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.
Eli Lilly Launches Foundayo Oral GLP‑1 Weight‑loss Pill in U.S., Priced From $149 per Month
Eli Lilly announced that its oral GLP‑1 weight‑loss medication Foundayo (orforglipron) is now available for purchase in the United States, with a retail price of $149 per month for self‑pay patients and as low as $25 per month for insured users. The launch follows FDA approval on April 1 and adds a second pill‑form GLP‑1 to the market, challenging Novo Nordisk’s Wegovy tablet.
OCE's Objections Caused Rejection, Not Vinay Prasad
$REPL my read of the RP1 CRL suggests OCE (CDER) took the lead in the review. Their objections led to the first rejection, as I previously reported, and nothing Replimune submitted for the second review was enough to support...
CT Senate Votes to Expand Psychedelic Treatment Program
The Connecticut Senate unanimously approved Senate Bill 191, expanding Yale’s psychedelic therapy pilot to include first responders, EMTs, and frontline healthcare workers alongside veterans. The legislation removes a provision that would have ended the study if the FDA approved psilocybin,...
Estrogen Patch Shortage Hits U.S. Women as Demand Surges 26% After FDA Warning Removal
A sudden shortage of estradiol patches, triggered by the FDA’s removal of a black‑box warning, has left U.S. women scrambling for hormone replacement therapy. Demand rose 26% and experts warn the gap could persist for up to three years, underscoring...
Drugs From a Text Prompt, Wegovy Pill Competition Dampens Lilly’s Surge
Agentic AI is revolutionizing drug discovery, allowing scientists to generate candidates from simple text prompts and run extended‑reality guided experiments. In parallel, Gilead announced a deal to acquire Tubulis for up to $5 billion, strengthening its antibody‑drug conjugate portfolio. Eli Lilly and...
Other News to Note for April 10, 2026
BioWorld’s April 10 briefing highlights three notable developments. Jiangsu and Shanghai Hengrui have patented novel Nav1.8 sodium‑channel blockers, a class of compounds with potential for pain and inflammatory disease therapies. New hematopoietic stem‑cell research links chronic inflammation to early‑stage leukemia, deepening...
China Biotech’s CRISPR Therapy Suggests US Drugmakers Will Face Competition
A Chinese biotech firm used CRISPR‑Cas9 to edit blood stem cells in five beta thalassemia patients, eliminating their need for regular transfusions. The ex‑vivo therapy reactivates fetal hemoglobin and showed durable engraftment with no serious adverse events over a year...
FDA Clears Low-Dose MRI Contrast Agent Vueway for Newborns and Infants
The U.S. Food and Drug Administration has granted an expanded indication for Bracco's Vueway (gadopiclenol) injection, allowing its use in neonates and infants for contrast‑enhanced MRI. The macrocyclic agent delivers high‑quality images at half the standard gadolinium dose (0.05 mmol/kg), addressing...
Using Menstrual Blood-Derived Particles to Treat Osteoarthritis
Lithuanian researchers have demonstrated that extracellular vesicles (EVs) harvested from menstrual‑blood‑derived mesenchymal stromal cells can stimulate cartilage regeneration in vitro, offering a cell‑free therapy for osteoarthritis. The EVs improved chondrocyte function and extracellular matrix synthesis even in cartilage cells taken...
Oricell Closes a ‘Pre-IPO’ Megaround to Aim CAR-T at Solid Tumors
Oricell Therapeutics, a Shanghai‑based biotech, closed a pre‑IPO financing round of more than $110 million to accelerate its CAR‑T programs targeting solid tumors, starting with liver cancer. Its lead candidate, Ori‑C101, targets the GPC3 protein and has shown a 60% response...
Vivatides Gets $54M; Wegovy Drops Cold Chain in EU; Gilead Takes Kymera Option
Vivatides Therapeutics announced a $54 million Series A round to accelerate its pre‑clinical siRNA and antisense oligonucleotide programs, with Sequoia Capital leading the investment. In Europe, Novo Nordisk confirmed that its obesity drug Wegovy will drop the costly cold‑chain requirement, simplifying distribution. Meanwhile,...
Shooting People In The Head and Heart with mRNA Vaccines, Murder One or Insanity?
A recent blog post dramatizes a WHO‑backed Global Vaccine Data Network (GVDN) study that examined 99 million vaccine recipients across eight countries. The study confirmed strong myocarditis and pericarditis signals after mRNA COVID‑19 vaccines, while Guillain‑Barré syndrome and cerebral venous sinus...
