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
The White House has drafted a drug‑pricing bill and is privately meeting with more than a dozen major pharmaceutical companies to secure their backing. The proposed legislation mirrors voluntary pricing agreements the administration previously struck, and notably would allow cash‑paid drugs to count toward patients’ deductibles. President Trump is pushing the measure as part of a broader affordability agenda in this election year. The effort reflects a strategic bid to build bipartisan support for health‑care reforms before the November vote.
At the 2026 American Academy of Dermatology meeting, phase 3 ADORING 1 and 2 trials demonstrated that once‑daily tapinarof cream significantly improves rash and itch in moderate to severe atopic dermatitis, with effects evident by week 1 and sustained through eight weeks. The studies...
In 1992, scientists discovered a chemical in Gila monster venom that mimicked GLP-1, the hormone your gut releases to signal fullness. By tinkering with its structure, pharma companies extended its duration from two hours (the Gila monster version) to one...
In a recent FDA Q&A, Dr. Sarah Yim explained that the agency has now approved 50 biosimilars covering 15 reference biologics, spanning treatments from oncology to diabetes. She clarified the distinction between biosimilars and interchangeable biosimilars, noting that the latter...
The FDA has approved an update to the neffy 1 mg epinephrine nasal spray label, eliminating the previous age minimum of four years. The only remaining eligibility criterion is a patient weight of at least 33 lb, covering children as young as...
Pharma firms are leveraging real‑world data (RWD) to map the patient journey of non‑small cell lung cancer (NSCLC) and uncover social determinants of health that hinder care. The new eBook highlights how gaps in biomarker testing, socioeconomic barriers, and incomplete...
Akeso Inc. announced a 51.5% year‑on‑year increase in 2025 commercial sales to RMB3.033 bn (about $425 m) and secured Chinese regulator clearance to launch Phase II trials of two first‑in‑class antibody‑drug conjugates. The results underscore the biotech’s rapid commercial expansion and its strategic...
Agentic AI is emerging as a pivotal technology in healthcare, building on generative AI momentum. Xaira Therapeutics unveiled the largest virtual cell model to date, enhancing complex biology simulations. Researchers redesigned lipid nanoparticles to avoid the liver and concentrate in...
On March 27, 2026 BioWorld reported a flurry of regulatory actions affecting a broad swath of biopharma and med‑tech companies. The snapshot lists approvals, designations and submissions for firms such as 3D Systems, Agilent, Deciphera, Royal Philips and several others....
Johnson & Johnson’s Darzalex (daratumumab) received European Medicines Agency approval for self‑administration, becoming the first oncology injectable cleared for home use. The Type II label change allows patients or caregivers to give the subcutaneous injection after the fifth dose, covering all...
CareTria’s CEO Willis Chandler told Pharmaceutical Commerce that 50% of patients abandon specialty drugs due to fragmented support and lengthy benefit verification. The company’s automated platform unifies provider, pharmacy, and payer workflows, slashing the time from prescription to therapy from...
Milestone Pharmaceuticals received FDA approval on December 12, 2025 for CARDAMYST, a 70 mg nasal spray of etripamil designed to rapidly convert acute paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm. The pivotal RAPID trial enrolled 255 adults across eight countries, showing...
In a debut interview for BioPharm Drug Digest, Bristol Myers Squibb’s senior vice‑president of Product Development, Manisha P. Desai, explains how strategic, end‑to‑end partnerships are reshaping bioprocessing and biopharma R&D. She highlights a shift from traditional fee‑for‑service outsourcing to deep collaborations that integrate...
Celldex Therapeutics reported Phase 2 data showing its KIT‑targeting antibody barzolvolimab dramatically improves quality‑of‑life scores for chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU). At Week 52, 94 % of CSU patients achieved a Dermatology Life Quality Index (DLQI) of 0‑1, and...
Researchers at the University of Pennsylvania identified the endothelial receptor TIE2 as a pivotal link between the MEKK3‑KLF2/4 and PI3K signaling cascades that drive cerebral cavernous malformations (CCMs). In mouse models, oral inhibition of TIE2 with the tyrosine‑kinase inhibitor rebastinib...
