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.
Biotech Investors Set to Meet with Key Congressional Panel
A bipartisan congressional commission focused on maintaining U.S. leadership in biotechnology will host a meeting with leading biotech investors next week. The investors, representing venture capital firms and industry funds, aim to discuss policy gaps, funding mechanisms, and regulatory hurdles. The dialogue is expected to inform the commission’s upcoming report on competitiveness and supply‑chain resilience. Officials hope the engagement will translate into actionable recommendations for Congress.
Prestige Biopharma Reports Topline P-III (SAMSON-II) Study Results for HD204 (Biosimilar, Avastin)
Prestige Biopharma announced topline results from its phase‑III SAMSON‑II trial comparing HD204, a biosimilar to Avastin (bevacizumab), with the reference product in 625 patients with advanced non‑squamous non‑small cell lung cancer. The study demonstrated an objective response rate (ORR) of...
Mosaic Therapeutics to Present Poster Highlighting Preclinical Data for Lead Program MOS101 at the American Association for Cancer Research (AACR)...
Mosaic Therapeutics will present preclinical data on its lead program MOS101—a combination of the next‑generation MDM2 antagonist ASTX295 and the FDA‑approved PARP inhibitor olaparib—at the AACR 2026 Annual Meeting. The poster focuses on BRCA2‑mutant, TP53‑wild‑type solid tumours and highlights the...
Apnimed Set to Exit Sleep Disorder Joint Venture with Shionogi for $100M Upfront
Japanese pharmaceutical company Shionogi is buying out Apnimed’s 50% stake in their sleep‑disorder joint venture for an upfront payment of $100 million. The acquisition gives Shionogi full control over the partnership’s pipeline, which focuses on treatments for conditions such as obstructive...
FDA Clears 7.2 Mg Wegovy HD, Boosting Weight‑Loss Potential by 19%
The U.S. Food and Drug Administration approved a 7.2‑milligram version of Novo Nordisk’s semaglutide weight‑loss drug Wegovy, dubbed Wegovy HD. Clinical data showed participants lost roughly 19% of body weight, about 47 pounds on average, compared with 16% on the...
Gubra‑AbbVie’s ABBV-295 Achieves Up to 9.8% Weight Loss in Early Trial
Gubra and AbbVie announced that participants in a Phase 1 multiple‑ascending‑dose study of ABBV-295 lost between 7.8% and 9.8% of their body weight after roughly three months. The amylin analog was well tolerated, positioning it as a potential new class of...
Regulators Tighten Grip on Weight‑Loss Drugs and Medical Devices Amid Rising Enforcement Actions
India's high court cleared Dr Reddys to produce the weight‑loss drug semaglutide, unlocking a billion‑dollar market, as health regulators in Ireland recalled 18,000 Philips Respironics machines over foam degradation. The twin moves underscore mounting compliance pressure across the pharma and...
Pharma Pulse: A Rare Disease Drug Approval and the Evolving Scope of Pharmacy Practice
The FDA has broadened approval for Imcivree (setmelanotide), creating the first targeted therapy for acquired hypothalamic obesity and reporting an 18.4% placebo‑adjusted BMI reduction in Phase III trials. Parallel research shows that deploying pharmacy technicians as vaccine injectors dramatically improves uptake...
Why CMS Is Tightening ASP Reporting and What Manufacturers Must Get Right
CMS will require pharmaceutical manufacturers to submit the "reasonable assumptions" used to calculate their quarterly Average Sales Price (ASP) beginning in 2026. The move formalizes the estimation process that underlies ASP, covering rebates, bundled discounts, free‑goods programs, 340B sales and...
Patented Chemo Reform Boosted Profits, Not Patient Benefits
Please. This is nonsense. You figured out a way to swap castor oil for albumin making it easier to administer paclitaxel, a standard chemotherapy. Same side effects. Look at the label. The best thing you did, for you, was secure...
Clemastine Fumarate Activates Lipophagy to Promote Oligodendrocyte Progenitor Cells Differentiation and Remyelination in a Cuprizone-Induced Demyelination Model
Researchers discovered that clemastine fumarate activates lipophagy in oligodendrocyte progenitor cells (OPCs), clearing lipid droplets that impede differentiation. In vitro, the drug enhanced OPC maturation and removed myelin debris, while in a cuprizone‑induced mouse model it restored myelin integrity and...
