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
START Center for Cancer Research has partnered with Trialing to broaden access to early‑phase oncology clinical trials throughout Europe. The exclusive agreement lets START distribute curated trial information and real‑time enrollment updates via Trialing’s platform, directly notifying oncologists when slots open. By streamlining the referral process, the collaboration aims to reduce access barriers and increase physician awareness of hundreds of active studies. The move builds on START’s recent alliance with Spain’s Fundación Rioja Salud to further expand trial reach.
Maryland’s life‑science cluster, home to over 2,700 institutions, is projected to generate a $16.7 billion R&D market by 2026. Six home‑grown biotech firms—SciNeuro, Gain Therapeutics, Theriva Biologics, Supernus Pharmaceuticals, Elixirgen Therapeutics and Altimmune—have secured sizable financing and strategic partnerships in the...
Clarity Pharmaceuticals presented Phase II Co‑PSMA data at the EAU Congress, showing its 64Cu‑SAR‑bisPSMA PET tracer outperforms the standard 68Ga‑PSMA‑11 in detecting prostate cancer recurrence at low PSA levels. In 50 men post‑radical prostatectomy, 64Cu‑SAR‑bisPSMA identified 63 lesions versus 24...
Cogent Biosciences announced that the U.S. FDA has accepted its new‑drug application for bezuclastinib in non‑advanced systemic mastocytosis (NonAdvSM), with a PDUFA target date of December 30 2026 and no advisory committee required. The filing is supported by the SUMMIT trial, which...
Ascendis Pharma released topline results from its Phase‑II New InsiGHTS trial evaluating TransCon hGH (lonapegsomatropin) administered once‑weekly versus daily somatropin in 49 prepubertal children with Turner syndrome. At week 52, the weekly formulation achieved an LS mean annualized height velocity...
Late line CRC therapies in development following $CTMX's data this week (from Guggenheim). A lot is riding on $CTMX's 10 mg/kg cohort which had just 19 evaluable patients (3 patients were excluded so ITT response rate is lower) so this needs...
In this episode, Immuneering CEO Ben Zeskin explains the company’s novel “deep cyclic inhibition” dosing strategy, which delivers intense, short‑duration MEK inhibition pulses instead of continuous suppression. By restoring the natural intermittent signaling rhythm in healthy cells while repeatedly ambushing...
Voro Therapeutics has signed a research collaboration with Daiichi Sankyo’s San Diego research institute to create tumor‑activated antibody‑drug conjugates (ADCs) using Voro’s PrimeBody platform. The partnership will focus on masked ADCs that employ proprietary masking domains and protease‑cleavable linkers to achieve...
Chinese researchers at Shandong University have engineered the probiotic strain Escherichia coli Nissle 1917 to synthesize and deliver the anticancer drug Romidepsin directly within breast‑tumor tissue in mice. The bacteria colonized the tumors, releasing the drug locally and achieving tumor‑inhibiting...
President Trump’s TrumpRx website claims to offer the world’s lowest prescription‑drug prices, but a New York Times analysis finds the opposite. The site lists only a few dozen negotiated U.S. prices, omitting widely used drugs such as statins and many high‑cost cancer...
On March 17‑18, 2026, major pharmaceutical companies, represented by Medicines Australia, began diverting critical medicines from the Strait of Hormuz sea lane to air freight and alternative routes to ensure delivery to Australia. CEOs Liz de Somer and Leyla Hannbeck...
TerraPower Isotopes announced on March 18, 2026 that it will build a new cGMP‑compliant manufacturing facility designed to raise actinium‑225 output by twenty times. The plant, slated for construction later this year, aims to address the growing demand for the...
On 6 March 2024, EU ambassadors in the Committee of Permanent Representatives (COREPER) reached a political compromise on a continent‑wide pharma reform. The deal tightens launch obligations for centrally authorised medicines, restricts the transferable exclusivity voucher, and creates a new antibiotic...
On March 18, 2024 the U.S. Food and Drug Administration approved AstraZeneca’s all‑oral, fixed‑duration combination of Calquence (acalabrutinib) and venetoclax for first‑line treatment of adult chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL). The decision follows the Phase III Amplify...
Researchers have engineered lipid nanoparticles tethered with a prodrug that releases an IDO‑1 inhibitor while simultaneously delivering mRNA encoding interleukin‑12. The dual‑action formulation, administered intratumorally, generated robust CD8⁺ T‑cell responses, mitigated T‑cell exhaustion, and produced complete tumor regressions in several...
No evidence that medicinal cannabis effectively treats anxiety, depression, or PTSD - according to the largest review of cannabinoids ever conducted.