The U.S. Food and Drug Administration has approved Novo Nordisk’s once‑weekly insulin, the first longer‑acting basal therapy for type‑2 diabetes in the United States. The product, insulin icodec, demonstrated non‑inferior HbA1c reduction and comparable safety to daily basal insulins in...
Outstanding piece here from @leilei_wuu on AstraZeneca's in vivo CAR-T for multiple myeloma. There's data on 5 patients, which is pretty lean, but 4 come out MRD negative in two months, which is extraordinary. We're going to see a lot...
The European Medicines Agency has issued a positive opinion on Sanofi’s subcutaneous version of Sarclisa, a drug for multiple myeloma, citing late‑stage trials that proved non‑inferior efficacy to the intravenous formulation. If the European Commission follows the EMA’s recommendation, the...
Brightseed unveiled the world’s first clinically validated enterprise AI platform, designed to unite discovery, development, and commercialization for health‑science products. The system targets the industry’s 75% early‑stage failure rate by eliminating fragmented workflows and late‑stage risk discovery. Powered by the...
A BioSpace webinar highlighted how biotech firms can close the expectation gap with the FDA to avoid last‑minute decision‑day setbacks. Speakers emphasized the FDA’s recent pledge—led by Commissioner Marty Makary and CBER Director Vinay Prasad—to provide regulatory navigation for small companies,...
Researchers reported that the oral GLP‑1 tablet orforglipron achieved greater weight loss and blood‑sugar reduction than injectable semaglutide (Ozempic) in a 52‑week phase‑3 study. The findings could shift prescribing patterns for obesity and type‑2 diabetes.
UT Health San Antonio has started a National Institute on Aging‑funded, randomized trial of rapamycin and everolimus in roughly 84 adults 65 to 90 years old. The six‑week study will assess safety, optimal dosing and biological markers of healthy aging,...
Researchers at Worcester Polytechnic Institute unveiled an artificial‑intelligence model that identifies Alzheimer’s disease from MRI scans with 93% accuracy. The breakthrough could shift screening from symptom‑based to image‑based detection, accelerating treatment and trial enrollment.
GlaxoSmithKline announced that the European Medicines Agency has accepted the marketing authorization application for bepirovirsen, an antisense oligonucleotide targeting chronic hepatitis B. The acceptance follows positive Phase III data from the B‑Well 1 and B‑Well 2 trials, which enrolled patients...
Nordic Cold Chain Solutions (NCCS) has opened a GLP‑1 & Small‑Format Packaging Innovation Lab to help pharmaceutical manufacturers, specialty pharmacies and e‑commerce players manage temperature‑sensitive drugs. The lab provides end‑to‑end services from early‑stage design and pilot testing to high‑volume production,...
AstraZeneca’s in‑vivo CAR‑T platform, acquired last year, has entered a Phase I/II trial in China for relapsed/refractory multiple myeloma. Early data show a 33% overall response rate with several partial remissions, but the study also reported one death due to severe...
The NCCN has revised its guidelines to place checkpoint inhibitors at the forefront of cutaneous squamous cell carcinoma (CSCC) treatment, extending their use beyond metastatic disease to neoadjuvant and adjuvant settings. PD‑1/PD‑L1 agents such as cemiplimab, cosibelimab and pembrolizumab are...
GLP‑1 receptor agonists are booming in the United States, where roughly 12 % of patients use them, but European uptake lags at about 2 % across the EU and UK. Consumer skepticism—especially in France, Italy and Spain—and the dominance of public‑health reimbursement...
Novartis announced it will pay up to $2 billion upfront to acquire Excellergy Inc., securing the biotech’s next‑generation anti‑IgE candidate. The move comes as Xolair, Novartis’ blockbuster allergy drug, prepares for imminent biosimilar competition that could erode its market share. By...
Researchers at UCLA Health and Stanford Medicine reported that a neoadjuvant regimen combining hypofractionated radiation, the experimental immunomodulator BO‑112, and anti‑PD‑1 therapy (nivolumab) can reshape the tumor microenvironment of soft‑tissue sarcoma. Preclinical mouse work and a Phase I trial in 14...
Researchers at the University of Chicago have unveiled a whole‑body spatial transcriptomics method that slices frozen mice and maps gene expression across millions of cells in a single cross‑section. Using a cryomacrotome and 600,000 spatial spots, the technique captured activity...
