Pharmaceuticals

Pharmaceuticals
Biologics

Zealand Pharma petrelintide hits 10.7% weight loss in Phase 2

ZUPREME-1 Phase 2 results, published in The Lancet, show petrelintide cut body weight by up to 10.7% with placebo-comparable GI tolerability.
ZUPREME-1 Phase 2 results, published in The Lancet, show petrelintide cut body weight by up to 10.7% with placebo-comparable GI tolerability.
Biologics
Pharmaceuticals

ALX Oncology's evorpacept hits 63.6% ORR in HER2+ gastric subgroup

Phase 2 ASPEN-06 data published in Nature Medicine show evorpacept doubling response rates in CD47-high, HER2-retained gastric cancer patients.
Phase 2 ASPEN-06 data published in Nature Medicine show evorpacept doubling response rates in CD47-high, HER2-retained gastric cancer patients.
Pharmaceuticals
Genomics

Belite Bio to present DRAGON Phase 3 tinlarebant data at Euretina

Belite Bio will present topline Phase 3 results for tinlarebant in adolescent Stargardt disease at Euretina in Vienna, ahead of a February 2027 FDA PDUFA
Belite Bio will present topline Phase 3 results for tinlarebant in adolescent Stargardt disease at Euretina in Vienna, ahead of a February 2027 FDA PDUFA
Pharmaceuticals
Genomics
Regulatory Science

Oryzon secures EMA approval to start HOPE-2 vafidemstat trial in PMS

Oryzon Genomics has received EMA authorisation to begin a Phase IIa study of vafidemstat in Phelan-McDermid Syndrome, a rare autism-linked genetic disorder with
Oryzon Genomics has received EMA authorisation to begin a Phase IIa study of vafidemstat in Phelan-McDermid Syndrome, a rare autism-linked genetic disorder with
Bioprocessing
Pharmaceuticals

Lifecore Biomedical to go private in $664m Webster Equity deal

Webster Equity Partners will acquire the CDMO for $6.28 per share in cash, plus CVRs worth up to $9.67 per share if performance
Webster Equity Partners will acquire the CDMO for $6.28 per share in cash, plus CVRs worth up to $9.67 per share if performance
Pharmaceuticals
Biologics

HUTCHMED files US NDA for savolitinib plus osimertinib in NSCLC

AstraZeneca has submitted a US NDA for savolitinib plus osimertinib in MET-driven EGFR-mutated NSCLC, backed by Phase III PFS and OS data.
AstraZeneca has submitted a US NDA for savolitinib plus osimertinib in MET-driven EGFR-mutated NSCLC, backed by Phase III PFS and OS data.
Biologics
Pharmaceuticals

Teva wins FDA approval for DEGEVMA denosumab biosimilar to Xgeva

Teva's DEGEVMA completes a full denosumab biosimilar portfolio covering both Xgeva and Prolia indications in the US market.
Teva's DEGEVMA completes a full denosumab biosimilar portfolio covering both Xgeva and Prolia indications in the US market.
Pharmaceuticals
Biologics

SCYNEXIS wins $214m BARDA contract to develop SCY-247 antifungal

The NASDAQ-listed biotech secured up to $214m in non-dilutive federal funding to advance its second-generation fungerp candidate through NDA submission.
The NASDAQ-listed biotech secured up to $214m in non-dilutive federal funding to advance its second-generation fungerp candidate through NDA submission.
Pharmaceuticals
Biotech

Addex Therapeutics posts H1 2026 loss as cash falls to CHF 0.8m

Addex reported a net loss of CHF 3.5m for the first half of 2026, with cash at CHF 0.8m after an ATM raise
Addex reported a net loss of CHF 3.5m for the first half of 2026, with cash at CHF 0.8m after an ATM raise
Pharmaceuticals
Biologics

Boehringer Ingelheim funds WHO Foundation obesity drive with $5m

The German pharma group will contribute $5 million over three years to strengthen obesity and metabolic health systems in resource-limited settings.
The German pharma group will contribute $5 million over three years to strengthen obesity and metabolic health systems in resource-limited settings.
Biologics
Pharmaceuticals

