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Every morning
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Tuesday recap
The U.S. FDA has accepted Roche’s new drug application for giredestrant combined with everolimus to treat ER‑positive, HER2‑negative, ESR1‑mutated advanced breast cancer. Phase III evERA data show a 44% reduction in disease progression or death overall and a 62% reduction in the ESR1‑mutated subgroup, extending median progression‑free survival to 9.99 months versus 5.45 months. The agency set a PDUFA deadline of December 18, 2026, positioning the regimen as a potential first oral SERD combo after CDK4/6 inhibitor therapy.
A shortage of bone cement from German supplier Heraeus Medical threatens NHS orthopaedic surgeries, potentially lasting two months. NHS England has asked trusts to prioritise emergency joint replacements, leaving elective patients at risk. UK‑based Biocomposites accelerated the launch of its...
Novartis announced the sale of its majority stake in its Indian generics and prescription business to a private‑equity‑led consortium for $159 million. The transaction transfers control of a portfolio that includes both off‑patent generics and branded medicines to the buyers. The...
Researchers led by Dr. Tien‑Chi Huang discovered a dramatic three‑dimensional reorganization of genome architecture in mouse and human embryonic germ cells as they enter meiosis. Centromeres relocate from the nuclear interior to the periphery, accompanied by reduced compartmentalization and increased...
Researchers report that the FDA‑approved antiepileptic levetiracetam reduces amyloid‑β42 production in mouse models of Alzheimer’s disease. The drug redirects amyloid precursor protein processing toward the non‑amyloidogenic pathway by modifying synaptic vesicle cycling and increasing surface APP expression. Mass‑spectrometry and electrophysiology...
Researchers increasingly rely on rapid, toxic mouse models that sideline the natural aging process, even though age is the chief risk factor for many diseases. In Parkinson's disease research, most pre‑clinical studies still use young rodents, obscuring how biological aging...
Johnson & Johnson announced a $1 billion investment to build a next‑generation cell‑therapy manufacturing facility in Montgomery County, Pennsylvania, slated to support 500 skilled jobs. The hub is a key element of J&J’s $55 billion U.S. manufacturing, R&D, and technology strategy. Meanwhile,...
Ok, so I have finally gotten around to writing out my updated thoughts/thesis on $NKTR. Link in this post. I'm about as bullish on the stock now as I've ever been. The document is very long (sorry, but it's free...give me...
Daiichi Sankyo appointed former Novartis chief medical officer John Tsai as its new CMO, succeeding Ken Takeshita after a five‑year tenure. Tsai brings a record of launching 160 projects and 15 regulatory approvals, including Zolgensma and Pluvicto, and recent experience leading biotech...
U.S. FDA has granted IND clearance for NexEos Bio’s ophthalmic solution NTX-1024, allowing the company to commence a combined Phase II/III clinical trial in vernal keratoconjunctivitis (VKC). The upcoming study will assess safety and efficacy after an open‑label investigator‑initiated trial...
#AZN Calquence combined with Venetoclax approved in US for treating Adults with Chronic Lymphocytic Leukaemia in a particular form.
En Carta Diagnostics announced that its EC Pocket Lyme test has received FDA Breakthrough Device Designation, accelerating its path to U.S. market entry. The point‑of‑need molecular assay detects Borrelia DNA directly from skin interstitial fluid using a microneedle sampler, delivering...
Serina Therapeutics has enrolled the first patient in its Phase Ib registrational trial of SER‑252 for advanced Parkinson’s disease. The study, conducted with Parkinson’s Australia and Neuroscience Trials Australia, will assess safety, pharmacokinetics, tolerability and early efficacy, with dosing slated to...
Syngene International has entered a strategic collaboration with VivaMed BioPharma to advance AI‑derived drug repurposing programmes. The partnership combines Syngene’s pre‑clinical development capabilities with VivaMed’s AI‑generated therapeutic hypotheses, creating a pathway from computational hits to translational validation. Together they will...
Researchers identified a MAPKKK called MEKK14 that activates a nitrate‑driven signalling cascade in Arabidopsis thaliana. The cascade triggers the circadian transcription factor CCA1, which in turn up‑regulates MEKK14, forming a positive feedback loop. This loop amplifies auxin signaling, leading to...
