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CHMP Recommends Sanofi's Tezeild for EU Approval in Stage 2 Type 1 Diabetes
The CHMP has backed EU approval for Sanofi’s Tezeild, supported by TN-10 study results showing the therapy can delay progression to stage 3 type 1 diabetes in patients with stage 2 disease. If authorised, Tezeild would become the first disease-modifying treatment for T1D in the EU.
German-based pharmaceutical machinery manufacturer Romaco is expanding its footprint in India with the localisation of format part production for its Noack 900 blister packaging machine series.
Zydus Receives Final Approval from USFDA for Leuprolide Acetate Injection
Zydus has secured final USFDA approval for its Leuprolide Acetate injection, a multiple-dose formulation indicated for the palliative treatment of advanced prostate cancer.
In the pivotal FENtrepid trial, Roche’s BTK inhibitor fenebrutinib demonstrated a meaningful reduction in disability progression in Primary Progressive Multiple Sclerosis (PPMS), performing at least on par with OCREVUS—the current standard and only approved treatment for PPMS.
Zimmer Biomet Receives FDA Clearance for Enhanced ROSA Knee with OptimiZe System
Zimmer Biomet Holdings, a global leader in medical technology, has received US Food and Drug Administration (FDA) 510(k) clearance of its ROSA Knee with OptimiZe, an enhanced version of its ROSA Knee System designed to deliver greater personalisation, accuracy and reproducibility in robotic-assisted total knee replacement surgery.
Under the terms of the partnership, Transition Bio is responsible for the discovery and optimisation of small molecules targeting TDP-43 until nomination of a development candidate, upon which Voyager will have an option to license the worldwide exclusive rights to develop and commercialise the programme.
Averra Packaging Doubles Clean Room Capacity, Adds New Inline Medical Thermoforming Machine
American packaging solutions provider Averra has completed a major clean room expansion at its Salt Lake City thermoforming facility, effectively doubling its clean manufacturing area.
FDA Approves Diagnostic Tool for Pembrolizumab Combo in Endometrial Cancer
The US FDA has cleared the OncoMate MSI Dx Analysis System as a companion diagnostic to guide pembrolizumab-based combination therapy in advanced endometrial cancer. The PCR-based assay determines microsatellite instability (MSI) status in tumour tissue, with support from Merck, developer of pembrolizumab and lenvatinib.
Alembic Pharmaceuticals Secures Multiple USFDA Approvals; Q2 Revenue Rises 16 Percent
Alembic Pharmaceuticals has announced a series of regulatory milestones, receiving final approval from the US Food & Drug Administration (USFDA) for four Abbreviated New Drug Applications (ANDAs) in the month.
Pfizer Completes Acquisition of Metsera
Pfizer has finalised its acquisition of Metsera, adding a portfolio of differentiated, clinical-stage obesity therapies with the potential to redefine future treatment standards. The deal strengthens and reshapes Pfizer’s internal medicine portfolio, positioning the company to compete more aggressively in therapeutic areas, globally.
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