Keeping the Door Open: Many Would Return to Companies That Laid Them Off
A BioSpace LinkedIn poll of 1,267 biopharma professionals revealed that 51% would consider returning to the employer that laid them off. Tight labor markets, limited local opportunities, and the appeal of consulting contracts drive this willingness. Respondents cite generous severance packages and familiarity with company culture as additional incentives. However, experts warn that re‑hiring carries a real risk of repeat layoffs unless the firm demonstrates financial stability and operational reforms.
Thermogenetics: How Proteins Are Controllable by Heat
Researchers at Heidelberg University have engineered modular, heat‑responsive protein switches that function within the narrow 37 °C‑40 °C physiological window. By integrating a plant‑derived sensory domain into diverse proteins, they created allosteric thermoswitches capable of rapid, reversible activation. The technology was validated...
STAT+: Gilead and South Africa Are Negotiating a License for Local Production of New HIV Drug
Gilead Sciences is in talks with the South African government to issue a voluntary licence for the local manufacture of lenacapavir, a novel HIV‑prevention drug. The agreement would enable South African firms, identified with help from Unitaid and the US...
Moderna Settles LNP Patent Dispute with Genevant Sciences and Arbutus Biopharma for ~$2.25B
Moderna agreed to a roughly $2.25 billion settlement with Genevant Sciences and Arbutus Biopharma, ending disputes over lipid nanoparticle (LNP) technology used in its COVID‑19 vaccine. The deal requires $950 million payable in July 2026 and an additional $1.3 billion contingent on an appellate...
Atlas Insights: Single-Cell Data Point to Druggable Nodes in Down Syndrome
Researchers have generated five single‑cell atlases of human brains affected by Down syndrome, providing unprecedented cell‑type and temporal resolution. The atlases pinpoint molecular signatures that correspond to distinct neuronal and glial populations across developmental stages. By integrating these data, scientists...
New HIV Cure Approach Forces Hidden Virus Into Tripping Immune Sensor
Researchers have unveiled a novel HIV‑cure strategy that forces dormant virus particles to reveal themselves to the body’s innate immune system. The method employs a STING‑pathway agonist to coax latent proviruses into producing viral RNA, which then triggers a potent...
New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers
The FDA released a draft Level 1 guidance titled “New Clinical Investigation Exclusivity (3‑Year Exclusivity) for Drug Products: Questions and Answers.” The document clarifies statutory and regulatory criteria for obtaining three‑year market exclusivity on new drug applications or supplements. It outlines...
Tracing Extracellular Vesicles' Journey From Cancer Cells to Urine
Researchers at the Institute of Science Tokyo directly traced small extracellular vesicles (sEVs) from tumors to urine in mouse models of brain, lung and pancreatic cancer. Using engineered RNA tracers and luminescent‑fluorescent reporters, they showed tumor‑derived sEVs appear in urine...
TriSalus Life Sciences Inc (TLSI) Q4 2025 Earnings Call Transcript
TriSalus Life Sciences reported Q3 2025 revenue of $11.6 million, a 57% year‑over‑year increase, while adjusted EBITDA loss narrowed to $5.4 million despite one‑time study charges. Gross margin slipped to 84% as new product launches strained manufacturing efficiency, but cash burn improved,...
Atea Pharmaceuticals Inc (AVIR) Q4 2025 Earnings Call Transcript
Atea Pharmaceuticals reported a $329.3 million cash position that funds its Phase III hepatitis C program through 2027 and supports a new hepatitis E pipeline. The CBEYOND and C FORWARD trials are on track, with enrollment completing next month and mid‑2026 respectively, and top‑line data...
Contineum Therapeutics Inc (CTNM) Q4 2025 Earnings Call Transcript
Compugen Ltd. reported a dramatic financial turnaround in its Q4 2025 earnings, posting a $56.8 million quarterly profit and $35.3 million annual profit after a year of losses. A $65 million upfront royalty monetization from AstraZeneca boosted cash to $145.6 million, extending the cash runway...
The Short-Chain Fatty Acid Butyrate Prevents Gut-Brain Amyloid-Β Pathology and Neuroinflammation in an Alzheimer Mouse Model
Researchers demonstrated that oral sodium butyrate supplementation prevents amyloid‑β accumulation and neuroinflammation in both the gut and brain of the SAMP8 mouse model of sporadic Alzheimer’s disease. Longitudinal analyses revealed early Aβ deposition in the enteric nervous system, leading to...