PDUFA and BsUFA Quarterly Hiring Updates
The FDA published its quarterly hiring updates for fiscal years 2023‑2027 under PDUFA VII and BsUFA III. FY2023 staffing was almost complete—CBER filled 99% of its 132 positions and CDER 90% of 77—while FY24 reached only 71% of 79 targeted FTEs. FY25...
FDA/Center for Research on Complex Generics (CRCG) Workshop on Bioequivalence Innovations for Generic Oral Products: Biowaivers, Bridging, and Development for...
On May 5‑6, 2026, the FDA’s Center for Research on Complex Generics hosted a two‑day workshop in Rockville, MD to explore innovative bioequivalence (BE) strategies for generic oral drugs. The agenda covered biowaivers, bridging studies, and development pathways for oncology agents,...
Biotech VCs Ramp up Checks on New Bets After Years of Focusing on Existing Portfolios
Biotech venture capitalists are shifting back to high‑risk, high‑reward investing, with 65% of Q1 2026 capital directed at new startups. Total venture funding in the sector rose to roughly $2.1 billion, up from $1.5 billion a quarter earlier, and average deal size climbed...
How to Master the Pharmacovigilance System Master File for Inspection Readiness
Mastering the Pharmacovigilance System Master File (PSMF) is essential for inspection readiness, as regulators use it to gauge a company’s PV compliance before any formal interview. In the EU and UK, the PSMF must be supplied within seven days of...
An Implantable Living Pharmacy Produces Drugs in the Body
Scientists from Northwestern, Rice, and Carnegie Mellon unveiled a sub‑cutaneous implant called HOBIT that can synthesize multiple biologic drugs inside the body. The device houses engineered cells in an alginate hydrogel and an electrocatalytic oxygenator that supplies oxygen, enabling sustained...
What’s in a Name? Moderna’s “Vaccine” Vs. “Therapy” Dilemma
Moderna has stopped calling its mRNA melanoma product a "vaccine," rebranding it as an individualized neoantigen therapy (INT) to sidestep growing political resistance to vaccines. The shift follows the cancellation of a $776 million federal bird‑flu vaccine contract and broader skepticism...
Verastem Oncology Announces Two-Year Median Follow-Up Data on AVMAPKI® FAKZYNJA® Combination Therapy (Avutometinib Capsules; Defactinib Tablets) in Recurrent Low-Grade Serous...
Verastem Oncology presented two‑year median follow‑up data from its Phase 2 RAMP 201 trial of the AVMAPKI® FAKZYNJA® combination (avutometinib + defactinib) in recurrent low‑grade serous ovarian cancer (LGSOC). The updated analysis confirmed a median duration of response of 31.1 months and a median progression‑free survival...
Personalized CRISPR Fixes Baby KJ’s Genetic Defect
In just 6 months a team at @ChildrensPhila & @PennMedicine designed a personalized CRISPR based Rx to correct the single misspelled letter in Baby KJ’s DNA that results in CPS1 deficiency. Recent advances in mRNA science & CRISPR gene...
Vutrisiran Cuts Risk of Advanced ATTR-CM, Improves Outcomes in Those Who Progress
Vutrisiran (Amvuttra) demonstrated in the phase 3 HELIOS‑B trial that it slows progression to advanced heart failure in transthyretin amyloid cardiomyopathy (ATTR‑CM), with 8.0% of treated patients reaching advanced disease versus 10.7% on placebo. Among the 61 patients who did progress,...
Emerging Therapies Bring Hope for Frail HNSCC Patients Unfit for Standard Treatment
Head and neck squamous cell carcinoma (HNSCC) cases are projected to rise to 273,000 by 2034, with frail and elderly patients expected to comprise 44% of the market. Standard curative regimens are often intolerable for this group, creating a sizable...
EU Launches PsyPal Trial to Test Psychedelic Therapy for Palliative Care Distress
The European Union has kicked off the PsyPal project, a clinical trial that will evaluate psychedelic‑assisted therapy for psychological distress among palliative‑care patients. The trial launched on 13 April 2026 at the Directorate‑General for Health and Food Safety, signaling a new research...
Revvity Unveils Its Signals BioDesign Offering
Revvity Signals Software introduced Signals BioDesign, a cloud‑native molecular cloning platform aimed at biotech and pharma R&D teams. The solution consolidates Golden Gate, Gibson assembly, restriction/ligation, primer design, and sequencing analysis, supporting up to 1,000 constructs per project. Integrated with...
