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The Biotech Times

@thebiotechtimes.bsky.social
23 followers 22 following 493 posts

Commercialising the frontiers of biological innovation. Intelligence for pharma executives, clinical researchers and life-science investors. A Disrupts Media title, alongside Disrupts, The Datatech Times and The Fintech Times.

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The Biotech Times @thebiotechtimes.bsky.social · 13h
New Era Energy secures 20-year power contract with Vistra for 207 MW to supply Phase 1 of its Texas data centre. Firm capacity through 2044 underscores the scale of infrastructure build-out backing AI and compute-intensive biotech workloads.
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New Era Energy inks 20-year, 207 MW power deal with Vistra
New Era Energy & Digital has contracted firm power for Phase 1 of its Texas data centre, with Vistra supplying up to 207 MW from an
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The Biotech Times @thebiotechtimes.bsky.social · 15h
Vironexis reports MRD-negative complete responses in all three antibody-naïve R/R ALL patients treated with VNX-101 in the SENTRY-CD19 trial, following a single infusion. Early-stage signal in a hard-to-treat population.
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Vironexis VNX-101 achieves MRD-negative responses in R/R ALL
All three antibody-naïve relapsed/refractory ALL patients in SENTRY-CD19 achieved durable MRD-negative complete responses after a single VNX-101 infusion.
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The Biotech Times @thebiotechtimes.bsky.social · 17h
CDT Equity and QIMA Life Sciences are testing novel tapinarof combinations in psoriasis and vitiligo using human patient skin tissue. Early-stage work on a candidate with real commercial traction.
biotech.disruptsmedia.com
CDT Equity and QIMA to test tapinarof combos in psoriasis
CDT Equity is partnering with dermatology CRO QIMA Life Sciences to evaluate novel tapinarof combinations in psoriasis and vitiligo using human patient skin tissue.
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The Biotech Times @thebiotechtimes.bsky.social · 19h
A quarter-century after Pronovost's ICU checklist cut infections sharply, US hospital patient harm rates remain largely flat. The evidence works, adoption doesn't.
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Patient safety checklist marks 25 years with reform agenda unfinished
Dr Peter Pronovost's ICU infection checklist turns 25, but patient harm rates in US hospitals have barely shifted in a generation.
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The Biotech Times @thebiotechtimes.bsky.social · 04/10/2026
Ultrahuman's HealthEx PowerPlug now integrates continuous ring data directly into medical records, connecting wearable biomarkers to a patient's full health history. A concrete step toward breaking down US healthcare's data silos.
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Ultrahuman merges ring data with medical records via HealthEx
Ultrahuman's HealthEx PowerPlug links continuous wearable biomarkers to a member's full medical history, aiming to close gaps in fragmented US healthcare records.
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The Biotech Times @thebiotechtimes.bsky.social · 04/10/2026
Syneos Health and Tufts CSDD benchmarked 133 trials and found operating model design, not whether you outsource, drives clinical performance.
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Syneos Health and Tufts CSDD study finds no superior CRO model
A benchmarking study across 133 trials found operating model design, not outsourcing choice, drives clinical development performance.
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The Biotech Times @thebiotechtimes.bsky.social · 04/10/2026
Rezera is launching REVEAL-PAD, a multi-centre observational study to characterise inflammation patterns in peripheral artery disease patients. The work will inform positioning ahead of the company's Phase 3 ruvonoflast trial in 2027.
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Rezera launches REVEAL-PAD study to map inflammation in PAD
The Boston biotech plans a prospective, multi-centre observational study to characterise PAD patients ahead of its Phase 3 ruvonoflast trial in 2027.
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The Biotech Times @thebiotechtimes.bsky.social · 04/10/2026
Jack Ady Cancer Centre in Lethbridge is running Alberta's first researcher-led cancer trial outside major cities. Two-session prostate radiotherapy protocol under investigation. Rural access to clinical research expands.
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Jack Ady Cancer Centre launches Alberta's first rural cancer trial
Lethbridge's Jack Ady Cancer Centre is trialling a two-session prostate radiotherapy protocol, the first researcher-led cancer trial outside Alberta's major cities.
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The Biotech Times @thebiotechtimes.bsky.social · 03/10/2026
GOA Therapeutics emerges from stealth with $15.5m to advance GOA26, a dual-action enzyme candidate that reduced blood alcohol by 61% in animal studies. IND filing planned Q4 2026.
