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
Dizal announced topline results from its Phase 3 WU‑KONG28 trial, comparing oral once‑daily Zegfrovy (sunvozertinib) to platinum‑based chemotherapy as first‑line treatment for advanced NSCLC with EGFR exon 20 insertion mutations. The study met its primary endpoint, demonstrating a statistically significant improvement in progression‑free survival assessed by blinded independent central review. Secondary endpoints—including confirmed overall response rate, duration of response, and disease control rate—also favored Zegfrovy across a global patient population. Dizal plans to engage regulators for a potential NDA submission based on these data.
Researchers engineered mesoporous silica nanoparticles (MSN) to encapsulate insulin and co‑formulated them with succinylated β‑lactoglobulin into pH‑responsive tablets. Surface grafting with polyethylene glycol and phosphonate groups boosted insulin solubility by roughly 2.5‑fold and stabilized the particles in gastrointestinal fluids. The...
U.S. weight‑loss drugmakers are slashing GLP‑1 prices to win cash‑pay customers as insurers balk at coverage. Eli Lilly reduced Zepbound’s monthly cost by $50‑$100, bringing it to $299, while Wegovy now sells for $149 a month, far below its $1,600 launch...
Induced pluripotent stem cells (iPSCs) are being engineered into diverse therapeutic cell types, while in vivo reprogramming aims to convert resident cells directly within patients, eliminating traditional cell‑manufacturing steps. Both strategies depend on precise recombinant growth factors, cytokines, extracellular matrix proteins...
Gene‑therapy candidates for hereditary hearing loss are gaining traction as safety concerns ease with localized delivery. Regeneron’s DB‑OTO and Eli Lilly’s AK‑OTOF have each demonstrated clinically meaningful hearing improvements in early‑stage trials, positioning them as frontrunners for the first approved deafness...
The FDA’s National Priority Voucher (CNPV) program, launched in June 2025, promises to cut drug review times from 10‑12 months to just one or two months for products that meet defined national priorities. Early successes include Johnson & Johnson’s Tecvayli/Darzalex...
Very important paper from our & @liquidai teams - deeply honored to have published with the geniuses @ramin_m_h & @xanamini . Take the super flexible model with high density of intelligence, post-train and fine-tune for basic...
On March 20, 2026, the DEA issued a technical amendment to its 2019 final rule that clarifies who may execute and revoke Power of Attorney documents for DEA Form 222 and who may sign the form itself. The amendment aligns...
Randomized phase 2b dose-escalation trial of stem cell therapy with laromestrocel for aging frailty 🌟Performance on the 6-minute walk test improved in a dose-response fashion 🌟Improved 6-minute walk test distance correlated with patient-reported outcomes 🌟The percentage of study subjects classified as frail decreased...
Researchers introduced K‑4, a novel AMPA‑receptor positive allosteric modulator, which produced rapid and sustained antidepressant‑like effects in treatment‑resistant depression rat models. Bulk RNA‑seq revealed that K‑4 markedly down‑regulated NADPH oxidase‑1 (NOX‑1) in the medial prefrontal cortex and lateral habenula. Pharmacological...
Allogeneic Mesenchymal Stem Cells Ameliorate Aging Frailty: A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial “Treated groups had remarkable improvements in physical performance measures and inflammatory biomarkers, both of which characterize the frailty syndrome. Given the excellent safety and efficacy...
ENAVATE Sciences GP, LLC bought an additional 157,800 Zenas BioPharma shares for an estimated $5.19 million, taking its position to $142.3 million (28.1% of ENAVATE’s reportable AUM). The move signals strong conviction in Zenas’s Obexelimab pipeline as the company prepares a BLA...
Eli Lilly announced on March 16 that its obesity treatment Zepbound will be sold directly to consumers for $299 a month for the 2.5 mg dose through LillyDirect and major pharmacy chains. A new savings card locks that price nationwide for the KwikPen...
The FDA issued a Drug Safety Communication clarifying that citalopram (Celexa) should not be prescribed above 40 mg daily because higher doses significantly prolong the QT interval and can trigger fatal Torsade de Pointes. The label now mandates a maximum of...
The FDA has updated labels for drospirenone‑containing oral contraceptives after reviewing epidemiologic studies that suggest a potentially higher risk of venous thromboembolism compared with other progestins. The new warnings note that some studies report up to a three‑fold increase in...
