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Every morning
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Tuesday recap
Eli Lilly has filed a notice of appeal challenging the FDA’s classification of its experimental obesity injection, retatrutide. The agency labeled the product as a new molecular entity, granting it a 12‑year data exclusivity period. Lilly argues the classification is incorrect and could restrict its ability to protect the drug’s market position. The appeal could reshape how compounders pursue obesity therapies using the 505(b)(2) pathway.
Longevity Global is launching the inaugural Longevity Innovation Forum in San Diego on March 11‑12, 2026, gathering leading scientists, clinicians, biotech founders and investors to accelerate healthy‑aging research. The two‑day summit features high‑profile speakers such as Mike Snyder, Eric Verdin,...
Merkel cell carcinoma log, day #566. Completed my 6th PET scan at Dana-Farber yesterday. The radar, such as it is, doesn’t reflect any Merkel cell carcinoma. Lymph nodes look clean. The more I do PET scans, though, the more I...
Scientists at EPFL applied a three‑factor (OSK) partial reprogramming cocktail to memory‑encoding engram neurons in 9‑10‑month‑old mice and Alzheimer’s‑model strains. Using a dual‑AAV system gated by doxycycline, OSK expression was limited to neurons active during a learning event, preserving cell...
BioWorld’s latest brief highlights three emerging biotech advances. Researchers pinpointed the SCAN network as a central circuit disrupted in Parkinson’s disease, offering a new therapeutic target. Astellas presented promising preclinical data on ASP-2246, an mRNA‑encoded NeuroD1 candidate aimed at neural...
On September 30, 2022 the FDA User Fee Reauthorization Act of 2022 re‑authorized the Generic Drug User Fee Amendments (GDUFA) through September 2027, marking the start of GDUFA III. The legislation sets new user‑fee rates for FY 2025 and FY 2026, including a...
Between January and February 2026 the FDA issued a cascade of regulatory updates covering new drug approvals, safety‑label revisions, draft guidances, and consumer alerts. The agency granted approval for pembrolizumab combined with paclitaxel to treat platinum‑resistant ovarian, fallopian tube, or...
GLP‑1 therapies are entering a new regulatory phase as the FDA stripped suicide‑ideation warnings from Saxenda, Wegovy and Zepbound and signaled tighter controls on compounded pills. At the same time, Novo Nordisk’s oral Wegovy has become the fastest drug launch...
The GEN podcast highlighted Women in Science Day, noting the term “scientist” was originally coined for a woman, and featured Medra CEO Michelle Lee discussing the integration of AI‑driven robotics into biological research. It also covered automation advances presented at...
Vertex Pharmaceuticals and CRISPR Therapeutics forecast combined Casgevy gene‑therapy and Journavx pain‑drug sales of $500 million in 2026, a 185 % jump from 2025. The therapy generated $115.8 million in 2025, with Q4 revenue of $54.8 million, and treated 111 patients that year, up...
Moonwalk Biosciences, founded by CRISPR pioneer Feng Zhang and former Illumina CTO Alex Aravanis, announced a strategic pivot from epigenetic editing to siRNA‑based obesity therapies. The company secured a $120 million Series A round to fund the new platform, which targets liver‑expressed...
Moderna’s chief financial officer indicated that the company cannot yet confirm whether its 2028 cash‑flow break‑even goal will hold, as the outlook for its seasonal flu vaccine remains uncertain. The flu shot, once expected to be a steady revenue stream,...
The FDA’s 2026 novel drug approvals catalogue highlights all new molecular entities receiving first‑time U.S. marketing authorization. A novel drug is defined as a product never previously approved or sold in the United States, and each entry links to the...
The AAPS National Biotechnology Conference will take place May 11‑14, 2026 in San Diego, gathering leading pharmaceutical scientists to discuss the latest advances in biologics, biotechnology products, and advanced therapies. The four‑day event offers sessions on new modalities, technologies, and novel strategies...
Eli Lilly has amassed roughly $1.5 billion worth of its experimental obesity drug orforglipron. The company began stockpiling the product months before the U.S. Food and Drug Administration is expected to grant approval later this year. Orforglipron, a GLP‑1 receptor agonist, joins...
