Malaysia, Australia Empower Women to Lead in Biotechnology Innovation
Malaysia and Australia launched an inaugural biotechnology session aimed at boosting women’s leadership in high‑growth sectors such as vaccine manufacturing and bioprocessing. The partnership aligns with Malaysia’s 2021‑2030 STI policy and Biotechnology Policy 2.0, leveraging Australia’s life‑science expertise and Malaysia’s strong female researcher base. Upskilling, mentorship and accelerator programs are designed to turn research into commercial ventures, supporting women‑led startups across agriculture, health and industrial biotech. The initiative seeks to position the region as an inclusive hub for global biotech innovation.
Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination
Blaine Labs, Inc. announced a voluntary nationwide recall of three lot numbers of its Revitaderm® and Tridergel™ wound‑care gels after detecting the environmental bacterium Lysinibacillus fusiformis. The affected products, 1‑oz and 3‑oz bottles containing 0.1% benzalkonium chloride, were distributed to...
Tackling Translation: The Parker Institute Model
The Parker Institute for Cancer Immunotherapy marks its tenth anniversary by spotlighting a deliberate approach to translating scientific discoveries into medicines. Founder Karen Knudsen notes that while U.S. discovery remains strong, the nation struggles with moving breakthroughs through development pipelines....
'No One Knows What They Are': Researchers Discover New Type of Cell That's Seen only During Pregnancy
Scientists at UCSF have produced a comprehensive single‑cell atlas of the human placenta and uterus, analyzing roughly 1.2 million cells from weeks 5 to 39 of gestation. The study uncovered a previously unknown cell subtype, decidual stromal cell 4 (DSC4), which appears only during...
Imaging AI Targeting Parkinson's Earns FDA's De Novo Classification
Neuropacs Corp. received FDA De Novo classification for its AI‑driven MRI software that differentiates Parkinson’s disease from atypical parkinsonian syndromes. The tool quantifies MRI patterns of multiple system atrophy Parkinsonian variant and progressive supranuclear palsy, achieving a 96% AUC in...
Life Bio’s Trial: Is the FDA Warming to Rejuvenation?
Life Biosciences received FDA clearance for its ER-100 investigational new drug, marking the first human trial of a cellular reprogramming therapy aimed at the eye. The Phase 1 study will enroll patients with glaucoma or non‑arteritic anterior ischemic optic neuropathy, emphasizing...
Key Differences Between Biotechnology and Pharmaceutical Industries
The article clarifies that biotechnology firms develop medicines using living organisms, while pharmaceutical companies rely on synthetic chemical processes. It highlights the rapid growth of the biotech sector, projecting a global market of $6.34 billion by 2035, and notes that biotech...
Neuroblastoma Tumor Growth in Mice Suppressed by Blocking Enzyme to Inhibit mTOR Signaling
Researchers at The Hebrew University of Jerusalem identified neuronal nitric oxide synthase (nNOS) as a driver of neuroblastoma growth and showed that its inhibition suppresses mTOR signaling. Using the selective inhibitor BA-101 and siRNA knock‑down, they reduced nitric oxide production,...
Life Biosciences Secures $80 Million Series D Financing
Life Biosciences announced the close of a fully‑subscribed $80 million Series D financing. The capital will fund operations through the second half of 2027, enabling the company to complete its Phase 1 trial of ER‑100. It also supports further development of the Partial...
Biotech M&A Spree Helps Lead SBIO to March Gains
Biotech merger‑and‑acquisition activity surged in March, with 22 deals worth about $36 billion, propelling the ALPS Medical Breakthroughs ETF (SBIO) up 8.4% for the month. Two of SBIO’s top holdings—Day One Biopharmaceuticals and Apellis Pharmaceuticals—became acquisition targets in transactions totaling $8.1 billion,...
Keratin May Act as a 'Brake' For Skin Inflammation, Pointing to Potential Treatments
Researchers at the University of Michigan discovered that keratin 16, a structural protein in skin, acts as a molecular brake on inflammation. Mutations or loss of the KRT16 gene caused a surge in type I interferon signaling, leading to severe skin inflammation...
Lupin Shares to Be in Focus on Thursday as USFDA Approves Dapagliflozin and Metformin Tablets
Lupin announced U.S. FDA approval of its dapagliflozin and metformin hydrochloride extended‑release tablets, covering four dosage strengths and matching the brand Xigduo XR in efficacy. The approval follows the company’s recent acquisition of European eye‑care specialist VISUfarma, which contributed roughly $58 million...