Regenxbio Inc (RGNX) Q4 2025 Earnings Call Transcript
Regenxbio reported that enrollment for its Duchenne gene therapy RGX-202 was completed ahead of guidance, with top‑line data slated for early Q2 2026 and a BLA submission planned for mid‑2026. The company confirmed manufacturing capacity of 2,500 annual doses and highlighted...
Microbial Assembly Line Makes Plastic Upcycling Programmable
Scientists engineered a programmable microbial assembly line that transforms PET plastic waste into pyruvate, a universal metabolic feedstock, which downstream microbes then convert into a range of valuable products such as dyes, biopolymers, fuels and electricity. The core bacterium, Pseudomonas...
Scientists Laud Potentially Life-Changing Drug for Children with Resistant Form of Epilepsy
Preliminary trials of Zorevunersen, an experimental therapy for Dravet syndrome, showed it is safe and well tolerated in 81 children. A single 70 mg dose reduced seizures by about 50%, and three doses cut seizures roughly 80% compared with baseline. The...
Elevated Glucose Levels Trigger STAT3 Activation, Promoting Tumor Growth in Colorectal Cancer Cells
University of Michigan researchers discovered that physiological glucose levels sustain aberrant STAT3 activation in colorectal cancer cells, driving tumor proliferation. The study identified glycosylated secreted proteins as mediators of this glucose‑dependent STAT3 signaling, a mechanism also observed in pancreatic, liver,...
Endothelin Receptor Antagonist REMS Information
The FDA has eliminated risk evaluation and mitigation strategy (REMS) requirements for embryofetal toxicity (EFT) across all endothelin receptor antagonist (ERA) medicines, concluding that labeling alone sufficiently communicates the risk. The change, effective April 2025, applies to ambrisentan, macitentan‑containing products, and...
When a Brain Signal Falters: Uncovering New Insights Into Autism Biology
A March 4, 2026 roundup from Bioengineer highlights a series of biotech breakthroughs. Researchers showed that plant DCL4 outcompetes DCL2, boosting RNA‑silencing efficiency, while short‑term antibacterial coatings were found to lose potency over time. Evo 2’s AI platform now models genetic code across...
Drug Trials Snapshots: MYQORZO
MYQORZO (aficamten), a cardiac myosin inhibitor, received FDA approval on Dec 19 2025 for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Approval is based on the SEQUOIA‑HCM phase III trial, a randomized, double‑blind, placebo‑controlled study of 282 patients across 14 countries. At 24 weeks,...
Orai1 Switches Ca2+ Signals, Balances Erythropoiesis
Researchers have identified the Orai1 calcium channel as a pivotal regulator of intracellular Ca2+ signals that govern erythropoiesis. Genetic ablation of Orai1 in mouse models leads to impaired red‑cell maturation and anemia, while pharmacologic activation rescues normal blood counts. The...
Photobiomodulation: Revolutionary Breakthrough or Scam?
The Valeda photobiomodulation system received FDA authorization in November 2024 and has been used clinically since summer 2025 to treat retinal aging. A modest 148‑eye, two‑year study showed statistically significant gains in best‑corrected visual acuity and a lower rate of progression to...
Syantra’s Breast Cancer Blood Test Isn’t Looking for Cancer at All
Syantra, a Calgary‑based biotech, is preparing to launch Onco‑ID, a breast‑cancer blood test that detects the body’s immune response rather than circulating tumor DNA. Using machine‑learning analysis of gene‑expression biomarkers, the test aims to identify cancer earlier than mammography and...
Missouri Team Shows How to Rewrite Bits Stored in DNA
University of Missouri researchers have demonstrated a technique to rewrite data stored in DNA, overcoming the long‑standing limitation that DNA‑encoded information was immutable. The method pairs a compact electronic module with a nanopore sensor, translating electrical signals into binary bits....
Mara Blue Launches Feasibility Study for Ireland’s First Marine Biorefinery in Castletownbere
The Mara Blue initiative has launched a feasibility study for Ireland’s first full‑scale marine biorefinery on Dinish Island near Castletownbere. Led by Munster Technological University in partnership with Pure Ocean Algae and the Castletownbere Fishermen’s Co‑op, the study is co‑funded...
With Evo 2, AI Can Model and Design the Genetic Code for All Domains of Life
Evo 2, an AI foundation model published in Nature, was trained on over 9.3 trillion nucleotides from 128 000 genomes spanning bacteria to humans. The model can pinpoint disease‑causing mutations, such as BRCA1 variants, with more than 90 % accuracy and design synthetic genomes...
