Know What's Happening in BioTech
Know What's Happening in BioTech
BioTech Pulse
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Daily
Every morning
Weekly
Tuesday recap
A new tool called AI‑enabled Quantum Refinement (AQuaRef) merges quantum‑mechanical calculations with machine‑learning to refine protein structures. Developed by Lawrence Berkeley National Lab and Carnegie Mellon, it is integrated into the Phenix software suite used worldwide. In tests on 71 proteins, AQuaRef delivered higher‑quality models at lower computational cost and correctly placed protons in the challenging DJ‑1 protein linked to Parkinson’s disease. Researchers now aim to expand its use to drug discovery and bio‑energy applications.
Lundbeck chief executive Charl van Zyl warned that Europe’s fragmented drug‑pricing regime threatens biotech sustainability and patient access. He cited recent remarks by HHS Secretary Robert F. Kennedy Jr. suggesting Europeans already pay higher prices than Americans. Van Zyl called...
The FDA has cleared Pylarify TruVu, a reformulated version of Lantheus’ PSMA‑targeting radiopharmaceutical piflufolastat F‑18. The new formulation improves stability at higher radioactive concentrations, enabling larger batch production and broader distribution. Lantheus plans a Q4 2026 commercial launch with a rolling geographic...
Johnson & Johnson has filed a Type II variation with the European Medicines Agency to add teclistamab, a bispecific T‑cell‑redirecting antibody, as a second‑line monotherapy for relapsed/refractory multiple myeloma. The Phase III MajesTEC‑9 trial, enrolling 614 patients, demonstrated a 71 % reduction in...
The FDA has expanded approval of leucovorin calcium tablets as the first therapy for cerebral folate transport deficiency linked to FOLR1 gene variants. The decision relied on published case literature, showing 87‑89% of patients achieved clinical improvement. In oncology, AstraZeneca...
Tenax Therapeutics Inc. posted a Q4 2025 net loss of $0.38 per share, reflecting continued investment in its clinical-stage pipeline. The company’s cardiopulmonary portfolio includes TNX-101, TNX-102 and TNX-103, which have all cleared Phase II trials for pulmonary hypertension in...
Australian startup Samsara Eco, which uses AI‑designed enzymes to break down plastics into reusable monomers, is raising more than $70 million to apply the technology to extract critical minerals from electronic waste. The company, backed by Temasek, Hitachi’s VC arm and...
Several U.S. universities have launched two‑year medication safety fellowships that rotate participants through academic training, a major pharmaceutical company, and the FDA. Butler University offers two tracks with Regeneron and Eli Lilly, Purdue partners with AbbVie, and Rutgers collaborates with Pfizer....
Peptide therapeutics are booming, with more than 2,000 candidates in discovery and pre‑clinical stages and projected global sales of $91.4 bn by 2025. Companies like Orocidin faced severe synthesis and purification hurdles for their QR‑01 peptide, but Syngene’s custom low‑loading resin...
Johns Hopkins Medicine is heading a five‑year, $24 million NIH‑funded Hepatitis B and HIV Cure Consortium that brings together research teams from the United States, Brazil, India, Senegal and Uganda. The first year will enroll 450 participants co‑infected with HIV and chronic...
Is biology finally becoming too complex for static models? For decades, biological modeling has relied on fixed equations, narrow simulations, and local approximations. That works until it doesn’t. Once you move into real systems, gene regulation, signaling cascades, protein networks, the...
A multicenter retrospective study of 17 Chinese patients with juvenile myasthenia gravis found that weekly efgartigimod 10 mg/kg for four weeks produced rapid and substantial clinical improvement. Clinically meaningful improvement was observed in 70.6% of patients by week 1 and 91.7% by...
BioNTech announced it will create an independent biotech company dedicated to next‑generation mRNA technologies. The spin‑out will be led by co‑founders Ugur Sahin and Özlem Türeci, who will assume management by the end of 2026. BioNTech will contribute core mRNA assets in...
CSL‑Behring broke ground on a $1.5 billion expansion of its Kankakee, Illinois manufacturing complex, slated to be operational by 2031. The project will add at least 300 pharmaceutical positions and roughly 800 construction jobs, with the state offering more than $200 million...
