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FDA grants accelerated approval to Zenbexus combination for previously treated multiple myeloma
The approval provides adults who have received at least one prior line of therapy with a new iberdomide-based combination, supported by higher minimal residual disease-negative complete response rates than the comparator regimen in EXCALIBER-RRMM.

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vor 1 Tag2 Min. Lesezeit


PTC Therapeutics wins auction for Sangamo’s ST-920 Fabry gene therapy in deal worth up to $211 million
The acquisition would add a BLA-stage, one-time AAV gene therapy to PTC’s rare disease portfolio, with a rolling US submission expected to complete in the fourth quarter of 2026.

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vor 1 Tag3 Min. Lesezeit


Health Canada licenses Light AI’s QuickScan Strep A smartphone software for suspected strep throat assessment
The Canadian authorisation moves Light AI’s AI-enabled throat-image analysis platform from investigational development into its first regulated market, providing healthcare professionals with a software-based tool to support assessment of suspected Group A Streptococcus infection.

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vor 1 Tag2 Min. Lesezeit


Drugmakers curb Swiss reimbursement submissions amid US international drug-pricing concerns
Interpharma says seven of 22 innovative medicines introduced between January 2025 and June 2026 were not submitted for Swiss reimbursement, as companies consider the potential implications of Swiss prices for the US market.

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vor 1 Tag3 Min. Lesezeit


Sentynl secures option for US alvelestat rights in Phase III-ready AATD lung disease programme
The agreement gives Zydus subsidiary Sentynl Therapeutics an option for exclusive US commercial and global manufacturing rights to Mereo BioPharma’s oral neutrophil elastase inhibitor, with Mereo leading preparations for pivotal development.

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vor 1 Tag3 Min. Lesezeit


FDA clears Wandercraft’s Eve self-balancing exoskeleton for personal use in adults with spinal cord injury
The clearance extends Wandercraft’s self-balancing exoskeleton technology beyond supervised rehabilitation, allowing eligible adults with spinal cord injuries to use Eve for hands-free upright mobility and daily activities with a trained companion.

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vor 1 Tag2 Min. Lesezeit


Mereo grants Sentynl US option for alvelestat in deal worth up to $475 million
The agreement gives Sentynl an exclusive pathway to commercialise the Phase III-ready rare lung disease therapy in the US while providing global manufacturing rights and funding support for late-stage development.

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vor 2 Tagen3 Min. Lesezeit


HanchorBio partners with Taiwan Cancer Moonshot team to advance precision immunotherapy development
The collaboration combines HanchorBio's immuno-oncology platform with Taiwan's national precision oncology programme to support biomarker-driven clinical development and translational research.

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vor 2 Tagen2 Min. Lesezeit


Philips and Exor extend relationship agreement and raise ownership cap to 22%
The amended agreement strengthens Exor's long-term commitment to Philips while allowing the healthcare technology investor to increase its maximum shareholding from 20% to 22%.

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vor 2 Tagen2 Min. Lesezeit


Scotland backs UCB's Zilbrysq while NICE appraisal in England remains unresolved
The differing reimbursement positions highlight how health technology assessment decisions can diverge across UK nations, affecting the timing of patient access to new medicines.

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vor 2 Tagen2 Min. Lesezeit


BeOne and Revolution Medicines partner on RAS-targeted oncology combinations and Asian licensing deal
The collaboration pairs BeOne’s oncology pipeline with four clinical-stage RAS(ON) inhibitors while giving BeOne regional rights to the Revolution Medicines assets across selected Asian markets.

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vor 3 Tagen3 Min. Lesezeit


Project Farma acquires SimoTech to expand GMP automation and digital manufacturing capabilities
The acquisition adds SimoTech’s automation engineering and digital manufacturing expertise to Project Farma’s existing life sciences manufacturing services, creating a broader offering spanning facility strategy through GMP operations.

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vor 3 Tagen2 Min. Lesezeit


Medios agrees to acquire 74% of Caelo to expand European pharmaceutical ingredients business
The acquisition would add Caelo’s €40 million-revenue API and excipients business and establish the German company as the anchor of Medios’ planned European network for pharmaceutical compounding ingredients.

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vor 3 Tagen2 Min. Lesezeit


Alfasigma agrees to acquire Nordic Pharma to expand European specialty care business
The acquisition would add Nordic Pharma’s €190 million-revenue business and Nordimet rheumatoid arthritis franchise while expanding Alfasigma’s direct commercial presence to 18 European countries and adding platforms in Canada and Japan.

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vor 3 Tagen2 Min. Lesezeit


aTyr Pharma cuts 60% of workforce to fund second Phase III study of efzofitimod in pulmonary sarcoidosis
The restructuring concentrates aTyr’s resources on a new late-stage study in patients with restrictive lung disease after its first Phase III trial missed its primary endpoint.

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vor 3 Tagen3 Min. Lesezeit


European Commission launches eligibility checker for EU Joint Clinical Assessments
The new tool is intended to help health technology developers determine whether a medicinal product falls within the EU’s Joint Clinical Assessment requirements before entering the formal HTA process.

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vor 3 Tagen3 Min. Lesezeit


ChemoMetec and Roche Diagnostics partner to integrate cell counting and bioprocess monitoring systems
The collaboration will connect ChemoMetec’s XcytoMatic 30 cell counter with Roche’s Cedex Bio Analyzer and establish a joint go-to-market strategy for the combined bioprocess monitoring solution.

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vor 4 Tagen2 Min. Lesezeit


EU Joint Clinical Assessment enters second year as pharmaceutical companies adapt evidence strategies
The EU Health Technology Assessment Regulation now requires eligible oncology medicines and advanced therapies to undergo a single European clinical assessment, increasing the importance of early evidence planning alongside EMA regulatory development.

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vor 4 Tagen3 Min. Lesezeit


Jazz Pharmaceuticals agrees $820 million Actio Biosciences acquisition to add precision epilepsy therapy ABS-1230
The acquisition would add a clinical-stage KCNT1 inhibitor for a rare genetic epilepsy with no FDA-approved treatments, while Actio’s remaining programmes will be transferred into a separate privately held company.

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vor 4 Tagen3 Min. Lesezeit


Amneal completes $750 million Kashiv BioSciences acquisition to create integrated biosimilars platform
The completed transaction combines Kashiv’s biologics R&D and manufacturing capabilities with Amneal’s commercial infrastructure, giving the company end-to-end control across biosimilar development, production and commercialisation.

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vor 4 Tagen3 Min. Lesezeit
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