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.
FDA Drug Safety Communication: Updated Information About the Risk of Blood Clots in Women Taking Birth Control Pills Containing Drospirenone
The FDA has updated labels for drospirenone‑containing oral contraceptives after reviewing epidemiologic studies that suggest a potentially higher risk of venous thromboembolism compared with other progestins. The new warnings note that some studies report up to a three‑fold increase in clot risk, while other data show no additional risk. The agency emphasizes that overall clot risk from any combined pill remains lower than the risk during pregnancy or the postpartum period. Women are urged to discuss individual clot risk factors with their healthcare providers before choosing a birth control method.
FDA Drug Safety Communication: New Warning and Contraindication for Blood Pressure Medicines Containing Aliskiren (Tekturna)
The FDA issued a drug safety communication on April 20, 2012, adding a contraindication for aliskiren‑containing antihypertensives when combined with ACE inhibitors or ARBs in patients with diabetes, and a warning for those with moderate to severe renal impairment. The...
FDA Drug Safety Communication: Updated Information on Drug Interactions Between Victrelis (Boceprevir) and Certain Boosted HIV Protease Inhibitor Drugs
The FDA issued an updated Drug Safety Communication warning that co‑administration of Victrelis (boceprevir) with ritonavir‑boosted HIV protease inhibitors—atazanavir, darunavir, or lopinavir/ritonavir—is not recommended for patients co‑infected with hepatitis C and HIV. The interaction lowers blood concentrations of both drugs,...
FDA Drug Safety Communication: Safety Review Update of Cancer Drug Revlimid (Lenalidomide) and Risk of Developing New Types of Malignancies
The FDA added a safety warning to Revlimid (lenalidomide) after clinical trials showed a markedly higher incidence of second primary malignancies in newly diagnosed multiple myeloma patients. Pooled data revealed a three‑fold increase (7.9% vs 2.8%) in cancers such as...
FDA Drug Safety Communication: Cefepime and Risk of Seizure in Patients Not Receiving Dosage Adjustments for Kidney Impairment
The FDA issued a Drug Safety Communication reminding clinicians to adjust cefepime doses for patients with creatinine clearance ≤ 60 mL/min. Non‑convulsive status epilepticus has been linked to inappropriate dosing, with 59 reported cases since 1996, 58 of which involved renal dysfunction...
FDA Drug Safety Communication: Seizure Risk for Multiple Sclerosis Patients Who Take Ampyra (Dalfampridine)
The FDA issued a Drug Safety Communication warning that dalfampridine (Ampyra), approved to improve walking in multiple sclerosis patients, carries a significant seizure risk, especially shortly after therapy initiation. Post‑marketing data show most seizures occur within days‑to‑weeks and in patients...
FDA Drug Safety Communication: FDA Recommends Against Use of Revatio (Sildenafil) in Children with Pulmonary Hypertension
The FDA issued a drug safety communication recommending that Revatio (sildenafil) not be prescribed to children aged 1‑17 for pulmonary arterial hypertension. A long‑term pediatric trial of 234 patients showed no exercise benefit and a three‑fold increase in mortality at...
Could Ozempic Help People Whose Cancer Has Spread to the Brain?
A large retrospective analysis of over 19,000 patients with cancer, type 2 diabetes and brain metastases found that those prescribed GLP‑1 receptor agonists such as Ozempic or Wegovy experienced a 37% reduction in three‑year mortality compared with matched controls. The survival...
Parents Skip Newborn Preventive Care as Vaccine Skepticism Sparks Hib Resurgence
Pediatricians are reporting a wave of parents refusing routine newborn preventive care, from vitamin‑K shots to early‑life vaccines. The trend has already produced a cluster of invasive Haemophilus influenzae type b (Hib) meningitis cases that were once rare, underscoring the public‑health...
The Deep Cave Bacteria Defying Modern Medicine
Scientists exploring the isolated Lechuguilla Cave discovered microbial communities that are resistant to virtually all natural antibiotics, despite being sealed off for millions of years. Genomic analysis of a *Paenibacillus* strain revealed dozens of known resistance genes and five entirely...
UniQure Bet Turns Into FDA Shitstorm and Short‑sell Speculation
I bet on uniQure thinking it was an obvious win win win. HD wins with expanded access. FDA wins by narrowly expanding authorization while vigorously monitoring follow up data. Investors win as the company proves what doctors are saying. Instead...
