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Related Concept Videos

Drug Regulation01:25

Drug Regulation

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Drug Control Governance: Regulatory Bodies and Their Impact01:03

Drug Control Governance: Regulatory Bodies and Their Impact

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Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
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Clinical Trials: Overview01:11

Clinical Trials: Overview

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Drug Discovery: Overview01:26

Drug Discovery: Overview

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Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
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Pharmacovigilance01:19

Pharmacovigilance

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
769
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

405
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
405
  1. Home
  2. Research Domains
  3. Commerce, Management, Tourism And Services
  4. Accounting, Auditing And Accountability
  5. Auditing And Accountability
  6. A Case Study Assessing The Impact Of M&a And Licensing On Fda Drug Approvals Of Leading Pharmaceutical Companies.
  1. Home
  2. Research Domains
  3. Commerce, Management, Tourism And Services
  4. Accounting, Auditing And Accountability
  5. Auditing And Accountability
  6. A Case Study Assessing The Impact Of M&a And Licensing On Fda Drug Approvals Of Leading Pharmaceutical Companies.

Related Experiment Video

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

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A case study assessing the impact of M&A and licensing on FDA drug approvals of leading pharmaceutical companies.

Alexander Schuhmacher1, Kyrylo Grinchenko2, Oliver Gassmann2

  • 1Technische Hochschule Ingolstadt Germany; University of St Gallen Switzerland.

Drug Discovery Today
|February 3, 2025

View abstract on PubMed

Summary
This summary is machine-generated.

Leading pharmaceutical companies

Keywords:
FDA approvalsM&APharma R&DR&D intensity

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Automated Acoustic Dispensing for the Serial Dilution of Peptide Agonists in Potency Determination Assays
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Related Experiment Videos

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

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Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation
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Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation

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Automated Acoustic Dispensing for the Serial Dilution of Peptide Agonists in Potency Determination Assays
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Automated Acoustic Dispensing for the Serial Dilution of Peptide Agonists in Potency Determination Assays

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Area of Science:

  • Pharmaceutical R&D and Drug Discovery
  • Biotechnology and Life Sciences
  • Healthcare Economics and Management

Background:

  • Despite increased FDA new drug approvals, pharmaceutical companies face R&D productivity challenges.
  • Understanding R&D drivers is crucial for optimizing drug development pipelines.
  • The study addresses the need for better insights into R&D concept context and output correlation.

Purpose of the Study:

  • To systematically assess the impact of R&D expenditures, R&D intensity, mergers & acquisitions (M&A), and licensing agreements on new drug approvals.
  • To identify key R&D factors influencing the success of leading pharmaceutical companies.
  • To provide data-driven insights for strategic R&D investment and decision-making.

Main Methods:

  • Systematic assessment of R&D data from leading pharmaceutical companies (2012-2021).
R&D productivity
R&D strategy
collaboration
drug licensing
  • Analysis of correlations between R&D expenditures, R&D intensity, M&A deals, licensing agreements, and new drug approvals.
  • Statistical evaluation of the impact of various R&D strategies on drug development outcomes.
  • Main Results:

    • R&D expenditures show a positive correlation with the number of new drug approvals.
    • The number of mergers & acquisitions (M&A) deals also correlates positively with new drug approvals.
    • No significant correlation was found between R&D intensity or licensing agreements and new drug approvals.

    Conclusions:

    • R&D spending and M&A activity are key drivers for new drug approvals in leading pharmaceutical firms.
    • R&D intensity and licensing agreements appear less impactful on the number of drug approvals.
    • Strategic focus on R&D investment and M&A may enhance pharmaceutical innovation and market success.