Oricell Therapeutics Secures $110 Million Pre‑IPO Funding, Spotlighting Investment Banking Activity
Oricell Therapeutics closed a pre‑IPO financing round exceeding $110 million, co‑led by Vivo Capital, Beijing Medical and Health Care Industry Investment Fund and Qiming Venture Partners. The capital will fund global expansion and pivotal trials for its lead CAR‑T candidate, while...
Chinese Researchers Demonstrate CRISPR Cure for Β‑Thalassaemia in Clinical Trial
A consortium of Chinese scientists has shown that an enhanced CRISPR/Cas9 platform can safely correct the genetic defect behind β‑Thalassaemia in patients. The study builds on the recent FDA approval of a CRISPR therapy for sickle‑cell anemia and suggests a...
Top Biotech Deals in March 2026
Biotech M&A activity peaked in March 2026 with twelve announced deals, eight of which were multi‑billion‑dollar transactions. The largest was Lilly’s $7.8 billion acquisition of Centessa, adding an orexin‑receptor‑2 program for narcolepsy. Other marquee deals included Biogen’s $5.6 billion purchase of Apellis, Merck’s...
Senju Launches First-in-Class Dry Eye Disease Drug in Japan
Senju Pharma has launched Avarept, the first TRPV1 antagonist drug for dry eye disease (DED) in Japan, licensed from Mochida and distributed by Takeda. The ophthalmic suspension is priced at ¥577.50 (approximately $3.63) per 5 ml bottle. DED affects over 20 million...
NVIDIA Just Helped Map 31 Million Protein Complexes and the Health Tech Investment Implications Are Enormous
NVIDIA, DeepMind, EMBL‑EBI and Seoul National University expanded the AlphaFold Protein Structure Database to include 31 million predicted protein complexes—23.4 million homodimers and 7.6 million heterodimers—across 4,777 proteomes. Using H100 DGX Superpod clusters, MMseqs2‑GPU and TensorRT‑accelerated inference, the team generated 1.8 million high‑confidence homodimer...
Pharmaceutical Tariffs and the Restructuring of Global Drug Supply Chains
The United States is rolling out new tariffs on imported pharmaceutical products, affecting an estimated $200‑$250 billion in annual trade. Because 70‑80% of active pharmaceutical ingredient (API) production is concentrated in India and China, manufacturers face limited flexibility and longer lead...
Oxford BioTherapeutics Partners with BMS to Develop Next-Generation T-Cell Engagers for Solid Tumors
Oxford BioTherapeutics (OBT) announced a multi‑year strategic collaboration with Bristol Myers Squibb (BMS) to discover and develop next‑generation T‑cell engager therapies for solid tumors. OBT will apply its OGAP‑Verify platform to identify tumor‑selective antigens and design candidate molecules, while BMS...
Oricell Therapeutics Raises $110 Million to Advance Global Cell Therapy Development
Oricell Therapeutics announced a $110 million pre‑IPO financing round aimed at accelerating its global cell‑therapy program. The capital will fund expanded clinical trials, manufacturing upgrades, and a broader market rollout, especially for its lead liver‑cancer therapy that is nearing pivotal studies....
NMN Daily Restores NAD, Supports Healthy Aging
David Sinclair takes 1 gram of NMN every single day. Here's why. As you age, your body loses up to 50% of a molecule called NAD. NAD is a molecule that acts like fuel powering your sirtuin genes - the genes responsible...
Young Mitochondria Transplants Could Reverse Aging and Disease
What if aging, ALS, Parkinson's, stroke, and diabetes all share a single upstream cause — and the fix is a transplant the size of a bacterium? Dr. Catherine Baucom and Van Hipp of MitoSense explain how injecting healthy young mitochondria...
Will RFK Jr.’s Peptide Push Bolster the Gray Market for Obesity Drugs?
Robert F. Kennedy Jr. is urging the FDA to reclassify more than a dozen synthetic peptides from the restricted Category 2 list to Category 1, allowing compounding by licensed pharmacies with a prescription. The move follows a high‑profile appearance on the Joe...
Biotech’s IPO Comeback; Trump’s Tariff Loophole for Pharma
Biotech IPO activity is resurging, highlighted by Evommune’s public listing and a panel at the BIO International Convention discussing renewed exit opportunities. AI-driven collaborations, such as Insilico Medicine and Aska Pharmaceutical, aim to tackle unmet needs in women’s health by...
