Today's Pharma Pulse
Ona lands $86.6M Series B, one of Spain’s biggest biotech rounds
Spanish biotech firm Ona announced an $86.6 million Series B financing, ranking among the largest venture rounds in Spain’s life‑science sector this year. The round was led by Seventure Partners with participation from existing backers and new strategic investors. The funding will be used to scale Ona’s AI‑driven drug discovery platform and accelerate its pre‑clinical programs.
Samsung Bioepis and Epis NexLab Sign Research Collaboration and License Agreement with G2GBIO to Develop Novel Assets Including Long-Acting Semaglutide
Samsung Bioepis and its sister firm Epis NexLab have signed a research collaboration and exclusive license agreement with G2GBIO to develop a long‑acting semaglutide formulation using G2GBIO’s proprietary microsphere technology. The deal grants Samsung Bioepis full rights to the semaglutide asset and an option to license a second G2GBIO candidate, plus first negotiation rights for three additional future assets. Epis NexLab will co‑develop the microsphere drug‑delivery platform, while financial terms remain confidential. The partnership aims to broaden Samsung Bioepis’ pipeline with sustained‑release biologics.
Clinical Trials Randomize Experiments, Keep Standard Care for All
The dog *also* got standard-of-care treatment. Who knows what worked? Randomize some getting one-off custom vaccines but whole group gets standard of care. How ALL modern clinical trials work. If true, put big money to improve. Otherwise don’t push snake oil on...
Vitamin B2 Pathway Identified as Potential Target for Cancer Therapy
A CRISPR‑Cas9 screen revealed that riboflavin (vitamin B2) sustains the ferroptosis suppressor protein FSP1, shielding cancer cells from iron‑driven lipid peroxidation. Depleting vitamin B2 destabilizes FSP1 and renders tumor cells highly susceptible to ferroptosis. The researchers demonstrated that roseoflavin, a bacterial analog...
At SXSW, Cuban and eMed CEO Draw Contrast Between Them and Other “Marketing” Companies
At SXSW, Mark Cuban and eMed CEO Linda Yaccarino announced a partnership that will route employer‑sponsored GLP‑1 weight‑loss prescriptions through Cuban’s Cost Plus Drugs. Yaccarino highlighted eMed’s 90 % one‑year retention rate, contrasting it with the 50‑60 % churn seen at direct‑to‑consumer players...
Graph AI Accelerates Longevity Drug Discovery in New Alliance
Solve Aging: Biophytis and LynxKite are expanding their alliance to use graph-based AI to speed discovery of new longevity drugs, aiming to map complex aging biology and surface novel targets for age-related disease. The “AI x longevity” stack is quietly...
Summit Midstream Corp (SMC) Q4 2025 Earnings Call Transcript
Summit Therapeutics reported a cash balance of $713 million and zero debt at year‑end, while GAAP operating expenses fell to $225 million. The FDA accepted its Biologics License Application for ivonesumab in EGFR‑mutant non‑small cell lung cancer, setting a PDUFA action date...
Monocyte Immune Shifts in HIV Patients on Injectable Therapy
Researchers published a longitudinal study showing that people living with HIV who switch from daily oral antiretrovirals to the long‑acting injectable combo cabotegravir‑rilpivirine experience an early, transient rise in monocyte activation followed by a sustained decline below baseline levels. Flow...
Approve Longevity Drugs for Disease First, Then Expand to Aging
The only sustainable path to development of longevity therapeutics is to get the potential longevity drug approved for a disease, then go for indication expansion and study it in the context of aging at different doses and regimens. To be...
Open‑source Hermes Agent for mRNA Vaccine Design
Has anyone built full open source tooling for Hermes Agent @NousResearch for Bioinformatics (mRNA vaccine design is the target)? It'll need new agent skills too. Would you use it if I built it? I have a few hours left to...
The Pink Pill: New Documentary Exposes the Long Battle to Bring Addyi — the First Libido Drug for Women —...
The documentary "The Pink Pill" chronicles the decade‑long fight to bring Addyi, the first FDA‑approved drug for women’s low libido, to market. Founder Cindy Eckert bought the rights after a major pharma abandoned the project, launched a 13,000‑patient trial, and...
AI Beats FDA, Prompting DIY Drug Use
AI's capabilities have outpaced the FDA's capabilities to regulate it There are literal cures that can be designed and synthesized but have no way to reach the market due to regulatory/ethics blocks People will, like with Peptides, start dosing themselves & their...
