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.
Pharma Pulse: MRNA Legal Wars and the Community Pharmacy Shield
BioNTech has filed a Delaware patent‑infringement lawsuit against Moderna, accusing the latter’s next‑generation COVID vaccine mNEXSPIKE of using BioNTech’s streamlined mRNA design. The disputed shot is projected to generate about 55 % of Moderna’s COVID revenue this season, making the case financially significant. Meanwhile, a new pharmacist‑led PRIME program, combining health coaching with a mobile app, doubled the likelihood that prediabetes patients achieved a clinically relevant 5 % weight loss. The findings highlight community pharmacies as pivotal players in metabolic‑health prevention.
Partner Therapeutics Reports P-II (eNRGy) Post-Hoc Results on Zenocutuzumab for NRG1+ NSCLC
Partner Therapeutics presented post‑hoc data from its Phase II eNRGy study of zenocutuzumab (Bizengri) in 27 patients with advanced NRG1‑positive non‑small cell lung cancer who received at least three doses beyond radiographic progression. Eight patients stayed on therapy for six months...
STAT+: Novo Nordisk’s Next-Gen Obesity Drug Stumbles in Comparison Study
Novo Nordisk’s next‑generation obesity drug CagriSema failed to demonstrate non‑inferiority to Eli Lilly’s tirzepatide in the 84‑week REDEFINE 4 study, achieving 20.2% weight loss versus 23.6% for tirzepatide. The open‑label trial showed the two treatments were not statistically equivalent. Following the announcement,...
J&J Reports Long-Term QUASAR Data for Tremfya in Ulcerative Colitis
Johnson & Johnson released long‑term QUASAR extension data for Tremfya (guselkumab) in ulcerative colitis, showing sustained efficacy through week 140. Clinical remission was achieved by 80.8% of patients, with 78.6% attaining histo‑endoscopic improvement and 53.6% reaching endoscopic remission. Approximately 89% of...
Podcast: Which Pharma and Medtech Companies Came Out on Top in 2025 Revenues?
The 2025 earnings season highlighted a clear hierarchy among healthcare giants, with Eli Lilly and AstraZeneca leading pharma revenue growth and Medtronic and Edwards Lifesciences topping medtech sales. The podcast hosted by Robert Barrie and Ross Law breaks down the financial results, noting...
STAT+: Pharma Lobbyists Focus on a Surprising New Target: The FDA
Health Secretary Robert F. Kennedy Jr. has pledged to purge industry influence from the FDA, yet the Trump administration’s injection of political priorities has reshaped the agency’s operating environment. Under the current administration, discussions that once were deemed off‑limits between...
Vanda Pharmaceuticals Reports the US FDA’s Approval of Bysanti (Milsaperidone) for Acute Bipolar I Disorder & Schizophrenia
Vanda Pharmaceuticals announced that the U.S. FDA has approved Bysanti (milsaperidone), an active metabolite of iloperidone, as a first‑line therapy for acute manic or mixed episodes in bipolar I disorder and for schizophrenia. The approval is based on demonstrated bioequivalence...
The Government’s Warning Shot? FDA and HHS Turn Up the Pressure on Compounding
The FDA, backed by HHS, issued a stark warning to compounding pharmacies that market GLP‑1 products such as semaglutide, after Hims & Hers promoted a compounded Wegovy copy. A press release announced intent to restrict non‑approved GLP‑1 APIs and referred...
'It Was Like Buying Groceries' - Woman Calls for Tighter Weight-Loss Jabs Checks
Emma Dyer bought weight‑loss injections online for £115, bypassing any medical assessment, and suffered a severe health collapse within days. Her experience reflects a wider surge, with an estimated 1.6 million UK adults using GLP‑1 drugs such as Mounjaro and Wegovy,...
Summit Therapeutics Inc (SMMT) Q4 2025 Earnings Call Transcript
Summit Therapeutics reported a strong cash position of $713 million with no debt at the end of 2025, while GAAP operating expenses fell to $225 million despite a rise in non‑GAAP R&D spend. The FDA accepted the Biologics License Application for ivonesumab...
Tarsus Pharmaceuticals Inc (TARS) Q4 2025 Earnings Call Transcript
Tarsus Pharmaceuticals reported record 2025 net product sales of $451.4 million, driven by XDEMVY adoption, and issued its first full‑year 2026 guidance forecasting $670‑$700 million, implying over 50% revenue growth. The company highlighted a 44% gross‑to‑net discount, a robust DTC campaign that...