AI-Driven Partnership Targets Unmet Gynecological Diseases
We are very happy to join forces together with the wonderful ASKA to go after Novel Targets for Women's Health. Gynecological diseases have long posed challenges, including difficult diagnosis, limited treatment options, and a substantial disease burden, affecting millions of...
You Can’t Unsee This
A recent British Journal of Ophthalmology study found that users of Wegovy, the higher‑dose GLP‑1 weight‑loss injection, face a five‑fold increased risk of non‑arteritic anterior ischemic optic neuropathy (NAION), an eye‑stroke that can cause blindness. The condition occurs in roughly...
Ecnoglutide Approval Intensifies Competition in China GLP-1 Obesity Market
China's National Medical Products Administration approved Sciwind Biosciences' Ecnoglutide injection, marking the country's fifth GLP‑1 obesity therapy. The drug demonstrated a 15.4% average weight loss in the Phase III SLIMMER trial, with over 90% of participants achieving at least 5%...
9th Annual Corporate Compliance & Transparency in Life Sciences Conference
The 9th Annual Corporate Compliance & Transparency in Life Sciences Conference convenes more than 20 compliance leaders, legal experts, and industry innovators for a single-stage event. Attendees will experience over 15 hands‑on presentations and case studies, targeting actionable strategies for...
P‑tau217 Predicts Dementia Risk with Combined Hormone Therapy
Blood levels of the Alzheimer's biomarker p-tau217 may help identify which women are more vulnerable to dementia when using combined hormone therapy after menopause, while estrogen-only therapy does not show the same association. menopause
Former Acorda CEO Joins Parkinson’s Cell Therapy Startup
How former Acorda CEO Ron Cohen landed at a Parkinson’s cell therapy startup https://t.co/93JYvJGM9I by @realJacobBell #biotech #startups
Accumulus Technologies Launches the Accumulus Connector, Delivering Live Integration Across Regulatory Systems
Accumulus Technologies launched the Accumulus Connector, extending its platform into customers’ existing pharma and biotech systems for live, bi‑directional regulatory communication. The Connector provides real‑time, one‑click global submissions to more than 70 national regulators, eliminating manual data reconciliation. By integrating...
Latest TechBio News
Evotec SE announced that its Seattle CDMO, Just‑Evotec Biologics, has been selected by BARDA’s BioMaP‑Consortium for a multi‑year, up‑to‑$10 million program to optimize manufacturing of a monoclonal‑antibody cocktail against Ebola and Sudan viruses. The same day, Evotec disclosed that partner Bristol...
Japan's Drug Prices Are Creating Problems for Washington and Tokyo Alike
President Donald Trump and Japanese Prime Minister Sanae Takaichi discussed a $40 billion U.S. nuclear investment and pledged cooperation on drug‑pricing reform. Japan plans a 4% cut to total drug spending, further lowering reimbursements for new medicines. The article warns that...
Direct Immune Cell Injection Eradicates Multiple Mouse Cancers
A potentially game-changing discovery by @UCSF's Justin Eyquem @j_eyquem & colleagues – injecting cancer-fighting immune cells directly into the body kills several types of cancers in mice. Paper in @Nature: https://t.co/EXbsfx7whl Summary/video by UCSF: https://t.co/qLYXXvEDTV
Oral PCSK9 Pill Slashes LDL Cholesterol by Up to 60% in Phase 3 Trial
Enlicitide, a once‑daily oral PCSK9 inhibitor, lowered LDL cholesterol by as much as 60% in a phase 3 trial of 2,909 high‑risk adults. The results, published in The New England Journal of Medicine, could shift cholesterol management from injections to...
Analyst Picks Pfizer and UnitedHealth as Long‑Term Buys Amid Market Turbulence
A market analyst recommends Pfizer (PFE) and UnitedHealth Group (UNH) as long‑term holdings despite recent market swings. The stocks trade at roughly 9x and 15x forward earnings, respectively, offering perceived discounts in a climate of gold price crashes, rising energy...
Bausch + Lomb’s ELIOS Glaucoma System Shows 76% IOP Reduction, Shares Rise 5%
Bausch + Lomb announced that its implant‑free ELIOS glaucoma treatment system met both primary efficacy endpoints in a 24‑month pivotal study, with 76% of patients achieving a 20% intraocular pressure reduction and 82% remaining medication‑free. The news sent the company’s shares up...
R3 Bio Pitches ‘Organ Sacks’ to Replace Animal Testing, Backed by Billionaire Fund
Bay Area biotech R3 Bio announced a plan to grow nonsentient “organ sacks” as a replacement for monkey testing, with backing from Singapore’s Immortal Dragons fund. The approach could reshape pre‑clinical drug safety studies if it proves scalable.
