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Determining the right regulatory pathway for your drug
12 July 2023 | By Altasciences
Understanding the different regulatory pathways available is critical to getting your drug to market as quickly and safely as possible.
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Biopharmaceuticals
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IFPMA reveals new CEO leadership lineup
CEOs from Pfizer, Roche and Daiichi Sankyo will join the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)’s new CEO leadership team.
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Post-approval R&D key in advancing oncology treatments
The Pharmaceutical Research and Manufacturers of America (PhRMA) has highlighted in a new report five R&D mechanisms that could facilitate full clinical value of oncology treatments after initial approval from the US Food and Drug Administration (FDA).
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WuXi Biologics proposes spin-off to support bioconjugate development
WuXi Biologics proposed spin-off and a separate HKEX listing of its subsidiary WuXi XDC means the company will be able to better capture the fast-growing global bioconjugate market.
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Bispecific antibody approved in Europe for DLBCL
European approval of the bispecific antibody treatment has the potential to change the current standard of care in diffuse large B-cell lymphoma (DLBCL).
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ebook: Accelerate the development of your small molecule
Altasciences’ Proactive Drug Development can accelerate the development of small molecules by up to 40%, from lead identification to clinical POC.
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Video: The EU Annex 1 Good Manufacturing Process (GMP) updated requirements
How the GMP requirements affect the manufacturing of sterile medicinal products from European Member States and products imported from outside Europe.
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Capsule formulation: future trends
In this Q&A, Recipharm’s Torkel Gren discusses developments in capsule formulation, including the shift away from gelatine and the potential for growth in the inhalation capsule market.
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Could faecal transplants improve melanoma immunotherapy?
In the first clinical trial of its kind, faecal microbiota transplants (FMT) were shown to improve immunotherapy response in advanced melanoma.
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Innovative PAT-based filtration strategy reported for continuous biomanufacturing
The PAT-based approach is the first of its kind to prevent membrane fouling when using a robust single-pass tangential flow filtration (SP-TFF) operation in bioprocessing, according to a paper.
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Innovation key for boosting UK biopharma competitiveness
Solutions for technology and government policy to address current challenges and drive economic growth in biopharma and Medtech have been recommended in new reports.
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Sustainable pharmaceuticals: what about pine-based painkillers?
UK researchers have developed two of the world’s most common painkillers from a pine-derived compound, meaning new sustainable turpentine-based pharmaceuticals could be on their way.
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BioNTech to support trial access for cancer immunotherapies
Signing of a major agreement between BioNTech SE and the UK government for cancer trials means more patients could access personalised immunotherapies.
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Clinical research organisation market anticipated to reach $140bn by 2033
According to a report, growing demand for cost-effective and efficient drug development processes is propelling the global clinical research organisation (CRO) market.
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PDA revises report on glass container manufacturing
Parenteral Drug Association (PDA)'s 2023 technical report on nonconformities in glass containers during pharmaceutical manufacturing represents best practices for identification and classification.
