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.
GSK Eyes October FDA Verdict on Chronic Hep B Drug
GlaxoSmithKline’s antisense drug bepirovirsen entered an accelerated FDA review, with a decision expected by October 26. The phase‑2 B‑WELL 1 and B‑WELL 2 trials showed a statistically higher functional cure rate versus placebo when added to standard hepatitis B therapy. If approved, bepirovirsen would be the first‑in‑class treatment targeting HBV mRNA, aiming for a functional cure that could reduce liver cancer risk. GSK projects peak annual sales of roughly $2.5 billion, supporting its goal of exceeding $51 million in revenue by 2031.
Novartis’ Sales Dip as Generics Pressure Intensifies, Radioequivalents Loom
Novartias first‑quarter net sales slipped 5% to $13.11 billion, primarily due to U.S. generic erosion of its heart‑failure drug Entresto. While earnings per share fell 11% to $1.65, growth was buoyed by double‑digit gains in Kisqali, Kesimpta and the radiopharma Pluvicto....
Revolution Levels Legal Threat on Erasca as Pancreatic Cancer Rivalry Heats Up
Revolution Medicines, after its Phase 3 pancreatic cancer drug daroxinrasib showed a median overall survival of 13.2 months and lifted its share price, sent a cease‑and‑desist letter to rival Erasca demanding the U.S. halt of ERAS‑0015, alleging patent infringement and misleading...
PapB Enzyme Enhances Ozempic; Endoscopic Procedure Cuts GLP‑1 Weight Rebound
Scientists at the University of Utah introduced PapB, an enzyme that macro‑cyclizes GLP‑1 peptides, potentially extending Ozempic’s efficacy. At the same time, a European‑based endoscopic duodenal mucosal resurfacing (DMR) trial demonstrated that patients maintained more than 80% of their weight...
AstraZeneca's Dual Immunotherapy Approved in China for Advanced Liver Cancer
AstraZeneca announced that China's National Medical Products Administration has approved tremelimumab (Imjudo) plus durvalumab (Imfinzi) for first‑line treatment of advanced or unresectable hepatocellular carcinoma (HCC). The decision is based on the global Phase III HIMALAYA trial and a supportive Chinese cohort...
Shandong Xinhua Pharmaceutical Q1 Profit Falls 25% as Chinese Drug Demand Slows
Shandong Xinhua Pharmaceutical posted a 25% drop in first‑quarter profit to RMB83.9 million ($11.7 million) versus RMB112.1 million a year earlier, while revenue slipped 0.2% to RMB2.423 billion ($339 million). The decline reflects slowing demand for its generic drugs and could curb investment in health‑tech...
Novartis Shares Fall as Entresto Sales Weaken
Novartis reported a 5% drop in first‑quarter net sales to $13.1 billion, driven by a 46% plunge in heart‑failure drug Entresto after U.S. patent expiry. Earnings per share fell 13% to $1.99 and the stock slipped nearly 3% as results missed...
Targeting Senescent Cells as a Treatment for Chronic Obstructive Pulmonary Disease
Researchers have introduced BCLXL-PROTAC, a proteolysis‑targeting chimera that degrades the anti‑apoptotic protein BCLXL in senescent lung cells. In primary small‑airway epithelial cells and fibroblasts from COPD patients, the compound induced caspase‑3‑mediated apoptosis and lowered classic senescence markers such as p21,...
Purdue Pharma Set for Dissolution After $8.3B Criminal Settlement
Purdue Pharma is poised to be dissolved after a federal judge delivers a criminal sentence that unlocks a $8.3 billion forfeiture, fine and penalty package. The deal also obligates the Sackler family to pay up to $7 billion over 15 years, with...
Senescent Macrophages Are Important in Liver Aging and Liver Disease
Researchers identified a distinct p21‑positive, TREM2‑positive senescent macrophage population that accumulates in aging and fatty livers. These cells drive chronic inflammation through a senescence‑associated secretory phenotype linked to type I interferon signaling. In mouse models, senolytic agents that selectively eliminate these...
Novartis Q1 Profit Falls to $3.16 Billion as Generic Competition Erodes Sales
Novartis AG posted a first‑quarter profit of $3.156 billion, down from $3.609 billion a year earlier, and revenue slipped 0.9% to $13.113 billion. The results missed analysts’ forecasts, reflecting pressure from generic rivals on several flagship drugs.
Asembia's AXS26 Summit: How Is Digital Innovation Transforming Programs for Patient Access?