Diagnostics Lag Is Holding Back New Therapies, Says Study
A new UCSF analysis published in Science warns that diagnostic development is lagging behind therapeutic breakthroughs because of regulatory and reimbursement gaps. The authors highlight that nearly half of the world’s population—about 47%—has limited or no access to essential tests,...
DualityBio Reports China NMPA Acceptance of BLA for Trastuzumab Pamirtecan in Metastatic HER2+ Breast Cancer
DualityBio announced that China’s National Medical Products Administration has accepted its Biologics License Application for trastuzumab pamirtecan (T‑Pam), an investigational antibody‑drug conjugate targeting HER2‑positive metastatic breast cancer. The submission is backed by interim data from the pivotal Phase III DB‑1303‑O‑3001 trial,...
FDA Probes Abortion Pill Anew After Court Keeps Mail Access Alive
The FDA announced a renewed, accelerated safety study of the abortion pill mifepristone, aiming to complete the review faster than typical academic timelines. The move follows a Louisiana federal judge’s decision to temporarily allow the drug’s distribution by mail while...
New GLP‑3 Drug Reta May Target Fat, Spark Hunger
Like it or not, GLP-1-based weight loss drugs are here to stay. 1/2) What's more, people are experimenting with newer evolutions, like "reta" (retatrutide/GLP-3). As an MD PhD & metabolism scientist, I decided to start my own experiment to help answer...
Replimune's FDA‑targeted Skin Cancer Drug Faces Another Rejection
Replimune $REPL skin cancer drug that became FDA flashpoint is rejected again https://t.co/7aOfKy8vC7 via @Jasonmmast
Chinese Trial Backs Base-Editing Drug for Thalassaemia
A Chinese investigator‑led trial of CorrectSequence Therapeutics' ex vivo base‑editing drug CS‑101 showed that all five patients with transfusion‑dependent beta‑thalassaemia became transfusion‑independent after a single infusion, with an average cessation time of 16 days and sustained hemoglobin gains over three months....
Psychedelic Therapies May Outpace GLP‑1s Commercially
I believe the commercial potential of #psychedelic therapies is likely to exceed that of GLP-1s. $ATAI $CMPS $DFTX
Optical Genome Mapping Enhances AML Classification and Treatment
Optical genome mapping [OGM] improves the accuracy of classification, risk stratification, & personalized treatment strategies for Pts w/ acute myeloid leukemia [Jul 17, 2024] @sanamloghavi et al. @AjHematology https://t.co/R5ZLgolhuj #AMLsm #leusm #PrecisionMedicine #oncopath https://t.co/kX7KUJLK0L
Sobi Reports Health Canada Approval of Empaveli for C3G and Primary IC-MPGN
Health Canada has granted approval for Empaveli (pegcetacoplan) to treat patients aged 12 and older with C3 glomerulopathy (C3G) or primary immune‑complex membranoproliferative glomerulonephritis (IC‑MPGN). The decision follows the Phase III VALIANT trial, which demonstrated a 68% reduction in proteinuria, stabilization...
International Mega-Analysis Shows Psychedelics Alter Brain Circuit Function
An international mega-analysis of psychedelic drug effects on brain circuit function lots of great researchers involved in this paper. (whole article) https://t.co/vKhH0duJqv
Biotech IPO Surge Expected; List on NYSE
Getting to know the @NYSE and Johanna and Eric has been a highlight of mine since their earliest support of BiotechTV. I have no doubt we will see a strong IPO pipeline for biotech this year, and I hope you...
CNN Debuts Kara Swisher’s Six‑Part Docuseries on Extending Human Lifespan
CNN launched a six‑part documentary series titled “Kara Swisher Wants to Live Forever,” premiering Saturday, April 11, 2026. Hosted by veteran tech journalist Kara Swisher, the series probes the science, technology and commercial forces shaping human longevity. The debut places...
NPPA Gene Therapy to Encourage Greater Regeneration Following Heart Attack
Researchers at Columbia Engineering have engineered an RNA‑lipid nanoparticle that programs skeletal muscle to secrete a pro‑ANP precursor, which the heart‑specific enzyme Corin converts into active atrial natriuretic peptide. This two‑phase gene‑therapy bypasses the need for direct cardiac drug delivery,...
FDA Pulls GSK's Wellcovorin Autism Approval After Company Request
The U.S. Food and Drug Administration has withdrawn its approval of GlaxoSmithKline's Wellcovorin, a branded leucovorin marketed for autism, after GSK formally requested the action. The reversal, noted in the Federal Register, underscores the unusual nature of pulling a drug...