Immunitybio Inc (IBRX) Q4 2025 Earnings Call Transcript
AbbVie reported a record $61.2 billion in net revenue for 2025, an 8.6% increase that beat guidance despite a $16 billion HUMIRA erosion. Adjusted EPS reached $10, $0.54 above the midpoint, while SKYRIZI and RINVOQ together generated $7.4 billion in Q4, delivering double‑digit...
Axsome Therapeutics Inc (AXSM) Q4 2025 Earnings Call Transcript
Axsome Therapeutics reported a 66% revenue surge to $639 million in 2025, driven by strong growth in Auvelity, Sunosi and the newly launched Cymbravo. Net loss narrowed to $183 million, a 35% improvement year‑over‑year, while cash rose to $323 million. The company secured...
BioMarin Pharmaceutical Inc (BMRN) Q4 2025 Earnings Call Transcript
BioMarin Pharmaceutical raised its fiscal 2025 total revenue guidance, now starting at $3.15 billion, and reaffirmed Voxzogo revenue between $900 million and $935 million. The company lifted non‑GAAP operating margin guidance to 26‑27% and lifted diluted EPS guidance to $3.50‑$3.60. A $221 million IPR&D...
First-of-a-Kind Stem Cell Therapies Set for Approval in Japan
Japan’s health ministry is set to grant conditional approval to two first‑of‑a‑kind regenerative medicines – Amchepry for Parkinson’s disease and ReHeart for severe heart failure – after tiny phase I/II trials involving seven and eight patients respectively. Both drugs are derived...
Novavax Targets S1 and S2 for Broader Protection
Novavax (unlike the mRNA vaccines) generates antibodies to both S1 and S2 units of the spike protein - explaining why it provides somewhat broader protection. I've personally gotten Novavax every time it was available at vaccine time.
Foresite Capital’s Key Criteria for Investing in Biotech Startups
22February: What does @ForesiteCapital look for in the therapeutics and instrument startups in which it invests? Read founder & CEO @JTananbaum MD's response + more insights from him and the firm's Michael Rome PhD in my latest Q&A interview for...
It Seems Bad That Temu Is Selling Peptides
A recent Futurism report reveals that the low‑cost e‑commerce platform Temu is selling a variety of peptide products, including BPC‑157 and GLP‑1‑like compounds, at prices as low as $4. These peptides, marketed as muscle, skin, or cognitive boosters, are often...
CRISPR Unlocks Causal Insights Into Immune Complexity
The complexity of our immune system is daunting. But there's a path to deconvolute it and understand causal relationships. It's CRISPR. open-access @JExpMed https://t.co/QF6Cvkbfz2 https://t.co/OTL2z1fow0
Study Lacks Equipoise: Control Babies Likely Infected
The key point here is that the proposed study would not have equipoise because almost certainly some babies in the control arm would get hepatitis from their infected mother.
GLP-1 Drugs Fail to Slow Cognitive Decline in Alzheimer’s Disease
Recent randomized trials testing GLP‑1 receptor agonists such as semaglutide and liraglutide in Alzheimer’s disease patients found no measurable slowing of cognitive decline. Earlier post‑hoc and observational analyses had suggested roughly a 50 % reduction in dementia incidence, raising hopes of...
Two Authors Shouldn't Qualify for Major Trial Abstract
Submitting an abstract for a late-stage large clinical trial for review at a major conference, where you're asking for an oral, but only having 2 authors should be disqualifying. Really, only *2* people acquired ALL the data for this? Disgraceful...
Teclistamab‑Daratumumab Shows Strong Benefit in RRMM
Teclistamab–Daratumumab in Relapsed or Refractory Multiple Myeloma [Feb 18, 2026] @End_myeloma et al. @NEJM https://t.co/PTSmdrV2zp #mmsm #tcellrx #ImmunoOnc QUICK TAKES: New phase 3 trial results are summarized in a short video.
Eli Lilly Invests $3.5B in Pennsylvania to Scale Next‑Gen Obesity Drug Manufacturing
Eli Lilly announced a $3.5 billion investment to build a new injectable‑medicine plant in Lehigh Valley, Pennsylvania. The facility, slated to break ground in 2026 and run by 2031, will focus on next‑generation obesity and metabolic drugs such as the triple‑agonist retatrutide....