Multiple Drugs Fail to Extend UM-HET3 Mouse Lifespan
Astaxanthin, meclizine, mitoglitazone, pioglitazone, alpha-ketoglutarate, mifepristone, methotrexate, and atorvastatin-telmisartan do not increase lifespan in UM-HET3 mice https://t.co/k0vERH4LSg
UK Study Reveals No Additional Advantage of Surfactant Therapy in Severe Bronchiolitis Cases in Infants
UK researchers completed the largest randomized trial evaluating exogenous surfactant in infants with severe bronchiolitis requiring mechanical ventilation. The Bronchiolitis Endotracheal Surfactant Study (BESS) enrolled 232 infants across 15 pediatric centers and found that surfactant administration did not shorten ventilation...
Low‑cost Patent‑free Vaccines Challenge Big Pharma, Expose Uninformed Freedom Rhetoric
But…I develop low-cost often patent free vaccines that bypass big pharma and provide access to people who can’t afford them. In the past people who espoused freedom were learned and read books. Now they’re just lazy mindless dummies who think...
AI Aims to Slash Biotech’s $3B, 13‑year Drug Timeline
The biotech industry spends $3 billion and 13 years to bring one drug to market. If you're still searching for a treatment that works, it exists but the process discovering it is too slow to actually help you in time. How Marc...
Psychedelic Drug MDMA Could Help Treat PTSD—But There's a Reason It's Not Widely Available
Australia became the first nation to reclassify MDMA from a prohibited to a controlled substance, permitting its use in PTSD treatment under strict conditions. The 2026 guidelines limit MDMA‑assisted psychotherapy to adults who have not responded to first‑line therapies, require...
Scientists' Risk Fuels Life‑Saving Medicines, Not COI Fear
Scientists who stick their necks out and make medicines are my heroes There’s too much concern about COI for seasoned scientists with exemplary records Without commercial activity, we’d have zero medicines and ER-100 would still be in mice, not FDA cleared for...
Blinding Doesn't Affect Psychedelic Trial Outcomes, Study Finds
It follows that if TADs are biased by expectancy, Open Label trials will show better outcomes than blinded. Further, if expectancy is not a strong driver of response to psychedelics, then blinding shouldn’t matter as much. This is what they...
Prothena Partners Present Data Supporting Next Generation Treatments for Parkinson’s and Alzheimer’s Disease at AD/PD™ 2026
Prothena and its partners presented new clinical data on prasinezumab for Parkinson’s disease and BMS‑986446 for Alzheimer’s disease at the AD/PD 2026 conference in Copenhagen. The PASADENA and PADOVA extensions suggest a two‑year disease‑progression delay and sustained biomarker effects, supporting the...
SGLT2 Inhibitors Boost Survival in Frail Seniors
Use of SGLT2 Inhibitors in Frail Older Adults is Associated with Increased Survival: A Retrospective Study https://t.co/tsJ5qJLBap https://t.co/4EvBWDftJ4
Prothena Partners Present Data Supporting Next Generation Treatments for Parkinson’s and Alzheimer’s Disease at AD/PD™ 2026
Prothena and its partners Roche and Bristol Myers Squibb presented late‑stage data on two neurodegenerative candidates at AD/PD™ 2026. Prasinezumab demonstrated a roughly two‑year delay in Parkinson’s disease progression, sustained motor benefits in the PADOVA open‑label extension, and favorable imaging and...
Henagliflozin Shows Potential Anti‑Aging Effects in Diabetes
Effect of henagliflozin on aging biomarkers in patients with type 2 diabetes: A multicenter, randomized, double-blind, placebo-controlled study 🔎"Our results suggest that henagliflozin may exert anti-aging effects by influencing multiple pathways, including the IGF-1 system, glucose metabolism, the immune system, and...
Metformin vs Dapagliflozin: Heart Protection in Diabetic Rats
Researchers compared metformin and dapagliflozin in diabetic rats subjected to myocardial infarction, finding dapagliflozin delivered stronger cardio‑protective effects. The SGLT2 inhibitor markedly reduced oxidative stress, inflammatory cytokines, and infarct size, while also improving calcium handling and contractile efficiency. Metformin showed...
Indian Pharmaceutical Industry Projected to Reach USD 130 Billion by 2030, Driven by Exports, Policy Push
India’s pharmaceutical sector is projected to expand from a $60 billion domestic market to $130 billion by 2030, according to the Economic Survey 2025‑26. Export revenues surged to $30.5 billion in FY25, a 16‑fold increase since 2000, while the industry now supplies roughly...
