Today's Pharma Pulse
Jazz Pharma’s Zepzelca misses survival goal in Phase III lung cancer trial
Jazz Pharmaceuticals reported that its lung‑cancer drug Zepzelca did not improve overall survival in the Phase III Lagoon trial for second‑line small‑cell lung cancer, jeopardizing its accelerated approval in this setting. The study of 724 patients showed median overall survival of 8.7 months with Zepzelca alone and 10.9 months with the combination, compared with 10.7 months for control.
Also developing:
By the numbers: Parabilis Medicines raises $2.4B in IPO
Idvynso, Merck’s Once-Daily HIV Pill, Wins FDA Approval
The FDA has granted approval to Merck’s Idvynso, a once‑daily fixed‑dose tablet combining doravirine and islatravir, for adults with HIV‑1 who are already virologically suppressed. The drug offers a two‑drug, tenofovir‑free regimen and is the first non‑INSTI option to demonstrate non‑inferior efficacy against the three‑drug standard Biktarvy in Phase III trials. Idvynso will become available in U.S. pharmacies after May 11, providing a new switching pathway for patients seeking reduced pill burden or fewer drug interactions.
ASCO26 Highlights Bispecifics, ADCs, RAS Revolution, Prostate Breakthrough
New, from #ASCO26: Bispecifics vs. ADCs, a ‘RAS’ revolution and a step change in prostate cancer https://t.co/rJehfuYEK0 @ByJonGardner and @Lilah_Alvarado $RVMD $MRK $SMMT $JNJ
Turning the Patent Cliff Into a Bioplant Opportunity
The looming 2030 patent cliff threatens roughly $300 billion in biopharma revenue as 200 drugs lose exclusivity. Phylloceuticals proposes a duckweed‑based (Lemna) expression system that can slash upstream production costs by up to 90% and cut overall expenses by two‑thirds. The...
Cancer Is Now a Story of the Good, the Bad and the Ugly – but Also Hope | Devi Sridhar
At the American Society of Clinical Oncology meeting, a new oral drug, daraxonrasib, doubled five‑year survival for pancreatic cancer patients in a 500‑person trial, offering a rare breakthrough for a disease with historically poor outcomes. A concurrent head‑and‑neck cancer vaccine,...
Targeted Drug Strips Cancer’s Cloak, Cuts Tumors 30%
Smart drug that strips cancer cells of ‘invisibility cloak’ can shrink tumours by 30%, trial shows https://t.co/e7EU1OEXky
Smart Drug that Strips Cancer Cells of ‘Invisibility Cloak’ Can Shrink Tumours by 30%, Trial Shows
Researchers at Oxford’s Greywolf Therapeutics reported that the oral drug GRWD5769, when paired with cemiplimab immunotherapy, caused tumor shrinkage in 26 of 83 heavily pre‑treated patients across six common cancer types. Fifteen of those patients saw reductions of at least...
Pharma’s Trial Problem: Outdated Systems, Broken Data, and the Coming AI Reset
Clinical trials now absorb 60‑70% of pharma R&D spend, yet they still run on legacy, site‑centric systems designed for paper workflows. This mismatch creates invisible waste, fragmented data flows, and escalating costs, limiting the impact of emerging AI tools. The...
Novartis Boosts Radioligand Therapy with Pluvicto Success and Actinium-225 Early Data
Novartis unveiled Phase 3 subgroup results showing Pluvicto cuts radiographic progression or death by 28% in metastatic hormone‑sensitive prostate cancer, while early data from its actinium‑225 radioligand demonstrated PSA halving in over half of patients previously treated with Pluvicto. The findings,...
Servier Reports 44‑month Median PFS for VORANIGO in IDH‑mutant Glioma at ASCO
Servier presented extended Phase 3 INDIGO results at the 2026 ASCO meeting, showing a median progression‑free survival of 44.1 months for VORANIGO in grade 2 IDH‑mutant glioma. The data, based on over three years of follow‑up, also highlighted a 72% seizure‑rate reduction and...
Corsair Pharma Announces Positive Phase 1 Results for the TRX-248 Transdermal System in Pulmonary Arterial Hypertension
Corsair Pharma announced that its TRX‑248 transdermal patch achieved positive results in a first‑in‑human Phase 1 trial for pulmonary arterial hypertension. The once‑daily patch delivered steady, therapeutically relevant treprostinil plasma levels over 24 hours with pharmacokinetics comparable to subcutaneous delivery and demonstrated...
