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
HHS Secretary Robert F. Kennedy Jr announced on a podcast that the federal government will lift restrictions on 14 injectable peptides, allowing compounding pharmacies to produce and sell them without the usual FDA review. The move bypasses the scientific advisory committee that previously rejected the peptides for safety and purity concerns. Most of these compounds are sold in the gray market, often manufactured in China, and lack human clinical trial data. The announcement has sparked alarm among regulators and pharmaceutical companies about eroding drug‑safety safeguards.
BullFrog AI Holdings saw its Nasdaq‑listed shares climb 126.24% to $1.15 after announcing a commercial agreement with a leading global pharmaceutical company. The deal gives the pharma partner exclusive access to a novel target candidate for major depressive disorder and...
The phase III SCOUT‑HCM trial showed that mavacamten (Camzyos) significantly reduced left ventricular outflow tract (LVOT) gradients in adolescents with obstructive hypertrophic cardiomyopathy (HCM) compared with placebo. Forty‑four patients aged 12‑17 were randomized to weight‑based doses of 2 or 5 mg daily, achieving a...
Doctors Without Borders has condemned Gilead Sciences for refusing to sell its long‑acting HIV prevention drug lenacapavir directly to the humanitarian organization. The company had previously negotiated a limited‑supply request, while a separate deal with the Global Fund aims to...
Eli Lilly’s oral selective estrogen receptor degrader INLURIYO (imlunestrant) received FDA approval on September 25 2025 for adults with advanced ER‑positive, HER2‑negative breast cancer harboring an ESR1 mutation after endocrine therapy failure. The decision rests on the EMBER‑3 trial, which enrolled 874...
Kevin Tang, newly installed CEO of Aurinia Pharmaceuticals, has revived his bid for Kezar Life Sciences with a $50 million offer of $6.95 per share, roughly matching Kezar’s $47 million market cap. The proposal follows Tang’s earlier, unsuccessful $1.10‑per‑share attempt made through...
Merck reported that its experimental oral PCSK9 inhibitor, enlici‑tide, outperformed a range of commonly prescribed cholesterol‑lowering medicines in a head‑to‑head comparator trial. The data bring the drug a step closer to becoming the first oral PCSK9 therapy on the market....
At the American Academy of Dermatology (AAD) meeting in Denver, Takeda, Alumis, Priovant and Incyte each unveiled late‑stage dermatology data, ranging from novel biologics to targeted small molecules. Sanofi and Biogen also presented, highlighting mixed results in eczema and lupus...
Eli Lilly is pressuring the U.K. government to raise NHS drug prices and eliminate the VPAG rebate scheme before it resumes new investment in Britain. The company is also exploring outcome‑based pricing for its anti‑obesity medicines. In parallel, Lilly struck a...
Accord BioPharma, Intas Pharmaceuticals and Bio‑Thera have filed four Inter Partes Review petitions challenging four Janssen patents covering golimumab treatment methods for ankylosing spondylitis and psoriatic arthritis. The petitioners contend that the claims are anticipated or obvious based on publicly...
Ocugen’s phase‑2 ArMaDa trial of the modifier gene therapy OCU410 showed a 31% reduction in geographic atrophy lesion growth and a 27% slower rate of ellipsoid zone loss at the medium dose, with 55% of treated eyes achieving at least...
The $UTHR news today is great for IPF patients. But it is also very good news for $LQDA given they have better delivery of the same drug. UTHR has 7-year orphan protection in IPF, but that can be overcome by...
A phase‑2b trial of inhaled mebufotenin (GH001) in 81 adults with treatment‑resistant depression showed rapid symptom relief, with 57.5% of the active‑treatment group achieving remission by day 8 versus none on placebo. The mean MADRS score fell by 15.2 points compared...
Everyone complains that clinical trial recruitment is hard. Fair. 📍 But here is a question not enough people ask: Have you looked closely at your 𝘁𝗿𝗶𝗮𝗹 𝗿𝗲𝗰𝗿𝘂𝗶𝘁𝗺𝗲𝗻𝘁 𝘀𝗶𝘁𝗲? I ran one through https://t.co/f9IW600hsB. The science was solid. The 𝗺𝗲𝘀𝘀𝗮𝗴𝗶𝗻𝗴 𝘄𝗮𝘀 𝗻𝗼𝘁. 📉 That is the disconnect. Too...
