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.
Monday Morning Update 4/6/26
The Washington Post published a first‑person account of severe liver failure and a subsequent transplant after using a compounded GLP‑1 weight‑loss product. The story highlights the safety risks of off‑label, non‑FDA‑approved formulations that are increasingly marketed alongside AI‑driven GLP‑1 therapies. Industry observers note that the incident could trigger tighter scrutiny of AI‑enabled weight‑loss companies that rely on compounded drugs. Additionally, a new “Chief Health AI Transformation Officer” (CHAITO) role is being discussed to guide AI integration in health systems.
Adrenal Organoid Replicates Human Development and Hormone Production
A new adrenal gland organoid accurately models human development and hormone production, offering a platform to study stress responses, disease mechanisms, and potential regenerative therapies for adrenal disorders. biotechnology
Phase 3 PREVAiLS Trial Begins Testing Pridopidine for ALS
Prilenia Therapeutics and Ferrer have opened enrollment for the PREVAiLS Phase 3 trial of pridopidine, a sigma‑1 receptor agonist, marking the only currently recruiting confirmatory study in amyotrophic lateral sclerosis. The trial will involve up to 500 participants across 60...
Silicon Valley's Immortality Bet Reaches 91‑year‑old
Longevity treatments for a 91-year-old. That's the kind of story that captures where Silicon Valley's immortality bet is actually heading. Great piece by @AmyDMarcus, who I had the chance to meet in Boston recently. She brings serious depth to this beat,...
Targetable Markers Define Antiprogestin-Resistant Breast Cancer
A new study in the British Journal of Cancer identifies a molecular triad—nuclear fibroblast growth factor‑2 (FGF2), androgen receptor (AR), and Wnt pathway activation—that defines a targetable subset of antiprogestin‑resistant luminal breast cancer. The researchers demonstrated that nuclear FGF2 cooperates...
K.C. Pharmaceuticals Recalls Over 3.1 Million Eye‑Drop Bottles From CVS, Walgreens and Others
K.C. Pharmaceuticals voluntarily recalled 3,111,072 bottles of over‑the‑counter eye drops sold at CVS, Walgreens, Kroger and other chains after the FDA identified a lack of assurance of sterility. The FDA classified the action as a Class II recall, prompting retailers to...
The Competitive Fiction of a “Best” Obesity Treatment
Novo Nordisk issued a press release claiming its Wegovy (semaglutide) tablets outperform the newly approved orforglipron (Foundayo) tablets, basing the claim on a simulated treatment comparison to be presented at the Obesity Medicine Association meeting. The article warns that such...
Incretin Modulators Boost Health, Happiness, and Longevity
Life is a marshmallow test. Incretin modulators help you win while staying happy. I often ask big audiences - "how many of you are on GLP1?" and only a couple hands go up. Sometimes, none. That's when I understood that...
Intranasal EV Vaccine Shields Mice From H5N1, H7N9
A potential universal flu shot? Intranasal EV vaccine protected mice from H5N1, H7N9 https://t.co/WroXpi6YP3 https://t.co/umAPlnRjbF
Intensive LDL‑Cholesterol Target Cuts Heart Attack and Stroke Risk, Study Shows
A three‑year Korean trial of 3,000 patients with atherosclerotic disease found that aiming for an LDL‑cholesterol level below 55 mg/dL reduced major heart attacks, strokes and deaths by about a third compared with the conventional 70 mg/dL goal. Researchers say the result...
AlphaFold3 Boosts Engineered Toad Pathway 40‑fold in Tobacco
They ported the 5-MeO-DMT pathway from the Sonoran Desert toad into tobacco plants and then used AlphaFold3 to debug the protein structure, leading to a 40x yield increase. Prompt psychedelic design.
Harvard COSMOS Trial Shows Daily Multivitamin Cuts Biological Aging by ~4 Months
A Harvard‑led sub‑study of the COSMOS trial, published in Nature Medicine, reports that two years of daily Centrum Silver multivitamin‑mineral supplementation slowed biological aging by roughly 4‑5 months. The finding provides the first randomized, large‑scale evidence that an over‑the‑counter supplement...
U.S. Slaps 100% Tariff on Patented Drug Imports, Prompting Industry Pushback
The United States announced a 100% tariff on imported patented pharmaceuticals and ingredients effective July 31, while exempting generic drugs. The move targets a market that accounts for roughly 40% of India’s pharma exports and has triggered swift responses from Indian...