Noteworthy Studies on JAK Inhibitors, Skin-Gut Relationship in Alopecia Areata: Maria Hordinsky, MD
Maria Hordinsky, MD highlighted the rapid evolution of alopecia areata therapy, noting three FDA‑approved Janus kinase (JAK) inhibitors launched in the last five years. She discussed the efficacy of agents such as dupilumab and baricitinib, while emphasizing emerging research on...
Dose as the Ultimate MPO Endpoint
Tristan Maurer’s Flash Talk framed dose as the definitive multiparametric optimization (MPO) endpoint for small‑molecule drug design. He argued that dose integrates exposure, pharmacology, and mechanism‑driven effects, making it the linchpin for balancing potency, ADME, and safety. The presentation highlighted...
AI Speeds up Therapeutic Drug Discovery and Design
3 Questions: Using AI to accelerate the discovery and design of therapeutic drugs | MIT News | Massachusetts Institute of Technology https://t.co/CZ4waA5IGg
DNA-Engineered Silver Nanoclusters Enable Precision Killing of Drug-Resistant Bacteria
A team led by Kirill Afonin at UNC Charlotte engineered programmable DNA scaffolds that organize silver nanoclusters into highly potent antimicrobial agents. The spatially arranged DNA‑AgNCs showed up to 78‑fold greater killing efficiency against ESKAPE pathogens and meningitis‑causing bacteria compared...
Indian Firms Roll Out $14 Generic Semaglutide as GLP‑1 Patent Expires
Indian drug makers announced the launch of $14 generic versions of Novo Nordisk's semaglutide following the expiry of its GLP‑1 patent. The low‑cost alternatives could reshape pricing for obesity and diabetes treatments in India and potentially influence global markets.
Aelis Farma Announces the Successful Start of the Recruitment of the Phase 2B Clinical Trial with AEF0217 for the Treatment...
Aelis Farma announced that recruitment has begun for its Phase 2B trial of AEF0217, a first‑in‑class signalling‑specific CB1 receptor inhibitor, aimed at treating behavioral and cognitive impairments in Down syndrome. The study will enroll 188 participants aged 16‑32 across ten...
FDA Drug Safety Communication: Planned Return of CardioGen-82 to Market with New Boxed Warning
On February 15, 2012, the FDA announced that Bracco Diagnostics’ CardioGen‑82 generator will re-enter the U.S. market after a voluntary recall in July 2011. The agency approved revised labeling that introduces a Boxed Warning and new “Alert Limits” for strontium‑82...
FDA Drug Safety Communication: Safety Update on Progressive Multifocal Leukoencephalopathy (PML) Associated with Tysabri (Natalizumab)
The FDA has revised the Tysabri (natalizumab) label to detail progressive multifocal leukoencephalopathy (PML) risk based on infusion count and prior immunosuppressant exposure. Data show 102 PML cases among 82,732 treated patients, with incidence rising sharply after 24 infusions. A...
Researchers Uncover Gut-Liver Serotonin Pathway that Limits Nanoparticle and Viral Delivery
Scientists at the University of Science and Technology of China identified a gut‑liver serotonin signaling axis that governs the rapid clearance of nanomedicines and viral vectors. The pathway links intestinal commensal bacteria to hepatic Kupffer cells, where serotonin amplifies phagocytic...
FDA Approves Nivolumab Regimen as First-Line Treatment for Classical Hodgkin Lymphoma
The FDA has granted first‑line approval for a nivolumab‑plus‑AVD regimen in patients aged 12 and older with stage III‑IV classical Hodgkin lymphoma. The decision follows the phase 3 SWOG S1826 trial, which showed a 58% progression‑free survival rate and a hazard ratio of...
Higher-Dose Semaglutide Approved Under New FDA Accelerated Review Process
The FDA granted accelerated approval to Wegovy HD, a 7.2 mg weekly semaglutide injection, marking the fourth product cleared under the National Priority Voucher pilot. Phase 3 STEP UP data showed a mean 20.7% weight loss, with nearly one‑third of participants shedding 25% or...
Early Use of Tirzepatide After Heart Attack or Stroke Linked to Key Cardiovascular Benefits
A real‑world propensity‑matched study of 1,666 non‑diabetic patients found that initiating tirzepatide within 14 days of an acute myocardial infarction or ischemic stroke cut the risk of emergency‑room visits, hospitalizations, acute kidney injury, repeat stroke and heart‑failure admission over two...
Top HHS Official Tamps Down Expectations on Scope of TrumpRx
The White House’s top drug‑pricing negotiator, Chris Klomp, clarified that the TrumpRx initiative is intended primarily to increase price transparency rather than serve as a broad marketplace for discounted drugs. He emphasized that the program will provide data tools and...