Exposure‑Response Guides Belantamab Dose in RR‑MM
Exposure–Response Analyses for Therapeutic Dose Selection of Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma [Sep 1, 2021] Ferron-Brady et al. Clinical Pharmacology & Therapeutics https://t.co/58kmDFKRwO #mmsm #oncopharm #caxtx
BCMA Targeting Advances Multiple Myeloma Treatment Landscape
Targeting BCMA in Multiple Myeloma [Aug 25, 2021] Tan & @UrviShahMD Current Hematologic Malignancy Reports https://t.co/lAhqwwa7u3 #mmsm #caxtx #CARTcell
Novartis Breaks Ground on $23B Biomedical Research Hub in San Diego
Novartis began construction of a new biomedical research hub in San Diego. The 466,000‑sq‑ft center, part of a $23 billion US R&D and manufacturing program, will house about 1,000 researchers and target neuroscience, oncology, global health, and age‑related diseases. Scheduled to...
Anti‑BCMA CAR‑T Triggers Immunoglobulin Isotype Switching
Immunoglobulin Isotype Switch after Anti-BCMA CAR T-Cell Therapy for Relapsed or Refractory Multiple Myeloma [Nov 10, 2021] Liang et al. @BloodAdvances https://t.co/KfreDCvIDH #CARTcell #mmsm https://t.co/7qNQBEoqkX
Antigen Escape Drives Resistance to BCMA Therapies
Antigen escape as a shared mechanism of resistance to BCMA-directed therapies in multiple myeloma [Jul 25, 2024] @RossFirestone et al. @BloodJournal https://t.co/cOh0YC2u9H #mmsm #ImmunoOnc #CARTcell #PrecisionMedicine #lymphoidneoplasia #immunobiologyandimmunotherapy https://t.co/6sbEv5KtLY
Topical Adquey (Difamilast) Wins FDA Approval for Atopic Dermatitis
The U.S. Food and Drug Administration has granted approval to Adquey, a 1% difamilast topical ointment, for the treatment of mild-to-moderate atopic dermatitis in patients two years and older. Developed by Otsuka and licensed to Acrotech Biopharma, the product is...
Supreme Court Rejection of Trump Tariffs Has Nuanced Implications for Pharma Importers
The Supreme Court struck down the broad tariffs imposed under the International Emergency Economic Powers Act, but left Section 232 duties untouched. Because most pharma tariffs were issued under Section 232, the ruling does not eliminate the targeted tariffs on drug imports....
AI Tool Sets New Standard in Diagnosing Rare Diseases
A new multi‑agent system called DeepRare, built on the DeepSeek‑V3 large language model and over 40 specialized tools, outperformed 15 competing AI models and human physicians in diagnosing rare diseases. Across 6,401 cases covering 2,919 rare conditions, it achieved a...
From Junk Science (Largely Non-Political) to Junk Medical Treatments (Mostly Associated with the Far-Right): A Financial Connection
Paul Krugman highlights a growing financial link between the multi‑billion‑dollar wellness industry and right‑wing extremist movements. He notes that U.S. spending on wellness reaches roughly $500 billion annually, with nutritional supplements alone accounting for about $70 billion, while regulators like the FDA...
STAT+: Pharmalittle: We’re Reading About an FDA Official’s Speech, a Grail Cancer Blood Test, and Much More
FDA drug‑center head Tracy Beth Høeg used her first staff address to flag two priority areas: the safety of antidepressants taken during pregnancy and the use of monoclonal antibodies that protect infants from RSV. She also signaled a continued interest...
The Pulse of Pharma Change in 2026
In a February 20, 2026 Pharm Exec Podcast, ZS CEO Pratap Khedkar, PhD, outlined three converging trends reshaping pharma: heightened AI integration, evolving ecosystem partnerships, and sweeping US‑driven policy reforms. Drawing on his nine‑year tenure leading ZS’s global pharmaceuticals practice and its advanced data‑science...
The US FDA Accepts Roche’s Giredestrant NDA for ESR1-Mutated, ER-Positive Advanced Breast Cancer
The U.S. FDA has accepted Roche’s new drug application for giredestrant combined with everolimus to treat ER‑positive, HER2‑negative, ESR1‑mutated advanced breast cancer. Phase III evERA data show a 44% reduction in disease progression or death overall and a 62% reduction in...
Pharma Pulse: J&J’s $1B Cell Therapy Hub and Hims & Hers’ Global Expansion
Johnson & Johnson announced a $1 billion investment to build a next‑generation cell‑therapy manufacturing facility in Montgomery County, Pennsylvania, slated to support 500 skilled jobs. The hub is a key element of J&J’s $55 billion U.S. manufacturing, R&D, and technology strategy. Meanwhile,...
NexEos Bio Receives US FDA IND Clearance to Advance NTX-1024 Into P-II/III Study for Vernal Keratoconjunctivitis
U.S. FDA has granted IND clearance for NexEos Bio’s ophthalmic solution NTX-1024, allowing the company to commence a combined Phase II/III clinical trial in vernal keratoconjunctivitis (VKC). The upcoming study will assess safety and efficacy after an open‑label investigator‑initiated trial...