Cipla Secures FDA Approval for Generic Nintedanib Capsules, Expanding U.S. IPF Portfolio
Cipla USA Inc. received final FDA approval for its generic Nintedanib capsules (100 mg and 150 mg) to treat idiopathic pulmonary fibrosis, positioning the company against Boehringer Ingelheim's Ofev. The launch comes as the U.S. imposes 100% tariffs on patented drugs, leaving...
Oral GLP‑1 Pill Approved as Cardiovascular and Longevity Game‑Changer for Biohackers
The FDA’s 2026 approval of Eli Lilly’s oral GLP‑1 agonist orforglipron marks a turning point for drug‑based biohacking, adding a needle‑free option to a class already shown to cut cardiovascular events by 20% and hint at longevity gains. Researchers cite robust...
Waseda Researchers Unveil Nanotube Injector Achieving 90% Cytoplasmic Transfer Efficiency
A team led by Professor Takeo Miyake at Waseda University demonstrated a gold‑membrane nanotube injector that can extract and deliver cytoplasmic contents—including functional mitochondria—between living cells with over 90% transfer efficiency and 95% cell viability. The breakthrough promises more precise...
Lipocine’s Oral Brexanolone Phase 3 Fails, Shares Crash 78%
Lipocine Inc.’s Phase 3 trial of LPCN‑1154, an oral brexanolone for postpartum depression, failed to meet its primary endpoint, triggering a 78% plunge in the company’s share price. The setback raises questions about the viability of oral neurosteroid therapies and...
NBTXR3 Surpasses 70% Enrollment, on Track For
$NBTX update: Their lead cancer drug NBTXR3 is now over 70% enrolled in its crucial Phase 3 trial. Target: complete enrollment by end of 2025. With cash into late 2027, they're funded to reach this major milestone. Biotech
Hong Kong: Advancing Smart Therapeutics, Translational MedTech
Hong Kong is positioning itself as a regional hub for biopharmaceutical innovation, focusing on advanced therapeutic products (ATPs) such as cell therapy. Invest Hong Kong is attracting mainland and international firms to set up R&D in the city, backed by...
Liver Specialist Amit Singal Joining Curve Biosciences
Amit Singal, a leading hepatology expert, has joined Curve Biosciences as chief medical officer. Singal currently serves as chief of hepatology at UT Southwestern Medical Center and authored the latest AASLD practice guidance on liver cirrhosis monitoring. Curve, based in San Mateo, leverages its...
Pharma Tariffs Pressuring Smaller Companies to Do MFN Deals
BioCentury’s website now outlines a comprehensive cookie framework that classifies cookies into five distinct groups: strictly necessary, functional, marketing, advertising, and analytics. Each category serves a specific purpose, from enabling authentication and core site functions to gathering anonymous usage metrics...
![[Correspondence] Suicidal Crisis: First Regulatory Approval of IV Racemic Ketamine](https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/9ee5b606511aef98e3b5be5706cf97fd.webp)
[Correspondence] Suicidal Crisis: First Regulatory Approval of IV Racemic Ketamine
In March 2026 France became the first country to grant regulatory approval for intravenous racemic ketamine as a treatment for adult severe suicidal crisis. Clinical trials have shown that a single 0.5 mg/kg infusion over 40 minutes can blunt suicidal ideation...
FTC Lauds PBM, Insulin Efforts As Triumphs To Justify 2027 Budget Request
The Federal Trade Commission has submitted a FY2027 budget request of $426.7 million and 1,183 full‑time positions. The request emphasizes continuing its consumer‑protection agenda, notably the 2024 administrative complaint accusing pharmacy‑benefit managers (PBMs) of inflating insulin prices. It also funds an...
FDA Approves Extension of Eylea HD Dosing Intervals
The FDA has approved an extension of dosing intervals for Regeneron's Eylea HD, allowing injections as infrequently as every 20 weeks for patients with wet age‑related macular degeneration (AMD) and diabetic macular edema (DME). The label update incorporates two‑year efficacy and...
Researchers Create Blended Immune System to Cure Type 1 Diabetes in Mice
Scientists have cured type 1 diabetes in mice by engineering a hybrid immune system that accepts donor insulin‑producing cells without long‑term immunosuppression. The breakthrough could reshape how autoimmune diseases are treated, moving beyond blanket immune suppression toward targeted tolerance.
