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
Recursion Pharmaceuticals CEO Najat Khan says AI’s worth will be judged by the medicines it helps create, not by the sophistication of the tools. She emphasizes deploying AI selectively in chemistry, trial execution, and out‑of‑domain predictions to generate clinical proof points. Recent Phase Ib/II data for REC‑4881 and $500 million in partnership milestones illustrate Recursion’s progress. Khan also advocates pre‑competitive ADMET data sharing to strengthen AI models across the industry.
Chris Klomp, the HHS Medicare director, warned that President Trump’s TrumpRx drug‑discount platform is not intended for the majority of Americans with health insurance. He clarified that the program targets cash‑pay patients, leaving the 170 million commercially insured and 68 million Medicare...
Enjoyed thinking about the new study by @psybalazs & the critique below by @RCarhartHarris. Clearly Robin's SSRI vs psilocybin is the best & only study to compare head to head & I think psychedelics likely offer improved functioning, limited administration...
BIOTECanada has praised the federal government’s launch of the Pharmaceutical and Life Sciences Sector Task Force, signaling a strategic push to strengthen Canada’s biotech and pharma ecosystem. The task force is tasked with reviewing investment incentives, regulatory frameworks, and market...
On December 2025 the FDA officially qualified dual‑energy X‑ray absorptiometry (DXA) bone density scans as the first surrogate endpoint for fracture outcomes in osteoporosis trials involving post‑menopausal women. The qualification, achieved through a request from the Foundation for the National...
Katrine Bosley: There's no question “hopes and aspirations” got ahead of the pace of any new science on gene editing #STATBreakthrough Seng Cheng: “The promise of gene therapy is correct. I think it has made that promise. and that's demonstrated by...
Jane Grogan from $BIIB again, on the fundamental challenge of drug discovery: do you believe what early experiments tell you? "We need to understand when [models] can be predictive and when they help at answering our hypothesis... “If you...
Basecamp Research announced the launch of its Trillion Gene Atlas, a project to collect and model genomic data from over 100 million species, expanding known genetic diversity a hundred‑fold. Backed by $85 million in venture funding, the initiative partners with Anthropic, Ultima...
$BIIB’s Jane Grogan on the impact of China on biotech innovation. “There's three times more PhDs that have been given last year in China than in the US. ... That's a lot of bright young things out there who are going...
$BMY chief scientist Robert Plenge: says there is “a joke” drug developers often repeat. “It's an overnight sensation a decade in the making. These things can actually be going on for a very long time, and then suddenly the field catches...
The FDA announced that the 32 mg intravenous dose of ondansetron (Zofran) will be withdrawn from the market due to its association with QT‑interval prolongation and the risk of Torsades de Pointes. The agency is coordinating a voluntary recall of all...
Novo Nordisk announced FDA approval of a high-dose formulation of its obesity injectable Wegovy in the United States. The approval was granted through a new FDA priority review voucher program, which Novo earned via a price‑cut deal with the Trump...
India’s wholesale pharmaceutical market is seeing 10‑15% price increases as the Iran‑US war disrupts key raw‑material imports, while Nigeria’s manufacturers caution that prolonged supply‑chain shocks could trigger shortages of essential medicines. Industry bodies in both countries have appealed to governments...
The FDA has issued a safety communication indicating that lamotrigine (Lamictal) may increase the risk of serious arrhythmias in patients with existing heart disease. The agency ordered in‑vitro studies after reports of abnormal ECGs, chest pain, loss of consciousness, and...
Thermal stability assays, especially differential scanning fluorimetry, are gaining traction as early‑stage de‑risking tools in drug discovery. By measuring protein melting temperatures, these assays reveal ligand‑induced stabilization, enabling rapid hit validation and prioritization. The article outlines best‑practice workflows, data‑interpretation guidelines,...
The FDA has introduced the Commissioner’s National Priority Voucher (CNPV) pilot, offering ultra‑fast approval pathways for drugs that align with the current White House policy agenda. The program could slash review times for qualifying products, giving participating companies a market...
The U.S. Food and Drug Administration has granted approval to GSK’s linerixibat (Lynavoy) for treating cholestatic pruritus in patients with primary biliary cholangitis (PBC). The decision rests on the GLISTEN phase‑3 trial, which demonstrated a statistically and clinically significant reduction...
