Business, energy, technology, markets and global industry news from Business News Today

Pharma & Biotech

PharmaDeviceNews Pharma & Biotech
Polpharma Biologics’ PB016 vedolizumab biosimilar has entered regulatory review with the United States Food and Drug Administration and European Medicines Agency, advancing a potential new competitor to Takeda Pharmaceutical Company’s Entyvio for ulcerative colitis and Crohn’s disease. Representative image.
Pharma & Biotech

PB016 versus Entyvio: Polpharma Biologics joins the emerging vedolizumab biosimilar race

Polpharma Biologics’ PB016 enters FDA and EMA review, adding a new vedolizumab biosimilar challenge to Takeda’s Entyvio franchise.

Read More
Datroway’s European Union approval expands first-line treatment options for patients with unresectable or metastatic triple-negative breast cancer who are not candidates for immunotherapy, following an overall survival benefit in the Phase 3 TROPION-Breast02 trial. Representative image.
Pharma & Biotech

Datroway EU approval expands first-line treatment options for metastatic triple-negative breast cancer

EU approval moves Datroway into first-line metastatic TNBC after TROPION-Breast02 showed survival gains, intensifying the TROP2 ADC race.

Read More
IMPACT Therapeutics’ senaparib licensing agreement with Pharmanovia could expand the ovarian cancer therapy’s commercial reach across Europe, the Middle East, Africa, Australia and New Zealand. Representative image.
Pharma & Biotech

IMPACT Therapeutics expands senaparib globally through 66-country Pharmanovia licence

See how IMPACT Therapeutics’ €423.5 million senaparib deal with Pharmanovia could shape its European ovarian cancer launch.

Read More
Representative image: Researchers prepare a personalized cancer cell therapy as Diakonos Oncology begins testing DOC1021 in patients with refractory melanoma that progressed after anti-PD-1 immunotherapy.
Pharma & Biotech

First DOC1021 patients treated in Phase 1/2 refractory melanoma trial

DOC1021 enters a Phase 1/2 refractory melanoma trial testing personalised dendritic cell therapy without lymphodepletion or high-dose IL-2

Read More
Representative image: Retina specialists review OCT scans as EyePoint’s $EYPT DURAVYU completes enrollment in two Phase 3 diabetic macular edema trials testing six-month dosing against aflibercept.
Pharma & Biotech

DURAVYU pivotal trials move closer to testing a longer-lasting diabetic eye treatment

DURAVYU completes enrollment in two Phase 3 DME trials testing six-month dosing against aflibercept, with results expected in late 2027.

Read More
Representative image: A cardiologist reviews heart imaging as Cytokinetics’ $CYTK aficamten gains UK approval and NICE backing for approximately 6,600 adults with symptomatic obstructive hypertrophic cardiomyopathy.
Pharma & Biotech

Aficamten wins UK approval and NICE backing for 6,600 adults with obstructive HCM

Aficamten gains UK authorisation and NICE backing for symptomatic obstructive HCM after Phase 3 improvements in exercise capacity.

Read More
Representative image: Clinicians review heart imaging and Duchenne muscular dystrophy trial data as Capricor Therapeutics’ $CAPR deramiocel faces heightened FDA uncertainty following a 9 to 3 advisory committee vote against its cardiomyopathy evidence.
Pharma & Biotech

Conflicting HOPE-3 analyses divide FDA panel over deramiocel in Duchenne muscular dystrophy

FDA advisers voted 9 to 3 against deramiocel’s Duchenne cardiomyopathy evidence after challenging the Phase 3 analysis and trial population.

Read More
Johnson & Johnson’s $1 billion Firefly Bio acquisition adds the preclinical Firelink degrader antibody conjugate platform to its oncology pipeline, strengthening its research into KRAS-driven cancers and other difficult-to-treat solid tumors. Representative image.
Pharma & Biotech

Johnson & Johnson just spent $1bn on a preclinical cancer platform: What must Firefly Bio prove next?

Johnson & Johnson closes its $1 billion Firefly Bio deal, adding a preclinical degrader antibody conjugate platform for KRAS-driven cancers.

Read More
ImmunityBio’s ANKTIVA has received United Arab Emirates marketing authorization for BCG-unresponsive bladder cancer and previously treated metastatic non-small cell lung cancer, expanding the immunotherapy’s international regulatory footprint. Representative image.
Pharma & Biotech

Why ImmunityBio’s UAE authorization gives ANKTIVA a broader cancer label than it has in the United States

ImmunityBio gains UAE authorization for ANKTIVA in broader bladder cancer and metastatic lung cancer uses, widening its Gulf commercial opportunity.

Read More
Sail Biomedicines’ in vivo CAR-T collaboration with Johnson & Johnson highlights growing investment in RNA-based immune-cell therapies for autoimmune diseases. Representative image.
Pharma & Biotech

Why Johnson & Johnson is staking $785m on Sail’s in vivo CAR-T platform before human trials

Johnson & Johnson backs Sail Biomedicines’ in vivo CAR-T platform with $785 million in initial payments and a $2.58 billion buyout option.

Read More