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
India’s Directorate General of Trade Remedies has launched an anti‑dumping investigation into ethyl chloroformate imports from China following a complaint by domestic producer Paushak. The probe, covering Oct 2024‑Sept 2025, could lead to duties that raise costs for drugmakers and agrochemical firms while protecting Indian manufacturers.
Merck Animal Health announced that the FDA has approved an expanded label for its once‑yearly injectable parasite control, Bravecto Quantum, adding treatment and control of Asian longhorned tick (Haemaphysalis longicornis) and Gulf Coast tick (Amblyomma maculatum) for 12 months. The product...
The FDA issued draft guidance to help drug developers validate new approach methodologies (NAMs) as alternatives to animal testing. The guidance outlines four validation principles—context of use, human biological relevance, technical characterization, and fit‑for‑purpose—to ensure NAM data are reliable for...
Matthew Turner, President of Patient Affordability at Paysign, says next‑generation copay assistance relies on ecosystem partnerships rather than a single‑vendor model, combining best‑in‑class services such as messaging, hub operations, and nursing education. He highlights financial threats like accumulator and maximizer...
MilliporeSigma, the life‑science arm of Merck KGaA, completed its €104 million acquisition of HUB Organoids and has since integrated the business into its Discovery Solutions unit. The company launched a partnership with Promega to develop real‑time reporter assays for organoids, while...
The U.S. Food and Drug Administration has opened an investigation after a patient died following self‑injection of Laennec, an allogeneic placental extract imported from Japan. A similar fatality occurred in Russia involving health influencer Anna Kolyada, whose companion fell seriously...
A Maryland bill would force pharmaceutical companies and patient advocacy groups to disclose any financial ties when they run disease‑awareness advertisements. The legislation requires drugmakers to state whether they sell or are developing a treatment for the condition featured, and...
Repeated head impacts in contact sports have been linked to lasting damage of the blood‑brain barrier (BBB), a finding that may underlie chronic traumatic encephalopathy (CTE). Researchers scanned 47 retired athletes using an MRI contrast agent that only enters brain...
The FDA released a draft guidance that details how biopharma firms can validate non‑animal approaches for early‑phase toxicology and safety studies. The document encourages the use of in‑vitro assays, computational modeling, and other modern methods to replace traditional animal testing....
A federal district court judge issued a preliminary injunction halting the Trump administration’s overhaul of the Advisory Committee on Immunization Practices, finding violations of the Federal Advisory Committee Act and gaps in vaccine expertise. The order pauses pending recommendations on...
Policy pressures such as Medicare price negotiations, Most Favored Nation rules, and new transparency mandates are reshaping how life‑science companies sell medicines. These forces are accelerating adoption of direct‑to‑patient (DTP) models that bypass traditional intermediaries to deliver drugs more affordably....
Regeneron scientists have integrated hydrogen‑deuterium exchange mass spectrometry (HDX‑MS) with AI‑driven computational analysis to pinpoint binding sites, geometry, and stoichiometry in sandwich ELISA assays. The approach rapidly distinguishes protected versus exposed regions of antibodies, boosting assay specificity and sensitivity. By...
Azalea Therapeutics, a spinout from Jennifer Doudna’s lab, reported in Nature that its in vivo CAR‑T approach can generate functional CAR‑T cells directly within mice and eradicate both solid and hematologic tumors. The technique uses infused gene‑editing particles that precisely...
Valbenazine (Ingrezza®), an oral selective VMAT2 inhibitor from Neurocrine Biosciences, received FDA approval for treating tardive dyskinesia and Huntington’s disease‑associated chorea. In the Phase 3 KINECT‑3 trial, a once‑daily 80 mg dose produced a statistically significant reduction in AIMS dyskinesia scores after...
UniQure’s experimental gene‑therapy for Huntington’s disease, which previously reported a 75% slowdown in disease progression, has received a third consecutive rejection from the FDA. The trial’s lead investigator, Ed Wild of University College London, praised the early data but warned...
Basecamp Research, an AI‑focused biotech startup backed by Microsoft and Nvidia, announced a trillion‑gene sequencing initiative. The company aims to collect genetic sequences for over a trillion proteins within the next two years. Leveraging high‑performance cloud computing and advanced generative‑AI...
