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Novartis' Phase III pelacarsen trial misses primary cardiovascular endpoint
Novartis reports that the Phase III Lp(a)HORIZON study of pelacarsen did not meet its primary cardiovascular endpoint in patients with elevated lipoprotein(a) and established cardiovascular disease.

nuaxia
14 hours ago2 min read


Novartis India targets therapy-aligned acquisitions and expansion into Tier 2 and Tier 3 markets
Novartis India is looking at therapy-aligned acquisition opportunities while seeking to deepen its presence in India's Tier 2 and Tier 3 markets.

nuaxia
14 hours ago1 min read


Qualcomm and ASUS launch pharmacy AI programme across southern Taiwan
Qualcomm and ASUS have launched an on-premises AI assistant programme for community pharmacies across southern Taiwan.

nuaxia
5 days ago2 min read


TScan Therapeutics cuts workforce by 75% and pauses Phase 3 programme in strategic pivot
TScan Therapeutics is cutting approximately 75% of its workforce and pausing further enrolment in its Phase 3 ALLOHA-2 study as it redirects resources towards in vivo cell therapy programmes for solid tumours.

nuaxia
5 days ago2 min read


Renalytix and Quest Diagnostics partner to expand kidneyintelX.dkd testing across the US
Renalytix has signed a multi-year agreement with Quest Diagnostics to expand US access to its kidneyintelX.dkd blood test for patients with type 2 diabetes and chronic kidney disease.

nuaxia
6 days ago1 min read


Novacyt and Illumina sign five-year collaboration framework
Novacyt and Illumina have entered into a five-year master collaboration agreement to explore molecular-diagnostics product development and commercial opportunities.

nuaxia
6 days ago1 min read


BeOne Medicines reaches US government agreement on cancer medicine access and pricing
BeOne Medicines has reached a voluntary agreement with the US government covering cancer medicine access, future pricing and continued investment in US pharmaceutical manufacturing.

nuaxia
6 days ago2 min read


ArsenalBio cuts 99 jobs as it pivots to in vivo CAR-T development
ArsenalBio is cutting 99 jobs as it restructures the company around a strategic shift towards in vivo CAR-T development.

nuaxia
6 days ago1 min read


Ascendis and BioMarin agree global Yuviwel patent settlement and licence
The binding term sheet resolves litigation between Ascendis Pharma and BioMarin while granting Ascendis a worldwide licence covering YUVIWEL and other navepegritide-related products.

nuaxia
7 days ago2 min read


FDA pushes faster generic drug development with 55 new product-specific guidances
The latest regulatory package is intended to reduce uncertainty, development costs and delays for generic manufacturers as the US government increases pressure to bring lower-cost medicines to patients more quickly.

nuaxia
Aug 282 min read


Bristol Myers Squibb ends $380 million Cellares CAR-T manufacturing partnership
BMS concluded that Cellares’ automated Cell Shuttle platform could not meet the specific requirements for commercial Breyanzi production, prompting Cellares to cut around 100 positions.

nuaxia
Aug 273 min read


Ireland’s HSE agrees to fund Skyclarys after Biogen improves commercial offer
The reimbursement decision clears the way for Irish patients with Friedreich’s ataxia to access the first treatment for the rare neurological disease, following prolonged negotiations over cost and clinical value.

nuaxia
Aug 272 min read


European Commission grants orphan designation to Vanda’s imsidolimab for generalised pustular psoriasis
The designation provides regulatory development incentives for Vanda’s IL-36 receptor inhibitor in the EU and follows orphan status for the investigational therapy in the US and Japan.

nuaxia
Aug 252 min read


BioPorto advances US regulatory pathway for adult AKI test following FDA feedback
The company has expanded its US clinical validation study to support a future FDA submission for its adult NGAL kidney injury test while continuing to grow adoption of the biomarker in clinical practice.

nuaxia
Aug 212 min read


Diaceutics and Precision Cancer Consortium launch NGS concordance study for oncology biomarker testing
The collaborative initiative aims to generate evidence on the consistency of next-generation sequencing (NGS) testing across routine clinical laboratories, supporting future improvements in precision oncology diagnostics.

nuaxia
Aug 212 min read


FDA seeks public feedback on regulatory approach for generative AI-enabled medical devices
The discussion paper launches a public consultation that could shape future regulatory expectations for AI-enabled medical devices, including premarket evaluation, risk assessment and postmarket monitoring.

nuaxia
Aug 202 min read


FDA grants Fast Track designation to Phanes’ spevatamig for first-line metastatic pancreatic cancer
The designation broadens regulatory support for the CLDN18.2 × CD47 bispecific antibody as Phanes advances its chemotherapy combination through Phase II development in metastatic pancreatic ductal adenocarcinoma.

nuaxia
Aug 192 min read


FDA accepts UroGen’s UGN-103 NDA for recurrent low-grade intermediate-risk bladder cancer
The submission seeks approval for a next-generation mitomycin formulation designed for intravesical treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, building on the same drug-delivery platform as FDA-approved Zusduri.

nuaxia
Aug 182 min read


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.

nuaxia
Aug 143 min read


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.

nuaxia
Aug 132 min read
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