A phase‑3, double‑blind trial of over 500 patients showed the ustekinumab biosimilar CT‑P43 achieved equivalent PASI75 response at week 12 and maintained comparable PASI50/75/90 rates through week 52. Safety, adverse‑event profiles, and antidrug‑antibody incidence mirrored those of reference ustekinumab. Patients who switched...
Sarepta Therapeutics will submit a supplemental NDA to the FDA seeking to convert the accelerated approvals of its Duchenne exon‑skippers Amondys 45 and Vyondys 53 into traditional approvals, despite the confirmatory ESSENCE trial failing to improve motor function. The company bolsters its...
A team at the Hebrew University of Jerusalem has unveiled a high‑resolution melting (HRM) PCR assay that simultaneously identifies sand‑fly species, detects Leishmania parasites, and determines the insect's blood‑meal source from a single specimen. The method was applied to nearly...
Glaukos announced that Epioxa™ HD/Epioxa™ is now commercially available, marking the first FDA‑approved, incision‑free topical drug for keratoconus. The therapy uses a riboflavin solution with the O₂n™ System and Boost Goggles, eliminating the need to remove the corneal epithelium. By...
Pfizer announced that the Phase 3 TALAPRO‑3 trial met its primary endpoint, showing that TALZENNA (talazoparib) combined with XTANDI (enzalutamide) significantly improved radiographic progression‑free survival (rPFS) in patients with HRR gene‑mutated metastatic hormone‑sensitive prostate cancer. The combination achieved a hazard ratio...
Eli Lilly’s late‑stage trial of the injectable retatrutide showed a 1.9% drop in HbA1c and a 15.3% weight loss after 40 weeks, outperforming placebo and matching its blockbuster Mounjaro. The drug targets the roughly 60% of type‑2 diabetics who are also...
Embecta Corp. announced a definitive agreement to purchase UK‑based Owen Mumford Holdings Limited for up to £150 million, with £100 million paid at closing and up to £50 million in performance‑based earn‑out. The deal, slated to close in Embecta’s fiscal Q3 2026, adds...
Let's look at how the FDA is treating $SRPT and $QURE differently. The FDA grants accelerated approval to Amondys and Vyondys to treat Duchenne muscular dystrophy. Sarepta conducts a post-marketing confirmatory study that fails to show a benefit for either...
But one set of trials (TAD) were open label and other set of trials (psychedelic) included impt elements of experimental control, procedures like randomization and blinding. Does functional unblinding mid-session justify treating these trials as procedurally equivalent? No.
Medable has launched Agent Studio, a no-code/low-code platform that lets pharmaceutical companies configure and deploy AI agents across the clinical trial lifecycle. The platform currently powers two agents—a document‑classification ETMF agent that processes over 80,000 records a year, and a...
This week's Biotech Scorecard newsletter: Six drugmakers, six months: Charting the FDA’s course in the post-Prasad era $REPL Pierre Fabre $ATRA $QURE $CAPR $RGNX https://t.co/sGa7G6YTDn
Very positive development for $SRRK - Genentech ceases drug development to spinal muscular atrophy - puts SRRK clearly in the lead Cantor on it now https://t.co/IjCyBm2Kcv
Excalipoint, a biotech focused on cancer T‑cell engagers, announced the close of a $68.7 million seed financing round. The capital, raised from leading venture firms and strategic investors, will fund the development of its bispecific antibody platform targeting solid tumors. The...
This definitely looks like a cardiac safety signal at the higher doses. The GLP-1's all slightly increase pulse rate as a starting point.
The Financial Times covered recent initiatives at Cancer Research UK (CRUK) including a nice piece on the ongoing Aleta Biotherapeutics clinical trial in CD19-CAR-T treated B cell lymphoma patients. https://t.co/9sDZEItapu
The U.S. Food and Drug Administration granted Breakthrough Device Designation to Nia Therapeutics’ Smart Neurostimulation System (SNS) for treating episodic memory loss in adults with moderate to severe traumatic brain injury. The fully implantable, closed‑loop system records neural activity from...