Anesthetics as Emerging Therapeutics for Post-Traumatic Stress Disorder (PTSD): Bridging Bench and Bedside
A recent Molecular Psychiatry review highlights anesthetics as a promising new class of therapeutics for post‑traumatic stress disorder (PTSD). It outlines how NMDA‑receptor antagonists, α2‑adrenergic agonists, GABA‑A modulators and certain opioids can modulate fear circuitry and memory reconsolidation. Pre‑clinical models...
HIV Remains Suppressed in Some Patients After Treatment Withdrawal
Scientists at Gladstone Institutes identified two host genes, DDIT4 and ZNF254, that act as molecular locks keeping HIV dormant after antiretroviral therapy (ART) cessation. Multi‑omic analysis of 75 participants from analytical treatment interruption trials linked higher expression of these genes,...
FDA Drug Safety Communication: Avandia (Rosiglitazone) Labels Now Contain Updated Information About Cardiovascular Risks and Use in Certain Patients
The FDA has added explicit cardiovascular risk information, including heart‑attack warnings, to the labeling and Medication Guide for rosiglitazone (Avandia) and its combination products. The revised label restricts use to patients already on the drug or those whose blood sugar...
Market Shifts Powering the Growth of Sterile Injectable Manufacturing
The sterile injectable contract manufacturing market is rapidly evolving as demand surges for both large‑scale biologics and niche, small‑batch therapies. Leading CDMOs are responding by expanding production capacity, building global redundancy, and investing heavily in specialized talent. Development and pre‑commercial...
Brief 5‑MeO‑DMT Trip Yields Month‑Long Antidepressant Boost
One of the most remarkable things about 5-meo-DMT as an antidepressant is that the psychoactive experience is so brief. 10 minute peak, perhaps. 20 min total. And people seldom remember it well. Yet it has possibly the largest anti-depressant effect...
Top 5 Fastest Growing Pharma & Biotech Companies in Europe in 2026
A Financial Times analysis of Statista data identifies Europe’s five fastest‑growing pharma and biotech firms between 2021 and 2024. Italy’s Itaste Medical surged to €18.4 billion in sales, a 2,035% absolute growth, while the UK‑based Grow Group expanded cannabis‑based medicines to...
Dr. Yeadon Comments on "Ex Pfizer Chief Toxicologist: Toxicology Studies Sacrificed to Speed."
Dr. Michael Yeadon highlights testimony from former Pfizer Europe chief toxicologist Dr. Helmut Sterz, who claimed essential toxicology studies were omitted to accelerate approval of Pfizer‑BioNTech’s mRNA COVID‑19 vaccine. Sterz alleges the product lacked carcinogenicity and reproductive toxicity data, was...
Plastic Waste Transformed Into Parkinson’s Drug in Bioengineering First
Researchers at the University of Edinburgh have engineered bacteria to transform PET plastic waste into levodopa, a primary treatment for Parkinson’s disease. By inserting a seven‑gene, four‑step biosynthetic pathway into Escherichia coli, the team converted both industrial PET feedstock and...
Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose Prevention
Since 1995 the FDA has moved from approving standard opioid products to implementing a comprehensive regulatory regime aimed at curbing misuse and overdose. Key milestones include the 2007 authority to require Risk Evaluation and Mitigation Strategies (REMS), a series of...
CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative
The FDA’s Center for Drug Evaluation and Research (CDER) launched the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) to create a regulatory pathway for emerging manufacturing technologies. FRAME focuses on four priority technologies—end‑to‑end continuous manufacturing, distributed manufacturing (including non‑traditional sites),...
More Data Support Investigational Drug Combo for HIV Therapy
Phase 3 data presented at the 2026 Conference on Retroviruses and Opportunistic Infections show that the doravirine‑islatravir (DOR/ISL) two‑drug regimen met non‑inferiority criteria versus the standard bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) triple‑pill. At week 48, 91.8% of participants on DOR/ISL achieved viral suppression compared...
BTK Inhibition in CLL: Comparing Brukinsa and Jaypirca Approaches
BTK inhibitors have become the cornerstone of chronic lymphocytic leukemia therapy, replacing traditional chemotherapy. Brukinsa (zanubrutinib) is a second‑generation irreversible inhibitor that offers high selectivity and strong efficacy in treatment‑naïve or early‑relapse patients, with reduced cardiovascular risk. Jaypirca (pirtobrutinib) is...
