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STAT+: After Canada required pharma to pay fees, drug agency recommended coverage more often

STAT

The analysis tallied a total of 258 approved drugs for which companies submitted applications between 2009 and 2020, and then examined funding recommendations that were subsequently made through December 2020 for most drugs. Recommendations for cancer treatments were reviewed through December 2021.

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Celltrion leads biosimilars deals landscape in South Korea, finds GlobalData

Express Pharma

Nelluri Geetha, Pharma Analyst at GlobalData, comments, South Korea has a long history in manufacturing biologicals and a regulatory pathway for biosimilars was introduced in South Korea in 2009.

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Pharmaceutical Negotiations Decoded: Lessons from the Trenches

Drug Patent Watch

Lessons from Past Pharmaceutical Negotiations Case Study: Merck and Schering-Plough Merger The 2009 merger between Merck and Schering-Plough, valued at $41.1 These may include: Pharmaceutical companies (big pharma and biotech firms) Contract research organizations (CROs) Regulatory bodies (e.g.,

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Pharmacogenomics

RX Note

2009 Clopidogrel Therapy and CYP2C19 Genotype, 2018 EMA recommendations on DPD testing prior to treatment with fluorouracil, capecitabine, tegafur and flucytosine, 2020 Tramadol Therapy and CYP2D6 Genotype, 2021

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Mapping the crisis: How data can help fix America’s growing pharmacy deserts

pharmaphorum

Website and content copyright © 2009- 2025 , pharmaphorum media limited or its licensors; all rights reserved. Website and content copyright © 2009- 2025 , pharmaphorum media limited or its licensors; all rights reserved. pharmaphorum – an EVERSANA company The rights of trademark owners are acknowledged.

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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

International Council for Harmonisation (ICH), 2009. Boca Raton: CRC Press. International Council for Harmonisation (ICH), 2022. Q2(R2) Validation of Analytical Procedures: Text and Methodology. Q8(R2) Pharmaceutical Development. International Council for Harmonisation (ICH), 2005. Q9 Quality Risk Management.

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QbD for biopharmaceutical product lifecycle management

European Pharmaceutical Review

References Innovative Solutions For Bioprocessing Challenges: How MSAT Drives Efficient Tech Transfer. Internet] Samsung Biologics. Available from: [link] Guidance for Industry – Q8(R2) Pharmaceutical Development. Internet] FDA. Available from: [link] Strategic Biomanufacturing Framework And Technologies For Successful Partnership.