Low‑Cost Vaccines Fight Pseudoscience, Yet Remain Unaccepted
Please @X I make low cost vaccines to help humanity and debunk pseudoscience. This is unacceptable
The Lethal Cost of Regulatory Perfection in Rare Disease
During a congressional hearing, neurologists warned that rare disease patients are dying while therapies linger in FDA review. The FDA recently rejected the SCA drug troriluzole, demanding more statistical certainty despite trial data showing over 50% fall‑risk reduction. Congress has...
GLP‑1 Drugs: Promising yet Unproven Healthspan Extension
GLP-1 drugs for extending healthspan? Intriguing but we're a long way off from evidence Discussed at length in Super Agers as a candidate drug beyond lifestyle + factors @TheEconomist gift link https://t.co/A2dpfcnApF https://t.co/3gY8iACeGs
Variant Bio Hunts Rare Traits For
From a tiny idea in our Lux office to deal after deal... ...@VariantBio finding outlier people, with outlier traits, in outlier parts of the world to make outlier drugs. organ by organ ... https://t.co/I5fK8nzZb4
Rethinking Where Patient Recruitment Begins
Clinical trials have long relied on site‑based recruitment, leaving under‑ and misdiagnosed patients underrepresented. Recent studies show digital outreach can identify symptomatic individuals who never enter traditional healthcare pathways, dramatically expanding the eligible pool. Digital campaigns have cut cost per...
Deconstructing Psychedelics to Engineer Non‑Hallucinogenic Therapies
How do you break psychedelic molecules into parts, like cars in a chop shop, and build new ones? A look into non-psychedelic psychedelic medicine by Clayton Dalton, an ER doc and Ferriss-UC Berkeley Psychedelic Journalism Fellow @ucbsoj & @SciPsychedelics https://t.co/b7R4aTNdyf
Regulators, Not Pharma, Block Self‑Testing Experimental Therapies
The Enemy isn't Big Pharma. It's the FDA and Regulators who won't allow you to test experimental therapies on yourself (or your dog). Even if it's life or death.
Lupin Taking Bigger Bets on Innovation, More Proprietary Products in India: Lupin MD
Lupin is pivoting toward proprietary new chemical entities (NCEs) in India, aiming to launch multiple innovative products by next year. The company plans to focus on cardiac, diabetes, respiratory and oncology molecules, leveraging lower development costs and faster time‑to‑market. AI...
Engineering Smarter, Healthier Babies Through Embryo Selection
The man engineering smarter, healthier babies before they're born: Jonathan Anomaly. This philosopher-turned-biotech founder says the future of your child's health starts at the embryo. Here are 9 things you need to know about embryo selection: https://t.co/XVQF5le4bE
Eli Lilly’s Employer Push Could Unlock New GLP-1 Demand
Eli Lilly has launched Employer Connect, a platform that lets large employers purchase its weight‑loss injection Zepbound at a discounted $449 price, aiming to close the coverage gap that leaves over half of workers without obesity drug benefits. The program bypasses...
Japan Becomes First to Approve Stem Cell Therapies for Parkinson’s and Heart Failure
Japan has become the first country to grant conditional approval for two regenerative medicines that use induced pluripotent stem cells—AMCHEPRY for Parkinson’s disease and RiHEART for severe heart failure. The Parkinson’s therapy implants dopamine‑producing neurons into the brain, while the...
Wegovy Users May Have 5 Times Risk of Vision Loss than Those on Ozempic
Researchers analyzing over 30 million adverse‑event reports found that patients using Wegovy, the high‑dose semaglutide injection for obesity, have about five times the odds of developing ischemic optic neuropathy (ION) compared with those on Ozempic, the lower‑dose diabetes formulation. The association...
Turning Personal Loss Into Open Cancer Vaccine Platform
Paul's story developing a cancer vaccine for Rosie inspired me. I'm going to build something so that EVERYONE can do the same thing. My dog Lady died of hemagiosarcoma and I wish I'd been able to save her too ETA - hopefully a...
Most Insomnia Meds Don’t Worsen Sleep Apnea
A systematic review and network meta‑analysis of 32 randomized trials examined twelve hypnotic agents in adults with obstructive sleep apnea (OSA). The analysis found that most sleep‑inducing drugs do not worsen the apnea‑hypopnea index or oxygen saturation, challenging the long‑standing...
Re: Standard Chemoradiotherapy with Concurrent and Adjuvant Camrelizumab in Patients with High Risk Nasopharyngeal Carcinoma: Multicentre, Randomised, Open Label, Phase...
A phase‑3 BMJ trial reported that adding camrelizumab to standard chemoradiotherapy improved 36‑month progression‑free, distant‑metastasis‑free and locoregional‑recurrence‑free survival in high‑risk nasopharyngeal carcinoma. The protocol combined two concurrent cycles with 17 adjuvant cycles, yet only 61.9% of patients completed the full...
