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Achieving FAIR bacterial identification
A study has reported a noninvasive assay for detecting Gram-negative bacteria biofilms that do not disrupt the pattern of bacterial growth.
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Drug Development
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Innovative personalised immunotherapy approved for multiple myeloma
Approval of the cell therapy by the US FDA could provide a treatment-free respite as early as first relapse for patients with multiple myeloma.
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Antibody-immunotherapy treatment shows benefit in serious endometrial cancer
The novel combination cancer therapy facilitated “exceptional” responses in some patients enrolled in a Phase II study for endometrial cancer.
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First-in-class anaemia therapy granted expanded approval
The expanded authorisation of Reblozyl is based on a Phase III trial which showed that the treatment nearly doubled the percentage of certain transfusion-dependent anaemia patients achieving haemoglobin increase, compared to epoetin alfa.
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Championing UK ATMP clinical trials
In this Q&A, Jacqueline Barry, Chief Clinical Officer for Cell and Gene Therapy Catapult, elucidates on how the Advanced Therapy Treatment Centre (ATTC) Network can strengthen UK ATMP clinical trials.
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Biopharmaceuticals contributing to manufacturing outsourcing trend
A report has highlighted how the outsourcing of manufacturing activities to contract manufacturers is facilitating more streamlined and efficient pharmaceutical drug development.
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ADC oncology acquisition to address solid tumours
The acquisition will give Genmab worldwide rights to three clinical candidates including a potential best-in-class folate receptor alpha (FRα)-targeted ADC for ovarian cancer.
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Lonza appoints new Chief Executive
The incoming CEO of the contract development and manufacturing organisation (CDMO) Lonza will transition into his new role over Summer 2024.
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Novel LAI antipsychotic approved in EU
The long-acting injectable (LAI) formulation is indicated as a once-every-two-months treatment for adults with schizophrenia.
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Pharmaceutical environmental monitoring market to value $38.1b by 2030
Technological solutions such as real-time monitoring could help expand the pharmaceutical environmental monitoring market up to the next decade, research says.
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Drug safety driving pyrogen testing market expansion
A lack of standardised testing methods and subsequent delayed product approvals is limiting growth of the pyrogen testing market, according to a report.
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CHMP meeting highlights: March 2024
At the Committee for Medicinal Products for Human Use (CHMP)’s March meeting, twelve medicines received positive opinions for marketing authorisations, including a new antibiotic and a novel oral medicine for a rare blood disorder.
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Next-gen Moderna COVID-19 vaccine shows promise
Phase III data shows that mRNA-1283 has a similar safety profile to Moderna's approved COVID-19 vaccines, the company states.
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Positive CHMP recommendation for antibiotic combination
EMA has recommended granting a marketing authorisation for Emblaveo for treatment of infections caused by multidrug-resistant bacteria.
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Novo Nordisk to buy Cardior Pharmaceuticals
The up to €1bn acquisition of Cardior Pharmaceuticals will strengthen Novo Nordisk’s pipeline in cardiovascular disease.
