. Louis, Missouri, APIIC convened a working group of 15 experts in an event titled “Pathway to Build Supply Chain Resilience for Critical Drugs.”

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Alta Sciences

OCTOBER 28, 2024

White Paper: Whole Genome Sequencing, Proteomics, and Function Characterization of the Sinclair Nanopig™ Discover how the Sinclair Nanopig™ is transforming nonclinical safety assessments. Read the white paper. Issue 41 of The Altascientist focuses on bioanalytical testing for immunomodulatory drugs. Watch it now.

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PPD

NOVEMBER 18, 2024

Regulatory oversight is foundational to the safe and effective development and commercialization of new drugs and medical devices. However, in the modern biotech and pharmaceutical industry, a PV RI team needs to do more than just monitor ever-changing regulations.

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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. , Smith rejected plaintiff’s analogy between books and drug package inserts. Paddock Pool Construction Co. ,

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