At Assembia’s AXS26 Summit, Syneos Health’s VP Kim Plesnarski explained how digital tools—wearables, sensors, smart pills—are reshaping patient access programs by feeding real‑time data into EMRs and clinician workflows. She emphasized that integrating these solutions early is critical to personalize...
Why Ireland Has Become a Strategic Hub for the Global Pharmaceutical Industry
Ireland has cemented its status as a global pharmaceutical hub, boasting over 90 FDA‑approved facilities, a workforce of 50,000, and $133 billion in annual pharma exports. The country’s regulatory track record and stable policy environment have attracted $16.3 bn of biopharma investment...
How to Get Pfizer & Moderna mRNA Out of Your Body
The article explains that Pfizer‑BioNTech and Moderna COVID‑19 vaccines rely on lipid‑nanoparticle‑encapsulated synthetic mRNA that is chemically altered with N1‑methylpseudouridine. This modification cloaks the RNA from innate immune sensors and dramatically slows enzymatic breakdown, extending its intracellular lifespan. Consequently, the...
Elanco Receives Emergency Authorizations for Negasunt Powder and Tanidil to Treat New World Screwworm in Livestock
Elanco Animal Health announced that the FDA granted an Emergency Use Authorization for Negasunt Powder and the EPA issued a Section 18 Emergency Exemption for Tanidil, enabling both products to prevent and treat New World screwworm in a wide range of...
We May Finally Have a Cure for Many Different Autoimmune Conditions
A novel cancer immunotherapy is being repurposed to eliminate rogue T‑cells that drive autoimmune diseases. Early trials show it can eradicate the pathogenic cells rather than merely suppressing symptoms, delivering faster and more durable remission. Dozens of global studies are...
Symptom-Based Approach Treats Opioid Withdrawal in Newborns with Minimal Drug Exposure
An NIH‑funded OPTimize NOW trial compared symptom‑based, as‑needed opioid dosing with traditional scheduled tapering for newborns with moderate to severe neonatal opioid withdrawal syndrome (NOWS). Among 383 infants cared for under the family‑centered Eat‑Sleep‑Console model, the symptom‑based group was ready for...
Oruka Reports Positive Data From Phase IIa Trial for Plaque Psoriasis
Oruka Therapeutics announced interim results from its EVERLAST‑A Phase IIa trial of ORKA‑001, a half‑life‑extended IL‑23p19 monoclonal antibody, in moderate‑to‑severe plaque psoriasis. Of the 63 patients receiving the 600 mg dose, 63.5% achieved PASI 100 by week 16, meeting the primary endpoint, with 83%...
Novartis CEO Warns Reality of Trump's Drug Pricing Policy Will Set in over 'the Next 18 Months'
Novartis chief executive Vas Narasimhan warned that President Donald Trump’s most‑favored‑nation (MFN) drug‑pricing rule will fully materialize within the next 18 months, tying U.S. prices to those in affluent foreign markets. The policy currently touches only 5‑10% of Novartis’s Medicaid sales...
An Octopus Probe for High-Performance >1,300 Nm NIR-II Fluorescence Molecular Imaging of Cancer
Researchers at Stanford introduced the Octopus (OCTP) probe, a modular NIR‑II fluorescence agent that emits beyond 1,300 nm and targets the folate receptor. In pre‑clinical mouse studies, OCTP delivered markedly higher tumor‑to‑background ratios and brighter tumor signals than the FDA‑approved Cytalux...
AES Cleanroom Technology Appoints John Groth as CRO to Drive Growth
AES Cleanroom Technology announced the appointment of John Groth as Chief Revenue Officer. Groth, who brings more than two decades of pharma manufacturing and capital‑equipment sales experience, will lead revenue‑generating functions as the company expands its modular cleanroom solutions for...
Intellia Files FDA BLA After Phase 3 Shows 87% Cut in HAE Attacks
Intellia Therapeutics announced a rolling biologics license application to the FDA after its Phase 3 HAELO trial demonstrated an 87% reduction in hereditary angioedema attacks with a single dose of lonvo‑z. The results, the first from an in‑vivo CRISPR therapy, could...
CMS Extends Medicare GLP‑1 Bridge Program, Keeping $50 Copay for Obesity Drugs Through 2027
The Centers for Medicare & Medicaid Services (CMS) announced that the Medicare GLP‑1 Bridge program, which offers obesity drugs at a $50 copay, will now run through the end of 2027 instead of ending in December 2026. The extension delays...