Pfizer, BioNTech Abort U.S. Updated COVID-19 Vaccine Trial as Enrollment Falters
Pfizer and its partner BioNTech have ended a U.S. phase III trial of an updated COVID-19 vaccine for healthy adults aged 50‑64, citing insufficient enrollment. The decision, announced in a March 30 letter, comes amid waning demand for boosters and...
RA/QA News Roll: Late March 2026
The late‑March FDA Group news roll highlights mounting political pressure on HHS officials after a POLITICO MAHA poll showed mixed support for President Trump’s health agenda, while the agency grapples with internal turnover that could impede reform. FDA leadership announced...
Resiliency in the Face of Volatility
Biotech markets are poised to sustain their outperformance as they navigate heightened geopolitical uncertainty. BioCentury’s Q2 2026 preview highlights strong follow‑on equity offerings and a robust M&A pipeline as primary catalysts. The sector’s resilience is underscored by more than $1 billion in...
Intranasal EV Vaccine Delivers Broad, Cross‑protective Flu Immunity
An intranasal vaccine using extracellular vesicles displaying inverted influenza hemagglutinins induced broad, cross-protective immunity in mice, offering a promising strategy for universal flu prevention at the mucosal level. vaccines
Epigenetic Strategy Restores Tumor Suppressor in Acute Myeloid Leukemia Models
Researchers at The Jackson Laboratory have demonstrated that inhibiting KDM4 enzymes can reactivate the silenced tumor‑suppressor gene ZBTB7A in acute myeloid leukemia (AML) models. Using a novel FISHnCRISP platform that combines fluorescence in‑situ hybridization, flow cytometry and CRISPR editing, they...
Zanubrutinib Demonstrates Favorable Tolerability in R/R CLL/SLL
A systematic review and meta‑analysis of four trials involving 508 relapsed or refractory CLL/SLL patients found that zanubrutinib (Brukinsa) has low treatment‑discontinuation (7.2%) and atrial fibrillation rates (2.9%). While 98.5% of patients experienced at least one adverse event, only 67%...
Operationalizing Seamless Care Between Community and Academic Centers: Turab Mohammed, MD
Dr. Turab Mohammed, a hematologist‑oncologist at Novant Health, outlined how community systems can operationalize seamless collaboration with academic centers through dedicated care‑navigation teams and real‑time communication protocols. He emphasized early referral of high‑risk leukemia and lymphoma patients to preserve T‑cell...
Multi-Target Gene Therapy for Osteoarthritis: Dual-Axis Modeling and In Silico Validation
A computational study proposes a multi‑target gene therapy for osteoarthritis that combines anti‑inflammatory, anabolic, and catabolic‑blocking transgenes delivered via a dual‑vector AAV system. Network perturbation modeling shows the multi‑axis approach achieves an ECM Recovery Score of 76.2, markedly higher than...
Update on FDA’s Ongoing Evaluation of Reports of Suicidal Thoughts or Actions in Patients Taking a Certain Type of Medicines...
The FDA’s November 1, 2024 drug safety communication reports a preliminary review of suicidal thoughts and actions among patients using glucagon‑like peptide‑1 receptor agonists (GLP‑1 RAs). After analyzing adverse event reports, clinical trials and observational studies, regulators found no clear causal link,...
Scientists Map How the Body Traps 'Sleeping' Tuberculosis
Scientists at James Cook University used spatial transcriptomics to map where latent Mycobacterium tuberculosis resides within lymph nodes and bone marrow, revealing how the immune system contains the dormant bacteria. The study, published in Nature Communications, identified CD8⁺ T cells...
FDA Adds Warning About Rare Occurrence of Serious Liver Injury with Use of Veozah (Fezolinetant) for Hot Flashes Due to...
On December 16, 2024, the FDA issued a Boxed Warning for Veozah (fezolinetant), the first non‑hormonal drug approved for menopausal hot flashes, highlighting a rare but serious risk of liver injury. The agency now mandates baseline liver testing and monthly...
Serious Liver Injury Being Observed in Patients without Cirrhosis Taking Ocaliva (Obeticholic Acid) to Treat Primary Biliary Cholangitis
The FDA’s latest safety communication reveals that Ocaliva (obeticholic acid) is causing serious liver injury in primary biliary cholangitis (PBC) patients without cirrhosis, including cases that required liver transplants or resulted in death. In a post‑market trial, 7 of 81...
FDA Adds Boxed Warning About a Rare but Serious Allergic Reaction Called Anaphylaxis with the Multiple Sclerosis Medicine Glatiramer Acetate...
