Today's Pharma Pulse
Ona lands $86.6M Series B, one of Spain’s biggest biotech financings
Spanish biotech Ona announced a $86.6 million Series B round, ranking among the largest venture financings 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 funds will expand Ona’s AI‑driven drug discovery platform and accelerate its pre‑clinical pipeline.
IMPORTANT REMINDER: Pfizer Whistleblower Fired Hours After Reporting “Nightmare” COVID Vaccine Trial
Brook Jackson, a senior associate at Ventavia Research Group, disclosed serious protocol breaches in Pfizer’s COVID‑19 vaccine trial, including mislabeled specimens and deliberate unblinding of participants. She reported these violations to the FDA on September 25 and was terminated by Ventavia within six hours. A 2022 BMJ letter highlighted that only nine of the 153 trial sites were inspected before the vaccine’s emergency authorization, suggesting systemic oversight failures. The incident raises questions about data integrity and whistleblower protection in large‑scale pharmaceutical studies.
Combining Ion Pumps and Click Chemistry Enables Precise Drug Release in the Body
Researchers at TU Wien have merged electronic ion pumps with click‑to‑release chemistry, creating an "iontronic click‑to‑release" system that delivers tiny trigger molecules instead of the drug itself. The triggers cleave immobilized drug linkers at the implant site, enabling precise, on‑demand...
White House Urges Mississippi To Reject Rx Fee Bill Over Drug Price Concerns
The White House is urging Mississippi legislators to reject a Senate‑amended bill that would impose a uniform $11.29 dispensing fee on every prescription. Federal officials argue the flat charge could raise out‑of‑pocket costs and undermine national drug‑price reduction efforts. The...
Office of Infectious Diseases Research Activities
The FDA’s Office of Infectious Diseases outlines its antimicrobial regulatory science agenda, referencing the 2020‑2025 National Action Plan that steers U.S. efforts against antibiotic‑resistant bacteria and fungi. It announces FY26 funding opportunities through a Broad Agency Announcement, with proposals due...
Why Has Marijuana Not Been Rescheduled? The Answer Is Obvious, Kinda
President Trump issued an executive order to move cannabis from Schedule I to Schedule III, yet the Department of Justice has not finalized the rule after more than three months. A senior Trump adviser and GOP operative Roger Stone has publicly urged...
From Our Perspective: The Orange Book at 40: A Valued FDA Resource Continually Enhanced by User Input
The FDA celebrated the Orange Book’s 40th anniversary, highlighting its role as the sole official source for therapeutic equivalence evaluations and reference listed drug data. The database, updated daily for generic approvals and monthly for NDA changes, underpins generic substitution,...
India Pushes Pharma Shift From Generic Volume to Biologics Innovation
Union Minister Anupriya Patel announced a $‑billion‑plus budget and regulatory reforms to steer India's pharmaceutical industry from a volume‑focused generics model toward biologics and biosimilars. The plan adds three new NIPER institutes and modernises the CDSCO, aiming to boost R&D...
Inactive Ingredients Database Download
The U.S. Food and Drug Administration has published its latest Inactive Ingredients Database for April 2026, offering both CSV and Excel formats that each weigh under 2 MB. The database is refreshed quarterly—April, July, October and January—and provides detailed fields such as...
EU Approves Dupixent for Children 2‑11 with Chronic Spontaneous Urticaria
Regeneron Pharmaceuticals and Sanofi announced that the European Commission has approved Dupixent for moderate‑to‑severe chronic spontaneous urticaria in children aged 2 to 11. The decision adds a new pediatric indication to the drug, which was already approved for adults and...
FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results
The FDA has sent reminders to more than 2,200 medical‑product companies and researchers, covering over 3,000 registered trials, to file required results on ClinicalTrials.gov. An internal analysis shows that 29.6% of studies likely subject to mandatory reporting still have no...
Quarterly Inactive Ingredient Database (IID) Change Log
The FDA’s Inactive Ingredient Database (IID) is updated each quarter, and the Change Log records all corrected, deleted, and Maximum Daily Exposure (MDE) replacement entries. The log spans 2020‑2026, with file sizes ranging from 21 KB to 357 KB, reflecting the volume...