October 5, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement - 10/05/2023
The FDA’s Oncologic Drugs Advisory Committee will meet virtually on October 5, 2023 to evaluate Amgen’s supplemental NDA for LUMAKRAS (sotorasib) in KRAS G12C‑mutated non‑small cell lung cancer. The committee will review data from the confirmatory CodeBreaK 200 trial, which could convert the existing...
Upcoming EL-PFDD Meetings
The FDA has posted a public list of disease areas where external organizations have submitted letters of intent for future Externally‑Led Patient‑Focused Drug Development (EL‑PFDD) meetings. Ten topics ranging from infertility to rare neurological disorders are scheduled between March and...
Leading HIV Researchers Reflect on Breakthroughs, Challenges at CROI 2026
The 2026 Conference on Retroviruses and Opportunistic Infections (CROI) highlighted major HIV research breakthroughs while underscoring persistent funding shortfalls. Experts praised advances in antiretroviral therapy, emerging adjunct treatments, and global advocacy, yet warned that reduced U.S. support could limit access...
Nanoparticle Vaccine Approach Takes on a New Target: Hepatitis C Virus
Scientists at Scripps Research have engineered a native‑like, stabilized version of the hepatitis C virus E1E2 glycoprotein complex and displayed it on self‑assembling protein nanoparticles (SApNPs). The nanoparticle vaccine candidate elicited strong, virus‑specific antibody responses in animal models. This breakthrough overcomes...
Five Projects Share £100m UK-US Cancer Grand Challenges Fund
Five interdisciplinary teams will receive up to £20 million each from the UK‑US Cancer Grand Challenges, adding £100 million to the programme and raising total investment to £465 million since 2016. The five projects, spanning 34 institutions in nine countries, target unconventional angles...
UniQure’s Delay, REGENXBIO’s Rejection Explained, Sarepta’s Ingram Steps Down, More
The FDA issued a complete‑response letter to UniQure, requiring a randomized, double‑blind, sham‑surgery Phase 3 trial for its Huntington’s disease gene therapy, and similarly rejected REGENXBIO’s Hunter syndrome candidate over study design flaws. Regulatory experts warned that the agency’s decision‑making appears...
Theolytics Awarded €8 Million Horizon Europe Grant to Fund Ovarian Cancer Study
Theolytics, an Oxford‑based biotech, secured an €8 million non‑dilutive Horizon Europe grant to fund its phase 2 OCTOPOD‑IV expansion trial of THEO‑260, a novel oncolytic therapy for advanced ovarian cancer. The grant, awarded after a rigorous review, will finance the phase 2a portion...
Bespoke Startup EveryONE Folds 1 Week After Plausible Mechanism Guidance
EveryONE Medicines announced its shutdown just a week after the FDA released draft guidance for its new bespoke pathway targeting personalized genetic therapies. The guidance requires each individualized drug to be submitted as a separate application, a burden that the...
Black Soldier Fly Larvae Show Promise for Safe Organic Waste Removal
Researchers demonstrated that black‑soldier‑fly (BSF) larvae can consume food waste, sewage sludge, and pig manure while substantially lowering the load of human‑pathogenic RNA viruses. In eight‑day trials, larvae grew across all feedstocks, and viral abundance dropped dramatically, though some viruses...
Aspire Biopharma and Microsize Collaborate for Alprazolam Powder Formulation
Aspire Biopharma has teamed with particle‑engineering specialist Microsize to develop a sublingual powder formulation of alprazolam, aiming for faster anxiety relief than traditional tablets. The partnership leverages Microsize’s micronisation expertise and Pace’s excipient compatibility and stability services to accelerate development....
Extracellular Vesicles: The Next Frontier in Regenerative Medicine and Drug Delivery?
Extracellular vesicles (EVs) are emerging as a versatile platform for regenerative medicine and targeted drug delivery. Researchers highlight their ability to transfer proteins, RNA, and lipids between cells, mimicking natural signaling pathways. Recent advances in isolation, engineering, and loading techniques...
UK Puts £50m Behind Expanded Clinical Trials Drive
The UK government announced nearly £48 million in equipment funding to accelerate commercial clinical trials across the NHS. The money will equip 51 NHS trusts and 79 primary‑care organisations with diagnostic tools, scanners and mobile research vans, with 60 % directed to...
ETH Zurich-Led Study Produces Functional 3D Printed Ear Cartilage, Paving Way for Clinical Reconstruction
Researchers from ETH Zurich, the Friedrich Miescher Institute and the Cantonal Hospital of Lucerne have 3D‑printed elastic ear cartilage that closely replicates natural tissue mechanics. Using patient‑derived cartilage cells embedded in a bio‑ink, they produced ear‑shaped constructs that retained shape...
