Today's Pharma Pulse
Ona lands $86.6M Series B, one of Spain’s biggest biotech financings
Spanish biotech Ona announced a $86.6 million Series B round, ranking among the largest venture financings 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 funds will expand Ona’s AI‑driven drug discovery platform and accelerate its pre‑clinical pipeline.
Life Bio’s Trial: Is the FDA Warming to Rejuvenation?
Life Biosciences received FDA clearance for its ER-100 investigational new drug, marking the first human trial of a cellular reprogramming therapy aimed at the eye. The Phase 1 study will enroll patients with glaucoma or non‑arteritic anterior ischemic optic neuropathy, emphasizing safety, tolerability and basic vision metrics. The agency’s new Plausible Mechanism Pathway (PMP) may allow the company to fast‑track organ‑specific rejuvenation approaches, potentially extending the platform to liver disease with ER‑300 by 2027‑2028. Success could shift longevity research from symptom management toward true age‑reversal therapies.
Statins Cut Mortality for Over‑80s Without Added Risks
Should people over age 80 use statins? The answer is increasingly: YES. A recent study found that patients over 80 on statins had a one-third reduction in mortality. Perhaps more telling, people who stopped their statins appeared to have a 1/3...
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PERMIT PARALYSIS: How a Single Administrative Error Sparked 10 Months of Critical Medication Shortages in Eswatini
An administrative error in November 2023 led Eswatini’s Ministry of Health to suspend Fortunate Bhembe, the sole official authorized to sign import permits for controlled medicines. With no successor appointed, the country’s primary supplier, SwaziPharm, could not secure new imports,...
Flu Shot Cuts Alzheimer’s Risk Up to 55%
💉 Want to reduce the risk of Alzheimer' by 55%? A simple flu shot at the dosage recommended by the CDC for those 65 and older should do the trick. With 165,000 people in the study, they also...
AI Drug Discovery: Hype Overwhelms Real Clinical Success
AI Drug Discovery – Revolution or Expensive Illusion? | Ep. 978 https://t.co/YLQ8QNlnWv [ 00:34 ] Billions into AI drug discovery [ 01:04 ] AI doesn’t cure diseases [ 01:38 ] Expensive illusion vs reality [ 02:23 ] Original pitch inefficiency problem [ 03:48 ] Only 10...
Lynavoy (Linerixibat) Wins FDA Approval for Rare Liver Disease After Alfasigma-GSK Licensing Deal
Alfasigma secured FDA approval for Lynavoy (linerixibat), the first U.S. therapy specifically indicated for cholestatic pruritus in primary biliary cholangitis (PBC). The approval follows a March licensing agreement with GSK that could be worth up to $690 million, including a $300 million...
Gilead to Acquire Germany's Tubulis for Up to $5 B, Boosting ADC Portfolio
Gilead Sciences agreed to buy German biotech Tubulis for $3.15 B in cash, with up to $1.85 B in contingent payments, expanding its antibody‑drug conjugate pipeline. The deal comes as Organogenesis shares jump 6.5% after a successful diabetic foot ulcer trial, underscoring...
Researchers Unveil Sub‑micron Light‑driven Nanorobots that Capture and Remove Bacteria
A team of scientists announced the creation of sub‑micrometer nanorobots powered by a 980 nm laser that can capture and transport bacteria. The bots, 920 nm in diameter and weighing 0.26 pg, reach speeds of 50 µm/s and demonstrate precise, programmable trajectories, marking a...
Key Differences Between Biotechnology and Pharmaceutical Industries
The article clarifies that biotechnology firms develop medicines using living organisms, while pharmaceutical companies rely on synthetic chemical processes. It highlights the rapid growth of the biotech sector, projecting a global market of $6.34 billion by 2035, and notes that biotech...
Neuroblastoma Tumor Growth in Mice Suppressed by Blocking Enzyme to Inhibit mTOR Signaling
Researchers at The Hebrew University of Jerusalem identified neuronal nitric oxide synthase (nNOS) as a driver of neuroblastoma growth and showed that its inhibition suppresses mTOR signaling. Using the selective inhibitor BA-101 and siRNA knock‑down, they reduced nitric oxide production,...