Review Highlights Multiple Treatment Options Available in DLBCL
A new review in Frontiers in Immunology outlines the expanding arsenal against diffuse large B‑cell lymphoma (DLBCL), the most common aggressive non‑Hodgkin lymphoma. While R‑CHOP still achieves durable remission in about 60% of patients, the authors detail how CAR‑T cells,...
Notices of Updates
The FDA released a series of updates between 2020 and 2026 that revise, recognize, or withdraw antimicrobial susceptibility breakpoints and standards for dozens of drugs. Recent actions include recognizing M100 MIC and disk‑diffusion breakpoints for amikacin, cefiderocol, and several beta‑lactam...
In the Clinic for March 20, 2026
The March 20, 2026 "In the Clinic" page aggregates a wide array of BioWorld snapshots, special reports, and infographics covering biopharma, medical technology, and emerging therapeutic areas. It links to daily data snapshots, market outlooks, and deep‑dive analyses such as the med‑tech...
AI Simulates Cells to Accelerate Drug Discovery
AI didn’t just enter biology. It’s starting to rebuild it from first principles. @MichaBreakstone sold his last company for $575M. Then he went after a harder problem. What if you could model how cells signal, respond, and adapt… before you ever run an...
FDA Must Add Spot Checks for Generic Drugs
Read “Bottle of Lies.” FDA needs to perform spot checks of generics - not just inspections.
Generic Semaglutide Versions Roll Out at Prices Pegged 80% Less that Novo Nordisk’s Ozempic
Indian drugmakers Natco Pharma, Glenmark Pharmaceuticals and Eris Lifesciences are set to launch generic semaglutide on March 23, 2026, just after the drug’s patent expired. The generics are priced roughly 80% less than Novo Nordisk’s Ozempic, with Natco’s vials costing...
Neuregulin‑2 Predicts Venetoclax Sensitivity in Non
Identification of a Novel Drug Sensitivity Biomarker Neuregulin-2 for Venetoclax in Non-t(11;14) Multiple Myeloma [Dec 12, 2021] Dai et al. Abstract 459 #ASH21 https://t.co/mnXEThuKgy #mmsm #PrecisionMedicine https://t.co/zx7d29Jzpk
HHS Weighs Appeal of Controversial Vaccine Schedule Ruling
To appeal or not to appeal (yet): The potentially politically dicey situation facing HHS over a preliminary court ruling this week on #ACIP and the rewritten childhood vaccination schedule. By @ChelseaCirruzzo. https://t.co/3P1PW1lDFT
Phase 3 Trial
.@SWOG S2213 Ph3 RCT Dara-VC Induction Followed by ASCT or Dara-VCD Consolidation & Daratumumab Maintenance in Pts w/ Newly Diagnosed AL Amyloidosis [Activated: 12/1/23] https://t.co/OizUfJCc2c #mmsm #bmtsm https://t.co/acq0EeyNFn
Phase 2 RCT Compares Dara‑
EAA241 - Ph 2 RCT Dara-Bor-Dex vs Cy-Bor-Dex in the treatment of Newly Diagnosed Multiple Myeloma with Light Chain Cast Nephropathy (LCCN) [Study activated 8/11/25] @keruakous https://t.co/1NgvVZ3fTA #NCT07085728 #mmsm @eaonc https://t.co/s8eqQJkQzK
Quadruplet Regimen Proves Effective in NDMM, Not Early
#EAOnc EQUATE EAA181 Effective Quadruplet Utilization After Tx Evaluation: Ph3 RCT NDMM Not Intended for Early ASCT [Activated: 10/27/20] PI= @myelomaMD https://t.co/qD26HMx3J8 #NCT04566328 #mmMRD #mmsm @eaonc @mweissmdphd @VincentRK @LynneWagnerPhD Wei Snyder Kostakoglu @mtmdphd
Daratumumab Boosts Revlimid Efficacy in Smoldering Myeloma
#EAonc EAA173 - Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM) - PI: @nsc_natalie https://t.co/VtBMJUjI5X Activated: Apr 30, 2019 #mmsm @eaonc #NCT03937635 @VincentRK @mweissmdphd https://t.co/lI3MqKHIiY
FDA Finally Holds Public Hearing on Priority Review Vouchers
Oh, *now* the FDA has decided to have a public hearing on the national priority review voucher program. After four drugs have completed the process. A year after the program was announced. This must be that "radical transparency" that @DrMakaryFDA...