Viridian Therapeutics’ shares tumbled 34% to $18.66 after its late‑stage trial of elegrobart for thyroid eye disease (TED) fell short of investor efficacy expectations, despite meeting the primary endpoint of reducing eye bulging. The four‑week regimen showed a 54% improvement...
The FDA granted accelerated approval to the oral co‑pack Avutometinib and Defactinib for adults with KRAS‑mutated, recurrent low‑grade serous ovarian cancer (LGSOC) after prior therapy. The regimen pairs a RAF/MEK inhibitor with a FAK inhibitor, marking a rare “novel‑novel” combination...
InvestorNews announced an InvestorTalk on March 31, 2026 at 9 AM EST featuring Brent Willis, President and CEO of Voyageur Pharmaceuticals Ltd. (TSXV:VM). Voyageur is advancing a vertically integrated strategy to produce barium and iodine contrast agents, highlighted by a 132,000‑tonne, 98.8% pure barium...
The SMART‑DECISION trial showed that stopping beta‑blockers one year after a myocardial infarction is non‑inferior to continuing them in stable, low‑risk patients without heart failure or reduced ejection fraction. Among 2,540 participants followed for a median of 3.1 years, the...
Eli Lilly is negotiating with the U.K. government to raise NHS drug prices and overhaul the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG). The company argues that current rebate rates of 25‑33% of revenues are unsustainable and threaten...
Prilenia Therapeutics and Ferrer have enrolled the first participant in PREVAiLS, a pivotal Phase 3, 500‑patient, randomized, placebo‑controlled trial of the sigma‑1 receptor agonist pridopidine for rapidly progressive ALS. The study, launched at Mass General Brigham, will span 48 weeks with...
Meiji Seika Pharma announced a strategic investment in U.S. biotech Centivax to accelerate its universal influenza vaccine, Centi‑Flu 01, currently in Phase 1 trials. The partnership leverages Meiji’s pharmaceutical expertise and Centivax’s computational immune‑engineering platform to target conserved viral regions, aiming for...
Biocytogen has licensed its RenNano® fully human heavy‑chain‑only antibody discovery platform to Japan’s Taisho Pharmaceutical, granting access to RenNano mice for in‑vivo generation and screening of VHH candidates. The agreement, whose financial terms remain undisclosed, adds to Biocytogen’s expanding portfolio...
Kardigan reported that its experimental hypertension drug tonlamarsen achieved a 67% average reduction in the angiotensinogen biomarker after five monthly doses, confirming target engagement. However, the Phase 2 trial showed no statistically significant difference in office systolic blood pressure between the...
The FDA approved a high‑dose formulation of Biogen’s SMA drug Spinraza, cutting the loading phase from four to two injections and adding a four‑month maintenance schedule. The new regimen, backed by the DEVOTE study, showed significant motor‑skill gains versus sham...
AstraZeneca is testing its COPD triple‑inhaler Breztri Aerosphere in uncontrolled asthma. Phase III KALOS and LOGOS trials showed 76‑90 mL improvements in FEV₁ and a 14% reduction in severe exacerbations versus standard ICS/LABA therapy. The studies enrolled about 4,300 patients across 20...
An international team of more than 40 scientists released the human E3‑ome, a curated atlas that consolidates 672 high‑confidence E3 ligases from over 1,100 candidates. The resource offers a gold‑standard reference for basic research and drug discovery, addressing long‑standing inconsistencies...
Consulting firms are being tapped to help fashion retailers overhaul sizing and supply‑chain strategies as GLP‑1 weight‑loss drugs reach 23% of U.S. households. With 80% of users expecting new clothing and 55% already buying, the shift is upending traditional demand...
The module introduces HitID screens, outlining key strategies for early-stage drug discovery. It references recent literature on medicinal chemistry optimization, successful hit‑to‑clinical transitions, DNA‑encoded library (DEL) approaches, ultra‑low‑molecular‑weight crystallographic screening, and fragment‑based drug discovery (FBDD). By consolidating these sources, the...
Zongertinib (Hernexeos) received FDA accelerated approval for first‑line treatment of HER2‑mutant advanced NSCLC, based on Beamion LUNG‑1 data presented at the European Lung Cancer Congress. In previously untreated patients (cohort 2), the drug achieved a 76% objective response rate and a...
1/🚨@TesseraTx has announced that it has received a grant from the Gates Foundation to fund an early-stage research which is aimed to develop a Gene Editing-based cure for HIV. This grant is build upon Tessera’s existing investment 🧵👇 from the Gates...