New Catalyst Quickly Builds Complex Molecules for Drug Discovery
A new catalytic method enables rapid, selective synthesis of branched molecules from simple, inexpensive reagents, streamlining early drug discovery and expanding access to complex molecular architectures. drugdiscovery
AbbVie Files Lawsuit to Address ‘Outdated’ Drug Discount Eligibility Program
AbbVie has filed a lawsuit against the U.S. Health and Human Services Department seeking updated guidance on the 340B drug discount program. The company argues that current rules allow hospitals and clinics to claim discounts for patients with minimal or...
Lupin Shares to Be in Focus on Thursday as USFDA Approves Dapagliflozin and Metformin Tablets
Lupin announced U.S. FDA approval of its dapagliflozin and metformin hydrochloride extended‑release tablets, covering four dosage strengths and matching the brand Xigduo XR in efficacy. The approval follows the company’s recent acquisition of European eye‑care specialist VISUfarma, which contributed roughly $58 million...
Subcutaneous Tepezza Demonstrates Phase III Efficacy in Thyroid Eye Disease
Amgen reported that its subcutaneous formulation of teprotumumab‑trbw (Tepezza) met the primary endpoint in a phase III trial for moderate‑to‑severe active thyroid eye disease, with 76.7% of patients achieving a ≥2 mm proptosis reduction versus 19.6% on placebo. The study also showed...
Two Cancer Startups Secure $237M for Antibody Innovations
A couple cool cancer drug startups profiled this week in TR. Sidewinder Therapeutics with $137M for bispecific ADCs https://t.co/tJcQwI7C4U and Stipple Bio with $100M for novel targets for antibody drugs. https://t.co/rbXkuaRpoe
Why Advisory Committees Remain Essential in an Era of Complex Medicines
A senior FDA official recently dismissed advisory committees as costly, slow, and theatrical, prompting renewed debate over their role in drug review. Advisory committees (AdComs) are independent panels that convene when a therapy presents a nuanced benefit‑risk profile, offering real‑time...
Wedbush Flags One NKTR Dosing Interval as Unviable
You'll never guess which of these two dosing intervals Wedbush says "may not be viable" for $NKTR Rezpeg moving forward. Won't mince words - This firm is responsible for the worst sellside work I've ever seen. Sorry to be harsh,...
Umary and Related Products
The U.S. Food and Drug Administration has issued a warning that Umary and Amazy dietary supplements contain undeclared prescription‑drug ingredients, including dexamethasone, diclofenac, and omeprazole. Laboratory testing confirmed these hidden drugs, prompting voluntary nationwide recalls by several distributors. Parallel alerts...
High-Dose Wegovy Debuts at $399 for Self-Paying Patients
Novo Nordisk has launched Wegovy HD, a 7.2‑mg semaglutide injection, priced at $399 per month for self‑paying patients. The FDA approved the higher‑dose formulation in March, expanding the company’s weight‑loss portfolio beyond the previous 2.4‑mg limit. The new price is...
Novo Undercuts Lilly with Pricier Wegovy; Insmed Braces for Flop
Novo underprices Lilly with higher-dose Wegovy; Insmed absorbs ‘expected’ study failure https://t.co/jN9GuuOf4s $NVO $LLY $INSM $VRTX $BIIB
PhRMA Head Steve Ubl to Step Down at End of Year
Steve Ubl, who has led the pharmaceutical lobbying coalition PhRMA for more than a decade, announced he will step down at the end of the year. Under his stewardship, the group amplified its influence on Capitol Hill, championing policies that...
2024 NIA‑AA Definition Connects Biomarkers Directly to Care
The 2024 NIA-AA biological definition of Alzheimer’s disease: linking biomarkers to clinical practice https://t.co/00cP1mXXHR https://t.co/VQ59YeIUR1
Genomics Predicts Individual Weight Loss From GLP‑1 Drugs
Genomics of GLP-1 drug response and side effects With genomic and demographic data it's possible to predict magnitude of weight loss response @23andMe https://t.co/iAS2Fjjxig https://t.co/AXsWnZw2Ub
Forecasting Protein Aggregation with an Improved Algorithm
Scientists at the Autonomous University of Barcelona have released the fourth generation of their protein‑aggregation forecasting algorithm, which leverages AlphaFold structural data and molecular‑dynamics simulations. The tool lets users evaluate aggregation risk, explore mutations, scan protein families, and assess pH...
Faster Process Development via “Transfer Learning”
Transfer learning—a form of AI that reuses models trained on historic data—promises to accelerate biopharmaceutical process development. By applying existing predictive models to new, related fermentations, companies can forecast critical metrics such as viable cell density and product titre from...
