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Innovation in pharma manufacturing quality systems

European Pharmaceutical Review

As the emphasis of new drug development gravitates towards new, ground-breaking therapies and vaccines, the requirements of manufacturing sites, equipment and processes need to be appropriate for this new environment. That is because of the relative expense of emerging therapies and the pressure on pricing for continuing product lines.

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Navigating the Challenges of Biopharma Product Launches: A Blueprint for Success

PM360

Embarking on the journey from product development to market success in the biopharma industry is no small feat. According to a McKinsey report , a startling 40% of biopharma products fail to meet their sales forecasts within the initial two years, prompting a critical reassessment of strategies for product launches.

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EU pharmaceutical legislation revisions: what are the implications for biopharma?

European Pharmaceutical Review

1 The changes form part of the 2020 Pharmaceutical Strategy for Europe will impact pharma and biopharma companies operating in Europe. The first is removal of the RDP extension for pan-EU launch within two years, instead requiring manufacturers to submit to local P&MA processes upon request by the member state.

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Access solutions: the missing link that prevents biopharma innovation from reaching patients

pharmaphorum

Science has taken a vertical growth trajectory, yet such innovations are, at best, slow to reach the patients in need. We believe that innovation in patient access models is the necessary catalyst to aid patients in starting on and staying on the therapies they need to improve their lives.

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Roche to acquire biopharma firm Good Therapeutics for $250m

Pharmaceutical Technology

We have focused on PD-1-IL-2 as a biology that has great potential for benefiting patients.”. The post Roche to acquire biopharma firm Good Therapeutics for $250m appeared first on Pharmaceutical Technology. Subject to necessary clearance, the acquisition is anticipated to conclude in the third quarter of this year.

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What is the future of biologic medicines?

European Pharmaceutical Review

As a result, the market is expected to reach $719 billion by 2030, 1 Sigma Mostafa, PhD, Chief Scientific Officer at KBI Biopharma shared with EPR. These trends have an impact on manufacturing capacity. There are a lot of conjugated products in the clinical pipeline and novel conjugation partners and chemistries are being tried.

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Medicinal cannabis: the route to good manufacturing practice registration

European Pharmaceutical Review

Crucially, January 2023 marked a key moment: the Medicines and Healthcare products Regulatory Agency (MHRA) granted Celadon Pharmaceuticals the first good manufacturing practice (GMP) registration since legalisation in 2018 for high Δ9-tetrahydrocannabinol (THC) cannabis active pharmaceutical ingredient (API).

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