FDA Drug Safety Communication: Safety Review Update of Recombinant Human Growth Hormone (Somatropin) and Possible Increased Risk of Death
The FDA updated its safety review of recombinant human growth hormone (somatropin) after the French SAGhE study raised concerns about a possible increased risk of death. The agency identified significant design flaws in the study and found no supporting evidence...
Kyorin Pharma Gains Global Rights to UBE’s Novel Drug Candidates
Kyorin Pharmaceutical Co. has signed a worldwide licensing agreement with Japan’s UBE Corp., securing exclusive rights to develop, manufacture and commercialize UBE’s novel drug candidates. The deal includes an undisclosed upfront payment and milestone‑based royalties, and it nudged Kyorin’s shares...
Europa Biosite Introduces Rapid RNA Production Technologies
Europa Biosite has formed a strategic distribution partnership with Quantoom Biosciences to bring Quantoom’s Ntensify® mano and micro RNA production technologies to European researchers. The deal also anticipates future distribution of Quantoom’s Ncapsulate® LNP formulation kits. By adding rapid, high‑quality...
FDA Approves Expanded Indication for Imcivree as Treatment for Hypothalamic Obesity
Rhythm Pharmaceuticals' Imcivree (setmelanotide) received FDA approval as the first treatment for acquired hypothalamic obesity, expanding its indication to adults and children aged four and older. The Phase III TRANSCEND trial demonstrated a 15.8% mean BMI reduction at 52 weeks, an...
US Patients Access Zegfrovy via Apex Oncology
Another win for Dizal, but how do US patients get hold of Zegfrovy? Via @ApexOnco -> https://t.co/4GVjyHS9vz https://t.co/bjjrnZkNL6
Rheumatology Enters the Gut-Brain-Immune Axis
Healio’s latest editorial highlights the expanding role of GLP‑1 receptor agonists in immune‑mediated inflammatory diseases, emphasizing weight‑independent anti‑inflammatory mechanisms. Emerging data suggest central nervous system GLP‑1 activation can modulate peripheral immunity, linking the gut‑brain‑immune axis. The FDA’s recent approval of...
QPX7728
Xeruborbactam (QPX‑7728) is a broad‑spectrum β‑lactamase inhibitor designed to revive the activity of β‑lactam antibiotics against multidrug‑resistant Gram‑negative bacteria. Developed by Qpex Biopharma and Shionogi, the molecule targets both serine‑ and metallo‑β‑lactamases, addressing a key resistance mechanism. Preclinical data show...
Takeda, Lilly Rejected by Supreme Court on Actos Fraud Lawsuit
The U.S. Supreme Court denied Takeda Pharmaceutical and Eli Lilly’s request to block a racketeering lawsuit, allowing a class action alleging the companies concealed Actos’s link to bladder cancer to proceed. The suit targets tens of thousands of insurers and other...
FDA Review and Study Data Lift Insmed Stock
FDA seeks feedback on voucher program; Study data lift ‘overhang’ on Insmed shares https://t.co/BCRJAUwGIJ $INSM + 7% $SRPT $SNY $GSK #biotech
Contributor: How Much? Addressing Medicines’ Cost and Value
The article argues that drug pricing debates must focus on aligning prices with the full value medicines deliver to patients and society. It critiques current health technology assessment (HTA) practices for using narrow benefit definitions, which can depress prices and...
The Six Biotech Companies in Portugal You Should Know About in 2026
Portugal’s biotech sector is gaining momentum, highlighted by BIO‑Europe Spring in Lisbon. Six home‑grown companies—Beat Therapeutics, BSIM Therapeutics, Exogenus, Immunethep, Mondego Bio and TechnoPhage—are advancing novel therapies ranging from DDR inhibitors for pancreatic cancer to exosome‑based wound treatments and bacteriophage...
Pfizer's Lyme Vaccine Data Remains Ambiguous, FDA Review Looms
As someone who lived in Vermont and still spends the summer there, it's disappointing to see the ambiguity in Pfizer's data on a new Lyme disease vaccine. It's a serious threat. Now we can move on to speculating on the...
Reimagining Migraine Treatment: Alon Ironi of Theranica on Nerivio’s Journey to Nationwide Coverage
Theranica’s Nerivio, a remote electrical neuromodulation (REN) device, has secured nationwide coverage for roughly 130 million lives through Blue Cross Blue Shield plans. The therapy’s dual acute and preventive indications offer a drug‑free alternative that expands access to underserved groups such...