news
European Commission approves novel antibiotic
Authorisation of the antibiotic combination, which targets multidrug-resistant bacteria, could help to address the global challenge of antimicrobial resistance (AMR).
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Regs & Legs
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Widening adoption of animal-free reagents for endotoxin testing
If the proposed USP Chapter < 86 > on using non-animal derived reagents is approved, it will be published for early adoption in November 2024, USP states.
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Genentech oncology treatment granted first-of-a-kind approval
The novel approval provides a dedicated therapy option for patients with ALK-positive early-stage lung cancer.
video
Webinar: How Pfizer utilises Enzyme Indicator technology for bio-decontamination validation
Melanie Eggers is a Sterilisation Validation Project Support Engineer at Pfizer Belgium. In this webinar, she explains how Pfizer has adopted Enzyme Indicator (EI) technology for its VHP bio-decontamination procedures. She outlines the differences in EIs compared to more traditional Biological Indicators and the way in which Pfizer utilises the…
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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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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.
article
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.
news
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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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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Positive CHMP recommendation for antibiotic combination
EMA has recommended granting a marketing authorisation for Emblaveo for treatment of infections caused by multidrug-resistant bacteria.