The negative oral Ozempic randomized trials (EVOKE, EVOKE+) for Alzheimer's disease have now been published @TheLancet https://t.co/Xx0YknTSC2
GLP-1 drugs have established benefit for Type 2 diabetes. New data suggests that extends to Type 1 diabetes, with heart, vascular, and kidney protection https://t.co/nZDKHoFIRm https://t.co/lTHIgoj4ir
This week’s corporate round‑up highlighted several pivotal moves: Novo Nordisk’s semaglutide patent lapses in India, prompting more than 40 firms to launch over 50 generic weight‑loss brands; BP agreed to sell its Gelsenkirchen refinery, targeting roughly $1 bn of operating‑cost savings;...
Okay here's a game - you're making nanobody therapeutics. AI can help you optimise them, but you need to prioritise order of feature importance. What is your order? Affinity Specificity Expressibility Clinical toxicity In vivo stability Purified stability Patentability Other?
Exclusive: Clarissa Desjardins' newest biotech has put its first drug in the clinic + raised $40M more. Congruence also expects to put 2 more molecules into clinic in early 2027, seeing its platform driving its R&D efficiency: https://t.co/pzxcnmKFBj
Quintessence Biotech introduced DACS, the first "living" artificial cell designed to streamline bio‑separation in cell and gene therapy (CGT) manufacturing. The lipid‑particle platform mimics cell size, deformability and antigen presentation, enabling a gravity‑based flotation method that replaces magnetic‑bead workflows. DACS...
Eli Lilly’s investigational injectable retatrutide achieved a 1.9‑point HbA1c reduction versus 0.8 points for placebo after 40 weeks, while participants on the highest dose shed 15.3% of body weight compared with 2.6% on placebo. The weight loss was still progressing at...
DiaMedica Therapeutics is advancing a recombinant tissue kallikrein (KLK1) to treat ischemic stroke and preeclampsia, leveraging the kallikrein‑kinin pathway to restore microvascular flow. Early trials show maternal blood‑pressure reductions, improved uterine‑artery Doppler indices, and no detectable drug in fetal circulation,...
AL‑S Pharma released Phase II (AP‑101‑02) data evaluating intravenous AP‑101 every three weeks in 73 ALS patients, including 52 with sporadic disease and 21 with SOD1 mutations. The trial met its primary safety and tolerability endpoint and demonstrated disease modification,...
Reviva Pharmaceuticals priced a $10 million public offering of 6.66 million shares and accompanying warrants at $1.50 each, with closing expected around March 20, 2026. The cash will fund the RECOVER‑2 Phase 3 trial of brilaroxazine for schizophrenia. The news sent the stock down more...
Scientists have isolated a gut‑bacterial metabolite, pTOS, that spikes in Burmese python blood after feeding and dramatically reduces appetite in obese mice. When administered to mice, pTOS caused a 9% body‑weight loss over 28 days without affecting energy expenditure. The...
The FDA has approved Icotyde, the first targeted oral peptide therapy for moderate‑to‑severe plaque psoriasis, offering a once‑daily pill that blocks the IL‑23 receptor. In pivotal trials, roughly 70% of patients achieved clear or almost clear skin by week 16,...
Europe’s pharmaceutical sector is losing its historic lead in R&D, with its share of global private research dropping from roughly half in 1990 to a third in 2025, while the United States now commands 55% and China is rapidly closing...
The 2025 review examines tocotrienols, a subset of vitamin E, as chemosensitizers that boost the effectiveness of conventional cancer drugs. Pre‑clinical studies show that combining tocotrienols with antiparasitic agents such as fenbendazole or mebendazole markedly increases tumor cell death. The analysis...
BioCina has launched a comprehensive Chemistry, Manufacturing and Controls (CMC) program for Patrys Ltd’s injectable formulation RLS-2201, a proprietary quetiapine product aimed at treating acute delirium in intensive‑care patients. The manufacturing effort is based in BioCina’s sterile facility in Perth...
A large pragmatic trial involving 1,565 overweight or obese youths with bipolar spectrum disorders found that adding metformin to a brief lifestyle program significantly blunted weight gain associated with second‑generation antipsychotics. Over six months, the metformin group’s BMI rose only...
After eight years of denying pharmaceutical preliminary injunctions, Australia’s Federal Court granted two rare orders in 2025‑26, favoring originators Janssen and AstraZeneca. The court applied the traditional two‑factor test—prima facie infringement and balance of convenience—but placed greater weight on the...