The FDA unexpectedly refused to review Moderna’s mRNA‑based flu vaccine, sparking alarm across biotech firms. Pediatricians are confronting the Department of Health and Human Services (HHS), demanding transparent guidance on pediatric flu immunization. The decision highlights perceived regulatory volatility under...
Immunic announced an oversubscribed private placement raising up to $400 million to fund its shift toward a commercial‑stage biotech. The capital injection will support late‑stage development programs and accelerate the search for a new chief executive officer. Meanwhile, Vertex Pharmaceuticals disclosed...
The episode opens with a celebration of Women in Science Day, highlighting the historic origin of the term “scientist” and the push for greater female leadership in biotech. Medra CEO Michelle Lee discusses how the company is merging robotics with...
Quince Therapeutics warned investors it may need bankruptcy protection after its lead drug eDSP failed a pivotal phase 3 trial for ataxia‑telangiectasia. The SEC filing disclosed less than $6 million in cash, $12 million in short‑term investments and a $16 million unsecured line of...
$CMPS first-in-line for potential psychedelic approval for Treatment Resistant Depression (TRD) . Likely war between "Old School FDA" and MAHA movement. Will be exciting to see the outcome. $HELP with strong data for Major Depressive Disorder (MDD) and Breakthrough Therapy Designation. New...
Ovid Therapeutics, under new CEO Meg Alexander, is re‑orienting its neuroscience pipeline toward first‑in‑class KCC2 modulators while advancing a drug‑resistant epilepsy candidate toward Phase 2. The company’s earlier flagship, soticlestat, failed in Phase 3, eliminating $600 million in potential milestones, prompting a strategic...
Vertex Pharmaceuticals reported that its late‑stage RAINIER trial of povetacicept in IgA nephropathy is proceeding without safety concerns, with primary data expected in the first half of 2026. The company is leveraging a priority‑review voucher for the upcoming FDA filing...
Organotics, a new biotech startup, is leveraging patient‑derived brain organoids to accelerate early‑stage testing of neuropsychiatric drugs. By reprogramming a patient’s blood or skin cells into induced pluripotent stem cells, the company creates vascularized, multi‑region mini‑brains that reflect individual genetics....
Paul Hudson has struggled to revitalize Sanofi’s R&D engine despite a series of high‑profile acquisitions since becoming CEO in 2019. The French group’s pipeline has underperformed, and recent buyouts have failed to deliver the expected boost in innovative drug candidates....
PTC Therapeutics has withdrawn its FDA filing for Translarna (ataluren) as a treatment for nonsense‑mutation Duchenne muscular dystrophy after the agency indicated the data would not meet the threshold for substantial evidence of effectiveness. The decision ends a decade‑long effort...
Medicare Part B lab spending reached $8.4 billion in 2024, up 5 % year‑over‑year. Genetic tests, though only 5 % of test volume, accounted for 43 % of the dollar value, driving a $3.6 billion surge. Utilization of molecular diagnostics jumped 160 % since 2018, while routine...
Lyell Immunopharma has administered the first dose of its investigational CAR‑T therapy, ronde‑cel (LYL314), in the Phase III PiNACLE‑H2H trial for relapsed or refractory large B‑cell lymphoma. The head‑to‑head study randomizes roughly 400 patients to receive either ronde‑cel at 100 × 10⁶ cells...
ProPhet, an Israeli AI‑driven startup founded in late 2024, leverages a novel machine‑learning platform that projects proteins and small molecules into a common interaction space. This approach allows the company to screen billions of compounds against targets previously deemed undruggable,...
The U.S. FDA declined to review Moderna's mRNA influenza vaccine, even though two phase‑3 trials involving 43,800 participants demonstrated a 27% efficacy advantage over the standard Fluarix vaccine and a 49% reduction in hospitalizations. FDA officials cited the comparator arm...
Novocure received FDA clearance for its Optune Pax tumor‑treating‑field device in locally advanced pancreatic cancer, marking the company’s first indication beyond brain tumors. The pivotal trial of 571 patients showed a statistically significant two‑month overall‑survival gain (16.2 vs 14.2 months) when the device was...