Zydus Lifesciences’ Anaemia Drug Desidustat Gets China Approval
Zydus Lifesciences has received NMPA approval for its oral anaemia drug Desidustat, targeting renal anaemia in adult chronic kidney disease patients who are not on dialysis. The therapy, a hypoxia‑inducible factor‑prolyl hydroxylase inhibitor, demonstrated efficacy and safety in Chinese Phase III...
First Human Age‑Reversal Trial Targets Whole‑Body Reset
The first human age-reversal trial is officially happening. But before the FDA cleared it, Harvard professor David Sinclair had to pull off a mice experiment most scientists thought was impossible: "These mice had their optic nerve regenerated. We were able to...
Drug Patents: Near-Term Generic Threat, Mid-Term Safeguards, Tirzepat
AI: Short-Term Cliffs (0-3 years remaining): Drugs like sacubitril/valsartan, dapagliflozin, pembrolizumab, ocrelizumab, daratumumab, and apixaban face imminent generic/biosimilar pressure Mid-Term Protection (4-7 years): Risankizumab and dupilumab have solid runway, supported by ongoing label expansions. Long-Term (8+ years): Tirzepatide's robust patents position it...
YolTech Therapeutics Receives FDA Clearance to Initiate Phase 2/3 Study of In Vivo Gene-Editing Therapy YOLT-202 in Alpha-1 Antitrypsin Deficiency...
YolTech Therapeutics announced FDA approval of its IND for YOLT-202, an in vivo adenine base‑editing therapy targeting Alpha‑1 Antitrypsin Deficiency. The clearance permits an open‑label, single‑dose Phase 2/3 expansion study across the U.S. and other regions. In the ongoing first‑in‑human trial,...
A Lab Mistake at Cambridge Reveals a Powerful New Way to Modify Drug Molecules
Cambridge chemists have unveiled a light‑driven “anti‑Friedel‑Crafts” reaction that forms carbon‑carbon bonds using only LED illumination at ambient temperature. The metal‑free method allows precise, late‑stage modifications of complex drug molecules, cutting months of multistep synthesis. Tested on a broad set...
Pretzel Therapeutics Presents PX578 Data Supporting POLG Disease Treatment
Pretzel Therapeutics presented preclinical data for its investigational small‑molecule PX578 at the 2026 MDA Clinical and Scientific Conference. The drug is designed to activate the mitochondrial DNA polymerase gamma (POLG) and restore mitochondrial DNA levels in patients with mitochondrial DNA...
What’s New Pussycat? FDA Assists Drug Sponsors Requesting New Clinical Investigation Exclusivity
The FDA released draft Q&A guidance that clarifies how drug sponsors can qualify for three‑year non‑patent exclusivity by conducting a “new clinical investigation.” It defines a new study as a human, non‑bioavailability trial whose results have not been previously relied...
Rare Disease Spotlight: Friedreich Ataxia Moves Beyond Mitochondrial Bandages
Friedreich ataxia (FA) received its first FDA‑approved therapy in 2023 when omaveloxolone, marketed as Skyclarys, earned accelerated approval. Biogen’s $7.3 billion acquisition of Reata Pharmaceuticals secured the drug and highlighted the market’s appetite for rare‑disease assets. Skyclarys works by activating the...
Network-Based Prediction of Drug Combinations with Quantum Annealing
The study introduces a quantum‑annealing algorithm that predicts effective drug combinations by casting the problem as a quadratic unconstrained binary optimisation (QUBO). It leverages the network‑medicine concept of disease modules and the “Complementary Exposure” principle, which seeks drugs that hit...
Kian Pee Wan May Be Harmful Due to Hidden Drug Ingredients
The FDA has issued a safety alert warning consumers not to purchase or use Kian Pee Wan, a product marketed as an appetite stimulant and weight‑gain aid. Laboratory testing revealed the supplement contains the prescription steroid dexamethasone and the antihistamine...
CMS Moves Forward with 3rd Round of Medicare Drug Negotiations
CMS announced that the third round of the Medicare Drug Price Negotiation Program will proceed with full manufacturer participation, covering 15 high‑cost, single‑source drugs and one drug slated for renegotiation. The agency will issue initial price offers by June 1, 2026,...