The FDA issued a drug safety communication on April 20, 2012, adding a contraindication for aliskiren‑containing antihypertensives when combined with ACE inhibitors or ARBs in patients with diabetes, and a warning for those with moderate to severe renal impairment. The...
The FDA issued an updated Drug Safety Communication warning that co‑administration of Victrelis (boceprevir) with ritonavir‑boosted HIV protease inhibitors—atazanavir, darunavir, or lopinavir/ritonavir—is not recommended for patients co‑infected with hepatitis C and HIV. The interaction lowers blood concentrations of both drugs,...
The FDA added a safety warning to Revlimid (lenalidomide) after clinical trials showed a markedly higher incidence of second primary malignancies in newly diagnosed multiple myeloma patients. Pooled data revealed a three‑fold increase (7.9% vs 2.8%) in cancers such as...
The FDA issued a Drug Safety Communication reminding clinicians to adjust cefepime doses for patients with creatinine clearance ≤ 60 mL/min. Non‑convulsive status epilepticus has been linked to inappropriate dosing, with 59 reported cases since 1996, 58 of which involved renal dysfunction...
The FDA issued a Drug Safety Communication warning that dalfampridine (Ampyra), approved to improve walking in multiple sclerosis patients, carries a significant seizure risk, especially shortly after therapy initiation. Post‑marketing data show most seizures occur within days‑to‑weeks and in patients...
The FDA issued a drug safety communication recommending that Revatio (sildenafil) not be prescribed to children aged 1‑17 for pulmonary arterial hypertension. A long‑term pediatric trial of 234 patients showed no exercise benefit and a three‑fold increase in mortality at...
A large retrospective analysis of over 19,000 patients with cancer, type 2 diabetes and brain metastases found that those prescribed GLP‑1 receptor agonists such as Ozempic or Wegovy experienced a 37% reduction in three‑year mortality compared with matched controls. The survival...
Pediatricians are reporting a wave of parents refusing routine newborn preventive care, from vitamin‑K shots to early‑life vaccines. The trend has already produced a cluster of invasive Haemophilus influenzae type b (Hib) meningitis cases that were once rare, underscoring the public‑health...
Scientists exploring the isolated Lechuguilla Cave discovered microbial communities that are resistant to virtually all natural antibiotics, despite being sealed off for millions of years. Genomic analysis of a *Paenibacillus* strain revealed dozens of known resistance genes and five entirely...
I bet on uniQure thinking it was an obvious win win win. HD wins with expanded access. FDA wins by narrowly expanding authorization while vigorously monitoring follow up data. Investors win as the company proves what doctors are saying. Instead...
Stem cell therapy shows promise for reversing aging-related frailty in new clinical trial 🗣️A clinical trial reports that a single dose can significantly improve physical strength and key signs of aging in older adults with frailty. https://t.co/5mw5r64imb https://t.co/uI88QpTEIa
UK researchers completed the largest randomized trial evaluating exogenous surfactant in infants with severe bronchiolitis requiring mechanical ventilation. The Bronchiolitis Endotracheal Surfactant Study (BESS) enrolled 232 infants across 15 pediatric centers and found that surfactant administration did not shorten ventilation...
“At least two career staffers at the FDA whose work includes compounding drugs said they learned of the health secretary’s plans to take action on peptides only from his appearance on Rogan’s podcast.” https://t.co/vpTDqstpDZ
Astaxanthin, meclizine, mitoglitazone, pioglitazone, alpha-ketoglutarate, mifepristone, methotrexate, and atorvastatin-telmisartan do not increase lifespan in UM-HET3 mice https://t.co/k0vERH4LSg
Australia became the first nation to reclassify MDMA from a prohibited to a controlled substance, permitting its use in PTSD treatment under strict conditions. The 2026 guidelines limit MDMA‑assisted psychotherapy to adults who have not responded to first‑line therapies, require...
But…I develop low-cost often patent free vaccines that bypass big pharma and provide access to people who can’t afford them. In the past people who espoused freedom were learned and read books. Now they’re just lazy mindless dummies who think...
The biotech industry spends $3 billion and 13 years to bring one drug to market. If you're still searching for a treatment that works, it exists but the process discovering it is too slow to actually help you in time. How Marc...
Prothena and its partners presented new clinical data on prasinezumab for Parkinson’s disease and BMS‑986446 for Alzheimer’s disease at the AD/PD 2026 conference in Copenhagen. The PASADENA and PADOVA extensions suggest a two‑year disease‑progression delay and sustained biomarker effects, supporting the...
