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.
Tirzepatide Outperforms Dulaglutide on Cardiorenal Outcomes in High-Risk Diabetes
A post‑hoc analysis of the SURPASS‑CVOT trial shows tirzepatide (Mounjaro) delivering superior cardiorenal protection compared with dulaglutide in patients with type 2 diabetes and established cardiovascular disease. Over a median 47‑month follow‑up, the composite of mortality, myocardial infarction, stroke, coronary revascularization, heart‑failure hospitalization, and serious kidney events occurred in 23.7% of tirzepatide recipients versus 27.4% on dulaglutide (HR 0.84, p<0.001). The advantage persisted across narrower composite definitions, reinforcing the robustness of the finding. These results suggest a potential shift in therapeutic preference for high‑risk diabetic patients.
Pharmaceutical Executive Daily: Shionogi Receives Contract Through BARDA's Project BioShield
Shionogi’s U.S. subsidiary secured a BARDA Project BioShield contract that could total $482 million to develop and manufacture its gram‑negative antibiotic Fetroja, with an initial $119 million funded. The agreement funds a U.S. production facility and expands research against high‑priority biothreat pathogens...
With Cash to Burn and Patent Cliffs Looming, Pharma Giants Are Buying More Biotechs
Big‑pharma M&A activity has accelerated in 2026, with 14 deals over $500 million in Q1 alone—nearly half the total deals recorded in 2025. Gilead’s $7.8 billion purchase of Arcellx and Eli Lilly’s $6.3 billion acquisition of Centessa illustrate a push into cell‑therapy, autoimmune and...
Post-Hoc Live: Biopharma M&A Is Back, with Barclays' Emily Field
Biopharma mergers and acquisitions are experiencing one of their strongest periods in years, as major pharmaceutical firms rush to absorb smaller biotech innovators. In a Post‑Hoc Live interview, Emily Field, head of U.S. biopharma‑catalytics equity research at Barclays, and deals...
How to Build an Effective Environmental Monitoring Program Under Annex 1
The EU GMP Annex 1 revision reclassifies Environmental Monitoring (EM) from a compliance checkbox to a core element of sterile‑product contamination control. Legacy, sampling‑driven EM programs no longer satisfy regulators; they must be rebuilt on risk‑based assessments, integrated with cleaning, HVAC...
States Continue to Advance New PBM and Drug Pricing Legislation in 2026
State lawmakers in Virginia and Ohio are moving ahead with aggressive pharmacy‑benefit‑manager (PBM) reforms in 2026. Virginia’s Affordable Medicine Act would apply the Inflation Reduction Act’s maximum fair price ceiling to state‑regulated health plans and require PBMs to report fees,...
Interpretability Becomes New Scalability in Synthetic Biology
One of the most clarifying conversations we've had about where biotech should go next. Krish Ramadurai of @aixventureshq argues interpretability is the new scalability, and that the founders who build mechanistic, measurable platforms will define the next era of synthetic biology. He...
Polygenic Scores Make Parental Genetic Choices More Intentional
Parents already make genetic decisions about the traits of their kids when they select a partner. Now those choices are becoming more conscious. @herasight is building polygenic scores that predict traits and diseases across diverse ancestries. Looking forward to hearing @JonathanAnomaly...
Compounding Research
The FDA has launched multiple research collaborations to evaluate the safety and efficacy of compounded drug products. Partnerships with the National Academies of Science, Engineering, and Medicine (NASEM) focus on bioidentical hormone therapy and topical pain cream ingredients, while its...
Human Drug Compounding Policies and Rules
The FDA has released a series of guidance documents, interim policies, and Federal Register notices spanning 2014‑2025 that shape human drug compounding under sections 503A and 503B of the FD&C Act. Recent 2025 interim policies address bulk drug substance use for both...
How Long-Read Sequencing Is Scaling Beyond the Specialist Lab
Advances in long‑read sequencing accuracy, throughput and cost are moving the technology from niche labs to large‑scale research. PacBio’s HiFi reads now deliver whole‑genome data at a few hundred dollars per sample, enabling thousands of genomes per instrument annually. The...
Easier Access to GLP-1s Sends Usage Far Beyond Original Predictions
Morgan Stanley Research now projects that 55 million U.S. consumers will be using GLP‑1 drugs by 2035, up from its earlier estimate of 33 million. The surge is driven by Medicare coverage and the introduction of oral formulations. Despite higher discontinuation and...
