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FDA approves off-the-shelf bispecific antibody cancer therapy
The US Food and Drug Administration (FDA) has approved the first bispecific antibody with a fixed-duration treatment in (R/R) diffuse large B-cell lymphoma (DLBCL).
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R&D innovation advancing small molecule innovator CDMO market
Accelerating advancement in research and technology is generating opportunities for biopharma to develop innovative small molecule drugs, a report shows.
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Why is microbiological testing in medical device manufacturing important?
Careful planning during manufacture means accurate microbiology testing methods can be developed, ensuring the safety and efficacy of medical devices, a paper reports.
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6.1 percent CAGR expected for pharmaceutical sterility testing market
The rising importance of quality and sterility is expected to drive the pharmaceutical sterility testing market in the next decade, a report says.
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UK medicines manufacturing must remain domestic
In a new report by the Medicines Manufacturing Industry Partnership (MMIP), nine recommendations were put forward to drive medicines manufacturing growth in the UK’s life sciences sector.
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Chikungunya vaccine demonstrates 99 percent immune response
If approved, VLA1553 could become the first licensed chikungunya vaccine available to address this unmet medical need.
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World’s largest lutetium-177 production site opens
The new German facility has Industry 4.0 capabilities and will produce radionuclides to help meet the rising demand for radiopharmaceuticals.
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£2.5b acquisition to boost Novartis’ renal portfolio
As part of its planned £2.5 billion acquisition of Chinook Therapeutics, Novartis will gain access to a targeted biologic for a rare kidney disease.
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Scientific journal: Reduce CNS drug development timelines by up to 40%
CNS drug development is complex, and partnering with an integrated CRO/CDMO can reduce your timelines by up to 40%. Learn more in The Altascientist.
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Could novel gene therapy treat sickle cell disease?
Researchers have revealed positive preliminary data from a CRISPR gene therapy trial for sickle cell disease.
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Novel nanofiltration method for microbial biosurfactant downstream processing
A paper has reported an innovative downstream method using nanofiltration for microbial biosurfactant production offers superior purity.
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Biopharma struggling to find talent with adequate digital skills
While there has been "strong progress" in addressing certain skills gaps, advancing tech like AI means biopharma are increasingly seeking talent with data skills, ABPI stated.
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New quality requirements for tobacco products
Here, Dave Elder explores proposals for new FDA rules on tobacco product manufacturing. How could strategies for controlling tobacco-specific nitrosamines compare with those for nitrosamine drug substance-related impurities?
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EDQM publishes annual report
Included in EDQM’s annual report were reflections on the 11th Edition conference, which highlighted key topics such as the potential of nanomedicines and Big Data.
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How can biopharma strengthen its resilience?
A recent report has found that since 2021, biopharma resilience has decreased, affecting areas such as supply chain, strength of the R&D ecosystem and manufacturing agility.