Janux Therapeutics Halts Development of EGFR‑Targeted TRACTr Candidate JANX008
Janux Therapeutics announced it will cease clinical development of JANX008, its EGFR‑targeted Tumor‑Activated T Cell Engager, after completing Phase 1a. The company said the data did not meet predefined activity thresholds, prompting a reallocation of resources to other TRACTr pipeline assets....
Breakthrough Prize Showcases Baby Gene‑Editing Miracle
The 2026 Breakthrough Prize ceremony (“the Oscars for science”) celebrated the achievements of many remarkable scientists and their students and collaborators last weekend. Here’s the video of the show: https://t.co/eCHUnDqrYX. And here’s the segment in which Anne Hathaway and Alex...
FDA Grants Breakthrough Therapy Designation to TERN-701 for Relapsed Ph+ CML
The FDA has awarded breakthrough therapy designation to TERN-701, Terns Pharmaceuticals’ oral BCR::ABL1 inhibitor, for adults with Philadelphia chromosome‑positive chronic myeloid leukemia who have failed at least two prior tyrosine kinase inhibitors. The decision follows phase 1/2 CARDINAL data showing...
10x Genomics Unveils A
I've been watching spatial biology for years. What @10xGenomics just announced changes the game. Serge Saxonov, CEO and Co-founder, 10x Genomics told Synbiobeta, "Biology is inherently complex, and as much progress as we have made, we still understand only a...
Low‑cost Vaccines Delivered, Autism Genes
What a dishonest & ignorant thing to write, I develop low-cost vaccines for global health, 100 million doses administered, without patenting the technology. Also as I’ve detailed we’ve learned a lot about the genetic basis of autism, >100 autism genes,...
Asgard Therapeutics to Unveil AT‑108 Gene Therapy Data at ASGCT 2026
Asgard Therapeutics announced that it will present advanced preclinical data on AT‑108, its first‑in‑class off‑the‑shelf gene‑based cancer immunotherapy, at the ASGCT Annual Meeting in Boston (May 11‑15, 2026). The study shows systemic anti‑tumor immunity, an abscopal effect, and identifies dosing...
AstraZeneca's Bretzi Inhaler Cleared for Asthma in Teens
#AZN Bretzi inhaler approved by US FDA for treating patients 12 years old and upwards for Asthma, following the KALOS and LOGOS Phase III trials. Previously got COPD approval.
Morgan Stanley Flags IL‑23 Combos, Seeks Novel MOAs
Immunology combination studies from Morgan Stanley ahead of DUET data next week. These are mainly coformulations of established drugs, it would be more intriguing to see novel MOAs added to an IL23 backbone. https://t.co/dde8MpBhUR
How Big Is Organon’s Biosimilar Push for Sun Pharma?
Sun Pharma’s $11.75 billion acquisition of Organon propels the Indian drugmaker into the global biosimilars market, placing it among the top ten players. Organon’s biosimilar portfolio generated $691 million in 2025, about 11 % of its total revenue, with 45 % of that coming...
Enhanced Exosomes Modulate OA Inflammatory Microenvironment
The role of exosomes and their enhancement strategies in the treatment of osteoarthritis "This article provides a comprehensive review and update on the research of exosomes, a type of extracellular vesicle, in the treatment of OA by modulating the inflammatory microenvironment..." https://t.co/xHjTCixJNE
Drugging the Undruggable: Cancer's Slipperiest Targets Finally Meet Their Match
Researchers at the University of British Columbia and BC Cancer have unveiled a novel drug design strategy that tightly binds intrinsically disordered proteins, long deemed undruggable. The new compounds exhibit binding affinities up to a million times stronger than previous...
From Trial‑and‑Error to Predictive Cell‑Fate Engineering
We’re still engineering biology by trial and error. SynBioBeta 2026 is May 4-7th in San Jose, California, you can learn more about the conference and get your tickets here: https://t.co/8abYWJ18mc @MichaBreakstone is building a model to predict cell fate with his new...
CDER Proposes to Withdraw Approval of TAVNEOS
The FDA’s Center for Drug Evaluation and Research has proposed withdrawing approval of TAVNEOS (avacopan) after uncovering data manipulation in the pivotal trial and a lack of demonstrated efficacy for severe ANCA‑associated vasculitis. The agency also flagged new safety signals,...
Lithium Interaction Poses Major Seizure Risk with Psilocybin
Most physicians were never taught psilocybin in medical school. Their patients in three states can now legally access it. Oregon's program has been operating since summer 2023. Colorado's healing centers came online in 2025. New Mexico passed its Medical Psilocybin...