Salk to Lead $41.3M ARPA-H Effort to Advance Sonogenetics Therapies
The Salk Institute secured a $41.3 million ARPA‑H award to advance sonogenetics, a technique that uses low‑intensity ultrasound to control engineered cellular proteins. Over the next five years, Salk’s Dr. Sreekanth Chalasani and a multi‑institutional team will develop ultrasound‑responsive proteins, wearable...
FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds
The FDA issued final guidance titled “Cannabis and Cannabis‑Derived Compounds: Quality Considerations for Clinical Research,” clarifying how sponsors can use both hemp and cannabis with THC levels above 0.3% in human drug trials. The guidance outlines source options—including the NIDA...
Review and Approval
The FDA approves biosimilars through an abbreviated pathway that relies on demonstrating high similarity to an existing reference biologic, rather than repeating full safety and efficacy trials. Manufacturers must provide analytical, animal, and clinical data, and the agency can waive...
DeepSeqAI Trains on Function to Future‑proof Biologics
Most AI protein tools are trained on structure. DeepSeqAI trains on function. They're running billions of experimental protein-protein interactions through their platform to map biologics against viruses, immune receptors, and the entire human proteome. The goal: candidates that hold up against...
Why Anthropic Chose Coefficient Bio Over Bigger Rivals?
Reading up on the Coefficient Bio deal. I totally get the industrial logic around why Anthropic should care about drug discovery. But why this particular company? There's lots of more scaled players doing this. Can anyone educate me? https://t.co/akFVmRUaYw
Vivatides Therapeutics Raises $54M for RNA Expansion
Vivatides Therapeutics announced a $54 million Series A round, led by Qiming Venture Partners and backed by several other investors. The funding will accelerate its proprietary extrahepatic delivery platform, designed to transport RNA molecules such as siRNA and antisense oligonucleotides beyond the...
Loyal Raises $100 Million: Dog Longevity Drugs Targeting IGF-1 and PPAR Pathways
Loyal, a veterinary biotech firm, announced a $100 million financing round to advance its canine longevity platform. The company targets the IGF‑1 and PPAR pathways to develop drugs that extend the lifespan of senior and large‑breed dogs. It has secured conditional...
Retail Pharmacies Fill Less than 2% of Mifepristone Orders
The FDA’s January 2023 removal of the in‑person dispensing rule let pharmacies, including mail‑order and retail outlets, fill mifepristone prescriptions. A USC study published in JAMA finds that only about 2,700 prescriptions are filled monthly, with mail‑order pharmacies handling more than...
TANGENT Phase 3 Study Meets Primary and Secondary Endpoints, SynOx Reports
SynOx Therapeutics reported that its Phase 3 TANGENT study of emactuzumab met both primary and secondary endpoints in tenosynovial giant cell tumor (TGCT). The five‑dose, eight‑week regimen achieved statistically significant RECIST responses and tumor volume reductions at six months. Patients also...
CRISPR Turns 25: Explore Its Past, Present, Future
Introducing the GEN Keynote Webinar: "CRISPR at 25: The Past, Present, and Future of Genome Editing" Guest speaker: Rodolphe Barrangou @CRISPRchef May 4, 2026: noon ET/9 am PT Sponsored by @elevatebio https://t.co/cYsSsaod4Y via @GENbio
F.D.A. Calls on Drug Developers to Publish Missing Data From Thousands of Trials
The FDA announced it has dispatched more than 2,200 letters to drug makers, device manufacturers and researchers, demanding the publication of clinical‑trial results that remain absent from ClinicalTrials.gov. An internal analysis shows roughly 30 % of studies under FDA review have...
Merck's $30B Offer Now Exceeds Revolution's Market Cap
Reminder that Merck tried to buy Revolution for $28-$32B (per Jan reporting from FT), vs current market cap after today's great data of $26.5B https://t.co/hoq2P0oiG9
Busy Biotech Day Highlights Promising Advances and Insightful Commentary
As usual, excellent summary by @ldtimmerman @timmermanreport of busy and promising biotech news day - as always delivered w insight and heart (especially thoughtful comments re: revmed drug in context of poignant recent @BenSasse interview)
ROIS Expands US Injectable Manufacturing Capacity
ROIS has completed the acquisition of a 370,000‑square‑foot injectable manufacturing facility in Phoenix, Arizona, adding high‑potent fill/finish and lyophilization capabilities for biologics and antibody‑drug conjugates (ADCs). The site already holds FDA, EMA and Japanese regulatory approvals, enabling immediate support for...
