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NICE recommends first licenced treatment for AL amyloidosis

European Pharmaceutical Review

NICE’s positive decision, which is detailed in the final appraisal document , follows an appeal against NICE’s original guidance from November 2022. The document highlighted that daratumumab in combination “increases the time until systemic AL amyloidosis gets worse compared with bortezomib plus cyclophosphamide and dexamethasone.”

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Whole genome sequencing and analysis of live biotherapeutic products

European Pharmaceutical Review

The US Food and Drug Administration (FDA) created live biotherapeutic products (LBP) as a new category in the 2012 guidelines. Therefore, characterisation of the microorganism(s) is of utmost importance to LBP quality documentation.

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FDA worried about Pfizer/Lilly pain drug safety ahead of key meeting

pharmaphorum

Safety has been an issue throughout development and in 2012 the FDA put tanezumab on clinical hold because of a class-related issue with joint destruction, which was finally lifted in 2015. Tanezumab is now the most developed of the two remaining drugs in development in the NGF class, in pain caused by osteoarthritis.

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NICE unlocks use of Amarin’s Vazkepa in 425k NHS patients

pharmaphorum

The just-published final technology appraisal document recommends that Vazkepa (icosapent ethyl) can be prescribed to people in England and Wales for adult patients with high-risk cardiovascular disease and elevated levels of triglycerides (1.7 mmol/litre or above) in their blood who are already taking statins. .”

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Annex 1 Implementation Strategies

ISPE

In 2012, there was a proposal for a complete revision which resulted in a concept paper in 2015. Annex 1 of the EC GMP Guide " Manufacture of Sterile Medicinal Products " has a long history. First published in 1989, there have been a total of 5 adaptations in 1996, 2003, 2005, 2007 and 2009, but no complete revision.

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Biogen agrees to pay $900 million in largest FCA Settlement Ever Secured without Government’s Intervention

The FDA Law Blog

district court of Massachusetts by former employee and whistleblower Michael Bawduniak in April 2012 as a qui tam action. Today, these two documents are key in navigating speaker programs in the industry. Wasserstein — On September 26, 2022, Biogen Inc. This lawsuit was brought to the U.S. See United States ex rel. Bawduniak v.

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

Impact Pharmaceutical Services

Given the highly successful working relationship that evolved over time, in 2012 the client established a Strategic Alliance Partnership with IMPACT. In addition, IMPACT manages the compilation of CSR appendices and also performs electronic publishing of the CSR and appendices to ensure all documents are submission-ready.