top of page


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
Sep 12 min read


FDA approves Lisraya as first oral treatment for adults with dermatomyositis
Priovant’s once-daily JAK/TYK2 inhibitor introduces a new FDA-approved treatment option for the rare autoimmune disease, supported by Phase III evidence of improvements across muscle, skin and physical-function measures.

nuaxia
Aug 282 min read


FDA approves Gilead’s Bixlenvo as single-tablet HIV option for patients on complex regimens
The once-daily combination of bictegravir and lenacapavir offers virologically suppressed adults a new route to simplify treatment, including patients previously requiring complex multi-tablet regimens.

nuaxia
Aug 282 min read


FDA approves Pfizer and BioNTech’s XFG-adapted COVID-19 vaccine for 2026–2027 season
The updated Comirnaty formulation targets the XFG variant and will begin shipping immediately for eligible older adults and people aged five to 64 at increased risk of severe COVID-19.

nuaxia
Aug 282 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


Haisco licenses obesity drug HSK47388 to new US biotech in deal worth up to $1.12 billion
The agreement gives a newly formed company backed by Population Health Partners and ARCH Venture Partners ex-China rights to Haisco’s Phase II-ready oral THR-β agonist for obesity and metabolic disorders.

nuaxia
Aug 273 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


4basebio and Genezen expand collaboration to advance synthetic DNA for viral vector manufacturing
The commercial partnership combines 4basebio’s cell-free hpDNA platform with Genezen’s viral vector CDMO capabilities to provide cell and gene therapy developers with an alternative to conventional plasmid DNA manufacturing.

nuaxia
Aug 273 min read


Monod Bio licenses AI-designed protein technologies to SignalChem for drug discovery assays
The non-exclusive agreement gives SignalChem access to Monod Bio’s LuxSit luciferase and NovoBodies technologies for custom research assays and protein-fusion services, extending the commercial reach of its AI-designed protein platform.

nuaxia
Aug 273 min read


Switchboard Health acquires Livara Health to add virtual musculoskeletal care
The acquisition moves Switchboard beyond specialty-care navigation into direct care delivery by integrating Livara’s virtual-first, value-based MSK model, alongside more than $5 million in new financing.

nuaxia
Aug 273 min read


Allegheny Health Network and START partner to expand early-phase cancer trials in Western Pennsylvania
The collaboration will establish a START clinical trial site inside AHN’s Allegheny General Hospital, connecting patients across the region with START’s portfolio of nearly 1,000 active early-phase oncology studies.

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


FDA approves first-in-class targeted therapy daraxonrasib for metastatic pancreatic cancer
The approval introduces the first RAS(ON) inhibitor for previously treated metastatic pancreatic ductal adenocarcinoma with a KRAS G12X mutation, establishing a new biomarker-directed option for one of the hardest-to-treat cancers.

nuaxia
Aug 272 min read


CDSCO approves Dr Reddy’s abatacept biosimilar for rheumatoid and psoriatic arthritis in India
The conditional marketing approval introduces a new intravenous abatacept biosimilar for patients with moderate to severe rheumatoid arthritis or active psoriatic arthritis who have responded inadequately to other disease-modifying treatments.

nuaxia
Aug 262 min read


FDA approves Ziihera-based first-line regimens for HER2-positive advanced gastroesophageal cancers
The approvals introduce zanidatamab-based first-line options for adults with HER2-positive unresectable locally advanced or metastatic gastric, gastroesophageal junction or oesophageal adenocarcinoma, with treatment determined by HER2 status.

nuaxia
Aug 262 min read


Valerio Therapeutics agrees €30 million Etherna acquisition alongside €40.25 million financing
The transaction combines Valerio’s targeted delivery technologies with Etherna’s mRNA, lipid nanoparticle and GMP manufacturing capabilities to build an integrated targeted RNA therapeutics platform.

nuaxia
Aug 263 min read


McKesson agrees $2.25 billion acquisition of Precision Medicine Group to expand biopharma services
The acquisition adds clinical research, biomarker, laboratory, market access and commercialisation capabilities to McKesson’s Oncology & Multispecialty business, extending its services across the drug-development pathway.

nuaxia
Aug 262 min read


Roche’s Genentech licenses Hanmi obesity candidate HM17321 in deal worth up to $2.3 billion
The agreement gives Genentech ex-South Korea rights to a Phase I non-incretin UCN2 analogue designed to reduce weight while preserving lean body mass, adding a differentiated mechanism to Roche’s growing cardiometabolic pipeline.

nuaxia
Aug 253 min read


Meiji Seika Pharma and Serum Institute partner to bring Japanese encephalitis vaccine to India
Meiji Seika Pharma group company KM Biologics and Serum Institute of India (SII) are collaborating to transfer technology for the development and manufacture in India of the Japanese encephalitis vaccine currently produced and marketed by KM Biologics in Japan. SII is expected to seek Indian regulatory approval as early as 2027, with the partnership intended to establish local manufacturing and supply of the vaccine for children in India.

nuaxia
Aug 253 min read


FDA approves Imaavy as first treatment specifically indicated for warm autoimmune haemolytic anaemia
The approval extends Johnson & Johnson’s FcRn-blocking therapy into wAIHA, providing a new targeted treatment for adults with a rare autoimmune blood disorder that can cause severe and persistent haemolytic anaemia.

nuaxia
Aug 252 min read
bottom of page