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Whitepaper: Unique Particle Sizes via Spiral Jet Mills
Discover how combining a spiral jet mill with an in-line classifier optimizes particle size distribution in pharmaceuticals, enhancing drug efficacy.
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Rapid microbiology testing market to value nearly $13bn by 2034
Driven by a rise in infectious diseases and advancements in digital technologies, increased demand for rapid microbiology testing is set to accelerate the market’s growth.
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Suanfarma realigns brand to showcase innovative spirit
The new identity of Suanfarma’s industrial brands signifies integration of its manufacturing sites as part of Suanfarma CDMO.
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Novo Nordisk $11b acquisition to support manufacturing capacity
As part of its acquisition of Catalent, Novo Holdings plans to sell three Catalent fill-finish sites, supporting the growth of the European and US manufacturing capacity.
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US legislation to benefit small molecule drug innovation
Passing of two key legislations in the US is set to support innovation for small molecule drugs and the biotech sector, Biotechnology Innovation Organization (BIO) asserts.
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Biogen refocuses its Alzheimer’s strategy
Part of Biogen’s prioritisation of its portfolio includes focusing on the advancement of its leading anti-amyloid beta Alzheimer’s treatment, LEQEMBI® (lecanemab-irmb).
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Biosensing technique promising for whole-genome detection
The bacterial detection method is robust and highly sensitive over a wide concentration range and does not require DNA amplification, research suggests.
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BCMA CAR T therapy facilitates potential autoimmune breakthrough
First use of a BCMA CAR T-cell therapy for immune-mediated necrotising myopathy (IMNM), enabled sustained depletion of autoantibodies beyond 18 months, a study shows.
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NICE recommends injectable bispecific antibody for aggressive blood cancer
Recommendation of AbbVie’s bispecific antibody for NHS use is based on a Phase I/II trial, which observed a 62 percent overall response rate in diffuse large B-cell lymphoma (DLBCL) patients.
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Immunotherapy drug achieves trial-first in fifty years
Major findings from a Phase III trial show that using immunotherapy drug pembrolizumab post-surgery extended survival and delayed disease recurrence in kidney cancer.
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Revised ISO guideline highlights toxicological evaluation of extractables and leachables
Included in the revised ISO 10993-17 guideline are requirements for toxicological risk assessment of medical device constituents, such as extractables and leachables (E&L).
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Eosinophilic esophagitis medicine approval expanded
Approval of the first treatment for patients one year old and over with eosinophilic esophagitis (EoE) was based on trial data showing a greater proportion of children given Dupixent achieved histological remission compared to placebo.
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Key vaccine adjuvant biosynthesised
UK scientists have unlocked the potential of bioengineering vaccine adjuvants, based on a study of the molecule QS-21.
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Eli Lilly EVP of Global Quality to retire
Following her leading contribution in key manufacturing and quality projects in Ireland and the US, Eli Lilly and Company’s Executive Vice President (EVP) of Global Quality is set to retire after nearly 35 years of service.
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FDA guidance highlights E&L considerations for ophthalmic drug products
In draft guidance on quality considerations for topical ophthalmic drug products, the US Food and Drug Administration (FDA) provided recommendations for E&L testing.
