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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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Drug Markets
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Strong growth for Sweden’s pharmaceutical exports
A focus on innovation and high quality is helping Sweden to strengthen its position as a key player in the global life sciences market, SwedenBIO states.
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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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UK advanced therapies to get £17.9 million boost
The initiative aims to support the UK as a location of choice for advanced therapy research, according to the Cell and Gene Therapy Catapult.
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FDA approves innovative gene therapy for MLD
Following US FDA approval of Lenmeldy™ (atidarsagene autotemcel) for early-onset metachromatic leukodystrophy (MLD), the US wholesale acquisition cost of the gene therapy has been set to $4.25 million.
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Lonza to acquire major biologics manufacturing facility
The new acquisition is set to boost Lonza’s large-scale biologics manufacturing capacity for mammalian therapeutics.
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Biologics driving continuous bioprocessing market expansion
Research predicts the global continuous bioprocessing market will witness a CAGR of 19.72 percent between 2024-2031.
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Novartis acquisition to address inflammation-driven diseases
Novartis’ new acquisition aims to advance first-in-class STING treatments for inflammation-driven diseases.
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FDA approval could shape liver disease treatment landscape
A novel liver therapy authorised under US Food and Drug Administration (FDA) Accelerated Approval, is a potential game-changer in the NASH treatment space.
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Manufacturer retracts acquisition deal due to “data integrity issues”
According to Olympus Corporation, concerns about the non-vascular metallic stents were found post-closing following the agreed acquisition of Taewoong Medical Co., Ltd.
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The future of targeted alpha therapy development and manufacture
Following the first industrial-scale facility for targeted alpha therapy (TAT) production in Europe beginning construction, in this exclusive Q&A, Julien Dodet, CEO of Orano Med, elaborates on the key trends in radioligand therapeutics and why TATs hold significant advantages as cancer treatments.
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Sandoz granted novel biosimilars approval
The approval authorises the interchangeability of denosumab biosimilars in the US to treat primary and secondary bone loss.
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Medical device manufacturers must remain “vigilant” to ensure data integrity of premarket submissions
With the integrity of a greater number of third-party-generated data called into question, the US Food and Drug Administration (FDA) is unable to rely on the data to grant marketing authorisation, the agency asserts.
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New antibody drug formulation wins novel MHRA approval
A new formulation of an antibody drug has been authorised via a process from the Medicines and Healthcare products Regulatory Agency (MHRA) that enables “considerably shorter” approval timelines.
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NICE recommends first licenced treatment for AL amyloidosis
Having been available in Scotland and Northern Ireland since 2022, NICE’s positive opinion of the combination treatment means it is now accessible on the NHS.