CorTec Becomes First German BCI Company to Get FDA Breakthrough Designation
The U.S. FDA granted Breakthrough Device designation to CorTec GmbH’s Brain Interchange, a fully implantable brain‑computer interface aimed at stroke rehabilitation. The system combines cortical signal recording with adaptive electrical stimulation in a closed‑loop platform to restore motor function. CorTec...
First Patients Treated in New PFA Trial
Pulse Biosciences has begun treating the first U.S. patients in the NANOPULSE‑AF pivotal trial using its nPulse nanosecond pulsed field ablation system for drug‑resistant paroxysmal atrial fibrillation. The device delivers five‑second, non‑thermal lesions without catheter repositioning, achieving a median 21‑minute...
Subcutaneous Tepezza Demonstrates Phase III Efficacy in Thyroid Eye Disease
Amgen reported that its subcutaneous formulation of teprotumumab‑trbw (Tepezza) met the primary endpoint in a phase III trial for moderate‑to‑severe active thyroid eye disease, with 76.7% of patients achieving a ≥2 mm proptosis reduction versus 19.6% on placebo. The study also showed...
Artificial Intelligence and Biology: AI’s Potential for Launching a Novel Era for Health and Medicine
Artificial intelligence is reshaping biology by rapidly predicting protein structures and gene variant effects, exemplified by AlphaFold’s Nobel‑winning breakthrough and AlphaGenome’s genome‑wide insights. Researchers are moving beyond correlation‑based models toward hybrid frameworks that combine causal knowledge with multimodal datasets, as...
High-Dose Wegovy Debuts at $399 for Self-Paying Patients
Novo Nordisk has launched Wegovy HD, a 7.2‑mg semaglutide injection, priced at $399 per month for self‑paying patients. The FDA approved the higher‑dose formulation in March, expanding the company’s weight‑loss portfolio beyond the previous 2.4‑mg limit. The new price is...
Forecasting Protein Aggregation with an Improved Algorithm
Scientists at the Autonomous University of Barcelona have released the fourth generation of their protein‑aggregation forecasting algorithm, which leverages AlphaFold structural data and molecular‑dynamics simulations. The tool lets users evaluate aggregation risk, explore mutations, scan protein families, and assess pH...
Faster Process Development via “Transfer Learning”
Transfer learning—a form of AI that reuses models trained on historic data—promises to accelerate biopharmaceutical process development. By applying existing predictive models to new, related fermentations, companies can forecast critical metrics such as viable cell density and product titre from...
Redefining Bioprocessing Using Reservoirs of Biochemical Diversity
Scientists have uncovered a trove of heat‑tolerant glycosyltransferase enzymes in the rhizosphere soils of desert plants in Saudi Arabia. These extremophile enzymes, identified through metagenomic analysis, could improve glycosylation steps in biologics manufacturing by operating under high‑temperature, low‑moisture conditions. The...
Plant Molecular Farming Comes of Age
Plant molecular farming (PMF) has evolved into a scalable, GMP‑compatible platform for producing complex biologics, leveraging low‑energy plant growth and advanced transient‑expression systems. Recent advances in sensor technology, AI‑enabled host engineering, and digital manufacturing have lowered infrastructure costs and accelerated...
Bayesian Statistical Analysis (BSA) Demonstration Project
The FDA’s CDER Center for Clinical Trial Innovation (C3TI) has launched a Bayesian Statistical Analysis (BSA) demonstration project to encourage the use of Bayesian methods in simple phase 3 trials. The program lets sponsors collaborate with FDA statisticians to apply Bayesian...
FDA Issues Series of Guidances Under Drug Competition Action Plan
The FDA released three new guidances under its Drug Competition Action Plan to streamline generic drug reviews. A final guidance clarifies the use of Information Requests and Discipline Review Letters, a revised draft updates procedures for aligning ANDA labeling with...
Approved First Generic for Apokyn Injection Cartridges Requires Separately Packaged Pen
The FDA approved Sage Chemical’s generic apomorphine hydrochloride cartridges, the first generic version of Apokyn for treating "off" episodes in advanced Parkinson’s disease. The generic cartridges work only with the proprietary Apokyn Pen, which must be obtained separately through specialty...
FDA Announces Evusheld Is Not Currently Authorized for Emergency Use in the U.S.
The FDA revised Evusheld's Emergency Use Authorization on Jan. 26, 2023, limiting its use to situations where susceptible SARS‑CoV‑2 variants comprise 90% or less of national cases. With current CDC data showing over 90% of circulating variants are resistant, Evusheld...
