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.
STAT+: Pharmalittle: We’re Reading About the FDA Pushing OTC Meds, Its New Trial Standards, and Much More
The FDA, under Commissioner Marty Makary, is pushing to expand over‑the‑counter (OTC) availability for safe prescription drugs such as nausea treatments and vaginal estrogen. Simultaneously, the agency proposes dropping the long‑standing requirement for two pivotal clinical trials, moving to a default of a single study for new drug approvals. Both initiatives are framed as ways to cut costs, reduce regulatory burden, and speed the delivery of medicines to patients. These moves reflect broader Trump‑era priorities to streamline drug regulation and stimulate market competition.
ViiV Healthcare Reports P-III (LATITUDE) Trial of Cabenuva in Adherence-Challenged HIV Patients
ViiV Healthcare presented results from the Phase III LATITUDE trial evaluating Cabenuva, a long‑acting injectable of cabotegravir and rilpivirine, in 453 adults with adherence challenges. Among 306 virally suppressed participants, the quarterly injection reduced cumulative regimen failure to 22.8% versus...
CMS Broadens Drug Price Negotiations to Part B Therapies
The Centers for Medicare & Medicaid Services announced a third round of drug price negotiations that for the first time includes Part B physician‑administered therapies. By extending the Inflation Reduction Act’s pricing provisions to infused medicines, the move pulls doctors into...
Pharma Pulse: FDA’s Moderna Reversal and Eli Lilly’s $100 Million IL-6 Bet
The FDA has reversed its earlier refusal-to-file and will review Moderna’s seasonal mRNA influenza vaccine, with a decision slated for August 5, 2026. Moderna now seeks full approval for adults aged 50‑64 and accelerated approval for those 65 and older. Meanwhile, Eli Lilly...
Covetrus to Merge with Cencora’s MWI Animal Health in a $3.5B Deal
Covetrus and Cencora have signed a definitive agreement to merge Covetrus with MWI Animal Health, creating a unified animal‑health platform valued at $3.5 billion. Cencora will receive $1.25 billion in cash, $800 million of preferred equity and $1.45 billion of common equity, securing a...
Antioxidant Nanoparticles May Protect Male Fertility During Chemotherapy
A preclinical study published in Reproductive and Developmental Medicine found that combining melatonin with zinc oxide nanoparticles mitigates cyclophosphamide‑induced reproductive toxicity in male rats. The antioxidant duo restored testosterone and luteinizing hormone levels, lowered oxidative stress markers, and preserved spermatogenic...
MSD and Mayo Clinic Team up to Advance AI in Drug Development
Merck & Co (MSD) and Mayo Clinic have launched a research partnership that leverages AI, advanced analytics, and multimodal clinical‑genomic data to accelerate drug discovery and precision medicine. The collaboration merges Mayo’s Platform architecture and de‑identified datasets—including imaging, labs, molecular...
Opinion: My Biggest GLP-1 Ethical Problem: Patients Who Don’t Want to Stop
GLP‑1 agonists have moved from scarcity to abundance, reshaping weight‑management practice. In 2023, shortages forced clinicians to ration these drugs, often off‑label for obesity. Today, the surplus creates a new dilemma: patients seeking extreme, unsustainable weight loss and refusing to...
UV Red Flag: Color-Changing ‘Living’ Material Warns of Harmful Radiation
Researchers at the Technical University of Munich have created a bio‑hybrid coating that visibly signals UV‑A exposure by turning from green to red. The sensor embeds dry Escherichia coli cells loaded with the photoconvertible protein mEosFP, which undergoes an irreversible...
Genentech’s Fenebrutinib Yields Positive Results in Phase III MS Trial
Genentech’s oral BTK inhibitor fenebrutinib met its primary endpoint in the Phase III FENtrepid trial for primary progressive multiple sclerosis, showing non‑inferiority to Ocrevus and a 12% risk reduction in confirmed disability progression. The drug also delivered a 26% lower risk...
STAT+: New FDA Guidance for Antibiotic Use in Food-Producing Animals Prompts Criticism over Antibiotic Resistance
The FDA’s Center for Veterinary Medicine issued new guidance urging drugmakers to add explicit duration limits to medically important antibiotics used in food‑producing animals. Currently, about 28% of these drugs are administered continuously for approved indications, but the guidance seeks...