The U.S. Federal Trade Commission announced it is closely monitoring how pharmaceutical companies respond to the upcoming patent cliff affecting numerous blockbuster drugs. FTC antitrust director Dan Guarnera said the agency’s “laser focus” on healthcare will target any anticompetitive conduct...
Zymeworks will present Phase 1 data on its folate‑receptor‑alpha ADC ZW191 and preclinical results for a novel pan‑RAS inhibitor ADC platform at the AACR Annual Meeting. The oral presentation will detail dose‑escalation safety and efficacy in advanced solid tumours, while...
ORIC Pharmaceuticals announced that two preclinical abstracts on its PRC2‑targeting agent rinzimetostat (ORIC‑944) have been accepted for poster presentation at the 2026 AACR Annual Meeting. The data show rinzimetostat, an allosteric EED inhibitor, maintains potency against EZH1‑overexpressing complexes and key...
ArriVent BioPharma will showcase two preclinical posters at the 2026 AACR Annual Meeting, highlighting its EGFR inhibitor firmonertinib and the dual‑target tetravalent ADC ARR-002. Firmonertinib demonstrates high‑potency inhibition of both classical EGFR mutations and exon‑20 insertion variants, with strong brain...
A BMJ study of more than 600,000 Veterans Affairs patients with type‑2 diabetes found that glucagon‑like peptide‑1 (GLP‑1) drugs significantly lowered the risk of developing substance‑use disorders, including alcohol, cannabis, nicotine, cocaine and opioids. The analysis compared GLP‑1 therapy with...
Our bottleneck for some of the biggest change ahead may be humans. I shared the story of Paul Conyngham and his dog Rosie on my Instagram when it broke. When I read the coverage, my shock was less that ChatGPT...
A NIH‑backed multicenter trial of 140 pregnant adults found that weekly injectable extended‑release buprenorphine achieved significantly higher rates of illicit opioid abstinence than daily sublingual buprenorphine, while also reducing serious maternal adverse events. The study, published in JAMA Internal Medicine,...
ABIONYX Pharma filed its Universal Registration Document (URD) for the fiscal year 2025 with the French regulator AMF on March 17, 2026 (filing D. 26‑0099). The URD is now publicly available on both the company’s website and the AMF portal. The...
Sanofi unveiled pre‑clinical data for an in‑vivo CAR‑T platform that delivers mRNA via lipid nanoparticles (LNPs) and a CD8‑targeting VHH nanobody, eliminating the weeks‑long ex‑vivo manufacturing step. The approach achieved tumor suppression in mice with less than 5% liver uptake...
Shivani Patel of ConnectiveRx explains how the Inflation Reduction Act forces pharmaceutical manufacturers to redesign patient‑assistance programs with a focus on gross‑to‑net protection rather than static access solutions. She emphasizes continuous program evaluation, cap adjustments, and alignment with channel‑distribution strategies...
Biotech firm Bicycle Therapeutics announced it will lay off roughly 30% of its workforce, about 86 employees, as it deprioritizes its experimental ADC zelenectide‑pevedotin. Regulators expressed doubts that the Phase 2 Duravelo‑2 trial data will support accelerated approval for metastatic bladder...
Autologous CAR‑T therapies dominate the current market but face logistical and clinical challenges. Patients must undergo leukapheresis, endure long vein‑to‑vein times, and often need bridging therapy, which can cause adverse events. To address these issues, companies are shifting toward off‑the‑shelf...
On February 20, 2026, the FDA issued warning letters to 30 telehealth companies for misleading claims about compounded GLP‑1 weight‑loss drugs such as semaglutide and tirzepatide. The agency highlighted that compounded products are not FDA‑reviewed for safety, efficacy, or quality,...
Delix Therapeutics announced the results of a Phase 1b study of zalsupindole, a selective 5‑HT2A receptor partial agonist, in patients with major depressive disorder. The trial, published in the January 2026 issue of ACS Chemical Neuroscience, demonstrated favorable safety, tolerability, and early...
A study asserts lack of disproportionate loss of muscle mass or strength cf weight loss from GLP-1 drug treatment, in mice and a small short term (12 weeks) trial in men The issue remains unsettled and counters the efforts by companies...
Researchers introduced BQTML‑CB, an NQO1‑responsive prodrug that releases cytochalasin B inside tumor cells, disrupting actin filaments and halting migration and proliferation. The design exploits the enzyme NQO1, overexpressed in many aggressive cancers, to achieve tumor‑selective activation while sparing NQO1‑deficient cells and...