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GOA Therapeutics exits stealth with $15.5m alcohol antidote
GOA26, a dual-action engineered enzyme and acetaldehyde scavenger, cut blood alcohol by 61% in porcine studies; an IND filing is planned for Q4 2026.
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The Biotech Times @thebiotechtimes.bsky.social · 03/10/2026
Firefly's FDA-cleared brain-function platform joining Radial's clinical OS across 27 US neurology practices. Integrates EEG/ERP data into a single AI-guided workflow for neurologists.
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Firefly Neuroscience Evoke platform to join Radial's AI clinical OS
Firefly's FDA-cleared EEG/ERP brain-function platform will be embedded into RadialOS, the AI-guided operating system used across 27 US brain medicine
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The Biotech Times @thebiotechtimes.bsky.social · 03/10/2026
Cooper hit $1.07bn in Q3 revenue but flagged a US channel inventory drag at CooperVision that will weigh into Q4.
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CooperCompanies posts $1.07bn Q3 revenue amid CVI inventory drag
CooperCompanies hit $1.07bn in Q3 revenue but warned a US channel inventory reduction at CooperVision will weigh into the fourth quarter.
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The Biotech Times @thebiotechtimes.bsky.social · 03/10/2026
Cardiff Oncology and Nerviano Medical Sciences have settled their dispute and broadened their onvansertib collaboration. The expanded deal clears the way for a global Phase 3 trial of the TP53 inhibitor candidate.
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Cardiff Oncology and NMS settle dispute and expand onvansertib deal
Cardiff Oncology and Nerviano Medical Sciences have resolved litigation and expanded their 2017 licence agreement, clearing the path for a global Phase 3 trial of
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The Biotech Times @thebiotechtimes.bsky.social · 02/10/2026
BioStem Technologies has secured $40m in committed equity financing from Roth Principal Investments. The Nasdaq-listed perinatal allograft maker will use the facility for working capital as it scales manufacturing.
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BioStem Technologies secures $40m committed equity facility with Roth
The Nasdaq-listed perinatal tissue allograft maker has agreed a $40 million at-will equity facility with Roth Principal Investments for working capital purposes.
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The Biotech Times @thebiotechtimes.bsky.social · 02/10/2026
AVAVA has raised $45m in a mixed equity-debt round led by Catalio Capital to expand its Focal Point Technology aesthetics platform and advance its device pipeline.
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AVAVA raises $45m to scale Focal Point Technology aesthetics platform
AVAVA secured a $45m mixed equity and debt round led by returning backer Catalio Capital to fund commercial expansion and its next-generation device pipeline.
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The Biotech Times @thebiotechtimes.bsky.social · 02/10/2026
Treace Medical presented five-year Lapiplasty data at AOFAS 2026 alongside two further clinical studies, demonstrating sustained outcomes across its bunion correction systems.
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Treace Medical reports 5-year Lapiplasty data at AOFAS 2026
Three clinical studies presented at AOFAS 2026 show sustained outcomes for Treace's bunion correction systems, including a milestone five-year dataset.
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The Biotech Times @thebiotechtimes.bsky.social · 02/10/2026
Teva's once-monthly olanzapine LAI shows 56% stabilisation and 4% relapse in Phase 3 SOLARIS data. FDA decision expected Q4 2026.
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Teva presents Phase 3 data on once-monthly olanzapine LAI TEV-'749
Post hoc SOLARIS data show 56% stabilisation and 4% relapse rates; an FDA decision on TEV-'749 is expected in Q4 2026.
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The Biotech Times @thebiotechtimes.bsky.social · 02/10/2026
Oryzon wins EMA green light for Phase IIa vafidemstat trial in Phelan-McDermid Syndrome. First clinical test of the histone deacetylase inhibitor in this rare autism-linked genetic disorder.
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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
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The Biotech Times @thebiotechtimes.bsky.social · 02/10/2026
Crossject has appointed a former FDA reviewer to lead US regulatory strategy for ZEPIZURE, while adding three executives to its board. The moves precede the specialty pharma firm's planned launch of its seizure auto-injector.
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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.
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The Biotech Times @thebiotechtimes.bsky.social · 01/10/2026
Roche opens a 95,000 sq m Innovation Center in Boston to house 500 staff focused on cardiovascular, renal and metabolic research. Part of a $50bn US investment push.