Navigating Uncertainty and Building Resilient Supply Chains: The Case for US-Based CDMO Partnerships
Pharmaceutical firms are accelerating onshoring efforts, with more than $270 billion pledged for U.S. manufacturing since early 2025 and 80% of global producers weighing domestic or near‑shore options. Legislative moves such as the BIOSECURE Act and incentives like BARDA Project NextGen are...
Rethinking Biotech’s Valley of Death as Federal Grants and Family Offices Step In
Federal budget approvals for 2026 dramatically increase nondilutive capital for biotech, raising NIH funding to $49 billion and expanding programs like CDMRP and ARPA‑H. Seed‑stage companies are responding, with 38 % planning to rely on grants and other non‑equity sources. Simultaneously, mission‑driven...
New Research Findings Challenge Old Beliefs About Myelin Repair in MS
Researchers using advanced imaging in mice discovered that oligodendrocyte precursor cells continuously differentiate into mature oligodendrocytes across the brain and spinal cord, regardless of myelin injury. This overturns the long‑standing belief that these cells only mature in response to damage....
MIT Develops Biodegradable “Smart Pill” To Track Medication Adherence
MIT engineers have unveiled SAFARI, a biodegradable ingestible sensor that confirms pill ingestion using a bioresorbable Faraday cage and RFID tag. The device activates once the cage dissolves in the gastrointestinal tract and transmits a signal within about ten minutes....
Keytruda Hangs On to Best Seller Crown as GLP-1s Gain Ground
Merck’s Keytruda remained pharma’s top‑selling drug in 2025, generating $31.7 billion and a 7 % year‑on‑year increase. However, the combined sales of GLP‑1 franchises—Eli Lilly’s tirzepatide line and Novo Nordisk’s semaglutide portfolio—totaled over $36 billion, overtaking Keytruda for the first time. The GLP‑1 market is...
Whole-Genome Sequencing Meets Real-World Outcomes: What 1,364 Breast Cancer Genomes Reveal About Treatment Response
A new Nature study sequenced the whole genomes of 1,364 breast cancers and linked the data to transcriptomics and real‑world treatment outcomes. The analysis showed that genome‑wide signatures such as homologous recombination deficiency, intratumoral heterogeneity, and copy‑number instability correlate with...
Early Research Shows New Blood Test Can Help Predict Testicular Cancer Recurrence
Early-stage testicular cancer patients could soon benefit from a blood‑based assay that detects microscopic disease after orchiectomy. The CLIMATE study, led by WEHI and ANZUP, identified the microRNA marker miR‑371 as a reliable predictor of relapse, which occurs in roughly...
EyePoint Inc (EYPT) Q4 2025 Earnings Call Transcript
EyePoint reported Q4 2025 results, highlighting rapid enrollment of over 900 patients in two pivotal wet AMD Phase 3 trials (Lugano and LUCHIA) with top‑line data expected mid‑2026. The company also initiated Phase 3 DME studies (COMO and CAPREIT) slated for first...
Keros Therapeutics Inc (KROS) Q4 2025 Earnings Call Transcript
Karyopharm Therapeutics reported Q4 2025 total revenue of $34.1 million, an 11.8% year‑over‑year increase, driven primarily by XPOVIO net product revenue of $32.1 million. The company trimmed R&D and SG&A expenses, improving operating performance by roughly 43% quarter‑over‑quarter, yet posted a GAAP...
Verastem Inc (VSTM) Q4 2025 Earnings Call Transcript
Verastem reported $1.7 million in COPIKTRA net revenue for Q1 2019, a 38% increase over the prior quarter, and achieved reimbursement coverage with more than 92% of targeted health plans. Clinical updates highlighted the Phase 3 DUO trial, which showed...
Niagen Bioscience Inc (NAGE) Q4 2025 Earnings Call Transcript
Niagen Bioscience reported Q2 2025 revenue of $31.1 million, a 37% year‑over‑year increase, and lifted full‑year revenue guidance to 22‑27%. Gross margin improved to 65% driven by a higher‑margin sales mix and inventory efficiencies. The company expanded its Niagen Plus clinic...
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[Comment] Considerations for Improving Non-Inferiority Trials
Non‑inferiority trials are increasingly employed to evaluate new therapies that may offer advantages beyond efficacy, such as safety or convenience. However, their design and analysis present unique methodological challenges that can compromise study validity. The commentary outlines essential considerations, including...