Landmark Federal Indictment for Pop Peptides Alleged ‘Scheme’ Even as RFK Jr. May Soon Un-Ban Some
A federal grand jury indicted Dr. Justin Watkins, owner of Utah's TruHealth Clinic, for relabeling Chinese‑manufactured peptides and selling them to more than 200 patients without disclosing the source or FDA status. The indictment alleges that the clinic repackaged the...
British Heart Foundation Receives Largest Donation
The British Heart Foundation received a £6 million (≈$7.7 million) donation from the Garfield Weston Foundation, the charity’s largest single gift ever. The money will bolster the BHF’s Centre of Research Excellence in Advanced Cardiac Therapies, a joint venture with the Medical...
Re: Glucagon-Like Peptide-1 Receptor Agonists and Risk of Substance Use Disorders Among US Veterans with Type 2 Diabetes: Cohort Study
A BMJ cohort study emulating a target trial found that US veterans with type 2 diabetes who were prescribed glucagon‑like peptide‑1 (GLP‑1) receptor agonists experienced significantly fewer incident substance‑use disorders (SUDs) and related adverse events compared with those on sodium‑glucose...
AI Slashes Amgen's Drug Development Timelines up to 70%
Morgan Stanley met with Amgen (biotech) management on how AI is benefiting their workflows. Key findings: - 8%: Approximate industry drug-development success rate Amgen cited as the baseline AI could help improve. - 10–14 years: Typical drug-development cycle time Amgen cited...
Scientists Are Finally Unlocking a Cancer Treatment’s Full Potential
German hematologist Fabian Müller applied experimental CAR‑T cell therapy to a 47‑year‑old woman suffering from three severe autoimmune diseases, achieving remission and eliminating her need for transfusions. CAR‑T, originally developed for cancer, is now delivering months‑to‑years of remission in multiple...
STAT+: 5 Years After Lupus Breakthrough, CAR-T Is Still Surprising Autoimmunity Researchers
Five years after a pioneering CAR‑T treatment rescued a teenage lupus patient, the therapy has sustained remission and reshaped expectations for autoimmune disease management. The case, led by German rheumatologist Georg Schett, proved that engineered T cells could safely target...
Relacorilant (CORT125134)
Corcept Therapeutics received FDA approval for relacorilant, branded Lifyorli, in combination with nab‑paclitaxel for platinum‑resistant ovarian cancer. The oral agent is a selective glucocorticoid‑receptor antagonist that blocks cortisol signaling without binding other steroid receptors, differentiating it from older cortisol‑pathway drugs....
GoodRx Expands Access to Eli Lilly and Company’s New Oral GLP-1, Foundayo™, and Zepbound® KwikPen® with Self-Pay Pricing at More...
GoodRx announced a partnership with Eli Lilly to offer the newly FDA‑approved oral GLP‑1 drug Foundayo (orforglipron) at a self‑pay price of $149 per month. The platform is also rolling out self‑pay pricing for Lilly’s injectable Zepbound (tirzepatide) KwikPen at $299...
Long-Term Bimekizumab Data Confirm Sustained Efficacy, Consistent Safety in Hidradenitis Suppurativa: Steven Daveluy, MD
Long‑term data from the BE HEARD 1 and BE HEARD 2 trials show that 86.1% of hidradenitis suppurativa patients treated with bimekizumab remained flare‑free over a three‑year period. The biologic’s safety profile stayed consistent from week 16 through year 3, with no new signals detected. Early...
Cartography Biosciences Advances Strategic Oncology Collaboration with Gilead’s First Option Target Exercise
Cartography Biosciences announced that Gilead Sciences exercised its first option to exclusively license a novel oncology target identified through Cartography’s ATLAS and SUMMIT single‑cell platforms. The target is part of a multi‑year collaboration aimed at tumor‑selective antigens in triple‑negative breast...
Eli Lilly’s Mounjaro Loses Ground to Less-Expensive Semaglutide Generics & Innovator Novo Nordisk’s Products
Eli Lilly’s tirzepatide brand Mounjaro saw sales dip to ₹114 crore in March, down from ₹135 crore in February, as low‑cost generic semaglutide entered the Indian market. The generics, launched by 13 firms across 26 SKUs, are priced 50‑80% below Novo Nordisk’s Ozempic, Wegovy...