Researchers have engineered biomimetic nanocarriers that combine liposomal structures with Myxobacteria outer‑membrane vesicles (OMVs) to deliver antibiotics. The hybrid carriers achieve higher drug loading and can penetrate intracellular Gram‑negative pathogens, while native OMVs avoid immune clearance and sustain extracellular exposure....
The review highlights how bacterial membrane composition critically shapes the activity of antimicrobial peptides (AMPs) and outlines experimental and computational strategies for their rational design. By examining case studies, it maps structure‑activity relationships that govern membrane disruption versus intracellular targeting....
The FDA issued a third complete response letter rejecting Aldeyra Therapeutics' lead dry‑eye candidate, reproxalap, citing a lack of substantial evidence and inconsistent efficacy data. The agency noted the drug failed to demonstrate clear benefit in well‑controlled studies, though no...
Gifthealth unveiled an off‑the‑shelf platform that enables manufacturers to offer Most Favored Nation (MFN) pricing through direct‑to‑patient (DTP) programs. The solution leverages Gifthealth’s position as the nation’s largest DTP partner, handling over 90% of U.S. DTP volume and supporting more...
Bristol Myers Squibb faces a major patent cliff as flagship drugs like Revlimid, Pomalyst, Opdivo and Eliquis lose exclusivity, threatening its revenue base. To counteract the decline, the company is reshaping its pipeline through internal R&D and high‑profile acquisitions, emphasizing...
Persistent Systems has partnered with NVIDIA to bring Agentic AI to the healthcare and life‑sciences sector, focusing on computational drug discovery. Leveraging NVIDIA’s full AI stack—including AI Enterprise, BioNeMo, the NeMo Agent Toolkit, and NIM microservices—Persistent built GenMolVS, a generative...
In February 2026 the European Commission and the CHMP granted marketing authorisations and positive opinions for a slate of innovative therapies spanning COVID‑19, oncology, cardiology, immunology and rare diseases. Notable approvals include Moderna’s mNEXSPIKE COVID‑19 vaccine, Hansoh’s Aumseqa for EGFR‑mutated...
In this DDW Highlights episode, Bruno Quinney reviews four major stories: a Mayo Clinic study linking the Parkinson's protein alpha‑synuclein to dramatically faster Alzheimer’s progression in women; a Texas A&M‑funded project testing extracellular vesicle (EV) therapy to modulate microglia and...
Pfizer disclosed topline Phase II (FOURLIGHT‑1) data showing that atirmociclib combined with fulvestrant outperformed fulvestrant alone or everolimus + exemestane in 264 HR+, HER2‑negative metastatic breast cancer patients previously treated with CDK 4/6 inhibitors. The trial met its primary endpoint, delivering a statistically significant...
Scientists are accelerating development of mRNA cancer vaccines, with more than 120 clinical trials targeting melanoma, brain, breast, lung and prostate tumors. Early studies, such as personalized vaccines for glioblastoma, demonstrate rapid immune activation and improved survival. Simultaneously, a false...
In response to suggesting peptide drugs should have good evidence on safety and efficacy in order to weigh the risks and benefit…
Ketamine, an operating-room anesthetic also prized as the street drug “K” is now at the heart of a largely unregulated online industry offering depression relief. https://t.co/pGd0TO5uFy via @WSJ
U.S. lawmakers warned that China dominates the supply chain for essential hospital and outpatient medicines, especially generic drugs that fill 90% of prescriptions. Witnesses at a Senate Aging Committee hearing highlighted that China controls roughly 90% of key starting materials...
From Prof Jin and my colleagues @scrippsresearch the largest in vivo CRISPR data engine, nearly 8 million cells, in collaboration with @nvidia and featured at GTC
Pfizer’s Ibrance successor moves forward with new study data https://t.co/ozXAZYmc3M by Kristin Jensen $PFE $LLY $NVS $RHHBY $ONC
Acute asthma and COPD exacerbations remain a costly, life‑threatening gap despite advances in chronic therapies. Connect Biopharma, led by Barry Quart, is the first biotech targeting these flare‑ups with a biologic that blocks IL‑4Rα, aiming to curb upstream inflammation. The...
The Trump administration is "gearing up for war" to push Congress to codify its drug pricing policy — despite little appetite for it on the Hill. Still, the pharma industry sees risk in the back-and-forth. https://t.co/DR2LotvXFq
Scientists from VIB and KU Leuven have identified the mechanism by which lecanemab (Leqembi) clears amyloid plaques in Alzheimer’s disease. Their study shows that the antibody’s Fc fragment engages microglia, reprogramming them to phagocytose and degrade plaques. Removing the Fc...