Trump’s New Pharmaceutical Tariffs Will Hit Small Drugmakers Hardest
The Trump administration revived pharmaceutical tariffs, imposing a 100% base duty on imported patented drugs and their active ingredients. While generic medicines and UK imports are exempt, firms with Most Favored Nation (MFN) agreements—such as Pfizer and Eli Lilly—are shielded, and...
Redefining Bioprocessing Using Reservoirs of Biochemical Diversity
Scientists have uncovered a trove of heat‑tolerant glycosyltransferase enzymes in the rhizosphere soils of desert plants in Saudi Arabia. These extremophile enzymes, identified through metagenomic analysis, could improve glycosylation steps in biologics manufacturing by operating under high‑temperature, low‑moisture conditions. The...
Plant Molecular Farming Comes of Age
Plant molecular farming (PMF) has evolved into a scalable, GMP‑compatible platform for producing complex biologics, leveraging low‑energy plant growth and advanced transient‑expression systems. Recent advances in sensor technology, AI‑enabled host engineering, and digital manufacturing have lowered infrastructure costs and accelerated...
FDA Recommends Health Care Professionals Discuss Naloxone with All Patients when Prescribing Opioid Pain Relievers or Medicines to Treat Opioid...
The FDA has mandated that manufacturers add naloxone guidance to the prescribing information for all opioid pain relievers and medications for opioid use disorder (OUD). Health‑care professionals must now discuss naloxone availability with every patient receiving an opioid prescription or...
Bayesian Statistical Analysis (BSA) Demonstration Project
The FDA’s CDER Center for Clinical Trial Innovation (C3TI) has launched a Bayesian Statistical Analysis (BSA) demonstration project to encourage the use of Bayesian methods in simple phase 3 trials. The program lets sponsors collaborate with FDA statisticians to apply Bayesian...
FDA Warns About Risks of Dental Problems Associated with Buprenorphine Medicines Dissolved in the Mouth to Treat Opioid Use Disorder...
The FDA has issued a new safety warning that buprenorphine tablets and films dissolved under the tongue or against the cheek can cause dental problems such as cavities, abscesses, and even tooth loss. The alert applies to both single‑ingredient buprenorphine...
FDA Issues Series of Guidances Under Drug Competition Action Plan
The FDA released three new guidances under its Drug Competition Action Plan to streamline generic drug reviews. A final guidance clarifies the use of Information Requests and Discipline Review Letters, a revised draft updates procedures for aligning ANDA labeling with...
Approved First Generic for Apokyn Injection Cartridges Requires Separately Packaged Pen
The FDA approved Sage Chemical’s generic apomorphine hydrochloride cartridges, the first generic version of Apokyn for treating "off" episodes in advanced Parkinson’s disease. The generic cartridges work only with the proprietary Apokyn Pen, which must be obtained separately through specialty...
FDA Announces Evusheld Is Not Currently Authorized for Emergency Use in the U.S.
The FDA revised Evusheld's Emergency Use Authorization on Jan. 26, 2023, limiting its use to situations where susceptible SARS‑CoV‑2 variants comprise 90% or less of national cases. With current CDC data showing over 90% of circulating variants are resistant, Evusheld...
FDA Updates Sotrovimab Emergency Use Authorization
The U.S. Food and Drug Administration revoked the Emergency Use Authorization for sotrovimab on April 5, 2022, after CDC data showed the Omicron BA.2 sub‑variant accounted for more than 50 % of cases in every HHS region. Earlier in the year the agency...
Advancing Novel Surrogate Endpoints For Rare Disease Drug Development Workshop - 05/18/2026
The FDA is hosting a virtual workshop on May 18, 2026 to advance novel surrogate endpoints for rare disease drug development. The event is part of the Rare Disease Endpoint Advancement (RDEA) Pilot Program, mandated by PDUFA VII and FDORA, which requires up...
FDA Works to Protect Consumers From Potentially Harmful OTC Skin Lightening Products
The U.S. Food and Drug Administration issued warning letters to twelve companies for selling over‑the‑counter skin‑lightening products that contain hydroquinone, an ingredient not approved for OTC use. The agency highlighted serious adverse events such as rashes, facial swelling, and permanent...
New Nasal Flu Vaccine Shows Promise in Mice
Researchers at Georgia State University have engineered an intranasal influenza vaccine that uses cell‑derived extracellular vesicles (EVs) to display inverted hemagglutinin (HA) proteins. The upside‑down HA exposes the conserved stalk region while masking the variable head, prompting cross‑protective immunity. In...
