Know What's Happening in Pharma
Know What's Happening in Pharma
Eli Lilly’s oral GLP‑1 pill and triple‑agonist trial reshape obesity drug race
The FDA approved Lilly’s oral GLP‑1 weight‑loss tablet Foundayo (orforglipron), which can be taken without food or water restrictions. In a Phase 3 trial, Lilly’s experimental injectable triple‑hormone agonist retatrutide achieved a 28.7% average body‑weight reduction, outpacing Novo Nordisk’s next‑generation candidates.
Also developing:
By the numbers: Lupin Limited acquires VISUfarma
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 activity and shortens carrier circulation. Depleting gut microbes or blocking serotonin production boosted tumor delivery of nanoparticles two‑ to three‑fold and increased gene‑editing efficiency up to fifteen‑fold. The findings offer a universal strategy to overcome one of the longest‑standing obstacles in drug‑delivery technology.
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...
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...
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...
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...
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,...
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...
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 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...
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
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...
.@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
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
Earendil Labs announced a $787 million financing round, the largest recent capital raise for AI‑enabled drug development. The funding, led by Sanofi and the Biotech Development Fund, will be used to scale its AI‑driven biologics discovery platform, expand R&D teams, and...
#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
#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
Dr. Gator’s latest update adds a new chapter to *Between a Shot and a Hard Place*, reflecting a year of rapid shifts in U.S. vaccine policy, legal battles, and scientific debate. The chapter details CDC schedule changes that now mirror...
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...
Imatinib (Gleevec®/Glivec®) is an oral ATP‑competitive inhibitor of the BCR‑ABL fusion tyrosine kinase, approved by the FDA in 2001 for Philadelphia chromosome‑positive chronic myeloid leukemia and other malignancies. The drug emerged from high‑throughput screening, structure‑activity relationship optimization, and structure‑based drug...
This is a recurrent fiasco. Health care companies that now the serious risk of their device or drug but keep selling it and do not acknowledge the hazard. Until so many people are harmed. Today's front page @nytimes by @katie_thomas @bostonsci...
The UK’s National Institute for Health and Care Excellence (NICE) has reopened its evaluation of Eli Lilly’s donanemab and Eisai’s lecanemab after initially rejecting them on cost grounds. A newly‑introduced cost‑effectiveness threshold of roughly £20,000 per quality‑adjusted life year (QALY)...
Novartis announced a deal worth up to $3 billion to acquire SNV4818, a pan‑mutant‑selective PI3Kα inhibitor aimed at hormone‑receptor‑positive, HER2‑negative breast cancer. The transaction includes $2 billion upfront and potential milestones exceeding $1 billion, with closing expected in early 2026. Collegium Pharmaceutical agreed...
ConnectiveRx VP Kristine McGaughey emphasizes that an 18‑to‑24‑month pre‑launch window is critical for specialty drug rollouts. Early alignment of market access, patient services, pricing, and hub teams prevents day‑one friction and enables rapid patient access. She contrasts emerging biopharma, which...
Why should tumor whole genome sequencing (WGS) be done for cancer? In real practice of medicine study of 888 patients with solid cancers, WGS directly led to clinical consequences in over 40% @NatureMedicine https://t.co/kFho0yuLS7
Giant biotech round that hit right after I sent Pro Rata: Earendil Labs raises $787M https://t.co/NWt2bBA9Lr
Researchers at China’s National Center for Nanoscience and Technology have developed an AI‑driven platform that screens ionizable lipids based on their three‑dimensional conformations. The model identified a novel lipid, P1, which delivers mRNA 14.8 times more efficiently than the clinically...
caveat here is that it was routine when Prasad ran CBER (at least 4 overrules in Prasad's 10 mo. tenure) but it didn't/doesn't still seem to be happening elsewhere in FDA
AI to understand the language of life. Our review @NatureBiotech just published https://t.co/i0WMaXBCHl Free access https://t.co/3LPulNxlD0 @VishRao5 @serena2z @BrianPlosky @pdhsu @BoWang87 @james_y_zou @marinkazitnik @pranavrajpurkar
The Ron Lanton Report highlights a fundamental shift where regulatory signals now drive company valuations and strategic choices before formal rules are enacted. Investors are pricing policy risk early, treating anticipated regulations as a capital‑allocation factor. The discussion spans FDA...
Political influence ‘a serious problem’ for FDA under Trump, former commissioner says https://t.co/52IR3LfECD via @statnews
The FDA granted a 54‑day fast‑track approval for Wegovy HD, a 7.2 mg semaglutide injection that delivered a 20.7% average weight loss in trials, under the National Priority Voucher program. In return, the maker committed to specific Medicare and Medicaid pricing...
