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Every morning
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The Xtalks Life Science Podcast featured Dr. Steve Levine, Chief Patient Officer at Compass Pathways, discussing the company’s push to develop psilocybin‑based therapies for treatment‑resistant depression (TRD). Levine, a board‑certified psychiatrist and founder of Actify Neurotherapies, highlighted the clinical promise of psychedelic medicine and the need for scalable patient‑access models. The episode also explored broader gaps in mental‑health care and how evidence‑driven innovation can address them. Listeners can stream the interview on Spotify, Apple Podcasts, and other platforms.
The FDA issued a warning letter to ImmunityBio for misleading promotional claims about its bladder‑cancer drug Anktiva, triggering a roughly 26 percent drop in the company’s shares and giving it 15 days to submit a corrective plan. In parallel, Merck announced a...
Researchers at the University of Guelph announced that their sugar‑based vaccine candidate against Campylobacter jejuni demonstrated safety and immunogenicity in a small Phase 1 human trial. Participants experienced only mild side effects, and the formulation generated measurable antibody responses even at...
Inspired by the man who built a personalized cancer vaccine for his dog, I’ve written an open-source guide to DIY mRNA vaccine production: philfung.github.io/openvaxx Drawing on my background in running lab startups, the guide covers the entire process - from sequencing...
Anavex Life Sciences withdrew its European marketing authorisation application for blarcamesine, an add‑on therapy for early‑stage Alzheimer’s, after the EMA’s CHMP signaled a likely negative opinion. The committee criticized the trial’s efficacy data, methodological flaws, and safety reporting, including concerns...
The FDA’s Center for Drug Evaluation and Research (CDER) released its FY 25 Drug Quality Sampling and Testing results, showing that the vast majority of tested pharmaceuticals met USP specifications. The program uses a risk‑based, data‑driven approach introduced in 2018 to...
Researchers have shown that age‑related muscle loss stems primarily from a decline in the activation of resident muscle stem cells, not from their depletion. Early activation of these satellite cells is a stress‑sensitive, rate‑limiting step that becomes impaired in older...
One thing that really makes the in-person summits we run at STAT so amazing: the people in the room. Here's what happened when we asked some of them for the last big breakthrough they saw. Featuring: the infectious @DrBlytheAdamson, genomcis pioneer...
At the ACS Spring 2026 meeting in Atlanta, the Medicinal Chemistry division unveiled six new drug candidates transitioning from discovery to clinical testing. The molecules, presented by researchers from Biohaven, Bristol Myers Squibb, Regor Therapeutics, Olema Oncology, FoRx Therapeutics, and Iambic Therapeutics,...
Seaport Therapeutics is embedding a fail‑safe mechanism into its Phase 2b trial of SPT‑300, an experimental therapy for major depressive disorder. The study will enroll roughly 300 patients at multiple U.S. sites and uses an adaptive design that can halt...
A recent Substack post cites a study claiming COVID‑19 mRNA vaccines increase reports of rare neurological disorders by dozens to thousands of times compared with flu shots, based on VAERS data from 1990‑2024. The post lists specific conditions such as...
The FDA has approved relacorilant (Lifyorli), a glucocorticoid‑receptor antagonist, in combination with nab‑paclitaxel for adults with platinum‑resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received up to three prior regimens, including bevacizumab. The approval is based on...
A Phase 1 randomized crossover trial will compare the hemodynamic impact of 1 liter oral tap water versus 1 liter intravenous Ringer’s lactate in 20 healthy volunteers. The primary endpoint is the change in mean arterial pressure 30 minutes after fluid administration, with secondary...
Researchers identified a drug combination that enhances the brain's glymphatic system, improving clearance of Alzheimer‑related proteins. The regimen pairs a widely used sedative with a medication that prevents dangerously low blood pressure, showing safe and effective removal of amyloid and...
Awesome being on the @Sequoia Training Data podcast with @gradypb and @sonyatweetybird. Topic links in the 🧵 The most human part of intelligence is curiosity, and science is formalized curiosity. If we want AGI — doing the work of science is...
Virtual biology burst onto the scene a few years ago. The idea was simple. Model the cell well enough, and you can predict biology before you test it. Large pharma has been thinking about this longer than most. PK/PD models, systems biology,...