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Roche opens Boston CVRM hub at Harvard campus as part of $50bn US push
Roche and Genentech have opened a 95,000 sq m Innovation Center in Allston, Boston, housing up to 500 staff focused on cardiovascular, renal and
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The Biotech Times @thebiotechtimes.bsky.social · 01/10/2026
NightWare wearable reduced nightmare distress by half in a 60-day pilot of San Francisco first responders with PTSD, published in Frontiers in Sleep.
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NightWare wearable cuts nightmare distress in first responder study
A peer-reviewed pilot in Frontiers in Sleep found NightWare halved nightmare distress in San Francisco police and fire personnel with PTSD over 60 days.
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The Biotech Times @thebiotechtimes.bsky.social · 01/10/2026
Senseonics and Beta Bionics are integrating Eversense 365, a year-long implantable CGM, with the iLet Bionic Pancreas. Commercial launch planned for Q4 2026.
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Senseonics partners Beta Bionics to link Eversense 365 with iLet
Senseonics and Beta Bionics plan to integrate the year-long implantable CGM with the iLet Bionic Pancreas, targeting a commercial launch in Q4 2026.
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The Biotech Times @thebiotechtimes.bsky.social · 01/10/2026
Belite Bio presents Phase 3 tinlarebant data in adolescent Stargardt disease at Euretina, with FDA PDUFA decision expected February 2027.
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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
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The Biotech Times @thebiotechtimes.bsky.social · 01/10/2026
Seer's Proteograph platform has now featured in 100+ peer-reviewed studies across disease biology, ageing and population-scale biomarker discovery. Validation at scale in the published literature.
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Seer hits 100 peer-reviewed publications for Proteograph platform
Seer's Proteograph Product Suite has featured in over 100 peer-reviewed studies, spanning disease biology, ageing and population-scale biomarker discovery.
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The Biotech Times @thebiotechtimes.bsky.social · 01/10/2026
Boehringer Ingelheim commits $5m to WHO Foundation obesity initiative across resource-limited settings over three years, targeting metabolic health systems strengthening.
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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.
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The Biotech Times @thebiotechtimes.bsky.social · 01/10/2026
Crossject swung to positive equity on a €15m raise and extended its BARDA contract to $48m through 2030. The Dijon emergency-medicine biotech now has runway to scale its auto-injector platform.
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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.
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The Biotech Times @thebiotechtimes.bsky.social · 01/10/2026
Penn Medicine and IBA have formed Noventra Oncology Alliance, a joint venture offering end-to-end advisory and operational support for health systems building or expanding proton therapy programmes globally.
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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.
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The Biotech Times @thebiotechtimes.bsky.social · 30/09/2026
Flow Neuroscience's FL-100 is now FDA-cleared for at-home use, the first prescribed tDCS headset for moderate to severe depression in the US market.
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Flow Neuroscience launches FDA-cleared at-home tDCS device FL-100
Flow Neuroscience's FL-100 headset is now available by US prescription, becoming the first FDA-approved at-home tDCS treatment for moderate to severe
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The Biotech Times @thebiotechtimes.bsky.social · 30/09/2026
Avacta's AVA6103 PDC hit preclinical PK predictions and showed clean safety across three dose levels in FOCUS-01. Early signals on a mechanism-of-action readout in solid tumours.
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Avacta reports clinical proof of mechanism for AVA6103 PDC in FOCUS-01
Avacta's next-generation pre|CISION peptide-drug conjugate showed a clean safety profile and matched preclinical PK predictions across three dose levels in solid
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The Biotech Times @thebiotechtimes.bsky.social · 30/09/2026
Ascendis Pharma regains full rights to its TransCon platform in cardiometabolic indications following the end of its Novo Nordisk collaboration.
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Ascendis Pharma to regain TransCon rights in metabolic diseases
Ascendis Pharma will reclaim full rights to its TransCon platform in cardiometabolic indications after ending its Novo Nordisk collaboration.
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The Biotech Times @thebiotechtimes.bsky.social · 30/09/2026
Addex Therapeutics burned through cash in H1 2026, posting a CHF 3.5m loss and ending the period with just CHF 0.8m on hand after an ATM raise. Runway pressure intensifying.
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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
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The Biotech Times @thebiotechtimes.bsky.social · 30/09/2026
RWS moves Tridion agentic tools into public preview for regulated content workflows. Tridion Agent and Tridion Connect aim at pharma and medtech managing high-volume technical documentation at scale.
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RWS launches Tridion agentic platform for regulated content workflows
RWS has put its Tridion Agent and Tridion Connect tools into public preview, targeting regulated industries managing high-volume technical documentation.