Professor Matthew Wood, Oxford’s leading neuroscientist, heads the Oxford‑Harrington Rare Disease Centre, a partnership designed to fast‑track therapies for rare neuromuscular and genetic disorders. He outlines a vision to make antisense oligonucleotides (ASOs) and gene‑editing tools more modular, scalable, and...
Boehringer Ingelheim received an Emergency Use Authorization (EUA) from the U.S. FDA for its NexGard chewable tablets to treat New World screwworm (NWS) infestations in dogs and puppies, and for NexGard COMBO topical solution to treat NWS in cats and...
Grail announced that its Galleri multi‑cancer blood test failed to achieve the primary endpoint in a large United Kingdom clinical trial. The study, which evaluated the test’s ability to detect early‑stage cancers across dozens of tumor types, showed promising signals...
Biotech stocks and ETFs rebounded strongly last year, and the ALPS Medical Breakthroughs ETF (SBIO) is positioned to benefit from that momentum. SBIO tracks nearly 90 companies with drugs in Phase II or III trials, but it carries a modest YTD...
Researchers at the University of Pennsylvania and Harvard have created an ultrathin, flexible electronic mesh that can be implanted into developing pancreatic tissue. The mesh delivers a 24‑hour rhythmic electrical pulse, coaxing stem‑cell‑derived islet cells toward functional maturity and synchronized...
Stanford researchers have created an intranasal vaccine that elicits a combined innate‑adaptive response, providing broad lung protection in mice. The formulation, containing TLR agonists and a harmless antigen, shielded animals for at least three months against SARS‑CoV‑2, other coronaviruses, two...
Researchers have engineered miniature, three‑dimensional spinal‑cord organoids that can be deliberately injured and subsequently repaired with a biocompatible gel. The gel promotes cell survival and rapid axonal regrowth, effectively modeling the healing cascade observed in vivo. This human‑derived platform provides...
The United Kingdom and Brazil have issued safety warnings linking GLP‑1 weight‑loss drugs to acute pancreatitis after recording 19 and 6 deaths respectively. Reports include roughly 1,300 UK and 145 Brazilian pancreatitis cases among millions of users, though the overall...
A collaborative team led by UNSW and Nutromics has demonstrated a wearable patch that continuously measures vancomycin levels using DNA‑based aptamer sensors. Published in Nature Biotechnology, the pilot trial showed the patch can track drug concentration in interstitial fluid, offering...
Grail’s multi‑cancer blood test Galleri failed to meet its primary endpoint in a large NHS‑partnered study, casting doubt on its early‑detection claims. The test, priced at $1,000, generated $136.8 million from 185,000 units sold in 2025 but remains unapproved by the...
A key study of $GRAL's Galleri test in the UK failed to reach its primary endpoint, but showed benefits on a secondary endpoint. Tell me what you all think. https://t.co/CDrvokqPop
FDA Commissioner Tracy Beth Høeg, in her inaugural staff address, announced a renewed focus on evaluating the safety of antidepressants prescribed during pregnancy and monoclonal antibody RSV prophylaxis for infants. She highlighted gaps in existing safety monitoring and pledged more...
The FDA announced it will drop the historic requirement for two adequate and well‑controlled studies in certain new‑drug approval pathways, a move that could accelerate timelines and lower development costs. The change is especially relevant for therapies targeting unmet medical...
Novo Nordisk’s shares have slumped 66% from their 2024 peak, reflecting weak 2026 guidance and fierce competition from Eli Lilly in the GLP‑1 arena. The Danish firm recently introduced the first oral GLP‑1 pill, positioning it ahead of Lilly’s upcoming tablet and...
Researchers at Gladstone Institutes discovered that red blood cells (RBCs) act as a primary glucose sink during hypoxia, explaining why people living at high altitude have lower blood sugar. PET/CT scans showed 70% of the extra glucose clearance in hypoxic...
Many thanks to Freedom Together Foundation medical research consortium for hosting my remarks this week @RockefellerUniv discussing our vaccine development program and my work on the history of medical science vs anti-science in America https://t.co/etbLqiezEA
Eli Lilly reported that its biologic Omvoh (mirikizumab) sustained steroid‑free remission for three years in Crohn’s disease patients in the Phase 3 VIVID‑2 open‑label extension study. More than 90% of participants remained in remission, with 80% experiencing relief from bowel urgency. The...
A recent open‑access study of 514 Canadian seniors examined peripheral inflammation using IL‑6 and C‑reactive protein. The analysis revealed that elevated IL‑6 levels were present in 12% of cognitively normal participants but rose sharply to 36‑55% among Alzheimer’s, mixed dementia,...
