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The EU AI Act: will regulation drive life science innovation away from Europe?

European Pharmaceutical Review

This dual-layer certification process can create significant delays, as each framework involves extensive assessments for safety and performance under separate requirements specific to medical device and AI-specific criteria.

Medical 105
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Navigating the regulatory challenge of PFAS for pharmaceutical manufacturers

European Pharmaceutical Review

In the EU, a joint PFAS Restriction Proposal under REACH was submitted, aiming for a full ban by 2028/2030. This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products. How will you ensure that vendors are complying with the requirements?

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Handling HPAPIs safely – what does it take?

European Pharmaceutical Review

There are emerging trends in oncology, with new chemical entities (NCEs) and antibody-drug conjugates (ADC) leading to increased demand for HPAPI manufacturing capabilities. Based on the latest report and data, HPAPI market size is expected to reach $32 billion by 2028. What training is required for employees to handle HPAPIs safely?

Safety 98
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Emerging Trends in Orthopedic Medical Device Industry

Medico Reach

million by 2028. However, this can lead to several issues, such as: Implantation resistance due to reactionary metabolism Allergic reactions to the nickel component found in stainless steel composites Widespread bone destruction due to immunological responses to cobalt particles. The US-based Enovis is leading this new development.

Medical 98
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More big wins for the AstraZeneca-Daiichi Sankyo collaboration

Pharmaceutical Technology

In 2019, Daiichi Sankyo entered a global development and commercialisation agreement with AstraZeneca for Daiichi Sankyo’s lead antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), in a deal worth $6.9bn. GlobalData estimates that global annual sales for datopotamab deruxtecan in the NSCLC setting will exceed $500m in 2028.

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Endometriosis market projected to grow at a CAGR of 10% between 2020 and 2030

Pharmaceutical Technology

GnRH antagonists have an improved safety and efficacy profile compared to the marketed GnRH agonists, which have significant side effects that are unappealing to patients. This therapy is currently in Phase II development and is expected to launch in the US and 5EU in 2027 and 2028, respectively.

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PROTAC development gains momentum, but clinical performance is poor

Pharmaceutical Technology

This makes early R&D less risky, as many lead compounds are discontinued due to inadequate pharmacokinetic profiles and require excessively high dosages to be pharmaceutically active. Non-small cell lung cancer leads as the indication with the highest number of PROTACs in the pipeline, currently sitting at 11 preclinical candidates.