Scientists who stick their necks out and make medicines are my heroes There’s too much concern about COI for seasoned scientists with exemplary records Without commercial activity, we’d have zero medicines and ER-100 would still be in mice, not FDA cleared for...
It follows that if TADs are biased by expectancy, Open Label trials will show better outcomes than blinded. Further, if expectancy is not a strong driver of response to psychedelics, then blinding shouldn’t matter as much. This is what they...
Prothena and its partners Roche and Bristol Myers Squibb presented late‑stage data on two neurodegenerative candidates at AD/PD™ 2026. Prasinezumab demonstrated a roughly two‑year delay in Parkinson’s disease progression, sustained motor benefits in the PADOVA open‑label extension, and favorable imaging and...
Use of SGLT2 Inhibitors in Frail Older Adults is Associated with Increased Survival: A Retrospective Study https://t.co/tsJ5qJLBap https://t.co/4EvBWDftJ4
Effect of henagliflozin on aging biomarkers in patients with type 2 diabetes: A multicenter, randomized, double-blind, placebo-controlled study 🔎"Our results suggest that henagliflozin may exert anti-aging effects by influencing multiple pathways, including the IGF-1 system, glucose metabolism, the immune system, and...
Researchers compared metformin and dapagliflozin in diabetic rats subjected to myocardial infarction, finding dapagliflozin delivered stronger cardio‑protective effects. The SGLT2 inhibitor markedly reduced oxidative stress, inflammatory cytokines, and infarct size, while also improving calcium handling and contractile efficiency. Metformin showed...
India’s pharmaceutical sector is projected to expand from a $60 billion domestic market to $130 billion by 2030, according to the Economic Survey 2025‑26. Export revenues surged to $30.5 billion in FY25, a 16‑fold increase since 2000, while the industry now supplies roughly...
Maria Hordinsky, MD highlighted the rapid evolution of alopecia areata therapy, noting three FDA‑approved Janus kinase (JAK) inhibitors launched in the last five years. She discussed the efficacy of agents such as dupilumab and baricitinib, while emphasizing emerging research on...
Tristan Maurer’s Flash Talk framed dose as the definitive multiparametric optimization (MPO) endpoint for small‑molecule drug design. He argued that dose integrates exposure, pharmacology, and mechanism‑driven effects, making it the linchpin for balancing potency, ADME, and safety. The presentation highlighted...
3 Questions: Using AI to accelerate the discovery and design of therapeutic drugs | MIT News | Massachusetts Institute of Technology https://t.co/CZ4waA5IGg
A team led by Kirill Afonin at UNC Charlotte engineered programmable DNA scaffolds that organize silver nanoclusters into highly potent antimicrobial agents. The spatially arranged DNA‑AgNCs showed up to 78‑fold greater killing efficiency against ESKAPE pathogens and meningitis‑causing bacteria compared...
Indian drug makers announced the launch of $14 generic versions of Novo Nordisk's semaglutide following the expiry of its GLP‑1 patent. The low‑cost alternatives could reshape pricing for obesity and diabetes treatments in India and potentially influence global markets.
Aelis Farma announced that recruitment has begun for its Phase 2B trial of AEF0217, a first‑in‑class signalling‑specific CB1 receptor inhibitor, aimed at treating behavioral and cognitive impairments in Down syndrome. The study will enroll 188 participants aged 16‑32 across ten...
Read “Bottle of Lies.” FDA needs to perform spot checks of generics - not just inspections.
On February 15, 2012, the FDA announced that Bracco Diagnostics’ CardioGen‑82 generator will re-enter the U.S. market after a voluntary recall in July 2011. The agency approved revised labeling that introduces a Boxed Warning and new “Alert Limits” for strontium‑82...
The FDA has revised the Tysabri (natalizumab) label to detail progressive multifocal leukoencephalopathy (PML) risk based on infusion count and prior immunosuppressant exposure. Data show 102 PML cases among 82,732 treated patients, with incidence rising sharply after 24 infusions. A...
Identification of a Novel Drug Sensitivity Biomarker Neuregulin-2 for Venetoclax in Non-t(11;14) Multiple Myeloma [Dec 12, 2021] Dai et al. Abstract 459 #ASH21 https://t.co/mnXEThuKgy #mmsm #PrecisionMedicine https://t.co/zx7d29Jzpk
