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Enhancing competitiveness of European life sciences
EFPIA’s reflections on the recent Conclusions of the Special Meeting of the European Council assert the importance of ensuring a more resilient and competitive life sciences sector.
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Regulation & Legislation
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European and Japanese Pharmacopoeias partner to harmonise pharmacopoeial standards
During the project, the European Pharmacopoeia (Ph. Eur.) and Japanese Pharmacopoeia (JP) will discuss the challenges in expanding the harmonisation of pharmacopoeial standards to both active substances and medicinal products.
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EFPIA reaction to European Parliament plenary vote
Following the recent European Parliament plenary vote, EFPIA asserts that aligning the next revision of the pharmaceutical legislation to increase Europe’s competitiveness will be a challenge.
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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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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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EP monographs allow rFC for water testing
As of 1 April, two European Pharmacopoeia monographs allow the use of rFC to test for bacterial endotoxins in pharmaceutical waters.
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Endotoxin testing: the international regulatory landscape
In this extract from EPR’s Pharma Horizon’s report, Evelyn Der, Lindsey Silva and Carmen Marín Delgado de Robles from Roche Group discuss the regulatory guidelines for bacterial endotoxin testing and the move towards adoption of recombinant methods.
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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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First-in-class biologic approved for rare lung disease
The biologic therapy offers a novel therapeutic option that targets a new treatment pathway in pulmonary arterial hypertension (PAH).
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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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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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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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Validation of analytical procedures – ICH Q2(R2)
The recently updated ICH Q2(R2) guidance marks a significant milestone in analytical procedure validation. Dave Elder explains why.
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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.