The episode explores the rapid convergence of organoid technology and artificial intelligence, highlighting how AI-driven image analysis, multidimensional data integration, and high‑throughput screening are transforming organoid research. It introduces the emerging field of Organoid Intelligence, where brain organoids act as...
Here the Moderna flu data the FDA refused to review. This is the most important slide from the company's study of its experimental flu vaccine-- exactly the data FDA said it wouldn't even review. And below is a thread of...
$IMMX momentum continues >Mizuho analyst initiates $14 PT >Lily acquisition of Orna Therapeutics $2.4 billion >AbbVie acquired Capstan Therapeutics $2.1 billion CAR-T heating up >Next milestone: imminent enrollment completion >Could NXC-201 be an eventual front-line therapy for AL Amyloidosis? >BLA submission projected Q3’26 https://t.co/cPpiiFHQal
Northwestern researchers engineered a spherical nucleic acid (SNA) vaccine in which the HPV16 E7 peptide is displayed at the nanoparticle surface via its N‑terminus. This N‑terminal orientation (N‑HSNA) generated up to eight‑fold higher interferon‑γ secretion and 2.5‑fold greater cytotoxicity than...
Nothing means more to a toolbuilder than knowing their tools and tutorials are helpful to someone. I'll take a comment like this over a million accolades and degrees worth of institutional validation any day. PCR Primer Design Guide here if...
To invest the billions it costs to make new medicines, companies need to be able to trust the word and actions of the FDA. To capaciously change the rules at the end of the game ultimately hurts patients.
Iliad Biotechnologies announced a $115 million Series B round, the largest venture deal of the week, led by RA Capital Management. New investors Janus Henderson and BNP Paribas Asset Management Alts also participated. The funding will accelerate Iliad’s intranasal vaccine program targeting pertussis...
A successful hunt of human genome variants identifying some (with MR) that provide causal evidence that BMI affects microbe composition @NatureGenet https://t.co/1uxvnFNrbK https://t.co/SuItRHAnFe
🧵 Single-cell RNA-seq is destructive. You sequence the cells, they're gone. So how do you reconstruct cellular trajectories? Like tracking stem cells as they differentiate? Enter CellRank. https://t.co/HqHnErHYNy
The EPCORE NHL‑1 trial released three‑year data showing that epcoritamab (Epkinly) delivers deep, durable remissions in heavily pre‑treated large B‑cell lymphoma. Among patients who achieved a complete response, 53% remained progression‑free at the data cutoff, with a median CR duration...
🧵Bioinformatics evolves fast. New tech. New data. New analysis. But here's how to stay grounded and not get overwhelmed: https://t.co/ZyxcLRExC6
Humbling 30 year Biotech stats shared by @verdadcap in a recent report: Just over 1,000 biotechs hit $200M mkt cap at some point. Of those, 67% have lost value (had cumulative negative returns), vs 48% for all other US companies....
The phase III LAIS trial showed that loberamisal, a novel neuroprotectant, raised the proportion of acute ischemic‑stroke patients achieving an excellent functional outcome (mRS 0‑1) to 69.7% versus 56.4% with placebo when given within 48 hours of symptom onset. The study enrolled 997...
The Catalyst Machine | Ep. 931 How Capital Markets Quietly Rewired Translational Therapeutics https://t.co/lWNRxW0wuQ https://t.co/l14X2JfrLX
I had such a fantastic experience with the Duckweed archivists at the Rutgers Duckweed Stock Cooperative. Many of their lines are open for commercial entities too for just $170+ship. Got some great duckweed for rapid prototyping in and customer service...
The Administration for Strategic Preparedness and Response (ASPR) has unveiled a $100 million Small Molecule Approaches for Rapid and Robust Treatment Prize to spur antiviral drug development. The competition targets viruses in the Togaviridae and Flaviviridae families, including dengue, Zika, West...
Earnings roundup: Neurocrine slumps, Alnylam battles skeptics and Ascendis eyes a competitor https://t.co/kU1ex80A24 by @realJacobBell $NBIX - 10% $ALNY - 4% $ASND - 2% $BBIO #biotech