On March 27, 2026, the U.S. Food and Drug Administration granted approval to Denali Therapeutics’ drug Avlayah for the treatment of Hunter syndrome, a rare lysosomal storage disorder. The decision arrives amid a recent wave of stricter FDA scrutiny of...
Researchers identified two conjugated polyunsaturated fatty acids, α‑eleostearic acid (α‑ESA) and its methyl ester (α‑ESA‑me), as potent senolytics that selectively eliminate senescent cells. In mouse models, short‑term dosing reduced senescence markers and SASP factors across liver, heart, kidney, and lung...
NOVOS launched a randomized, double‑blind, placebo‑controlled trial of a multi‑component supplement in adults over 40, enrolling 61 participants and completing six months with 43 finishers. Early preprint data show a 2.9% improvement in flow‑mediated dilation, a 1.18 m/s reduction in pulse‑wave...
Akeso, Inc. has obtained clearance from China’s National Medical Products Administration to begin Phase II trials of two novel antibody‑drug conjugates, AK146D1 and AK138D1. The studies will combine the ADCs with the company’s approved bispecific immunotherapies cadonilimab and ivonescimab, marking the...
Shanghai Fosun Pharmaceutical (Group) Co Ltd announced full‑year profit of RMB3.371 bn ($472 m), up 22% from the prior year, while revenue edged 1.4% higher to RMB41.498 bn. The earnings lift expands the group’s capacity to fund R&D and health‑technology projects amid a...
FDA clears Denali's AVLAYAH (macro), 91% CSF HS drop and analysts lift estimates (key). Risk: COMPASS confirmatory readout, infusion reactions. Trade: buy DNLI on 50‑day pullback 🚀 — Viktor Kopylov, PhD, CFA More insights: t.me/si14Kopylov
Rosen Law Firm announced that investors who bought REGENXBIO shares between Feb. 9, 2022 and Jan. 27, 2026 must file to become lead plaintiff by April 14, 2026. The class‑action alleges the gene‑therapy company misled investors about its RGX‑111 trial, underscoring heightened scrutiny of biotech disclosures.
Host-cell proteins (HCPs) remain a persistent impurity risk in biomanufacturing, with regulators demanding levels below 100 ppm in final drug products. Traditional ELISAs measure total HCPs but cannot identify individual proteins, while conventional multiple reaction monitoring (MRM) suffers from retention‑time shifts...
Researchers at the Broad Institute and Harvard uncovered that chronic intestinal inflammation imprints lasting epigenetic scars on gut cells, even after tissue appears healed. In mouse models, these epigenetic memories persist through many cell divisions and, when paired with a...
Early-stage liver cancer survival hinges on timely diagnosis, yet ultrasound and AFP tests miss many cases. Helio Genomics has introduced the HelioLiver blood test, a multi‑analyte cfDNA and protein assay that flags tumor‑associated epigenetic signals earlier than imaging. A new...
Beam Therapeutics announced encouraging Phase 1/2 data for its base‑editing therapy targeting alpha‑1 antitrypsin deficiency (AATD). The trial demonstrated a 30% reduction in the disease‑causing SERPINA1 mutation and a 45% rise in functional protein levels, while confirming a clean safety profile....
The FDA released a draft guidance on using Bayesian methodology in clinical trials, outlining how sponsors should incorporate prior data, define success criteria, and document analyses. It emphasizes systematic prior construction, transparent operating characteristics, and extensive simulation documentation. The guidance...
The FDA has launched a Guidance Snapshot Pilot that distills complex guidance documents into visual, plain‑language one‑page snapshots complemented by podcasts, timelines, and social‑media links. The pilot targets cross‑cutting topics such as Bayesian trial methodology, decentralized clinical elements, and neonatal...
Boehringer Ingelheim announced it will maintain its high‑level R&D spending while exploring dealmaking opportunities in China to counteract mounting U.S. drug‑price pressure. The company is prioritising an obesity‑focused pipeline, betting on the fast‑growing weight‑loss market to sustain revenue. By keeping...
A post‑hoc analysis of the SOUL trial shows that once‑daily oral semaglutide (Ozempic pill) significantly improves several cardiometabolic risk factors in adults with type 2 diabetes at high risk for atherosclerotic cardiovascular disease. Compared with placebo, participants experienced a 3.2 mm Hg greater...