AstraZeneca announced that its investigational COPD antibody achieved positive results in two Phase 3 trials, marking a turnaround after a previous mid‑stage failure. The studies demonstrated statistically significant improvements in lung function and exacerbation rates across a broader patient population...
Human Longevity, Inc. and the LEV Foundation announced a strategic partnership to analyze blood samples from centenarians and supercentenarians. The collaboration will use HLI's AI‑driven precision longevity platform and LEV’s expertise in lifespan extension to uncover molecular drivers of exceptional...
Novo Nordisk announced that the U.S. Food and Drug Administration has approved Awiqli (insulin icodec-abae), the first and only once‑weekly basal insulin for adults with type 2 diabetes. The approval follows the ONWARDS phase 3a trial program involving roughly 2,680 patients and...
A preclinical study in Small describes an inulin‑butyrate nanogel that releases butyrate directly in the inflamed colon of mice, markedly improving colitis outcomes. The nanogel remains stable through the upper GI tract and is enzymatically activated by colonic microbes, delivering...
Hyman, Phelps & McNamara (HPM) announced a vacancy for a 3rd‑to‑6th year associate attorney on its drug development team. The role supports clients through the full FDA pre‑market lifecycle, from pre‑IND strategy to IND, NDA/BLA submissions and dispute resolution. Candidates...
Hims & Hers announced it will stop actively marketing compounded GLP‑1 drugs and focus on a broader portfolio of FDA‑approved, branded GLP‑1s through a new partnership with Novo Nordisk. The pivot follows a 70% stock plunge and aims to sustain...
It was a pleasure to participate in the Investment and Innovation Pathways to a Healthy Asia session at the Global Investors’ Symposium in Hong Kong. A timely discussion on where durable value is being created in healthcare across Asia, from prevention...
The life of a chemist is about to change dramatically as we move away from tedious trial-and-error and deeper into the comfort of the prompt window. We don't need fewer medicinal chemists; we need more high-novelty drugs on the market...
Simulations Plus has launched strategic partnership programmes with three pharmaceutical companies to embed AI‑driven modelling into the drug development lifecycle. The collaborations will integrate Simulations Plus platforms—ADMET Predictor, GastroPlus, Thales and MonolixSuite—into model‑informed drug development (MIDD) workflows, enabling natural‑language interaction and automated...
Early details of what's in the White House's drug pricing bill text — and who's getting a sneak peek of it https://t.co/Yt8usm4yOa
AstraZeneca lung drug gets ‘surprise’ win in COPD trials https://t.co/QuRlOQtzdT @ByJonGardner $AZN $RGN $SNY $RHHBY
Zhongzhi Pharmaceutical Holdings Limited announced a full‑year 2025 net profit of RMB17.29 million ($2.4 million), an 82% plunge from the previous year, while revenue dropped 21.5% to RMB1.737 billion ($243 million). The sharp contraction underscores growing pressure on Chinese drug makers amid a tightening...
We can vibe-code cancer vaccines, and you think no one is going to be able to vibe-code a doomsday virus?
Novartis targets Xolair successor in buyout of startup Excellergy https://t.co/eGYQ2AxTd5 by @gwendolynawu $NVS $RHHBY #startups #biotech
Now at 1M+ views. What struck me most here wasn’t the views. It was the engagement. People are ready to engage seriously with aging biology. Now the opportunity is to turn that energy into stronger collaboration, better translational science, and...
As someone who has covered cancer drug development for 25 years, one of the few things I am sure of is that the odds of technology folks thinking they understand biology are much higher than the odds they actually do.
Couple interesting meetings for FDA Commissioner Makary: met with Arnold Ventures on Mar. 3 about "collaboration opportunities" https://t.co/vEyhDu5xaW and with $MNPR on "establishing a regulatory mechanism" on Mar. 13 https://t.co/DHaD6IlvCS
Pharma’s appetite for psychedelic therapies is rapidly accelerating, with M&A interest heating up across the sector.
When we seeded Denali the idea was to break the curse of the blood/brain barrier. It took a decade and tons of faith and money. Biotech is hard. Curing diseases is hard. This is a good summary. ...