Accurately predicting success and failure rate of late stage trials for new drugs could legitimately accelerate pharma. The late stages are where most of the time and money go, and are a bottleneck on bringing drugs to market today.
UK Biotech Day 2026 will take place on May 27‑28 at the Radisson Hotel & Conference Centre London Heathrow. The two‑day conference convenes executives, R&D scientists, investors, legal and finance professionals from pharma, biotech, medtech, and tech‑bio sectors. Positioned as...
Really interesting. One of their predictions is 100% success chance for $MLTX in psoriatic arthritis.
Elegant in theory, unproven in practice: setidegrasib and the case (or not) for KRAS degradation in NSCLC and pancreatic cancer: https://t.co/NuaOJ2amgn https://t.co/i9FpK4W19W
The U.S. generic drug market, long driven by the Hatch‑Waxman Act, now supplies about 90% of prescriptions but only 10% of drug spend. Price erosion of 70‑80% within two years and the entry of six to eight competitors have turned...
30March: How did @EliLillyandCo and @InSilicoMeds begin and expand their collaboration into the up-to-$2.75B partnership announced Sunday? Read about $LLY and $3696 in the latest for @GENbio from me and colleague @xiaofei_lin: https://t.co/KtXOWFjGdq
New: 5 FDA decisions to watch in the second quarter of 2026 https://t.co/AVvu8i9kgh $REPL $LLY $AXSM $PFE $ARVN $IONS $ARWR #biotech
The U.S. FDA has approved a higher‑dose version of Biogen’s gene‑replacement therapy for a rare genetic muscle‑weakening disorder, likely spinal muscular atrophy. The new regimen starts with two 50 mg loading doses two weeks apart, followed by a 28 mg maintenance dose...
“Longevity tourism” Plenty of folks willing to travel & pay for “stem cells as magical thinking” and a growing panoply of unproven & sometimes dangerous “#longevity” therapies. Caveat emptor. By @PeterWardJourno in @Slate https://t.co/jq9rPrcRK2
Unicycive Therapeutics reported FY 2025 results, highlighting the FDA’s acceptance of its oxylanthanum carbonate (OLC) New Drug Application resubmission with a PDUFA target date of June 29 2026. The company is preparing commercial operations for a potential Q3 2026 launch, while its cash balance...
Researchers analyzing more than 15,000 human fat samples have identified the SLIT3 protein as a potent enhancer of brown‑fat calorie burning. The discovery suggests a novel, metabolism‑focused avenue for obesity treatment and biohacking beyond appetite‑suppressing drugs.
A Chinese biotech company administered the first-in-human dose of a hepatitis D‑targeted monoclonal antibody in Beijing, marking a world‑first for the disease. The trial details were not disclosed, and it comes as the broader pharma sector grapples with earnings pressure,...
Researchers at The Jackson Laboratory and MIT unveiled a polymer‑based microneedle skin patch that captures immune cells and inflammatory biomarkers within 15‑30 minutes. The device could transform vaccine response tracking and chronic disease monitoring by eliminating the need for blood...
AstraZeneca announced that its experimental monoclonal antibody tozorakimab met primary endpoints in two late‑stage COPD trials, delivering a clinically meaningful reduction in moderate‑to‑severe flare‑ups. The data lifted the company’s shares as much as 3.8% and underpin a sales outlook of...
Eli Lilly and Hong Kong‑listed Insilico Medicine have sealed a partnership that could be worth up to $2.75 billion, including a $115 million upfront payment. The deal gives Lilly exclusive global rights to Insilico’s pre‑clinical oral candidates and taps the biotech’s generative‑AI platform....
Researchers at South Korea's KAIST have demonstrated that graphene oxide can selectively eradicate bacterial cells while leaving human cells intact. The finding points to a new class of nanomaterial‑based antibiotics that could help combat the growing threat of antimicrobial resistance.
Eli Lilly is urging the United Kingdom to overhaul its drug‑pricing framework, warning that persistently low prices could deter future investment and calling for outcomes‑based reimbursement models, especially for obesity therapies. At the same time, the U.S. Food and Drug Administration...
Japan is experiencing a nationwide shortage of Concerta, the primary stimulant used to treat adult ADHD, as demand surges. The shortage, first noted in late 2023, persists despite Janssen Pharmaceutical’s promise of a two‑month fix, with officials now estimating several...