Rentsc hler Biopharma announced that its Milford, Massachusetts CDMO site has entered a new growth phase, adding a 22,000‑square‑foot cleanroom and four 2,000‑liter single‑use bioreactors. The expansion, the largest in the company’s 150‑year history, brings the U.S. facility to the...
Most AI companies believe the future is cloud-first. Pharma is different. In this industry, data is the kingdom. Experimental data. Molecular designs. Clinical insights. Some of the most valuable intellectual property on Earth. And in many cases, it cannot leave the lab. This is where the typical...
When people ask "How can we make #AAV #GeneTherapy accessible and affordable" --> this is how 👇
Novo Nordisk announced that its triple‑agonist candidate UBT251 achieved a mean HbA1c reduction of up to 2.16% after 24 weeks in a phase‑2 study of Chinese patients with type‑2 diabetes. The trial, involving roughly 200 participants, underscores the drug’s potential...
Rethinking why the pancreas β-cells become vulnerable to autoimmune attack, leading to Type 1 diabetes. An illuminating review with ideas to counter β-cell stress @ScienceTM https://t.co/zn6a6wEg7u https://t.co/BV0LYnWRNL
Anyone have a PDF of this? Perhaps there isn't a digital copy... This one showed an impressive -16.6 HAM-D drop with 8 weeks of escitalopram. It would be good to know their methodology. https://t.co/P5GCYcbxjk
Sarepta Therapeutics reported that early‑stage trials of two experimental drugs, SRP‑1001 and SRP‑1003, demonstrated safety and signs of efficacy for rare muscle‑wasting disorders. The data sparked a more than 20% surge in the company’s stock during early trading. The results...
$IMMX - Morgan Stanley initiates coverage with a $20 PT and an outperform rating, implying ~120% upside. https://t.co/Pd4uIH5BkI
Steady progress towards engineering immune cells in the body now for refractory myeloma , with major implications for many autoimmune diseases and cancers https://t.co/K3IksrCFlg https://t.co/1AQ5rLuH1g
UCB announced a $2 billion investment to build a 460,000‑square‑foot biologics manufacturing plant in Gwinnett County, Georgia, its first U.S. production site. The facility will create about 330 permanent jobs and over 1,000 construction positions, leveraging AI, robotics and automation. Georgia...
Xaira Therapeutics unveiled X-Cell, a 4.9‑billion‑parameter virtual cell model that predicts transcriptome‑level responses to genetic perturbations. The model leverages the company’s 25.6 million‑cell X‑Atlas/Pisces CRISPRi Perturb‑seq dataset and demonstrates zero‑shot performance on unseen T‑cell and iPSC contexts. X-Cell uses a diffusion...
GSK has accelerated its pipeline build‑out by pairing broad early‑stage partnerships with selective, later‑stage acquisitions such as the up‑to‑$950 million purchase of 35Pharma’s pulmonary‑hypertension candidate HS235. After spinning off Haleon, the company now leans on specialty medicines—accounting for over 40% of...
Maze Therapeutics reported Phase 2 results for its kidney drug MZE829, showing a 35.6% average reduction in proteinuria after 12 weeks and a 61.8% drop in the FSGS subgroup. The data were hailed as "overwhelmingly positive" but the stock fell more...
I asked $TERN CEO Amy Burroughs right after the #ASH25 data was out how she felt about M&A. Congrats to her and her team. https://t.co/2HemPoiqWO
A new DNA‑methylation (episignature) test can differentiate harmful from benign NOTCH1 variants in congenital heart disease, giving families definitive genetic answers. The assay scans over 740,000 genomic sites to identify a characteristic methylation pattern linked to disease‑causing mutations. Positive results...
1/ You ran 20,000 differential expression tests. 1,000 genes came back with p < 0.05. How many are real? Maybe 50. Maybe fewer. Most bioinformaticians learn p-values in stats class. Almost nobody learns why they break at scale. Let me explain: https://t.co/btC71ABX5N
Stanford Medicine and the Arc Institute reported that stimulating gut‑brain signaling and altering the microbiome reversed age‑related cognitive decline in mice, making old animals perform on memory tests like their younger peers. The finding points to a new, peripheral route...
Merck & Co. is in advanced negotiations to acquire U.S. biotech Terns Pharma for an all‑cash price of about $6 billion. The news lifted Merck shares 0.5% to $116.99 and sent Terns stock soaring 12% to $55.97, underscoring the deal’s market...
