North America

The United States and Canada.
Digital Health

Globus Medical acquires Duke-incubated AI firm Higgs Boson Health

The NYSE-listed musculoskeletal device maker is buying Durham-based Higgs Boson Health to build out a surgical intelligence and patient-journey platform.
The NYSE-listed musculoskeletal device maker is buying Durham-based Higgs Boson Health to build out a surgical intelligence and patient-journey platform.
Biologics

CLINUVEL posts tenth consecutive profit as cash hits A$252m

The Melbourne biopharmaceutical company reported FY2026 net profit of A$33.9m and plans to use its balance sheet strength to accelerate US expansion.
The Melbourne biopharmaceutical company reported FY2026 net profit of A$33.9m and plans to use its balance sheet strength to accelerate US expansion.

BlossomHill Therapeutics prices upsized $150m IPO on Nasdaq

The San Diego oncology biotech priced 9.375 million shares at $16.00 each, with underwriters holding a 30-day option to buy a further
The San Diego oncology biotech priced 9.375 million shares at $16.00 each, with underwriters holding a 30-day option to buy a further
Diagnostics
Digital Health

CapsoVision posts 10% revenue growth as AI Highlights eyes FDA clearance

The capsule endoscopy company reported Q2 2026 revenue of $3.6m and expects US clearance of its AI-assisted reading tool by end of Q3.
The capsule endoscopy company reported Q2 2026 revenue of $3.6m and expects US clearance of its AI-assisted reading tool by end of Q3.

Catheter Precision lands Cardinal Health deal and Johns Hopkins order

The cardiac electrophysiology device maker also placed its first VIVO 3D imaging system in Germany, marking a step into one of Europe's largest EP
The cardiac electrophysiology device maker also placed its first VIVO 3D imaging system in Germany, marking a step into one of Europe's largest EP
Bioprocessing

PharmAla secures MDMA patent and hires Canaccord as banking partner

PharmAla Biotech has been granted a US process patent for enantioselective MDMA production and pulled its APA-01 licensing deal with Restora Neurosciences.
PharmAla Biotech has been granted a US process patent for enantioselective MDMA production and pulled its APA-01 licensing deal with Restora Neurosciences.
Biologics

Tenax Therapeutics presents Phase 3 LEVEL data at ESC 2026

TNX-103 showed a 26.3-metre walk improvement and 47% NT-proBNP reduction in lower-function PH-HFpEF patients, shaping the LEVEL-2 trial
TNX-103 showed a 26.3-metre walk improvement and 47% NT-proBNP reduction in lower-function PH-HFpEF patients, shaping the LEVEL-2 trial
Regulatory Science

Teva bids $57.5m for BioXcel dexmedetomidine film in bankruptcy sale

Teva has entered a stalking-horse bid for BXCL501, a sublingual agitation treatment under FDA review with a PDUFA date of 14 November 2026.
Teva has entered a stalking-horse bid for BXCL501, a sublingual agitation treatment under FDA review with a PDUFA date of 14 November 2026.
Biologics

BioXcel Therapeutics files Chapter 11, eyes Teva asset sale

BioXcel Therapeutics has entered Chapter 11 bankruptcy, naming Teva as stalking-horse bidder for IGALMI and a pending agitation sNDA.
BioXcel Therapeutics has entered Chapter 11 bankruptcy, naming Teva as stalking-horse bidder for IGALMI and a pending agitation sNDA.
Biologics

CRISPR Therapeutics' CTX310 shows durable lipid cuts at one year

Phase 1a data published in NEJM show a single CTX310 infusion sustained 79% mean ANGPTL3 reduction and 53% LDL reduction at one year.
Phase 1a data published in NEJM show a single CTX310 infusion sustained 79% mean ANGPTL3 reduction and 53% LDL reduction at one year.
Biologics
Biotech

Eascra Biotech wins $7.96m NASA contract for space-made nanomedicine

The Worcester, MA startup will use microgravity manufacturing to advance its RNA-delivery nanoparticle platform toward FDA clinical trials by 2028.
The Worcester, MA startup will use microgravity manufacturing to advance its RNA-delivery nanoparticle platform toward FDA clinical trials by 2028.
Diagnostics
Digital Health

Heartflow FFRCT cuts unnecessary heart catheterisations by 44%

Independent Dutch government-funded FUSION trial found adding Heartflow's AI analysis to standard CT scans halved avoidable invasive coronary procedures at one year.
Independent Dutch government-funded FUSION trial found adding Heartflow's AI analysis to standard CT scans halved avoidable invasive coronary procedures at one year.
Diagnostics

Quoin Pharmaceuticals raises up to $50m in private placement

The rare-disease specialist said upfront proceeds of $30.8m, plus warrants, will fund its Netherton Syndrome programme into the second half of 2029.
The rare-disease specialist said upfront proceeds of $30.8m, plus warrants, will fund its Netherton Syndrome programme into the second half of 2029.
Regulatory Science

Quoin Pharmaceuticals hits interim Phase 2/3 endpoints for QRX003

Quoin's topical serine protease inhibitor met both primary and key secondary endpoints in six Netherton Syndrome patients after 12 weeks of treatment.
Quoin's topical serine protease inhibitor met both primary and key secondary endpoints in six Netherton Syndrome patients after 12 weeks of treatment.
Regulatory Science

FDA grants ZYN nicotine pouches modified risk tobacco status

Philip Morris International's ZYN pouches become the first nicotine pouches to receive FDA Modified Risk Tobacco Product authorisation, allowing lower-risk marketing
Philip Morris International's ZYN pouches become the first nicotine pouches to receive FDA Modified Risk Tobacco Product authorisation, allowing lower-risk marketing
Biologics

argenx acquires Forte Biosciences, adding anti-CD122 antibody

argenx has completed its takeover of Forte Biosciences, gaining FB102, an anti-CD122 antibody with clinical data in vitiligo and coeliac disease.
argenx has completed its takeover of Forte Biosciences, gaining FB102, an anti-CD122 antibody with clinical data in vitiligo and coeliac disease.
Digital Health

BrainsWay Deep TMS data show 70% cut in suicidal ideation in MDD

A peer-reviewed secondary analysis found suicidal ideation fell from 22.5% to 6.7% of patients after six weeks of Deep TMS treatment for
A peer-reviewed secondary analysis found suicidal ideation fell from 22.5% to 6.7% of patients after six weeks of Deep TMS treatment for
Diagnostics

Conavi Medical wins FDA 510(k) for hybrid IVUS-OCT imaging system

The Toronto-based medical device firm secured FDA clearance for its Novasight Hybrid platform and targets first U.S. hospital placements in H2 2026.
The Toronto-based medical device firm secured FDA clearance for its Novasight Hybrid platform and targets first U.S. hospital placements in H2 2026.
Biologics

Corvus Pharmaceuticals publishes Phase 1 soquelitinib data in Blood

Final Phase 1/1b data for the ITK inhibitor in T cell lymphoma show durable responses and support an ongoing Phase 3 trial in relapsed
Final Phase 1/1b data for the ITK inhibitor in T cell lymphoma show durable responses and support an ongoing Phase 3 trial in relapsed
Biologics

CytomX wins FDA Fast Track for EpCAM ADC in metastatic colorectal cancer

The FDA granted Fast Track Designation to Varseta-M, an EpCAM-directed ADC, ahead of a planned registrational study starting in early 2027.
The FDA granted Fast Track Designation to Varseta-M, an EpCAM-directed ADC, ahead of a planned registrational study starting in early 2027.
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