North America

The United States and Canada.

Mobia Medical publishes two-year Vivistim VNS stroke trial data

Two-year follow-up from the VNS-REHAB trial shows durable upper-limb motor gains in 76% of participants, published in Neurology.
Two-year follow-up from the VNS-REHAB trial shows durable upper-limb motor gains in 76% of participants, published in Neurology.
The Biotech Times Editorial Team  · 
Biologics

Spero Therapeutics raises $105m royalty financing to fund SP001 Phase 2

The Cambridge biotech is monetising Utebzi royalties via a KKR-backed deal to fund its anti-CD40L immunology candidate SP001.
The Cambridge biotech is monetising Utebzi royalties via a KKR-backed deal to fund its anti-CD40L immunology candidate SP001.
The Biotech Times Editorial Team  · 
Biologics

Spero Therapeutics licenses anti-CD40L antibody SP001 from Innovent

Spero gains ex-China rights to a Phase 2-ready monoclonal antibody targeting autoimmune diseases, in a deal worth up to $1.1 billion.
Spero gains ex-China rights to a Phase 2-ready monoclonal antibody targeting autoimmune diseases, in a deal worth up to $1.1 billion.
The Biotech Times Editorial Team  · 
Regulatory Science

Claria Medical wins FDA De Novo clearance for hysterectomy device

The Claria System is the first integrated tissue containment and removal device cleared by the FDA, cutting median uterine extraction time to four minutes.
The Claria System is the first integrated tissue containment and removal device cleared by the FDA, cutting median uterine extraction time to four minutes.
The Biotech Times Editorial Team  · 
Biologics

Mesoblast hits 300-patient target in Phase 3 back pain trial

Mesoblast said its pivotal rexlemestrocel-L trial is now fully enrolled, with top-line results expected in mid-2027 and a BLA filing to follow.
Mesoblast said its pivotal rexlemestrocel-L trial is now fully enrolled, with top-line results expected in mid-2027 and a BLA filing to follow.
The Biotech Times Editorial Team  · 
Biologics

FDA clears lecanemab subcutaneous autoinjector for Alzheimer's

Eisai and Biogen's LEQEMBI IQLIK autoinjector gains FDA approval as an initiation dose, offering patients a home-use alternative to intravenous infusion.
Eisai and Biogen's LEQEMBI IQLIK autoinjector gains FDA approval as an initiation dose, offering patients a home-use alternative to intravenous infusion.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Elevar Therapeutics receives FDA CRL for rivoceranib-camrelizumab in HCC

The FDA cited manufacturing deficiencies at a listed site, not clinical data concerns, in declining to approve the first-line hepatocellular carcinoma combination.
The FDA cited manufacturing deficiencies at a listed site, not clinical data concerns, in declining to approve the first-line hepatocellular carcinoma combination.
The Biotech Times Editorial Team  · 
Biologics

Sana Biotech's HIP-modified islets show durable function at 14 months

NEJM follow-up data show HIP-modified islet cells surviving and producing insulin at 14 months in a type 1 diabetes patient without immunosuppression.
NEJM follow-up data show HIP-modified islet cells surviving and producing insulin at 14 months in a type 1 diabetes patient without immunosuppression.
The Biotech Times Editorial Team  · 
Biologics

Immutep efti shows 30.9-month mOS in 1L NSCLC despite trial setback

Mature INSIGHT-003 data show efti plus pembrolizumab and chemotherapy achieved 30.9-month mOS in low PD-L1 first-line NSCLC patients.
Mature INSIGHT-003 data show efti plus pembrolizumab and chemotherapy achieved 30.9-month mOS in low PD-L1 first-line NSCLC patients.
The Biotech Times Editorial Team  · 
Diagnostics

Aligos Therapeutics completes enrolment in Phase 2 HBV study

Aligos has fully enrolled 245 participants in B-SUPREME, its Phase 2 trial of pevifoscorvir sodium in chronic hepatitis B, with topline data expected in
Aligos has fully enrolled 245 participants in B-SUPREME, its Phase 2 trial of pevifoscorvir sodium in chronic hepatitis B, with topline data expected in
The Biotech Times Editorial Team  · 
Diagnostics