Autologous iPSC Dopamine Cells Boost Parkinson’s Function without Immunosuppression
I’ve been following @jeannefrances's work for years, and what @AspenNeuro just reported out of Copenhagen is the kind of result that changes a field. Twelve months after receiving their own reprogrammed dopamine neurons, eight Parkinson's patients are showing real, measurable...
China Races to Build Record Biobank to Rival US Drugs Research
China is constructing a national biobank that will house blood and DNA samples from 33,000 children, targeting brain‑disease research. The initiative, led by the Chinese Institute for Brain Research, seeks to create a data‑rich platform that rivals the United States’...
The BioPharm Brief: FDA Advances Autoimmune Pipeline with New Delivery Options and Priority Review
The FDA cleared a subcutaneous autoinjector for anifrolumab, allowing at‑home treatment of moderate‑to‑severe systemic lupus erythematosus. It also granted Priority Review to nipocalimab for warm autoimmune hemolytic anemia, a rare blood disorder, accelerating its path to market. AbbVie submitted a...
April 30, 2026: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement - 04/30/2026
The FDA’s Oncologic Drugs Advisory Committee will meet on April 30, 2026 to evaluate two AstraZeneca submissions: NDA 220359 for camizestrant tablets combined with CDK4/6 inhibitors in ESR1‑mutated hormone‑receptor‑positive breast cancer, and sNDA 218197/S‑004 for Truqap (capivasertib) plus abiraterone in PTEN‑deficient metastatic hormone‑sensitive prostate...
Intellia’s Data Reveal Tees Up FDA Filing for CRISPR-Based In Vivo Gene-Editing Med
Intellia Therapeutics filed a rolling FDA submission for lonvo‑z, its CRISPR‑based in‑vivo gene‑editing therapy for hereditary angioedema (HAE). In a placebo‑controlled Phase 3 trial of 80 patients, a single infusion cut swelling attacks by 87% versus placebo and left 62% of...
SBIA Resources in Chinese 中文信息
The FDA’s Small Business and Industry Assistance (SBIA) program has released Chinese-language versions of six recent webinars, covering critical topics such as the Drug Supply Chain Security Act, establishment registration, electronic submission requirements, eCTD data standards, GDUFA II, and generic drug...
ERAS-0015 Linked to Fatal Pneumonitis After Care Withdrawal
$ERAS safety update, from tonight's slides. One Grade 3 TRAE of pneumonitis progressed to Grade 5 after withdrawal of supportive care per patient decision. The patient was a 66 year-old male with heavily pretreated metastatic pancreatic adenocarcinoma who received 24 mg of ERAS-0015. The patient had...
FDA Grants Breakthrough Designation for Efimosfermin for MASH
GSK’s investigational liver drug efimosfermin received FDA breakthrough therapy designation for metabolic dysfunction‑associated steatohepatitis (MASH). A phase‑2 trial showed 45.2% of patients achieved at least one‑stage fibrosis improvement versus 20.6% on placebo, and 67.7% attained MASH resolution compared with 29.4%...
Gluten Triggers Immune Response at 3 Mg, Below Current Labeling Limits
Researchers in Australia demonstrated that a single gluten dose as low as 3 mg provokes measurable immune activation in celiac disease patients, well under the 20 ppm threshold used for gluten‑free labeling. The finding raises questions about the adequacy of current safety...
FDA Grants Accelerated Approval to Regeneron's Otarmeni Gene Therapy for Genetic Hearing Loss
The U.S. FDA has granted accelerated approval to Regeneron Pharmaceuticals’ Otarmeni (lunsotogene parvec‑cwha), the first in‑vivo gene therapy for OTOF‑related sensorineural hearing loss. The decision, based on a 20‑patient CHORD trial, makes the treatment free for U.S. patients and expands...
NIH Studies Often Ignore Sex Differences, Hindering Precision Medicine
Less than half of NIH-funded health studies analyze results by sex, potentially overlooking critical differences that impact diagnosis, treatment, and drug development for both men and women. precisionmedicine
Over Half of Gray Market Peptides Fail Quality Standards
New pre-print on gray market peptides using @finnrick_tests data: 41.6% to 71.1% of gray market peptide samples failed to meet basic quality criteria, and measurable endotoxin contamination was present in 15% of samples. @Krysia830073
Erasca Shows Promising 40% PDAC, 62% NSCLC Responses
$ERAS Erasca touts strong, though preliminary, results in trial of pancreatic and lung cancer therapy $RVMD 40% uORR in PDAC; 62% uORR in NSCLC https://t.co/90BkD7tBeN