Researchers at Friedrich‑Alexander‑Universität Erlangen‑Nürnberg successfully vitrified mouse brain slices and, in a limited trial, an entire mouse brain, preserving neuronal structure and function after rewarming. By using a high‑concentration cryoprotective agent cocktail, they avoided ice crystal formation, maintained synaptic architecture,...
Researchers at the Technical University of Denmark discovered that antibiotic resistance measurements can shift dramatically when test conditions change. Standard laboratory assays use fixed, uniform environments, but altering factors such as growth medium or temperature can make the same bacterium...
The Advanced Research Projects Agency for Health (ARPA‑H) has launched the Delphi program to develop modular biosensors that can monitor multiple physiological signals such as inflammation markers, hormones, and drug levels. The initiative relies on electronic "chiplet" technology, allowing developers...
The Advanced Research Projects Agency for Health (ARPA‑H) has unveiled the Delphi program to create modular biosensors that can monitor multiple biomarkers such as inflammation markers, hormones, and drug levels. The initiative relies on electronic "chiplet" technology, allowing developers to...
Nurix Therapeutics has launched NX-1607, the first orally bioavailable small‑molecule inhibitor of the immune regulator CBL‑B, into a Phase 1a/1b trial for advanced cancers. CBL‑B modulates activation of T, B and NK cells, and NX-1607 locks the protein in an inactive...
Researchers at Johns Hopkins found a single dose of psilocybin dramatically increased smoking cessation rates compared with nicotine patches. In a randomized trial of 82 smokers, 17 of 41 participants who received psilocybin remained abstinent after six months versus four...
Scientists announced ETVAX, the first oral vaccine that targets enterotoxigenic *E. coli* (ETEC) in children, after a large‑scale trial in The Gambia. The study involved 4,936 infants aged six to 18 months and demonstrated a 48% reduction in moderate‑to‑severe ETEC...
Novo Nordisk received an FDA warning letter on March 5, 2026 for failing to report suspected side effects of its GLP‑1 medicines. The violations were uncovered during a 2025 inspection of the company’s facilities and were described as “serious.” The agency warned...
Dubai is positioning itself as a long‑term hub for healthcare and life sciences through two complementary free‑zone clusters – Dubai Healthcare City (DHCC) and Dubai Science Park (DSP). DHCC is undergoing a $1.3 bn expansion that will create six tightly linked...
The FDA has defined the scope of pre‑submission facility meetings to curb manufacturing‑related complete response letters that delay drug approvals. It agreed to cover prior production‑site inspections, novel process elements and supply‑chain node strategies, while rejecting topics such as alternative...
Arizona's biotech sector is booming, with $3.7 billion invested over the past seven years and a growing pipeline of innovative companies. Nectero Therapeutics secured a $96 million Series D to develop a fast‑track, breakthrough‑designated endovascular treatment for abdominal aortic aneurysms, while Humabiologics obtained...
Researchers at Jeonbuk National University used a quartz crystal microbalance to compare calcium‑phosphate mineralization on titanium dioxide nanoparticles coated with polydopamine (PDA) versus zein. Real‑time measurements showed PDA‑coated particles accumulated 7,780 ng of mineral, roughly 37% more than the 5,641 ng recorded...
This morning's BioNTech news strikes me as very odd. Certainly, founder Ugur Sahin and Ozlem Tureci shouldn't feel compelled to run the company forever, and they may not be the right people to manage both the continued decline of Covid-19...
BioNTech co‑founders Ugur Sahin and Özlem Türeci will leave the company by year‑end to launch an unnamed mRNA‑focused venture, with BioNTech retaining a minority stake and licensing key technology. The split allows BioNTech to concentrate on its late‑stage cancer pipeline...
Deaminet 2026 showcased accelerating advances in base and prime editing, highlighted by rapid Addgene distribution growth and new mechanistic insights such as PE6d’s heightened processivity and ABE8e’s dimer‑driven efficiency. Novel off‑target detection platforms like beCasKAS and Inrich‑seq revealed far more unintended...