FDA Updates Sotrovimab Emergency Use Authorization
The U.S. Food and Drug Administration revoked the Emergency Use Authorization for sotrovimab on April 5, 2022, after CDC data showed the Omicron BA.2 sub‑variant accounted for more than 50 % of cases in every HHS region. Earlier in the year the agency...
Advancing Novel Surrogate Endpoints For Rare Disease Drug Development Workshop - 05/18/2026
The FDA is hosting a virtual workshop on May 18, 2026 to advance novel surrogate endpoints for rare disease drug development. The event is part of the Rare Disease Endpoint Advancement (RDEA) Pilot Program, mandated by PDUFA VII and FDORA, which requires up...
New Nasal Flu Vaccine Shows Promise in Mice
Researchers at Georgia State University have engineered an intranasal influenza vaccine that uses cell‑derived extracellular vesicles (EVs) to display inverted hemagglutinin (HA) proteins. The upside‑down HA exposes the conserved stalk region while masking the variable head, prompting cross‑protective immunity. In...
Merck Adjusts Its Vaccine Supply Deal in China; Soleno Withdraws EU Application
Merck and its Chinese partner Zhifei have revised their COVID‑19 vaccine supply agreement, lowering the committed volume and adding a flexible delivery schedule to reflect waning demand. The updated contract preserves Zhifei’s exclusive distribution rights but shifts risk back to...
Jeito Capital, Prominent Biotech Investor, Raises $1.2B for Next Fund
Jeito Capital announced the close of its Jeito II fund, raising €1 billion (about $1.2 billion) – the largest capital raise ever for an independent European biopharma fund. The fund will back 15‑20 clinical‑stage drugmakers, allocating up to €150 million ($162 million) per company across...
Gilead Takes Another Big Swing at Expanding Beyond HIV
Gilead Sciences has earmarked roughly $11 billion this year for three strategic acquisitions aimed at strengthening its cancer and immunology pipelines. The moves signal a decisive pivot away from its historic reliance on HIV therapeutics toward broader biotech markets. The targeted...
AI Uncovers Significant Misdiagnoses in Carcinoma Type, Study Shows
Caris Life Sciences published a JAMA Network Open study showing its GPSai algorithm identified misdiagnoses in lung squamous cell carcinoma (SCC). Among nearly 4,000 cases, 123 (3.1%) were re‑classified as metastases from other primary sites. The AI model combined molecular,...
New Light Shed on Who Benefits Most From Weight-Loss Jabs
A new study published in Nature examined 15,000 people who used GLP‑1 weight‑loss drugs such as Wegovy and Mounjaro and found that two genetic variants linked to appetite and digestion significantly boost weight loss and increase nausea risk. Carriers of...
New Gene Therapy May Help Protect the Hearts of Patients with Friedreich's Ataxia
Lexeo Therapeutics reported early-phase results for its investigational gene therapy AAVrh.10hFXN (LX2006) in Friedreich’s ataxia–associated cardiomyopathy. In a phase 1 trial of 17 adults, a single intravenous infusion was well tolerated and produced signals of cardiac improvement, while neurological scores remained...
Wildflower Once Used to Treat Wounds and Sore Throats Shows Promise in Fighting Dangerous Superbugs
Researchers at Irish universities have demonstrated that extracts from the wildflower tormentil (Potentilla erecta) possess strong antimicrobial activity against multidrug‑resistant bacteria, including strains that cause pneumonia and urinary‑tract infections. The study identified ellagic acid and agrimoniin as the key compounds...
Lab-Grown Pineal Gland Organoids Produce Melatonin, Offering a New Sleep Model
Researchers at Yale School of Medicine have engineered human pineal gland organoids that synthesize and release melatonin. By coupling these organoids with a nerve‑cell assembloid, they demonstrated stimulus‑dependent hormone secretion and successfully restored melatonin production in mice lacking a native...
Pemivibart Shows Safety, Prevents COVID-19 in CLL Subset in Phase 3 CANOPY Trial
A phase 3 CANOPY subset analysis evaluated pemivibart, a recombinant IgG1 monoclonal antibody, for pre‑exposure COVID‑19 prophylaxis in patients with chronic lymphocytic leukemia (CLL). Among 29 CLL participants, none developed symptomatic SARS‑CoV‑2 infection over a 180‑day follow‑up, and the safety profile...
