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Novel design proposed for aseptic processing areas
The approach offers key benefits such as facilitating a reduction in the risk of microbial contamination and reduction in the required air change rate in aseptic processing.
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Catherine Eckford (European Pharmaceutical Review)
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EMA proposes streamlined approach for biosimilar development
In certain cases, analytical comparability exercises and PK data could be sufficient for demonstrating biosimilarity, the EMA highlights in its new paper.
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Innovative framework could enhance process efficiency in manufacturing quality control
The proposed approach demonstrates benefit for real-world application, establishing more robust, adaptive, and economical process systems, the research suggests.
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Novo Nordisk gains rights to novel small molecule inhibitor
As part of the agreement with Novo Nordisk, Lexicon Pharmaceuticals is eligible for total of $1 billion in upfront and potential milestone payments, alongside royalties.
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Shift to automated and sustainable options shaping environmental monitoring market
Addressing key challenges in the pharmaceutical and biotechnology environmental monitoring market, such as high technology costs, while leveraging key market drivers is critical for the sector to thrive, analysis suggests.
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Tariffs could threaten medicine innovation, industry bodies warn
Biotechnology Innovation Organization (BIO) and the International Generic and Biosimilar medicines Association (IGBA) highlight the need for industry cooperation to support the potential impact of tarrifs.
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FDA approves first-in-class oral antibiotic
The drug is the first in a new class of oral antibiotics for uncomplicated urinary tract infections in nearly three decades.
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MSD to advance investigational Lp(a) inhibitor in nearly $2b deal
The new license agreement will support development of a potential additional treatment option for patients at risk of atherosclerosis.
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Optimal biosafety cabinet cleaning strategy proposed
The research highlights a potential approach to address cross-contamination challenges during cell-processing operations.
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Innovating intelligent cleanroom control systems
The proposed technique outperformed traditional controllers, supporting improved air quality control in cleanrooms, according to the study.
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Drug for rare form of Alzheimer’s “scientifically promising”
The anti-amyloid drug study highlights the importance of longer-term follow-up to determine benefits and risks of dementia treatments.
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Psilocybin therapy demonstrates sustained clinical benefit in treatment-resistant depression
The new data shows potential of the psilocybin treatment to provide durable, longer-term antidepressant effects in patients with treatment-resistant depression (TRD).
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Novo Nordisk industry membership reinstated
The company now has ABPI membership after a two-year suspension involving concerns relating to its compliance with the industry body’s code of conduct.
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AstraZeneca cell therapy acquisition to advance in vivo therapies
The company’s new acquisition, valued up to $1 billion, supports development of in vivo cancer treatments and the future of cell therapy.
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Nanomaterial research potential “game-changer” for drug delivery
The throughput achieved by the researchers exceeded that of other reported methods by orders of magnitude, supporting the advancement of precision nanomaterials.
