Know What's Happening in BioTech
Know What's Happening in BioTech
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Every morning
Weekly
Tuesday recap
Novo Nordisk announced FDA approval of a high-dose formulation of its obesity injectable Wegovy in the United States. The approval was granted through a new FDA priority review voucher program, which Novo earned via a price‑cut deal with the Trump administration. The move is intended to help Novo regain ground after losing market share to Eli Lilly’s competing weight‑loss drugs. Analysts remain uncertain how much the higher dose will boost Novo’s sales.
$BMY chief scientist Robert Plenge: says there is “a joke” drug developers often repeat. “It's an overnight sensation a decade in the making. These things can actually be going on for a very long time, and then suddenly the field catches...
$ATAI is currently covered by 13 analysts, with price targets spanning $7 to $25. I believe though that the view of most investors and analysts on @ataibeckley appears largely anchored only to the initial lead indication and drug we are pursuing:...
Thermal stability assays, especially differential scanning fluorimetry, are gaining traction as early‑stage de‑risking tools in drug discovery. By measuring protein melting temperatures, these assays reveal ligand‑induced stabilization, enabling rapid hit validation and prioritization. The article outlines best‑practice workflows, data‑interpretation guidelines,...
Scientists introduced TH07, a topical blend of finasteride, minoxidil, and latanoprost, aimed at treating androgenetic alopecia. In a pilot trial of 34 men, the 23 participants receiving TH07 reported 52% dense hair growth and higher satisfaction versus groups using each...
Sarepta Therapeutics will submit a supplemental NDA to the FDA seeking to convert the accelerated approvals of its Duchenne exon‑skippers Amondys 45 and Vyondys 53 into traditional approvals, despite the confirmatory ESSENCE trial failing to improve motor function. The company bolsters its...
Fauna Bio announced that its Convergence™ AI platform has achieved a target designation milestone in its obesity discovery partnership with Eli Lilly, triggering a contractual payment. The designated target stems from comparative genomics of over 450 mammal species, especially hibernators,...
Let's look at how the FDA is treating $SRPT and $QURE differently. The FDA grants accelerated approval to Amondys and Vyondys to treat Duchenne muscular dystrophy. Sarepta conducts a post-marketing confirmatory study that fails to show a benefit for either...
The Financial Times covered recent initiatives at Cancer Research UK (CRUK) including a nice piece on the ongoing Aleta Biotherapeutics clinical trial in CD19-CAR-T treated B cell lymphoma patients. https://t.co/9sDZEItapu
Union Minister Dr Jitendra Singh announced that India's bioeconomy reached $195.3 billion in 2025, marking an 18% annual rise and putting the country on track for a $300 billion sector by 2030. The milestone reflects rapid scaling of biotech startups, government funding...
The negative oral Ozempic randomized trials (EVOKE, EVOKE+) for Alzheimer's disease have now been published @TheLancet https://t.co/Xx0YknTSC2
GLP-1 drugs have established benefit for Type 2 diabetes. New data suggests that extends to Type 1 diabetes, with heart, vascular, and kidney protection https://t.co/nZDKHoFIRm https://t.co/lTHIgoj4ir
The U.S. Food and Drug Administration granted Breakthrough Device Designation to Nia Therapeutics’ Smart Neurostimulation System (SNS) for treating episodic memory loss in adults with moderate to severe traumatic brain injury. The fully implantable, closed‑loop system records neural activity from...
Okay here's a game - you're making nanobody therapeutics. AI can help you optimise them, but you need to prioritise order of feature importance. What is your order? Affinity Specificity Expressibility Clinical toxicity In vivo stability Purified stability Patentability Other?
1/ My last thread on Claude use cases got a lot of attention. The number one question: "how do you actually use extended thinking for biology?" Here's my exact Claude Code workflow for genomics questions where regular prompting falls short.
Gossamer Bio announced a near‑half workforce reduction after its Phase 3 seralutinib trial failed to meet statistical significance in pulmonary arterial hypertension. The company will lay off 77 employees, about 48 % of staff, aiming to preserve cash while its future path...