PF-06826647
Ropsacitinib (PF‑06826647) is an oral TYK2 kinase‑domain inhibitor that progressed to Phase 2b trials for plaque psoriasis and hidradenitis suppurativa. Unlike the approved TYK2 drug deucravacitinib, which binds the JH2 pseudokinase domain, ropsacitinib engages the active JH1 kinase domain, offering a...
ASCO26: Platinum-Resistant ADC Leader Elahere Stumbles in Platinum-Sensitive Disease
AbbVie’s Elahere, the only FDA‑approved FRα‑targeted ADC for platinum‑resistant ovarian cancer, failed to meet its primary endpoint in the Phase II MIROVA trial for platinum‑sensitive disease. The combination of Elahere with carboplatin produced a 66.2% overall response rate but showed no...
Turn Therapeutics Reports Interim Analysis Findings and Adaptive Optimization Strategy From Phase 2 GX-03 Trial in Moderate-to-Severe Atopic Dermatitis
Turn Therapeutics released interim data from the first 50 participants in its Phase 2 GX‑03 trial for moderate‑to‑severe atopic dermatitis. By week 4, 92.6% of patients receiving the topical polyhexanide formulation achieved at least a 50% reduction in eczema severity (EASI‑50), compared...
ASCO: Immatics Posts Data on PRAME Pipeline Ahead of Pivotal Readout
Immatics used the ASCO meeting to unveil data on its PRAME‑targeted cell therapies, highlighting early results from next‑generation candidate IMA203CD8 and its lead product anzu‑cel. In a Phase I study, IMA203CD8 induced responses in 12 of 19 gynecologic cancer patients, including...
Will Real-Time Clinical Trials Become the New Standard for Drug Development?
Regulators, sponsors, and technology providers are testing real‑time clinical trial monitoring, allowing continuous data review instead of traditional milestone checkpoints. The FDA’s pilot with AstraZeneca and Amgen demonstrated feasibility, showing earlier issue detection and the potential for faster regulatory decisions....
Moderna Partners with CEPI on Ebola Vaccine Efforts Amid Outbreak in Africa
Moderna and the Coalition for Epidemic Preparedness Innovations (CEPI) have struck a partnership that allocates up to $50 million to advance an experimental mRNA vaccine targeting the Bundibugyo ebolavirus (BDBV). The funding will support preclinical work, Phase 1 trials and manufacturing capacity...
From Covalent to Noncovalent 14-3-3 Modulator, Unintentionally
Researchers at the University of Leicester discovered that an acrylamide‑based compound (compound 7) dramatically improves the binding affinity between estrogen‑receptor‑alpha and 14‑3‑3σ, shifting the K_D from 206 nM to 2.8 nM. Unlike the previously studied covalent warhead WR‑1065, compound 7 does not form a...
Hanmi, Lilly Ink $75M Upfront Deal to Co‑develop GLP‑2 Analog Sonefpeglutide
Hanmi Pharm and Eli Lilly have entered a licensing agreement for the long‑acting GLP‑2 analogue sonefpeglutide. The deal provides Hanmi with a $75 million upfront cash payment and potential milestone payments of up to $1.185 billion, while granting Lilly exclusive worldwide rights...
Oricell's GPC3 CAR‑T Therapy Ori‑C101 Posts 66.7% Response Rate in Late‑Line Liver Cancer
Oricell Therapeutics announced that its GPC3‑targeted CAR‑T candidate Ori‑C101 achieved a 66.7% objective response rate in a registrational Phase Ib BEACON study of 18 late‑line hepatocellular carcinoma patients, signaling a potential new benchmark for solid‑tumor immunotherapy.
Innovent Reports Positive Phase I Data for IBI363 in Immunotherapy‑resistant NSCLC
Innovent Biologics, together with Takeda, disclosed encouraging Phase I proof‑of‑concept data for IBI363 in 136 patients with advanced NSCLC that had progressed on prior immunotherapies. The bispecific fusion protein earned two FDA fast‑track designations and three Chinese breakthrough therapy designations, positioning...