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The Biotech Times @thebiotechtimes.bsky.social · 30/09/2026
IBA to install first gantry proton therapy centre in central Italy. Rome's IFO has signed for a Proteus ONE system, extending gantry-based treatment access to central and southern regions.
biotech.disruptsmedia.com
IBA to install first gantry proton therapy centre in central Italy
IBA has signed a contract with Rome's IFO to deliver a Proteus ONE proton therapy system, bringing gantry-based treatment to central and southern
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The Biotech Times @thebiotechtimes.bsky.social · 30/09/2026
Roquette hit €2.6bn revenue in H1 2026, up 9%, as pharma excipients and margin work pay off. The French ingredients house is tightening its shift to higher-value biotech supply.
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Roquette posts 9% revenue growth in H1 2026 on pharma excipient gains
The French plant-based ingredients group lifted H1 turnover to €2.6bn, with pharmaceutical excipients and its Shift & Lead transformation plan driving margin improvement.
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The Biotech Times @thebiotechtimes.bsky.social · 30/09/2026
Roche's sefaxersen met its Phase III primary in IgA nephropathy, cutting proteinuria versus placebo in 459 adults at 37 weeks. Key next step: regulatory filing timelines.
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Roche sefaxersen hits Phase III primary endpoint in IgA nephropathy
Interim IMAgINATION trial data show sefaxersen significantly reduced proteinuria versus placebo at 37 weeks in 459 adults with IgAN.
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The Biotech Times @thebiotechtimes.bsky.social · 30/09/2026
Cibus licenses gene-editing technology to Crystal Crop for mustard cultivation across India's 8.5 million hectare growing region, targeting yield improvements through non-GMO editing methods.
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Cibus and Crystal Crop partner to gene-edit India's mustard crop
The deal gives Crystal Crop exclusive India rights to Cibus gene-editing technology targeting higher mustard yields across 8.5 million hectares.
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The Biotech Times @thebiotechtimes.bsky.social · 29/09/2026
Tenaya's PKP2-ARVC gene therapy cleared for expedited FDA pathway on Phase 1b/2 interim signals. TN-401 is an AAV9 candidate targeting a rare inherited heart rhythm disorder.
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Tenaya wins FDA RMAT designation for ARVC gene therapy TN-401
Tenaya Therapeutics has secured RMAT designation for TN-401, its AAV9-based gene therapy for PKP2-associated ARVC, backed by Phase 1b/2 interim data.
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The Biotech Times @thebiotechtimes.bsky.social · 29/09/2026
Leios Therapeutics has secured FDA sign-off on its Phase 3 design for 10XB-101, an injectable treatment for submental fat. The 505(b)(2) pathway clears a defined regulatory route to market.
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Leios Therapeutics clears FDA end-of-phase 2 meeting for 10XB-101
The La Jolla biotech secured FDA alignment on Phase 3 design for its injectable submental fat treatment, clearing the path to a 505(b)(2
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The Biotech Times @thebiotechtimes.bsky.social · 29/09/2026
Veracyte acquires Convergent Genomics for up to $180m, adding the UroAmp urinary tumour DNA platform to its bladder cancer portfolio. Commercialisation targeted for late 2028.
biotech.disruptsmedia.com
Veracyte acquires Convergent Genomics for up to $180m
Veracyte is adding the UroAmp urinary tumour DNA platform to its bladder cancer portfolio, with commercialisation targeted for late 2028.
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The Biotech Times @thebiotechtimes.bsky.social · 29/09/2026
HUTCHMED presenting Phase III data on savolitinib-osimertinib combination for NSCLC at ESMO 2026. Two studies, SAFFRON and SANOVO, both positive. Oral presentations in Madrid this October.
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HUTCHMED takes savolitinib-osimertinib combo to ESMO 2026
Two positive Phase III NSCLC studies, SAFFRON and SANOVO, will feature as oral presentations at ESMO Congress 2026 in Madrid this October.
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The Biotech Times @thebiotechtimes.bsky.social · 29/09/2026
Ocugen's OCU400 gene therapy wins provisional approval in The Bahamas for retinitis pigmentosa, clearing the way for patient access within 90 days. A regulatory win outside the US amid the company's ongoing development path.
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Ocugen's OCU400 gains provisional approval in The Bahamas for RP
Ocugen's modifier gene therapy OCU400 has received provisional LARTA approval in The Bahamas, enabling expanded access for retinitis pigmentosa patients within 90 days.