Anti-Aging Gene Therapy in Alzheimer’s and ALS with Klotho Neurosciences’ Dr. Joseph Sinkule — Episode 243
The Xtalks Life Science Podcast featured Joseph Sinkule, CEO of Klotho Neurosciences, discussing the company’s secreted α‑Klotho gene therapy platform aimed at age‑related neurodegenerative diseases such as Alzheimer’s, ALS and Parkinson’s. Klotho leverages a patented anti‑aging gene to develop cell‑ and...
FDA to Review Moderna’s Flu Jab on Agency Pivot
The FDA has reversed its earlier refusal and will now evaluate Moderna’s mRNA‑1010 seasonal flu vaccine using a two‑track approach: a full Biologics License Application review for adults 50‑64 and an accelerated approval pathway for those 65 and older, contingent...
Global Conference to Tackle Longevity Clinical Translation
The National University of Singapore Academy for Healthy Longevity is hosting the Geromedicine Conference on February 26-27, 2026, bringing together geroscience researchers, clinicians, and industry leaders. The event emphasizes clinical translation of molecules such as NAD+ precursors, urolithin A, and ergothioneine,...
How Does Cholera Colonize the Gut? Unmasking Virulence Activation with Cryo-EM
Cryogenic electron microscopy enabled researchers to solve five structures of Vibrio cholerae transcription activation complexes, revealing how the bacterium initiates virulence in the human gut. The study shows ToxR and TcpP transcription factors bind the RNA polymerase α‑C‑terminal domain via...
Patent Cliff Pressures to Drive Big Pharma M&A
The looming patent cliff, projected to strip up to $300 billion in annual drug sales by 2032, is keeping large pharma firms focused on strategic acquisitions rather than triggering a sudden surge in deal volume. Dan Chancellor of Norstella notes that...
Global Genomics: Representative Research Is Key to Unlocking the Full Potential of Precision Medicine
Professor Segun Fatumo highlights the stark under‑representation of African genomes in global research, where over 86% of GWAS participants are of European ancestry despite Africa housing the greatest genetic diversity. He explains how this gap limits the accuracy of polygenic...
The Biotech Bi-Weekly: A 48-Channel SPR Platform, Robust RNA-Seq Libraries and Microgravitational Discoveries
Carterra unveiled Vega, the industry’s first 48‑channel high‑throughput SPR platform, delivering roughly 12‑fold higher screening capacity for small‑ and large‑molecule drug candidates. Covaris introduced the truCOVER® Total RNA Library Prep Kit, enabling robust RNA‑seq libraries from as little as 10 ng...
Opinion: I Was a Moderna Exec when the Covid Vaccine Rolled Out. That Spirit of Possibility Is No More
Former Moderna executive Richard Hughes IV reflects on the exhilaration of the COVID‑19 vaccine launch, describing a once‑vibrant "spirit of possibility" that drove rapid innovation. He recounts his personal journey from unknown outsider to key player in a global health...
STAT+: At Drugmakers’ Forum, Oz Gets a Friendly Embrace, While Makary Faces Tough Questions
At a PhRMA‑hosted forum, CMS Administrator Mehmet Oz engaged warmly with Pfizer CEO Albert Bourla, championing vaccines and proposing closed‑door policy talks and even suggesting industry executives consider government jobs. In contrast, FDA Commissioner Marty Makary was sharply questioned by...
Free Access to Single-Cell Long-Read mRNA Sequencing Tech with New Grant
ArgenTag, now a PacBio Compatible Partner, has launched a grant that provides free access to its Single‑Cell RNA Library Kit for Long‑Read Sequencing. The kit uses a gravity‑based microfluidic chip to isolate individual cells, capture full‑length mRNA, and prepare barcoded...
DDW Highlights: 17 February 2026
In this 16‑minute DDW Highlights episode, host Bruno Quinney recaps five major drug‑discovery stories from the past week, focusing on a breakthrough study linking specific biomarkers to improved cancer survival rates and the launch of a multinational consortium tackling chronic...
Rare Disease Month Developments, Part 1 – The Good: RPD PRV Program Renewed, FDA Rare Disease Hub’s 2026 Strategic Agenda...