The future of promising therapeutics is on the line in the Trump administration's FDA, says the agency's former commissioner https://t.co/vyt49FkDsb
Researchers have engineered a tri‑specific scaffold cell (TriSC) platform in the probiotic strain *Escherichia coli* Nissle 1917 that uses three orthogonal coiled‑coil motifs to create a programmable, reversible surface. The system enables simultaneous, selective attachment of multiple nanobody cargos and...
Good news for America’s children. ACIP was devoid of vaccine expertise and made harmful and ideologically driven recommendations that went against pediatric medical science. Hopefully we can rebuild pubic confidence in vaccines despite their efforts to undermine it, but it...
Roche announced it will discontinue development of its anti‑myostatin antibody emugrobart for spinal muscular atrophy (SMA) after the Phase 2/3 MANATEE trial failed to demonstrate consistent muscle‑growth or motor‑function benefits. The study enrolled 259 patients and compared emugrobart plus Evrysdi against...
The FDA approved Rhythm Pharmaceuticals' once‑daily injection Imcivree for acquired hypothalamic obesity in adults and children aged four and up. Clinical trials showed an 18‑percentage‑point weight‑loss advantage over placebo, making it the first therapy for this rare, brain‑injury‑driven condition. Rhythm...
Roche’s Genentech has halted the Phase III development of its muscle‑preserving therapy for spinal muscular atrophy (SMA) and facioscapulohumeral muscular dystrophy (FSHD). The decision follows disappointing efficacy signals and safety concerns that emerged in late‑stage trials. The program also included an...
NICE has agreed to revisit its June 2025 rejection of Eli Lilly’s Kisunla (donanemab) and Eisai’s Leqembi (lecanemab) for NHS reimbursement. The appeal will send the dossiers back to the appraisal committee to re‑examine clinical benefits, long‑term data, infusion costs and unpaid...
Northwestern researchers discovered that microglia within glioblastoma uniquely express the fructose transporter GLUT5 and metabolize fructose to suppress immune activity. In mouse models, genetic deletion of GLUT5 halted tumor growth and provoked a strong CD8⁺ T‑cell response. The study, published...
Shionogi announced the first patient enrollment in its global Phase II Esprit trial, evaluating the oral substrate‑reduction therapy S‑606001 in adults with late‑onset Pompe disease. The 52‑week, double‑blind, placebo‑controlled study will run across the EU, the UK and the United States,...
Researchers at Technion’s Levenberg Laboratory have created a first‑of‑its‑kind three‑dimensional implant that merges muscle, fat, a hierarchical blood vessel network and, uniquely, a lymphatic system. The construct is printed with a custom extracellular‑matrix bio‑ink and matured in a flow‑controlled bioreactor....
Psychedelic research has surged, but recent psilocybin trials reveal modest benefits that fail to outpace placebo. A German study with 144 treatment‑resistant depression patients found no statistically significant advantage for high‑dose psilocybin. An open‑label review of 24 trials concluded psychedelics...
$NVS paying $2bn for Synnovation's SNV4818, after $LLY paid $1.5bn for Scorpion's STX-478. Mechanistically, seems like good news for $RLAY, bad for $OKUR & $COGT
LivaNova received FDA Premarket Approval for its aura6000 neurostimulation system, targeting adults with moderate‑to‑severe obstructive sleep apnea (OSA) who cannot use or have failed first‑line therapies. The approval is based on the OSPREY randomized controlled trial, which showed a 65%...
Novartis announced the acquisition of experimental breast‑cancer drug SNV4818 from Synnovation Therapeutics for a $2 billion upfront payment, with up to $1 billion in milestone‑based earn‑outs. The oral agent is in a Phase 1/2 study targeting mutant PI3Kα in HR‑positive, HER2‑negative tumors while...
#compchem #machinelearning #quantumcomputing New preprint: "The Convergence Frontier: Integrating Machine Learning and High Performance Quantum Computing for Next-Generation Drug Discovery". @qubit_pharma https://t.co/4D23DV0uAk
Researchers from UCLA, Stanford, Utah, and Columbia have engineered T cell receptors to strengthen catch‑bond interactions with prostate cancer antigens, improving cytotoxic function. By altering just one or two amino acids in the TCR, the modified cells exhibit longer bond...
Scientists at University College London have engineered bio‑grown oesophageal segments using patient‑derived stem cells and implanted them into minipigs, restoring normal swallowing. The grafts were seeded onto decellularized scaffolds, covered with a biodegradable mesh, and integrated functional muscle, nerves, and...
The AlphaFold moment was never the finish line. It was the starting gun. @saakohl helped build the system that cracked protein structure prediction… then left @GoogleDeepMind to go one step further. Design the molecules themselves. From scratch. In silico. Before a single experiment...
Researchers at the Institute of Physical Chemistry (IPC PAS) and the University of Warsaw have created a magnetic‑field‑driven system that arranges endothelial‑cell‑coated microparticles into predefined lattices, prompting the growth of microvascular networks with precise architecture. By using super‑paramagnetic beads and micromagnets,...
