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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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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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CHMP meeting highlights: January 2024
In its first meeting of 2024, the CHMP recommended a generic medicine for schizophrenia and refused a marketing authorisation (MA) for geographic atrophy.
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Medicines for Europe calls for simpler SPC manufacturing waiver
To ensure timely market entry of generics and biosimilars in the EU, the Supplementary Protection Certificate (SPC) Manufacturing Waiver must be clearer, asserts Medicines for Europe.
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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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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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First-of-a-kind psoriasis study outcomes revealed
Phase III data for Janssen’s innovative IL-23 inhibitor has revealed that the biologic is effective for adults with moderate to severe plaque psoriasis (PsO) across all skin tones.
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Sanofi bets $1.7b on potential best-in-class rare disease therapy
Under its newly agreed acquisition, Sanofi is to acquire Inhibrx, Inc., adding INBRX-101 to its portfolio, a therapy that could improve the treatment options available for alpha-1 antitrypsin deficiency (AATD).
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NICE recommends innovative breast cancer drug
The first BRCA-targeted treatment has been recommended for advanced breast or metastatic breast cancer by the National Institute for Health and Care Excellence (NICE).
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Could novel antibiotic successfully treat a ‘priority 1 pathogen’?
Highlighting the potential of a novel antibiotic against acinetobacter infections, GlobalData explained that nine other drugs, alongside this promising treatment, are in clinical development for this indication.
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UK ATMP sector “robust”, research finds
The cell and gene therapy (CGT) sector in the UK is “robust”, with a stable clinical trials landscape, according to research from Cell and Gene Therapy Catapult (CGT Catapult) and the UK BioIndustry Association (BIA).
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Long-term findings from CAR NK cell therapy trial revealed
One-year results from a cancer therapy trial has reported key findings for the selection criteria for allogeneic cord blood donors in CAR NK cell manufacturing.
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Market outlook to 2032: future trends across the seven major markets
Challenges such as market exclusivity and patient treatment preference are expected to shape the insomnia and Gaucher disease therapy landscape in the seven major markets (7MM) in 2032, research predicts.