Childhood Dementia Explained by Synaptic Dysfunction, Opens New Therapies
Researchers at Flinders University used human iPSC-derived cortical neurons to model Sanfilippo syndrome, revealing that excitatory synapses become hyperactive early in development. This chronic overactivity mirrors the hyperactivity and sleep disturbances observed in affected children and appears to drive cognitive...
Post-HSCT Gilteritinib May Improve Outcomes in R/R FLT3-Mutated AML
A systematic review of eight studies suggests that post‑transplant gilteritinib maintenance may markedly improve survival for patients with relapsed or refractory FLT3‑mutated acute myeloid leukemia. One‑year overall survival rates ranged from 72.3% to 100%, while two‑year overall survival hovered around...
Sidewinder Therapeutics Raises $137 Million to Advance Bispecific ADCs
Sidewinder Therapeutics announced a $137 million Series B round, surpassing expectations and bringing its total capital to $162 million. The round was led by Frazier Life Sciences and Novartis Venture Fund, with participation from OrbiMed, DCVC Bio, Goldman Sachs, and others. The funding...
A New Way To Target Metastatic Cancer
Researchers have unveiled a protein‑based delivery platform that homes to lymph nodes and releases an immune‑activating antibody only in the presence of metastatic cancer. The two‑step system first accumulates in nodes after bloodstream injection, then opens in the tumor’s chemical...
Noninvasive Stool DNA Testing May Outperform Colonoscopy Long-Term in Real-World CRC Screening
A new microsimulation study published in the Journal of Medical Economics finds that three rounds of next‑generation multitarget stool DNA (mt‑sDNA) testing over ten years outperform a single colonoscopy in real‑world colorectal cancer (CRC) screening. Higher patient adherence—72% versus 38%...
Can Biopeptides Reclaim Weight Loss From GLP‑1 Drugs?
Biotech startup Lembas is developing biopeptide ingredients that trigger satiety pathways, positioning them as a functional‑food complement to GLP‑1 weight‑loss drugs rather than a replacement. The short, bioavailable peptides aim to activate a cascade of gut hormones, delivering six to...
Researchers Develop Graphene Nanodrum and AI Platform for Rapid Single-Cell Bacterial ID and Antibiotic Testing
Researchers at TU Delft, its spin‑off SoundCell, and Reinier Haga MDC have created a graphene‑based nanodrum platform that reads the nanomotion of individual bacteria and feeds the data to AI models for rapid identification and antibiotic susceptibility testing. The label‑free...
Extracellular Vesicles: A Growing Pipeline Still Searching for Validation
Extracellular vesicles (EVs), once hailed as natural delivery vehicles, have generated a sizable pipeline but no approved therapeutics yet. More than 90 clinical studies are evaluating both native MSC‑derived vesicles and engineered platforms for regeneration, gene editing, and vaccines. Companies...
MRNA Pioneer Katalin Karikó to Give Johns Hopkins Commencement Address
Nobel laureate Katalin Karikó will deliver the commencement address at Johns Hopkins on May 21. Karikó, whose mRNA work underpins the Pfizer/BioNTech and Moderna COVID‑19 vaccines, will receive a Doctor of Humane Letters. Her career, marked by early setbacks and decades‑long...
SLAS Announces the Cohort for Innovation AveNEW at SLAS Europe 2026
SLAS announced the twelve startups selected for its Innovation Ave NEW program at the SLAS Europe 2026 conference in Vienna. The cohort, representing companies from seven countries, will showcase new laboratory‑automation and discovery technologies on a dedicated exhibition floor. SLAS will cover...
Insmed Scraps Skin Plans for Lung Disease Drug as Competitors Make Headway
Insmed announced it will drop development of its lung‑disease drug Brinsupri for hidradenitis suppurativa after the Phase 2b CEDAR trial showed no efficacy, with placebo outperforming both tested doses. The study also missed secondary endpoints, prompting the company to cease the...
Asthma Exacerbations Drop with Medium-Dose ICS to Biologic Switch
A recent analysis of 2016‑2023 Optum claims data shows that asthma patients who switched from a medium‑dose inhaled corticosteroid (ICS) directly to a biologic experienced markedly larger reductions in exacerbations and systemic corticosteroid fills than those who escalated to high‑dose ICS....
Nuvalent Reports the US FDA’s NDA Submission for Neladalkib to Treat ALK-Positive NSCLC
Nuvalent has submitted a New Drug Application to the U.S. FDA for neladalkib, an ALK‑selective inhibitor intended for patients with advanced ALK‑positive non‑small cell lung cancer (NSCLC) who have progressed after prior tyrosine‑kinase inhibitor (TKI) therapy. The filing is backed...