FDA Zeroes in on Houman Hemmati for CBER Lead
FDA narrows in on search for new biologics and vaccines leader - and we’re hearing @houmanhemmati is a top contender for CBER - https://t.co/qMx8wv32fG
Delaying Generics Boosts Profits Far More than Small Gaps
That gap doesn't look like it could be the largest price-fixing scam in history. it looks like 4% of a generic drug's price. Brand drugs sell for 10-20 times as much as generics, Delaying generic entry by even 6 months...
FDA Narrows in on Search for New Biologics and Vaccines Leader
The U.S. Food and Drug Administration is close to naming a new director for its Center for Biologics Evaluation and Research (CBER), ending the turbulent tenure of Vinay Prasad. Sources say the leading candidate is Dr. Susan K. Lee, a...
October - December 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System...
The FDA’s Adverse Event Reporting System (FAERS) prompted a wave of labeling revisions between 2023 and 2025, adding new safety warnings to dozens of drugs. Notable changes include hypersensitivity alerts for cabotegravir injectables, fecal incontinence risks for several atypical antipsychotics,...
Pharmaceutical Executive Daily: FDA Issues Second CRL for Replimune's RP1 Melanoma Treatment
The FDA issued a second complete response letter rejecting Replimune’s biologics license application for RP1 combined with nivolumab in advanced melanoma, citing insufficient data to isolate RP1’s contribution. Replimune’s CEO warned of job cuts and a scale‑back of U.S. manufacturing....
Kailera Therapeutics (KLRA) IPO Deck
Kailera Therapeutics (KLRA) is preparing an initial public offering to fund its GLP‑1‑based obesity drug platform, which includes both injectable and oral candidates. The company’s pipeline spans multiple clinical stages, from early‑phase studies to late‑stage trials, positioning it to capture...
A Novel Approach To The Treatment Of Antibiotic Resistant Infections
Researchers have engineered microscopic, cell‑like particles that hunt drug‑resistant bacteria while sparing healthy microbes. The particles use protein‑based recognition to bind unique bacterial markers and deliver toxic proteins or bactericidal chemicals in a two‑step process. Laboratory tests showed a single...
Off‑the‑Shelf CAR‑T Shows Promise Delaying Lymphoma Relapse
Allogene data suggest ‘off-the-shelf’ CAR-T could delay relapse in lymphoma https://t.co/UrSNYpQFqB by @gwendolynawu $ALLO + 25%
UniQure Investors Face April 13 Deadline to Lead Securities‑fraud Lawsuit
UniQure N.V. shareholders who purchased ordinary shares between September 24 and October 31, 2025, have until April 13, 2026 to file a motion to serve as lead plaintiff in a securities‑fraud class action. The lawsuit, filed by Rosen Law Firm,...
Sarcopenia -- New Clues
Recent preclinical and clinical work links low‑grade inflammation to age‑related muscle loss, or sarcopenia, and shows that ibuprofen can blunt this process. In 20‑month‑old rats, a five‑month ibuprofen regimen cut inflammatory markers by up to 60% and boosted post‑prandial muscle...
Fragments vs the E3 Ligase KLHL12
Researchers at Vanderbilt screened 13,824 fragments against the E3 ligase KLHL12, a protein overexpressed in many cancers but absent from heart tissue. The campaign yielded 35 initial hits, with compound 7k emerging as the most potent, displaying sub‑micromolar affinity in...
Pancreatic Cancer Drug Nearly Doubles Survival in Trial
Revolution pancreatic cancer drug nearly doubles survival in key trial https://t.co/SvJicU0LIz @ByJonGardner $RVMD + 38%
AI Company Becomes First Autonomous Drug Prescriber in Utah
An editorial @JAMA_current on @doctronic (the AI company now prescribing renewal medications without physician involvement in Utah) entitled "The First AI Drug Prescriber" https://t.co/Wo1rVhnr4s https://t.co/hAcYbYLmIv
Allogene’s First Cut of Data on ‘Off-the-Shelf’ CAR-T Shows Promise
Allogene Therapeutics reported that its off‑the‑shelf CAR‑T candidate cleared all detectable lymphoma cells in just over half of trial participants. The interim analysis stems from the pivotal ALLO‑501/ALLO‑501A study in relapsed or refractory B‑cell lymphoma. Researchers highlighted a complete molecular...