Vaccination Boosts Survival in Multiple Myeloma Patients
Rates of Influenza and Pneumococcal Vaccination and Correlation with Survival in Multiple Myeloma Patients [Dec 6, 2022] @mtmdphd et al. @AjaiChari CLML https://t.co/kUQeRmdKWV #NCT02761187 #mmsm #IDonc #ClinicalTrials #caxtx https://t.co/L7r9caCcGN
Navigating Myeloma MRD: Risks, Benefits, and Treatment Decisions
MT @hhashmi87 #IMS25 Great Meet The Expert talk by @bdermanmd on MRD in Myeloma Risk vs benefit Who can stop treatment Active surveillance post discontinuation #mmMRD #mmsm https://t.co/YOBOPs7hQL
No Broad Autism Approval for Leucovorin, Despite FDA Commissioner’s Prior Suggestions
The FDA on March 10 expanded leucovorin’s label to cover a very rare genetic folate‑transport disorder, not autism. Earlier, Commissioner Marty Makary suggested the drug could help “hundreds of thousands of kids” with autism, creating expectations of a broad approval. FactCheck.org...
MRD‑Negative Patients May Stop Myeloma Maintenance Therapy
Discontinuation of maintenance therapy in multiple myeloma guided by multimodal measurable residual disease negativity (MRD2STOP) - @bdermanmd et al. @ajjakubowiak #ASCO24 Abstract 106 https://t.co/FBTY7SnCxK #NCT04108624 #mmsm #mmMRD
ODAC Backs MRD as Early Endpoint for Myeloma Approvals
A Historic Turning Point: ODAC Unanimously Votes [4/12/24] in Favor of MRD Testing as an Early Endpoint in Myeloma Clinical Trials to Support Accelerated Approvals of New Treatments [Apr 18, 2024] @IMFmyeloma https://t.co/eDOgIrpVeR #mmMRD #mmsm #ctsm @FDAOncology https://t.co/W3vwHRTzhE
How Dompé Is Innovating in Neuro-Ophthalmology with the FDA’s CNPV Program
Dompe, a privately owned biopharma, is advancing an intranasal nerve growth factor (NGF) therapy to treat non‑arteritic anterior ischemic optic neuropathy (NAION), a leading cause of sudden vision loss affecting roughly 6,000 U.S. patients annually. The approach leverages NGF’s neuroprotective...
Clinicians Show Mixed Adoption of MRD in Myeloma
Clinician attitudes and practices toward measurable residual disease in multiple myeloma [Jun 7, 2020] @bdermanmd @jagoda_jasielec @ajjakubowiak Brit J Haematol https://t.co/8zhxYfYwZQ #mmsm #mmMRD https://t.co/QTlR2gv5Q0
Understanding MRD's Role in Multiple Myeloma Management
#mmMRD healthcare social media hashtag [Nov 21, 2020] Minimal/measurable residual disease (MRD) in multiple myeloma. Submitted by @bdermanmd to @symplur @healthhashtags https://t.co/grkkiox2yh #mmsm No longer available at Symplur https://t.co/IGDrNALHBP
Bacterial Strain Breaks Decades-Old Bottleneck in Chemotherapy Drug Manufacturing
An international research team has engineered a bacterial strain that boosts doxorubicin output by 180% compared with current industrial methods, overcoming three long‑standing bottlenecks—insufficient redox partners, drug‑binding “sponge” proteins, and suboptimal enzyme positioning. The findings, published in Nature Communications, detail...
Bimatoprost Implant Reduces IOP, Improves Vision at 12 Months
SpyGlass Pharma’s Bimatoprost Drug Pad‑IOL System demonstrated significant intra‑ocular pressure (IOP) reductions and vision gains in a phase 1/2 trial of 104 patients with open‑angle glaucoma or ocular hypertension undergoing cataract surgery. At 12 months, the 78 µg dose lowered mean IOP 34%...
FDA Approves Cosentyx for Pediatric Hidradenitis Suppurativa
The U.S. Food and Drug Administration has approved Novartis' secukinumab, marketed as Cosentyx, for adolescents aged 12 and older with moderate‑to‑severe hidradenitis suppurativa (HS). This marks the first IL‑17A inhibitor cleared for a pediatric indication, extending the drug’s adult HS...
Kenai: Off-the-Shelf Parkinson’s Progenitors with Precision Transplant Tech
Kenai, a new allogeneic cell‑therapy company, is developing off‑the‑shelf iPSC‑derived progenitor cells for Parkinson’s disease, paired with a precision brain‑delivery platform that uses real‑time functional imaging. The approach builds on Japan’s recent approvals of iPSC‑based Parkinson’s treatments and aims to...
Jeonbuk National University Researchers Develop DDINet for Drug-Drug Interaction Prediction
Researchers at Jeonbuk National University have unveiled DDINet, a lightweight neural network designed to predict drug‑drug interactions (DDIs) for previously unseen compounds. The model employs five fully‑connected layers and molecular fingerprints, with Morgan fingerprints delivering the best results. Using a...