Boehringer Ingelheim and NIPER Sign MoU on Pharmaceutical Research
Boehringer Ingelheim India has signed a memorandum of understanding with the National Institute of Pharmaceutical Education and Research (NIPER) in Raebareli to deepen collaboration on pharmaceutical technologies and novel drug delivery systems. The agreement grants NIPER access to Boehringer’s opnMe...
Boehringer Ingelheim Secures US FDA’s EUA for NexGard and NexGard COMBO to Treat NWS
Boehringer Ingelheim received an Emergency Use Authorization (EUA) from the U.S. FDA for its NexGard chewable tablets to treat New World screwworm (NWS) infestations in dogs and puppies, and for NexGard COMBO topical solution to treat NWS in cats and...
Rare Disease Month Developments – Part 3: The Ugly (Just Kidding) – See You at Rare Disease Week
Rare Disease Week convenes on Capitol Hill, bringing patients, advocates, regulators, and industry together to shape policy for rare disease therapies. Hyman, Phelps & McNamara will be prominently represented, highlighted by Frank Sasinowski receiving the EveryLife Foundation’s Abbey Lifetime Achievement...
STAT+: Texas Attorney General Sues Sanofi for Allegedly Providing Kickbacks to Doctors to Prescribe Its Drugs
Texas Attorney General Ken Paxton filed a lawsuit alleging Sanofi paid kickbacks to physicians by offering free nursing staff and insurance‑support services. The alleged scheme was designed to steer prescriptions toward Sanofi’s drugs for chronic conditions such as diabetes, multiple...
Amicus Therapeutics Inc (FOLD) Q4 2025 Earnings Call Transcript
Amgen reported double‑digit revenue and earnings growth for 2025, driven by strong performance across its oncology, rare‑disease, biosimilar and general‑medicine portfolios. Fourteen products surpassed $1 billion in sales, with Repatha, Evenity and Tespire each posting over 30% year‑over‑year growth. The company...
Pharmaceutical Executive Daily: FDA Plans to Remove Two Study Requirement for New Drug Approvals
The FDA announced it will drop the historic requirement for two adequate and well‑controlled studies in certain new‑drug approval pathways, a move that could accelerate timelines and lower development costs. The change is especially relevant for therapies targeting unmet medical...
ACIP February Meeting Cancelled: Report
The Advisory Committee on Immunization Practices (ACIP) cancelled its scheduled February 25‑27, 2026 meeting, and no new date has been announced. The cancellation occurs amid a wave of senior HHS leadership changes, including the departure of Deputy Secretary Jim O’Neill and General...
Eli Lilly Announces Positive Results for Treating Crohn’s Disease with Omvoh
Eli Lilly reported that its biologic Omvoh (mirikizumab) sustained steroid‑free remission for three years in Crohn’s disease patients in the Phase 3 VIVID‑2 open‑label extension study. More than 90% of participants remained in remission, with 80% experiencing relief from bowel urgency. The...
From Launch to Loss of Exclusivity- Reducing Access and Affordability Barriers Across the Brand Lifecycle
CoverMyMeds outlines how access and affordability challenges evolve across a biopharma brand’s lifecycle, from launch through loss of exclusivity, and offers actionable, data‑driven strategies to mitigate them. The firm emphasizes real‑time analytics, provider‑focused tools, and tailored patient assistance to reduce...
A Circulating Inflammation Suppressor Decreases Mortality
Researchers used Mendelian randomization to demonstrate that the inflammatory cytokine IL6 directly increases all‑cause mortality, while its soluble receptor IL6R has the opposite effect. Elevated circulating IL6R was linked to lower risk of lung cancer, diabetes, stroke and coronary artery...
Valneva’s Lyme Disease Vaccine Offers Beacon of Hope Amid 2025 Sales Dip
Valneva reported a 3.3% decline in product sales to €157.9 million in 2025, driven primarily by regulatory suspensions of its chikungunya vaccine Ixchiq in the US and UK. Despite the sales dip, total revenue rose to €174.7 million, buoyed by a licensing...
DHL Group Invests €2bn in Healthcare Logistics Push
DHL Group announced a €2 billion strategic investment to expand its Life Sciences & Healthcare air‑freight cold‑chain network. The rollout adds more than 30 GDP‑compliant aviation hubs and a dedicated Boeing 777F route between Brussels and Cincinnati, linking Europe’s life‑science cluster...