My @8VC partner Francisco is giving key testimony today about CCP crushing our ability to develop cures. China has legit innovators - but also a culture of stealing, and working around patents. Our legacy FDA is so slow that they can...
Questioning the benefit of an implant to close the left atrial appendage vs medical therapy in a randomized trial @NEJM https://t.co/N0hpdIfmLe https://t.co/8bkk8FzLuY
Ionis Therapeutics announced that the primary completion date for its Phase 1/2a prion disease trial has been pushed to February 2027, extending the study timeline by more than two years. In parallel, Arvinas reported new biomarker data from its Parkinson’s disease program,...
A new finding after stopping GLP-1 drugs in a large cohort with Type 2 diabetes: rapid erosion of CV benefit/protection New @bmj_latest by @zalaly @Biostayan https://t.co/JG6yB8wTJJ See thread: https://t.co/6JvfIIjVBw https://t.co/wUgWhvs9Yy
CBER changes its standard operating procedures to open the door to RMAT designations for therapies on clinical hold - https://t.co/bZmhga8xxC
Structure Therapeutics reported a 16.3% weight loss after 44 weeks in a Phase 2 trial of its oral GLP‑1 pill, positioning it as a competitive alternative to Eli Lilly’s and Novo Nordisk’s candidates. Rhythm Pharmaceuticals disclosed that its obesity drug Imcivree failed in...
What if we could engineer T cells in the body, making CAR T vs cancer, autoimmune diseases, and other applications far more practical, much less expensive? A step forward today via genome editing T cells https://t.co/FjgQA8NUlu https://t.co/XXk43WL1ac https://t.co/rpC7eCAlJH
We're about to see an explosion of AI models for Science like Andre's LigandForge and I'm here for it!
Crossbow Therapeutics, founded by biotech veteran Briggs Morrison, announced a $77 million Series B round to accelerate its off‑the‑shelf T‑cell engager platform. The funding, led by a mix of venture capital and strategic investors, will support the advancement of three preclinical candidates...
A randomized clinical trial of repeated doses of psilocybin for the treatment of obsessive–compulsive disorder 73.3% were responders (⩾35% reduction in YBOCS scores), with 40% in remission. These effects diminished but remained substantial at 6 months. https://t.co/tp2SPIKDrB
$MRK's PD-1 x VEGF bispecific reveal, & other key #AACR26 presentations, via @APEXONCO -> https://t.co/ob1eswxCWF $RVMD $AMGN $GILD $BCYC $SDGR
Aspen Neuroscience reported encouraging early data from a small autologous cell therapy trial for Parkinson's disease. The treatment, derived from each patient's own skin cells and reprogrammed into dopaminergic neurons, was safely implanted in twelve participants, showing graft survival and...
RBC: Revolution, Xenon, Arrowhead among top #biotech takeover targets https://t.co/h1toH9szrU by @realJacobBell $ARWR $XENE $RVMD $DYNE
Emerging evidence supports 5-MeO-DMT as a promising, ultra-short-acting psychedelic for treatment-resistant depression and other psychiatric conditions, warranting larger randomized controlled trials. https://t.co/6CcEOSat1F
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) will begin delivering aligned guidance in June, enabling simultaneous licensing and reimbursement decisions for new medicines. Twenty‑seven companies have signed up...
Potential of mitochondrial transfer to prevent or treat Parkinson' s disease, in mouse and monkey models @CellCellPress https://t.co/c0oqfagddX https://t.co/KyBc1zQttc
Does it stack the deck in favor of the standard antidepressants to pull data from placebo-controlled trials for one condition (the psychedelic) and compare it with single condition data for the standard antidepressants? Also...
Sanofi’s oral glucosylceramide synthase inhibitor venglustat has earned U.S. FDA breakthrough therapy designation for treating the neurological aspects of type 3 Gaucher disease. The designation follows the Phase III LEAP2MONO trial, which showed significant improvements in motor and cognitive scores compared with...