Makena (Hydroxyprogesterone Caproate Injection) Information
The FDA’s Center for Drug Evaluation and Research has proposed withdrawing approval of Makena, a hydroxyprogesterone caproate injection originally granted accelerated approval in 2011 to reduce preterm birth risk. A confirmatory trial—four times larger than the pivotal study—failed to demonstrate...
Pure Indulgence Aesthetics - 723267 - 04/01/2026
The FDA issued a warning letter to Pure Indulgence Aesthetics after a December 2025 inspection revealed serious DSCSA violations. The spa dispensed significantly more Botox units than it purchased from AbbVie, suggesting use of unauthorized sources, and was found with...
Psilocybin Mushrooms Are Going Mainstream, but Scientific Research and Regulation Lag Behind
Psilocybin mushroom use is exploding in the United States, with recent estimates showing about 11 million adults tried the substance in 2026. Legal reforms have decriminalized possession in cities like Denver and created supervised‑use programs in Oregon and Colorado, but most...
Office of Prescription Drug Promotion (OPDP) News
The FDA’s Office of Prescription Drug Promotion issued a final guidance on Jan 6 2025 that clarifies its enforcement policy for firm‑initiated communications of scientific information on unapproved uses (SIUU) to health‑care providers. The document specifies permissible source publications—journal reprints, clinical practice...
Are Genetically Engineered Humans Coming
CRISPR technology now makes germline editing of human embryos technically feasible, though current U.S. policy blocks federal funding and FDA approval. Private startups are exploring the market despite regulatory uncertainty, and some jurisdictions lack explicit bans. While disease‑preventing edits could...
GSK’s Leucovorin
what a timeline - Sept. 1999 - $GSK withdraws Wellcovorin (leucovorin) bc it's not selling Sept. 2025 - GSK is told by FDA to apply for a new indication for leucovorin after an FDA review of lit. March 2026 - FDA approves...
PharmaShots Magazine-April-2026 Edition
The April 2026 edition of PharmaShots spotlights AI’s rapid infiltration into pharmaceutical compliance, turning regulatory oversight into a continuous, data‑driven process. It also details a wave of high‑value deals, with Biogen, Eli Lilly and Merck acquiring AI‑centric assets and forging partnerships...
Prescription Drug User Fee Amendments
The FDA sent FY2025 clean‑up and FY2026 PDUFA fee invoices, with payments due Jan 20 2026 and Nov 13 2025 respectively. FY2026 fee rates rose to $4.68 million for full applications, $2.34 million for half‑fees, and $442,213 for annual program fees. Effective Oct 1 2025 the agency will...
Avalyn Plots IPO to Push Inhaled Pulmonary Fibrosis Pipeline Through Clinic
Avalyn Pharma announced its intent to launch an IPO on Nasdaq under the ticker AVLN, though the number of shares and target raise remain undisclosed. The company will channel the proceeds into advancing its inhaled pulmonary‑fibrosis pipeline, beginning with AP01,...
FDA‑Approved Chemotherapy Drug Doxorubicin Shows Promise Against Drug‑Resistant Herpes
Researchers at the University of Illinois Chicago reported that doxorubicin, an FDA‑approved chemotherapy agent, can inhibit drug‑resistant herpes simplex virus type 1 in early laboratory studies. The finding could accelerate a new treatment option for patients whose infections no longer respond...
Sir Demis Hassabis Wants to Automate Drug Design
DeepMind CEO Demis Hassabis reiterates his ambition to automate drug design using artificial intelligence. After AlphaFold earned the 2024 Nobel Prize in Chemistry for protein‑folding predictions, DeepMind is now channeling its expertise into generative models that can design therapeutic molecules...
Two Gene Variants Predict Weight‑Loss Drug Response and Side‑Effects
Researchers analyzing data from nearly 28,000 23andMe participants identified two genetic variants that modestly influence how much weight people lose on GLP‑1 drugs and their risk of nausea. The findings, published in Nature, could pave the way for more personalized...
Mysterious 'Compound X' Clears Toxic Parkinson’s Proteins From Brain
Researchers at Swinburne University disclosed that an undisclosed molecule, dubbed compound X, eliminated toxic protein clumps linked to Parkinson's disease in mice. The treatment activated the brain's glymphatic waste‑clearance system, resulting in measurable gains in balance and overall mobility. While the...