Multiple vaccines offer benefits beyond protecting the vaccinated individual from the disease the vaccine targets. Some protect fetuses in the womb, some protect people who are immunocompromised, some protect seniors. As vax rates fall, these benefits are threatened. https://t.co/zmiws8gAnw
Exclusive: Clarissa Desjardins' newest biotech has put its first drug in the clinic + raised $40M more. Congruence also expects to put 2 more molecules into clinic in early 2027, seeing its platform driving its R&D efficiency: https://t.co/pzxcnmKFBj
Quintessence Biotech introduced DACS, the first "living" artificial cell designed to streamline bio‑separation in cell and gene therapy (CGT) manufacturing. The lipid‑particle platform mimics cell size, deformability and antigen presentation, enabling a gravity‑based flotation method that replaces magnetic‑bead workflows. DACS...
Eli Lilly’s investigational injectable retatrutide achieved a 1.9‑point HbA1c reduction versus 0.8 points for placebo after 40 weeks, while participants on the highest dose shed 15.3% of body weight compared with 2.6% on placebo. The weight loss was still progressing at...
AL‑S Pharma released Phase II (AP‑101‑02) data evaluating intravenous AP‑101 every three weeks in 73 ALS patients, including 52 with sporadic disease and 21 with SOD1 mutations. The trial met its primary safety and tolerability endpoint and demonstrated disease modification,...
Researchers discovered that neutrophils from older individuals adopt a senescence‑like phenotype, marked by elevated SASP factors and reduced antimicrobial metabolism. RNA‑seq of lung neutrophils after Streptococcus pneumoniae infection revealed diminished glycolysis and ROS production, impairing bacterial clearance. Aged neutrophils also...
Spinal Elements has received FDA 510(k) clearance for its 3D printed Ventana A anterior lumbar interbody fusion (ALIF) system, a device engineered with a hinged architecture to maximize bone graft volume and containment. The system employs a specialized additive‑manufacturing process...
Scientists at Germany's Helmholtz Centre for Environmental Research have assembled a three‑species bacterial consortium that can completely degrade diethyl phthalate at concentrations up to 888 mg/L within 24 hours at 30 °C. The discovery, published in Frontiers in Microbiology, demonstrates cross‑feeding synergy and...
Scientists have isolated a gut‑bacterial metabolite, pTOS, that spikes in Burmese python blood after feeding and dramatically reduces appetite in obese mice. When administered to mice, pTOS caused a 9% body‑weight loss over 28 days without affecting energy expenditure. The...
The U.S. FDA has extended its review of Lanteus’ PET imaging agent LNTH‑2501 by three months, moving the PDUFA target date to June 29. LNTH‑2501, a Ga‑68 edotreotide kit for detecting neuroendocrine tumors in adults and children, remains unapproved and...
BioCina has launched a comprehensive Chemistry, Manufacturing and Controls (CMC) program for Patrys Ltd’s injectable formulation RLS-2201, a proprietary quetiapine product aimed at treating acute delirium in intensive‑care patients. The manufacturing effort is based in BioCina’s sterile facility in Perth...
AstraZeneca announced plans to construct a cell‑therapy manufacturing base and an innovation centre in Shanghai. The facilities will produce CAR‑T cancer treatments for China and broader Asian markets, positioning the company as the first global drugmaker with end‑to‑end cell‑therapy capabilities...
A large pragmatic trial involving 1,565 overweight or obese youths with bipolar spectrum disorders found that adding metformin to a brief lifestyle program significantly blunted weight gain associated with second‑generation antipsychotics. Over six months, the metformin group’s BMI rose only...
XOMA Royalty Corp announced a 68% surge in royalty receipts to $33.6 million for 2025, a portfolio now exceeding 120 assets and a $16 million share repurchase. The results sparked a 5.2% pre‑market rally and set the stage for multiple 2026 regulatory...
Longeveron raised $15.9 million in a private placement, extending its cash runway into the fourth quarter of 2026. The company reported a $22.7 million net loss for 2025, driven by higher personnel, CMC, and severance costs, while revenue fell 50% to $1.2 million....
A recent preclinical study demonstrates that cannabidiol (CBD) directly engages the TrkB neurotrophin receptor through its PTB‑binding domain, recruiting the adaptor protein FRS2 to trigger robust downstream signaling. This activation attenuates amyloid‑β deposition, tau hyperphosphorylation, and neuroinflammation in transgenic Alzheimer’s...
RNA epigenetics has expanded to over 170 chemically modified nucleotides that shape gene expression at transcriptional and post‑transcriptional levels. The review highlights m6A as the most studied mark, detailing its writer‑METTL3/14 complex, erasers FTO/ALKBH5, and diverse readers that control RNA...