Annexon to present ARCHER II baseline data at Retina Society meeting

Annexon will give two oral presentations on vonaprument at the Retina Society annual meeting, with Phase 3 month-15 results expected in Q4 2026.
Annexon will give two oral presentations on vonaprument at the Retina Society annual meeting, with Phase 3 month-15 results expected in Q4 2026.
Medical Devices
Diagnostics
Pharmaceuticals
Cell & Gene Therapy
Biologics

Penn Medicine and IBA form Noventra Oncology Alliance JV

The joint venture will offer end-to-end advisory and operational support to health systems building or expanding proton therapy programmes worldwide.
The joint venture will offer end-to-end advisory and operational support to health systems building or expanding proton therapy programmes worldwide.
Pharmaceuticals
Biologics
Diagnostics

ITM reports re-treatment and dosimetry data for ITM-11 at ASTRO

Real-world SwissNET registry data showed patients re-treated with 177Lu-edotreotide achieved nearly triple the median overall survival of those switched to
Real-world SwissNET registry data showed patients re-treated with 177Lu-edotreotide achieved nearly triple the median overall survival of those switched to
Pharmaceuticals
Medical Devices
Regulatory Science

Crossject strengthens balance sheet as BARDA deal extended to $48m

The Dijon-based emergency-medicine biotech returned to positive equity after a €15m capital raise, with its BARDA contract now extended through 2030.
The Dijon-based emergency-medicine biotech returned to positive equity after a €15m capital raise, with its BARDA contract now extended through 2030.
Pharmaceuticals
Medical Devices
Regulatory Science

Crossject expands board and hires ex-FDA lead ahead of ZEPIZURE launch

The French specialty pharma firm has added three executives to its board and appointed a former FDA reviewer to lead US regulatory strategy for ZEPIZURE.
The French specialty pharma firm has added three executives to its board and appointed a former FDA reviewer to lead US regulatory strategy for ZEPIZURE.
Pharmaceuticals
Diagnostics

Milestone Pharma enrols first Canadian patient in AFib-RVR trial

Milestone Pharmaceuticals has activated the Montreal Heart Institute as its first Canadian site for the ReVeRA-301 Phase 3 study of etripamil nasal spray in
Milestone Pharmaceuticals has activated the Montreal Heart Institute as its first Canadian site for the ReVeRA-301 Phase 3 study of etripamil nasal spray in
Pharmaceuticals
Biologics
Cell & Gene Therapy

C4 Therapeutics cemsidomide shows T-cell data at IMS 2026

Biomarker data from two trials support cemsidomide's T-cell activating mechanism, as the 75 µg dose combination with elranatamab clears safety review.
Biomarker data from two trials support cemsidomide's T-cell activating mechanism, as the 75 µg dose combination with elranatamab clears safety review.
Pharmaceuticals
Regulatory Science

Newron's ENIGMA-TRS 2 US enrolment hold stays as ex-US sites expand

The FDA has confirmed its US clinical hold on evenamide's ENIGMA-TRS 2 trial; Newron is expanding enrolment across Europe, Asia and Latin America.
The FDA has confirmed its US clinical hold on evenamide's ENIGMA-TRS 2 trial; Newron is expanding enrolment across Europe, Asia and Latin America.
Pharmaceuticals

Vistagen sees fasedienol signal in severe social anxiety

Exploratory subgroup analyses from two trials showed fasedienol reduced anxiety symptoms in participants with very severe social anxiety disorder.
Exploratory subgroup analyses from two trials showed fasedienol reduced anxiety symptoms in participants with very severe social anxiety disorder.
Pharmaceuticals
Biologics

PridCor Therapeutics advances Phase 2 SHIELD Long COVID study

The Alabama biotech has made its first payment to Mount Sinai under a clinical agreement, with enrollment in the 150-patient SHIELD trial expected shortly.
The Alabama biotech has made its first payment to Mount Sinai under a clinical agreement, with enrollment in the 150-patient SHIELD trial expected shortly.
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