Sticking with the science. I find that really impressive. BioNTech founders Uğur Şahin and Özlem Türeci are leaving the biotech they founded to start a new one. Maybe by the time they have something for the clinic, the FDA will...
"AI will not replace biological reasoning, but it may become indispensable for navigating biological systems whose complexity exceeds human intuition." A perspective on future applications for cancer neuroscience https://t.co/TnDFZ7NRFN @scisignal https://t.co/ijbhfbjXcs
China is actively targeting ultra‑expensive gene therapies, challenging the notion that these treatments are immune to price competition. Recent regulatory approvals and centralized procurement initiatives have forced manufacturers to negotiate steep discounts on therapies that once commanded multi‑million‑dollar price tags....
Crazy cool > Embedded soft, stretchable electronics into tiny clusters create cyborg islet organoids. Miniature pancreas-like tissue can eavesdrop on the electrical charging of individual lab-grown cells, learning to sense glucose and release hormones. https://t.co/0ntJ3cJ16n
Last fall the administration was talking about leucovorin as a potential treatment for large numbers of people with #autism. Today's approval suggests the evidence supports its use in a much smaller group of people, @rosebroderick_ reports. https://t.co/NlJR8KlaqP
The U.S. Food and Drug Administration has approved the generic form of leucovorin, also known as folinic acid, for treating cerebral folate deficiency (CFD). The decision widens the drug’s label despite the absence of new clinical trial data, relying on...
BioNTech founders to step down and helm new mRNA startup https://t.co/yjvsVRQH2D by @Lilah_Alvarado $BNTX - 20%
Xenon hits a ‘home run’ in epilepsy; FDA restarts review of Duchenne cell therapy https://t.co/l40xYeW2Xh $XENE $CAPR + 15% $REGN $PFE $ABBV $GSK #biotech
Credence Research forecasts the global cell and gene therapy manufacturing market to surge from $19.3 billion in 2024 to $146.2 billion by 2032. The compound annual growth rate is estimated at 28.8%, propelled by rising demand for advanced therapies, expanding commercialization, and...
$BBIO $ALNY moving higher on apparently good news re: Pfizer's tafamidis patent defense. If you have access to Umer Raffat's research, he has all the details.
Has anyone experienced or is anyone aware of a documented adverse event from taking BPC157 (that was obtained from gray market or compounding pharmacy sources)? If so, please let me know.
Breakout Ventures announced the close of its third fund, raising $114 million to back AI‑driven biotech startups. The capital will be deployed to early‑stage companies, including a University of Chicago spin‑out focused on computational small‑molecule design and a stealth venture tackling...
Predicting Alzheimer's disease up to 25 years in advance of any symptoms with the p-tau217 biomarker blood test, among 2,766 women mean age 70 https://t.co/aOActAUN27 https://t.co/Bxl2YZxnlf
DNA Repair gene alterations and efficacy from gemcitabine and nab-paclitaxel with/without durvalumab and tremelimumab in metastatic pancreatic ductal adenocarcinoma https://t.co/v39bOreJwu
Good moment to resurface this blog post explaining why I believe $ATAI is the best-positioned company in the psychedelic biotech sector 😉🚀
Why simulating an entire cell cycle took years, multiple GPUs and six days per run https://t.co/41xr8Bnn4C https://t.co/9LcRqDswYT
Correction: I took down a post about Thursday's #VRBPAC meeting because it contained an error. #FDA has named 6 temporary voting members (not 2), which will bring the number for the meeting to 9. The temps are all former members....
$CAPR resubmission of the deramiocel application accepted by the FDA. New decision date: Aug. 22. https://t.co/mWSyyXg8di
1/ Your most powerful lab tool isn't a pipette. It's a keyboard. If you're a biologist who hasn't learned to code yet, here are 10 rules that changed everything for me: https://t.co/DhSXBXGitk
How CRISPR works (in nature) and how it’s being leveraged as a tool for gene editing to cure and prevent diseases. Dr Alex Marson MD PhD of UCSF on the Huberman Lab podcast out now. https://t.co/fiL48JHxSL
$GSK is ostensibly the "sponsor" that won the approval but is once again saying it won't produce the drug.