Innovent’s CDMO Gets Green Light to Make Biologics at Large Chinese Plant
Innovent Biologics’ CDMO, Altruist Biologics, received its first 20,000‑liter biologics production license from China’s NMPA for the Hangzhou plant, marking the country’s inaugural facility of this scale. The site, equipped with four 20,000‑liter bioreactors, will be expanded to 172,000 liters, complementing...
From Fringe to Formulary: How Integrative Medicine, Peptides, and the D2C Biomarker Stack Are Reshaping the Boundaries of Evidence-Based Care
Integrative health, once a fringe market, now commands a $30 billion out‑of‑pocket industry with 37 % of U.S. adults spending on modalities like acupuncture, functional‑medicine and peptide protocols. Federal agencies are building measurement tools—NIH’s NCCIH $170 M Whole Person Health Index—and the VA’s...
C4 Therapeutics and Roche Enter Oncology Collaboration Worth Over $1B to Develop DAC with Payload
C4 Therapeutics and Roche have signed a multi‑billion‑dollar partnership to develop degrader‑antibody conjugates (DACs) for cancer treatment. The deal launches two undisclosed oncology programs, with C4 providing its Torpedo degrader payload platform and Roche handling antibody selection, conjugation, and downstream...
Innate Pharma Poised for Breakthrough with Astra Phase III
Innate Pharma $IPH. €110m market cap, decent net cash position (runway for another few Qs), and several key drug programs reaching critical milestones. The most significant is a Phase III trial (monalizumab in lung cancer) run with Astra $AZN, with...
FDA Reopens Mifepristone Safety Review Amid Court Pressure
FDA is working on another safety review of abortion drug mifepristone, after a Louisiana court order/pressure from @HawleyMO - FDA in 2021 said it did not find increases in adverse events after allowing remote prescribing https://t.co/FcznZ41p45
Scientists Advance mRNA Immunotherapies for Cancer, Funding Lags
Now in addition to our @TexasChildrens @BCM_TropMed protein vaccines for global health, our scientists are refining the mRNA technology for new immunotherapies for pancreatic cancer and triple negative breast cancer, if only the grant support would hold… https://t.co/NEgq6DX4qz
AI‑Native Platforms Treat Genome Like Code, Transform Biotech
Investor Liliana Nordbakk believes the genome behaves like code and AI-native biology platforms will transform biotech. Excited to have her speaking at #SynBioBeta2026. Visit the SynBioBeta website to read the full article. https://t.co/3WOSXsz1zy
AI Creates Hypotheses; Medra Builds Factories to Test Them
AI is generating hypotheses, Medra is building the factories that test them and deliver the life-changing discoveries:
Eli Lilly's GLP-1 Pill Ignites Rivalry with Novo
Lilly launches GLP-1 pill, kicking off showdown with Novo Nordisk https://t.co/zM6udFvuNE by Kristin Jensen $LLY $NVO #obesity
B‑cell Reboot Shows Promise Across Multiple Autoimmune Diseases
More success for rebooting B cells towards cure of different autoimmune diseases beyond lupus, MS and others https://t.co/sFGMiFeiEF https://t.co/Dbvca9eox8
Beyond T(11;14): Expanding Venetoclax Use in Myeloma
Venetoclax in myeloma: t(11;14) and what else? {Commentary} [Apr 2, 2026] Catherine Pellat-Deceunynck @BloodPortfolio https://t.co/Zar26htoUT #mmsm #PrecisionMedicine https://t.co/zm0Fv6GY2l
Mixed Metastatic Sites Confound Apparent Treatment Effects
Your clinical trial baseline is a mix of liver mets, lung mets, bone mets, and primary tumors. You compare it to post-treatment samples from different sites. The "treatment effects" you find will mostly be tissue site differences. https://t.co/0PyjMM2Znl
Needham’s M&A Note Erroneously Flags LLY‑VKTX Deal
1000% certain ,Needham made a mistake in their "The Biotech M&A Landscape" note -(or maybe Viking got bought and they are the only ones that know it lol) calling out a few M&A targets and inadvertently mentioning a $LLY $VKTX...
Nasal Anti‑CD3 Cuts Neuroinflammation in Long‑COVID Mice
Our new preprint by @peowenlu @SaefIzzy @weinerlabhms and colleagues shows that nasal anti-CD3 monoclonal antibody treatment can reduce neuroinflammation in a mouse model of Long COVID, even when administered at 4 weeks after infection 🧠 https://t.co/P8FZA2XA37