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The Biotech Times @thebiotechtimes.bsky.social · 29/09/2026
Kessler Foundation and UPnRIDE are studying real-world use of the FDA-cleared standing mobility platform in rehabilitation settings. Early data on clinical adoption and patient outcomes could inform device positioning in post-acute care.
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Kessler Foundation and UPnRIDE partner on upright mobility study
Kessler Foundation and UPnRIDE are studying real-world use of the FDA-cleared standing mobility platform among rehabilitation patients.
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The Biotech Times @thebiotechtimes.bsky.social · 29/09/2026
ITM's 177Lu-edotreotide data from SwissNET shows re-treated patients achieved nearly three times the median overall survival of those who switched therapy. Real-world dosimetry insights from a phase 3 candidate at scale.
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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
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The Biotech Times @thebiotechtimes.bsky.social · 29/09/2026
Ingenio Care has launched a US healthcare marketplace indexing 7.5m providers with CMS pricing and quality data built in. Potential to reshape how payers and patients navigate provider selection and cost.
biotech.disruptsmedia.com
Ingenio Care launches AI-enabled national healthcare marketplace
The Illinois-based digital health company says its marketplace lists over 7.5 million US providers with CMS pricing and quality data.
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The Biotech Times @thebiotechtimes.bsky.social · 29/09/2026
Avaí Bio and Austrianova have outlined preclinical progress on Klothonova, an encapsulated-cell therapy candidate targeting ageing. The joint venture presented GMP cell-bank data at a Miami longevity conference.
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Avaí Bio and Austrianova present Klothonova encapsulated-cell data
The preclinical joint venture presented its α-Klotho cell-encapsulation programme at a Miami longevity conference, outlining progress on a GMP cell bank.
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The Biotech Times @thebiotechtimes.bsky.social · 29/09/2026
Annexon will present Phase 3 baseline data on vonaprument for retinal disease at the Retina Society meeting, with month-15 results due Q4 2026.
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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.
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The Biotech Times @thebiotechtimes.bsky.social · 29/09/2026
Revelyx Bio's Phase 2 data for YY003, a recombinant liquid botulinum toxin, shows 80.8% of participants hit the composite primary endpoint at 40 units. Rapid onset by week one, no neutralising antibodies detected.
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Revelyx Bio Phase 2 data back recombinant liquid botulinum toxin YY003
YY003 hit its composite primary endpoint in 80.8% of participants at the 40-unit dose, with rapid onset by week one and no neutralising
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The Biotech Times @thebiotechtimes.bsky.social · 29/09/2026
Actimed Therapeutics has completed recruitment for its Phase 2a trial of S-pindolol benzoate, enrolling over 100 patients to test preservation of lean mass during semaglutide therapy.
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Actimed Therapeutics completes PROACT Phase 2a recruitment
The London biotech has enrolled over 100 patients in a trial testing S-pindolol benzoate to preserve lean mass during and after semaglutide therapy.
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The Biotech Times @thebiotechtimes.bsky.social · 29/09/2026
Dialybrid closed a €15m Series A and implanted its Silkothane hybrid arteriovenous graft in the first patient of an Italian pilot trial.
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Dialybrid raises €15m Series A and achieves first-in-human implant
The Italian medtech closed a €15m Series A and implanted its Silkothane® hybrid arteriovenous graft in its first patient in an ongoing Italian pilot trial.
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The Biotech Times @thebiotechtimes.bsky.social · 29/09/2026
EC approves leriglitazone for cerebral adrenoleukodystrophy. NEZGLYAL is the first oral drug licensed for cALD in young boys, a rare X-linked neurological disorder with no prior pharmacological option.
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EC approves leriglitazone as first pharmacological cALD treatment
Neuraxpharm and Minoryx win EU marketing authorisation for NEZGLYAL, the first oral drug approved for cerebral adrenoleukodystrophy in young boys.
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The Biotech Times @thebiotechtimes.bsky.social · 28/09/2026
Pharmazz's sovateltide has won FDA Orphan Drug Designation for neonatal hypoxic-ischaemic encephalopathy. The endothelin-B receptor agonist now qualifies for US development incentives including tax credits and market exclusivity.
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Pharmazz wins FDA Orphan Drug Designation for sovateltide in NHIE
Pharmazz's endothelin-B receptor agonist sovateltide gains Orphan Drug Designation for neonatal hypoxic-ischaemic encephalopathy, unlocking US development incentives.
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