Lonza has expanded its advanced synthesis portfolio to provide end‑to‑end support for antibody‑drug conjugates (ADCs) and other bioconjugates. The company fully integrated the Synaffix‑derived ADC platform—including GlycoConnect® conjugation, HydraSpace® spacers and toxSYN® linker payloads—into its services. A new dual‑payload ADC...
Researchers at UC Berkeley and the Arc Institute unveiled MULTI‑evolve, a machine‑learning framework that predicts how multiple amino‑acid mutations affect protein function in a single experimental round. The workflow first estimates single‑mutation effects, then measures pairwise interactions, and finally trains...
Researchers at Hebrew University used a virus‑based CRISPR/Cas9 system to edit the regulatory domain of the HMGR enzyme, removing its metabolic brake and dramatically increasing terpenoid production. The edit boosted scent intensity and flower size in petunias and enhanced flavor‑related...
🆕@Nature Genome sequencing of >800,000 people finds Epstein-Barr virus reads and their association with other autoimmune diseases besides multiple sclerosis, including type 1 diabetes, inflammatory bowel disease, and hypothyroidism https://t.co/FKCV4OInT5
Researchers unveiled e2MPRA, a massively parallel reporter assay that simultaneously measures regulatory activity, chromatin accessibility, and H3K27ac modifications across thousands of cis‑regulatory elements. Validated on ~10,000 synthetic and native sequences, the method links single‑base mutations to multi‑layered gene‑regulatory outcomes. The...
Recent court‑released Epstein files contain emails that link Harvard professor George Church’s Personal Genome Project to Jeffrey Epstein. The correspondence documents a skin‑biopsy taken from Epstein, proposals to generate induced pluripotent stem (iPS) cells, and even CRISPR editing ideas, with...
Altesa, run by former Trump official, raises $75M for well-traveled lung drug https://t.co/bUx5dcvNJy by @gwendolynawu #biotech #startups
Researchers used Mendelian randomization to demonstrate that the inflammatory cytokine IL6 directly increases all‑cause mortality, while its soluble receptor IL6R has the opposite effect. Elevated circulating IL6R was linked to lower risk of lung cancer, diabetes, stroke and coronary artery...
These proposed reforms to pre-clinical drug development and to smoothing the transition to first-in-human studies could be the most consequential steps toward leveling the playing field with China. https://t.co/oVY6N3xo9Y
The most used multicancer early detection (MCED) blood test (liquid biopsy) uses methylation (GRAIL). But combining that with DNA fragmentomics, as reported today @NatureCancer, improves early detection https://t.co/VkNDR4XuW3
Verdiva Bio, an obesity‑focused biotech, is gearing up for a data‑heavy 2026, with Phase 2 results for its lead long‑acting peptide slated for the third quarter. The company is also courting strategic partnerships, eyeing potential deals with major pharma players after...
FDA leaders say one pivotal trial, not two, should be ‘default’ for drug approvals https://t.co/ADRb1miphf by Kristin Jensen #biotech
Vanda Pharmaceuticals received FDA approval for tradipitant (Nereus®), an oral selective NK1 receptor antagonist, to treat motion‑induced nausea and vomiting. The approval marks the first new drug for motion sickness in more than four decades, highlighting a significant regulatory milestone....
BioSpace’s Denatured podcast featured Verdiva Bio’s R&D head Jane Hughes and MitoRx CEO Jon Rees discussing next‑generation obesity therapies that move beyond the limitations of GLP‑1 agonists. They highlighted how GLP‑1 treatments can cause muscle loss and suffer from poor...
Biogen announced it is halting the combination‑therapy arm of its multiple sclerosis (MS) trial after interim data showed insufficient efficacy and safety concerns. The decision pauses enrollment in the experimental regimen while the company continues evaluating its monotherapy components. Meanwhile,...
Multiomic integration reveals tumoral heterogeneity of lipid dependence within lethal group 3 medulloblastoma https://t.co/tpjJiRa08t https://t.co/z7aIYerTqO
Valneva reported a 3.3% decline in product sales to €157.9 million in 2025, driven primarily by regulatory suspensions of its chikungunya vaccine Ixchiq in the US and UK. Despite the sales dip, total revenue rose to €174.7 million, buoyed by a licensing...