Endogenex completes 350-patient enrolment in ReCET diabetes device trial

Endogenex has fully enrolled its sham-controlled ReCET study of a duodenal pulsed electric field device for type 2 diabetes across 40 sites.
Endogenex has fully enrolled its sham-controlled ReCET study of a duodenal pulsed electric field device for type 2 diabetes across 40 sites.
The Biotech Times Editorial Team  · 
Diagnostics

Tarsus Pharmaceuticals acquires iRenix Medical for up to $565m

Tarsus is acquiring iRenix and its IRX-101 ocular antiseptic, backed by Phase 2b/3 data showing significant pain and corneal toxicity reductions.
Tarsus is acquiring iRenix and its IRX-101 ocular antiseptic, backed by Phase 2b/3 data showing significant pain and corneal toxicity reductions.
The Biotech Times Editorial Team  · 
Biologics

FibroBiologics wins patent allowance for 3D spheroid wound therapy

The Houston biotech secured USPTO allowance for fibroblast spheroid wound healing claims that directly cover its Phase 1/2 CYWC628 diabetic foot ulcer programme.
The Houston biotech secured USPTO allowance for fibroblast spheroid wound healing claims that directly cover its Phase 1/2 CYWC628 diabetic foot ulcer programme.
The Biotech Times Editorial Team  · 
Bioinformatics

NorthStrive and Yuva Biosciences validate four ANT1-inducing compounds

Four AI-selected small molecules increased ANT1 expression in human skeletal muscle cells, advancing NorthStrive's muscle-preservation programme toward confirmatory
Four AI-selected small molecules increased ANT1 expression in human skeletal muscle cells, advancing NorthStrive's muscle-preservation programme toward confirmatory
The Biotech Times Editorial Team  · 
Biologics
Bioprocessing

VERAXA Biotech taps ATUM to develop cell lines for BiTAC-TCE programme

VERAXA has engaged ATUM's Leap-In Transposase technology to generate stable clonal cell lines for its lead conditional T-cell engager candidate ahead of
VERAXA has engaged ATUM's Leap-In Transposase technology to generate stable clonal cell lines for its lead conditional T-cell engager candidate ahead of
The Biotech Times Editorial Team  · 
Diagnostics
Genomics

DiamiR and AlzLabs join forces on Alzheimer's biomarker study

DiamiR Biosciences and AlzLabs will combine protein and microRNA blood biomarkers to improve early detection of Alzheimer's disease.
DiamiR Biosciences and AlzLabs will combine protein and microRNA blood biomarkers to improve early detection of Alzheimer's disease.
The Biotech Times Editorial Team  · 
Diagnostics
Biotech

Urteste wins USPTO patent for urine-based Panuri pancreatic cancer test

The Polish diagnostics company secured US patent protection for its non-invasive Panuri test as a European clinical trial enrols its first participants.
The Polish diagnostics company secured US patent protection for its non-invasive Panuri test as a European clinical trial enrols its first participants.
The Biotech Times Editorial Team  · 
Biotech

PetMed Express confirms revised $3 takeover bid from SilverCape

SilverCape Investments has lowered its unsolicited offer to $3.00 per share, down from $4.00 in December, as PetMeds' board evaluates its options.
SilverCape Investments has lowered its unsolicited offer to $3.00 per share, down from $4.00 in December, as PetMeds' board evaluates its options.
The Biotech Times Editorial Team  · 
Regulatory Science

Incannex secures US patent for IHL-42X sleep apnoea therapy to 2040

Incannex Healthcare has won a USPTO patent covering its oral OSA combination therapy IHL-42X, with baseline protection running to July 2040.
Incannex Healthcare has won a USPTO patent covering its oral OSA combination therapy IHL-42X, with baseline protection running to July 2040.
The Biotech Times Editorial Team  · 
Regulatory Science

CervoMed secures US patent on neflamapimod for pure DLB to 2042

CervoMed has received a USPTO notice of allowance for a patent covering neflamapimod in pure dementia with Lewy bodies, extending protection into 2042.
CervoMed has received a USPTO notice of allowance for a patent covering neflamapimod in pure dementia with Lewy bodies, extending protection into 2042.
The Biotech Times Editorial Team  · 
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