Thrilled to be interviewed by imminent cardiologist and clinical trialist Mike Gibson yesterday about the new draft Bayesian guidance at FDA: https://t.co/I3uNISITKQ #Statistics #bayes #pharma #clinicaltrials #rct @CMichaelGibson
Europe's Biotech Investing Crisis: @OtelloVC Otello Stampacchia of Omega Funds discusses the drive to increase EU biotech investment on The Long Run. Sponsored by @AlphaSenseInc & Dash Bio https://t.co/ORIeN8IDEq
Excalipoint Therapeutics, a Shanghai‑based biotech, closed a $68.7 million seed round, including a $41 million founding raise and a $27.7 million extension led by MPCi, Centurium Capital, Lilly Asia Ventures, and Eisai Innovation. The capital will fund six tri‑specific T‑cell engager candidates, notably...
It was a fun privilege to share a few thoughts on building biotechs with Nature Biotechnology for their 30th Anniversary issue - covering a broad range of topics including translating science into medicines, technology cycles, and financing biotech companies... https://t.co/LbnWMSJI9f
Chinese biotech startup Excalipoint banks $69M for next-gen T cell engagers https://t.co/809RqRWJNL by @gwendolynawu #biotech #startups
Johnson & Johnson received FDA clearance for Icotyde, the first oral daily pill for moderate‑to‑severe plaque psoriasis. The drug, originally called icotrokinra, is approved for patients aged 12 and older and is designed to replicate the efficacy of injectable biologics...
Myriad Genetics announced FDA approval of its MyChoice CDx test as a companion diagnostic for GSK’s Zejula (niraparib) in advanced ovarian cancer. The clearance follows the PRIMA trial, which showed that patients identified as HRD‑positive derived significant benefit from Zejula...
Biotech startups face the notorious "valley of death" as they move from proof‑of‑concept to commercialization, but investors remain active, with a 70.9% jump in venture‑financing deal value between Q2 and Q3 2025. A GlobalData survey shows 39% of respondents are...
A phase 2 trial of the Na‑GST1/Al–CpG vaccine demonstrated near‑complete protection against hookworm infection in healthy adults, with vaccinated participants shedding a median of zero eggs per gram versus 67 in the placebo group. The study, conducted in Washington, DC,...
Researchers from Griffith University and biotech firm Marinova evaluated brown and green seaweed polysaccharides for their ability to block norovirus attachment. Fucoidan, a sulfated fiber from brown seaweed, demonstrated the strongest and most consistent inhibition of virus‑like particles binding to...
Samsung Bioepis and Sandoz have signed a global license, development and commercialization agreement covering up to five biosimilar candidates, including the preclinical SB36 biosimilar to Entyvio (vedolizumab). Samsung Bioepis will manage development, manufacturing and regulatory submissions, while Sandoz will handle...
The U.S. Ninth Circuit Court of Appeals denied dismissal motions by AbbVie, AstraZeneca, Novartis and Sanofi, allowing a whistleblower False Claims Act suit over alleged 340B program overcharges to proceed. The lawsuit, filed by Adventist Health System/West, claims the manufacturers...
Xaira, the biotech AI startup with the deepest funding round, launched its first model, X‑Cell, on Tuesday. The platform uses deep learning to generate virtual cell representations from multi‑omics data, enabling researchers to simulate cellular responses without physical experiments. Early...
eClinical Solutions is leveraging its elluminate platform to help sponsors adapt to the FDA’s new requirement for a single pivotal trial, a move aimed at strengthening efficacy evidence and patient safety. The platform offers highly customizable centralized monitoring, AI‑driven risk...
R1 Therapeutics announced a $77.5 million oversubscribed Series A round to advance AP306, a first‑in‑class pan phosphate transporter inhibitor for hyperphosphatemia in chronic kidney disease patients. The funding, led by Abingworth, F‑Prime and DaVita Venture Group, also secured an exclusive global licence...
Researchers at the Medical University of Graz conducted one of the largest genome‑wide association studies on tick‑borne encephalitis (TBE), analyzing about 1,600 patients from multiple European nations. The study pinpointed variants in the cholesterol‑transport gene ABCG1 as a genetic risk...