Merck Adjusts Its Vaccine Supply Deal in China; Soleno Withdraws EU Application
Merck and its Chinese partner Zhifei have revised their COVID‑19 vaccine supply agreement, lowering the committed volume and adding a flexible delivery schedule to reflect waning demand. The updated contract preserves Zhifei’s exclusive distribution rights but shifts risk back to...
Jeito Capital, Prominent Biotech Investor, Raises $1.2B for Next Fund
Jeito Capital announced the close of its Jeito II fund, raising €1 billion (about $1.2 billion) – the largest capital raise ever for an independent European biopharma fund. The fund will back 15‑20 clinical‑stage drugmakers, allocating up to €150 million ($162 million) per company across...
Gilead Takes Another Big Swing at Expanding Beyond HIV
Gilead Sciences has earmarked roughly $11 billion this year for three strategic acquisitions aimed at strengthening its cancer and immunology pipelines. The moves signal a decisive pivot away from its historic reliance on HIV therapeutics toward broader biotech markets. The targeted...
Genomic Drivers of Venetoclax Resistance in T(11;14) Myeloma
Genomic mechanisms of resistance to venetoclax in multiple myeloma with t(11;14)(CCND1;IGH) [Apr 2, 2026] @MKaddouraMD et al. @lbaughn @BloodPortfolio https://t.co/qmI6giPG6K #mmsm #PrecisionMedicine https://t.co/hpwUcavTg9
New Gene Therapy May Help Protect the Hearts of Patients with Friedreich's Ataxia
Lexeo Therapeutics reported early-phase results for its investigational gene therapy AAVrh.10hFXN (LX2006) in Friedreich’s ataxia–associated cardiomyopathy. In a phase 1 trial of 17 adults, a single intravenous infusion was well tolerated and produced signals of cardiac improvement, while neurological scores remained...
Wildflower Once Used to Treat Wounds and Sore Throats Shows Promise in Fighting Dangerous Superbugs
Researchers at Irish universities have demonstrated that extracts from the wildflower tormentil (Potentilla erecta) possess strong antimicrobial activity against multidrug‑resistant bacteria, including strains that cause pneumonia and urinary‑tract infections. The study identified ellagic acid and agrimoniin as the key compounds...
RFK Jr. Pushes to Overturn Peptide Ban, Officials Dispute Claims
RFK Jr. May Reverse a Peptide Ban He Calls “Illegal.” Former FDA Officials Say He Mischaracterized Their Work. https://t.co/glqreTHvKA https://t.co/Vi4OTryX3p
Pemivibart Shows Safety, Prevents COVID-19 in CLL Subset in Phase 3 CANOPY Trial
A phase 3 CANOPY subset analysis evaluated pemivibart, a recombinant IgG1 monoclonal antibody, for pre‑exposure COVID‑19 prophylaxis in patients with chronic lymphocytic leukemia (CLL). Among 29 CLL participants, none developed symptomatic SARS‑CoV‑2 infection over a 180‑day follow‑up, and the safety profile...
Lymph-Node CD8+ T Cells Amplify PD-1 Blockade in GI Cancer
PD-1 antibody-bound progenitor-exhausted CD8+ T cells in lymph nodes boost PD-1-blockade anti-tumor immunity in gastrointestinal cancer https://t.co/VKoxzy6oUq https://t.co/cQG2sLWtL2
Post-HSCT Gilteritinib May Improve Outcomes in R/R FLT3-Mutated AML
A systematic review of eight studies suggests that post‑transplant gilteritinib maintenance may markedly improve survival for patients with relapsed or refractory FLT3‑mutated acute myeloid leukemia. One‑year overall survival rates ranged from 72.3% to 100%, while two‑year overall survival hovered around...
Sidewinder Therapeutics Raises $137 Million to Advance Bispecific ADCs
Sidewinder Therapeutics announced a $137 million Series B round, surpassing expectations and bringing its total capital to $162 million. The round was led by Frazier Life Sciences and Novartis Venture Fund, with participation from OrbiMed, DCVC Bio, Goldman Sachs, and others. The funding...
A New Way To Target Metastatic Cancer
Researchers have unveiled a protein‑based delivery platform that homes to lymph nodes and releases an immune‑activating antibody only in the presence of metastatic cancer. The two‑step system first accumulates in nodes after bloodstream injection, then opens in the tumor’s chemical...