Congress renewed the Rare Pediatric Disease Priority Review Voucher (RPD PRV) program, extending it to September 30 2029 and eliminating the dual sunset dates. The FDA released its Rare Disease Innovation Hub’s 2026 Strategic Agenda, allocating $1 million in funding and outlining plans...
Silencing Growth Hormone Has Strong Effects in Mouse Brains
Researchers engineered mice lacking growth hormone receptors specifically in adipose tissue (Ad‑GHRKO) and observed striking brain benefits in aged males. Compared with control mice, the Ad‑GHRKO group showed increased neuronal activity, reduced neuroinflammation, lower tau phosphorylation, and fewer senescence markers....
Who Qualifies for the New FDA PreCheck Pilot Program?
The FDA has opened submissions for its PreCheck Pilot Program, targeting new U.S. drug‑manufacturing facilities that will begin construction by the March 1 2026 deadline. Eligible sites must be stand‑alone plants, located in the United States or its territories, and commit to...
🎧 The GLP-1 Business Model Problem, Ep. 1 with Prof. Alex Miras
In the inaugural episode, host Alex discusses the GLP‑1 business model with obesity expert Prof. Alex Miras, who emphasizes that the drug itself drives the bulk of weight loss—about 20% versus 2.5% from behavioral support—making extensive multidisciplinary care unnecessary for...
Longevity Innovation Forum in San Diego
Longevity Global is launching the inaugural Longevity Innovation Forum in San Diego on March 11‑12, 2026, gathering leading scientists, clinicians, biotech founders and investors to accelerate healthy‑aging research. The two‑day summit features high‑profile speakers such as Mike Snyder, Eric Verdin,...
Cellular Reprogramming Rescues Memory-Encoding Neurons
Scientists at EPFL applied a three‑factor (OSK) partial reprogramming cocktail to memory‑encoding engram neurons in 9‑10‑month‑old mice and Alzheimer’s‑model strains. Using a dual‑AAV system gated by doxycycline, OSK expression was limited to neurons active during a learning event, preserving cell...
Creating CAR-T Cells Using Current Alzheimer’s Antibodies
Researchers engineered CD4+ T cells with chimeric antigen receptors (CARs) derived from FDA‑approved Alzheimer’s antibodies aducanumab and lecanemab. The lecanemab‑based CAR (Lec28z) selectively bound fibrillar amyloid‑beta and reduced plaque burden in mouse brains, especially when delivered via transient mRNA transfection....
Can a Citizen Petition Denial Turn a Warning Letter Into Final Agency Action? The Curious Case of Hybrid Pharma
The Southern District of Florida held that a denial of a citizen petition transforms the underlying FDA warning letters into final agency action, allowing judicial review. Hybrid Pharma sued after the FDA refused to rescind two warning letters and the...
Young Microbes Rejuvenate Intestinal Function in Mice
Researchers performed heterochronic fecal microbiota transplants, moving gut microbes from young to aged mice, which reactivated canonical Wnt signaling and enhanced intestinal stem cell regeneration. Aged mice receiving young microbiota showed increased expression of Wnt3, Ascl2, Lgr5 and improved epithelial...
ACI’s 22nd Annual Paragraph IV Disputes: Elevate Your 2026 Hatch-Waxman Strategy
The American Conference Institute will host its 22nd Annual Paragraph IV Disputes Conference on April 21‑22, 2026 in New York’s Times Center. The two‑day forum gathers brand‑name and generic drug stakeholders to discuss Hatch‑Waxman litigation strategies, recent case law, and evolving PTAB practices. Featured...
DDW Highlights: 10 February 2026
In this 15‑minute episode, DDW host Bruno Quinney recaps five major stories from the past week, highlighting breakthrough cancer therapies that promise greater efficacy and safety, and new research aimed at enhancing brain function in Alzheimer’s patients. He also touches...
Sixth Circuit Affirms Steep Sentence in FDC Act Counterfeiting Case
The Sixth Circuit Court of Appeals affirmed a 90‑month prison term for Omar Wala, who pleaded guilty to conspiring to manufacture and distribute counterfeit generic alprazolam pills on the dark web. The court upheld the district court’s fraud loss calculation,...