A newly engineered DNA base editor significantly reduces bystander edits while maintaining high on-target efficiency, offering a more precise tool for gene therapy and genetic research. geneediting
Researchers at UC San Diego have engineered a minimally evolved adenine base editor (ME‑ABE) that dramatically cuts bystander DNA edits while preserving the high on‑target efficiency of newer ABE8 variants. By reverting five specific mutations in the older ABE7.10 scaffold,...
Merck Animal Health announced that the FDA has approved an expanded label for its once‑yearly injectable parasite control, Bravecto Quantum, adding treatment and control of Asian longhorned tick (Haemaphysalis longicornis) and Gulf Coast tick (Amblyomma maculatum) for 12 months. The product...
Prodeon Medical received FDA 510(k) clearance for its Urocross Expander System, a non‑permanent, retrievable implant designed to treat lower urinary tract symptoms caused by benign prostatic hyperplasia. Clinical data from the Expander‑2 randomized trial showed a 48.1% mean improvement in...
Questioning the benefit of an implant to close the left atrial appendage vs medical therapy in a randomized trial @NEJM https://t.co/N0hpdIfmLe https://t.co/8bkk8FzLuY
Excited to have fintwit's biotech whisperer, @A_May_MD , on the podcast tmr. We'll be talking all things biotech and maybe some $NKTR and $ABVX. Any questions for Adam?
MilliporeSigma, the life‑science arm of Merck KGaA, completed its €104 million acquisition of HUB Organoids and has since integrated the business into its Discovery Solutions unit. The company launched a partnership with Promega to develop real‑time reporter assays for organoids, while...
A new finding after stopping GLP-1 drugs in a large cohort with Type 2 diabetes: rapid erosion of CV benefit/protection New @bmj_latest by @zalaly @Biostayan https://t.co/JG6yB8wTJJ See thread: https://t.co/6JvfIIjVBw https://t.co/wUgWhvs9Yy
MiniMed, the diabetes‑tech spin‑out of Medtronic, received FDA clearance for its MiniMed Flex insulin pump, a device roughly half the size of the 780G model and operable via smartphone. The pump, featuring a 300‑unit reservoir, targets Type 1 patients aged 7+ and...
The U.S. Food and Drug Administration has opened an investigation after a patient died following self‑injection of Laennec, an allogeneic placental extract imported from Japan. A similar fatality occurred in Russia involving health influencer Anna Kolyada, whose companion fell seriously...
What if we could engineer T cells in the body, making CAR T vs cancer, autoimmune diseases, and other applications far more practical, much less expensive? A step forward today via genome editing T cells https://t.co/FjgQA8NUlu https://t.co/XXk43WL1ac https://t.co/rpC7eCAlJH
Repeated head impacts in contact sports have been linked to lasting damage of the blood‑brain barrier (BBB), a finding that may underlie chronic traumatic encephalopathy (CTE). Researchers scanned 47 retired athletes using an MRI contrast agent that only enters brain...
It's the future it's possible that we'll use cells plus silicon for compute. In this experiment, scientists used a mouse brain organoid (brain-in-a-dish) to play a video game, showing living cells can solve digital tasks. Reaching 46% proficiency in a...
TerraPower Isotopes is committing $450 million to build a cGMP‑compliant actinium‑225 manufacturing plant in Philadelphia, a move that will expand production capacity roughly twenty‑fold. The 250,000‑square‑foot facility, slated to begin output in 2029, will create 225 full‑time jobs and benefits from...
The FDA released a draft guidance that details how biopharma firms can validate non‑animal approaches for early‑phase toxicology and safety studies. The document encourages the use of in‑vitro assays, computational modeling, and other modern methods to replace traditional animal testing....
eXoZymes’ cell‑free biomanufacturing platform was independently run by Cayman Chemical at pilot scale, moving from a 1‑L test to a 100‑L reactor. The process produced over 500 g of pharma‑grade N‑trans‑caffeoyltyramine (NCT) with 99.6 % purity and maintained >99 % conversion despite pH...
A randomized clinical trial of repeated doses of psilocybin for the treatment of obsessive–compulsive disorder 73.3% were responders (⩾35% reduction in YBOCS scores), with 40% in remission. These effects diminished but remained substantial at 6 months. https://t.co/tp2SPIKDrB