The FDA issued a new boxed warning for glatiramer acetate (Copaxone, Glatopa), highlighting a rare but potentially fatal anaphylactic reaction. Data from 1996‑2024 show 82 reported cases worldwide, including six deaths, with most events occurring within an hour of injection...
FDA Requires Warning About Rare but Severe Itching After Stopping Long-Term Use of Oral Allergy Medicines Cetirizine or Levocetirizine (Zyrtec,...
The FDA issued a drug safety communication warning that stopping long‑term use of oral antihistamines cetirizine (Zyrtec) or levocetirine (Xyzal) can trigger rare but severe itching (pruritus). Between April 2017 and July 2023, 209 cases—including 197 in the United States—were...
FDA Adds Warning About Serious Risk of Heat-Related Complications with Antinausea Patch Transderm Scōp (Scopolamine Transdermal System)
The FDA has issued a Drug Safety Communication adding a new warning to the Transderm Scōp scopolamine patch about serious heat‑related complications, including hyper‑temperature, hospitalization and death. The warning follows 13 reported cases worldwide—seven in the U.S.—with four hospitalizations and two...
FDA Requires Expanded Labeling About Weight Loss Risk in Patients Younger than 6 Years Taking Extended-Release Stimulants for ADHD
The FDA is requiring a uniform "Limitation of Use" label for all extended‑release stimulants used in ADHD treatment, warning that children under six years face higher drug exposure and a significant risk of weight loss. The agency’s analysis of clinical...
FDA Is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use
The FDA has mandated that manufacturers of extended‑release/long‑acting opioid analgesics update their prescribing information to reflect new post‑marketing study results. Two large PMR studies (3033‑1 prospective cohort and 3033‑2 retrospective cohort) found that roughly 22% of long‑term users develop opioid...
FDA Removes Risk Evaluation and Mitigation Strategy (REMS) Program for the Antipsychotic Drug Clozapine
The FDA announced that, effective June 13 2025, the risk evaluation and mitigation strategy (REMS) for clozapine is being eliminated. While the drug’s potential to cause severe neutropenia remains, the agency concluded that updated labeling and a new Medication Guide provide sufficient...
FDA to Recommend Additional, Earlier MRI Monitoring for Patients with Alzheimer’s Disease Taking Leqembi (Lecanemab)
On August 28, 2025 the FDA issued a drug‑safety communication recommending an additional magnetic resonance imaging (MRI) scan before the third infusion of Leqembi (lecanemab) for Alzheimer’s patients. The agency’s analysis identified 101 serious cases of amyloid‑related imaging abnormalities with...
K.C. Pharmaceuticals Recalls 3.1 Million Eye‑Drop Bottles Over Sterility Concerns
K.C. Pharmaceuticals announced a voluntary recall of over 3.1 million bottles of over‑the‑counter eye drops sold across the United States. The FDA classified the action as a Class II recall on March 31, 2026, citing a lack of assurance of sterility. The recall...
Nanotech Study Shows Targeted Reprogramming of Scar and Dermatitis Skin Microenvironments
Researchers published in the Journal of Pharmaceutical Investigation that multifunctional nanoparticles can reprogram pathological skin microenvironments, delivering anti‑inflammatory and antifibrotic agents directly to scar tissue and atopic dermatitis lesions. The approach modulates immune cells and fibroblast activity, promising more effective,...
Trump Targets NIH Funding Amid $1.5T War Spend
Trump once again going for draconian cuts to NIH, though not as catastrophic as he sought for the last round (and didn't get). Meanwhile, he wants $1.5T for war. I doubt he'll be any more successful with NIH cuts than...
5‑MeO
I mis-spoke here. This study showed 5-meo-DMT much more effective than psilocybin. This was specifically on treatment resistant depression. A 15 point MADRS reduction there is ~2x psilocybin and ~3x ketamine. 5-meo-DMT really is the most potent antidepressant known to...
Time-to-Market Is SynBio’s Biggest Scaling Hurdle
Great conversation with Jamie Bacher about the one challenge synbio must solve: time to market. Jamie argues that scaling biotech requires more than great strains—process dev, downstream, analytics, and new financing models all matter. Excited to have him at #SynBioBeta2026. Read the...
Trump Proposes $5 B NIH Cut; Congress Unlikely to Approve
NIH would get $5 billion cut under Trump’s 2027 budget, but Congress unlikely to go along https://t.co/PPQbrSBwi0 via @statnews