Revolution Medicines' Pancreatic Cancer Drug Shows Late‑Stage Success
This is big. All cancers suck. Pancreatic somehow manages to suck even more. Revolution Medicines says its potential breakthrough pancreatic cancer drug succeeds in late-stage trial https://t.co/rFVsvi0mQD
GSK Reports Strong Results for B7-H4 ADC in Gynecological Cancers
GSK’s investigational antibody‑drug conjugate mocertatug rezetecan (Mo‑Rez) demonstrated robust activity in its Phase 1 BEHOLD‑1 trial, achieving a 62% objective response rate in platinum‑resistant ovarian cancer and 67% in recurrent or advanced endometrial cancer. The drug targets the B7‑H4 immune checkpoint,...
Orforglipron
Orforglitron, an oral non‑peptide GLP‑1 receptor partial agonist developed by Eli Lilly and Chugai, received FDA approval for chronic weight management. The drug distinguishes itself from oral semaglutide by requiring no fasting or special dosing constraints, enabling once‑daily administration. Clinical trials...
Researchers Use Nanomaterials and Ultrasound to Create Light Inside the Body
Stanford researchers have created a noninvasive method that uses focused ultrasound to activate biocompatible ceramic nanoparticles, generating light at any point inside the body. The proof‑of‑concept, demonstrated in mice, produced blue 490 nm light that could stimulate neurons and mimic photodynamic...
USP Adds Tamiflu, Trulicity to Vulnerable List as Upstream Analysis Reshapes Supply Concerns
The United States Pharmacopeia (USP) has refreshed its vulnerable medicines list, adding Tamiflu (oseltamivir) and Trulicity (dulaglutide) after expanding its risk assessment to include key starting materials (KSMs). The new analysis shows 48 of the 100 flagged drugs depend on...
Multiplexed In‑Vivo Screening Drives Next‑Gen Drug Development
Multiplexed in vivo screening is the future of drug development. @ManifoldBio is multiplexing protein therapies in vivo. @GordianBio is multiplexing gene therapies in vivo. @waypointbio is multiplexing cell therapies in vivo. GT Bio is multiplexing LNPs in vivo. 50Y portcos all https://t.co/DT2AwXbKtB
Allogene Stock Sails After CAR T Clears Residual Lymphoma in Early Data Cut
Allogene Therapeutics reported interim results from its Phase 2 ALPHA3 trial showing its off‑the‑shelf CAR‑T product cema‑cel cleared measurable residual disease in 58.3% of patients versus 16.7% in the observation arm. The therapy also achieved a 97.7% drop in circulating tumor...
How This Biotech Stock Skirted Today's Selloff
Revolution Medicines (RVMD) surged 35.5% to $131.35, briefly touching a record $135.81 after reporting that its pancreatic‑cancer pill daraxonrasib cut death risk by 60% in a Phase 3 trial. Leerink and Guggenheim raised price targets to $147 and $174, respectively. The...
Hidden Antivirals Discovered in a Plant-Derived Supplement
Researchers identified a new family of trace molecules, dubbed dicitriosides, hidden in a 90 %‑purity isoquercitrin supplement. These triterpenoid‑cinnamate compounds exhibit nanomolar potency against Ebola, Zika and SARS‑CoV‑2, outperforming the original mixture by roughly 25‑fold. The antiviral activity was isolated to...
BioNTech's HER2 ADC Succeeds in Phase 2 Study, FDA Filing Planned
BioNTech announced that its HER2‑targeted antibody‑drug conjugate, trastuzumab pamirtecan (formerly BNT323), achieved robust efficacy in a Phase 2 trial of HER2‑positive metastatic breast cancer. The study reported a 45% overall response rate and a median progression‑free survival of 8.2 months, with...
ALLO May
Has $ALLO found a niche for allo Car-T at last? It's early days, so the answer is maybe. Via @APEXONCO -> https://t.co/bO3A1hpAY8