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Increasing patient engagement with UK clinical trials

pharmaphorum

Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. Gareth has been with the Clinical Research Network since 2009. Embedding the patient voice not only in research, but everything they do.

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How to get acquisition ready – a seller’s guide to merger and acquisition in pharma

pharmaphorum

In 2018, over 60% of all new molecular entities came from smaller biopharma firms, compared with just over 30% in 2009. So, how do smaller pharmaceutical companies at the cutting edge get ready for their acquisition milestone, so they maximise their value and attractiveness?

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Bridging the healthcare digital divide: a gradual approach to adopting ePI

European Pharmaceutical Review

These standardised documents provide meticulously curated and scientifically approved information. The responsibility of printing paper leaflets is currently a key regulatory obligation for pharmaceutical companies. They detail the medication’s intended use, proper administration, potential side effects and precautions.

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Biogen’s $900 million settlement signals scrutiny on speaker fees

Pharmaceutical Technology

Bringing an end to a 13-year deliberation on a whistleblower lawsuit, Biogen recently agreed to pay a $900 million settlement , amidst increased government alertness on pharmaceutical fraud. In 2009, Tysabri was performing well, having yielded $776 million in sales after being first approved in 2004, as per Biogen’s 2009 financial filings.

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Case Study 1 – Establishment of a Long-Term Medical Writing Partnership

Impact Pharmaceutical Services

In 2009, IMPACT (now part of Syner-G BioPharma Group) was contracted by a mid-size global pharmaceutical company to prepare 2 Phase 3 clinical study reports (CSRs) for a biologic agent for the treatment of Crohn’s disease. Download a PDF of this case study. Establishment of a Long-Term Medical Writing Partnership.

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Why Are FDA Inspections So Ineffective and Disappointing?

The People's Pharmacy

There have been problems with records in the past: deceit, falsification of documents and even outright fraud. Since the start of 2013, pharmaceutical companies based in the U.S. The FDA apparently gave the company a green light to keep manufacturing and allowed ongoing generic drug export to the U.S. Here’s the kicker.

FDA 72
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A Systemwide Approach to Managing the Risks of Continuous Manufacturing

ISPE

One of the most important components of SRM is the company’s risk appetite statement. This document is approved by the firm’s board of directors and sets the tone for risk-taking at the company by key risks and setting risk tolerances for how much risk the board is willing to take across all business activities. April 2009.