AstraZeneca Aims for a New Blockbuster Run in Cardio Disease
AstraZeneca has received FDA approval for Baxfendy, a first‑in‑class aldosterone synthase inhibitor targeting hypertension, marking its entry into a new blockbuster arena beyond its oncology stronghold. The drug is positioned as the cornerstone of the company’s next‑generation cardiovascular, renal and...
Abemaciclib May Be New Standard for Sarcoma Subtype
Abemaciclib dramatically extended progression‑free survival in a phase‑3 SARC041 trial for patients with advanced dedifferentiated liposarcoma, achieving a median PFS of 9.7 months versus 1.5 months on placebo. The study, the first positive phase‑3 effort in this sarcoma subtype, also...
Oncolytics Biotech® Announces Positive Initial Preclinical Findings Supporting Further Evaluation of Pelareorep in Combination with RAS-Targeted Approaches
Oncolytics Biotech reported that its oncolytic virus pelareorep, when paired with RAS‑targeted inhibitors, produced markedly stronger anti‑tumor effects in a solid‑tumor preclinical model. The company will extend this work to pancreatic ductal adenocarcinoma and colorectal cancer, testing KRAS G12C, pan‑RAS and...
Lilly Maintains Deal Streak with $1.2B Pact for Hanmi's GLP-2 Candidate
Eli Lilly signed a licensing deal with South Korean biotech Hanmi Pharm worth up to $1.2 billion to develop the GLP‑2 agonist sonefpeglutide. The agreement provides Lilly exclusive worldwide rights, except in Korea, with an upfront $75 million and milestone payments tied to...
What China’s New CGT Rules Mean for Biotech Business
China's State Council Order No. 818, effective May 1 2026, establishes a national framework for clinical research and commercial translation of advanced biomedical technologies, including cell and gene therapies. The order creates a dual‑track regulatory system, allowing qualified hospitals under the National Health...
ASCO26: Verzenio Gives Hope of Liposarcoma Treatment Advance
An investigator‑initiated phase 3 SARCO41 trial showed Eli Lilly’s CDK4/6 inhibitor Verzenio (abemaciclib) significantly prolonged progression‑free survival in patients with advanced dedifferentiated liposarcoma, achieving a median PFS of 9.7 months versus 1.5 months on placebo. Overall survival also trended higher, with more than...
ASCO: Biopharma Has Pancreatic Cancer ‘Surrounded’ as Immuneering’s Drug Adds 9 Quality Months
Immuneering reported that its MEK inhibitor atebimetinib combined with modified gemcitabine/nab‑paclitaxel (mGnP) produced a 17.3‑month median overall survival in a Phase 2a trial of 55 first‑line metastatic pancreatic‑cancer patients, nearly doubling the 8.5‑month benchmark from the historic MPACT study. The regimen...
Haisco Enters ~$3.05B License and Research Collaboration with Lilly to Develop Novel Medicines Across Multiple Therapeutic Areas
Haisco Pharmaceutical has signed a licensing and research collaboration with Eli Lilly valued at roughly $3.05 billion. Haisco will discover about five target programs, while Lilly will lead IND‑enabling studies, clinical development, and global commercialization. Lilly receives exclusive worldwide rights to certain...
Trump Signs Executive Order to Fast‑Track Psychedelic Research, Boosting Spiritual‑Based Therapies
President Donald Trump signed an executive order on April 18, 2026 that accelerates federal research into psychedelic medicines and awards priority review vouchers to Compass Pathways, Usona Institute and Transcend Therapeutics. The move has ignited a surge in biotech stock...
Daraxonrasib Pill Doubles Survival in Advanced Pancreatic Cancer
An international Phase III trial found the oral KRAS inhibitor daraxonrasib doubled median overall survival for patients with metastatic pancreatic cancer, extending it from 6.6 to 13.2 months. The study also reported a lower rate of severe side‑effects, positioning the...
ASCO26: BMS and J&J Debut Shining Multiple Myeloma Data
At ASCO 2026, Bristol Myers Squibb reported that its cereblon‑modulating combo MeziKd delivered an 18‑month median progression‑free survival (PFS) versus 8.3 months for carfilzomib‑dexamethasone alone, with an 80.2% overall response rate. Johnson & Johnson’s bispecific antibody Tecvayli cut the risk...
Agios Inks $165 M Global License Deal with Oscotec for ITP Drug Cevidoplenib
Agios Pharmaceuticals has signed an exclusive worldwide license agreement with Oscotec Inc. to develop and commercialize cevidoplenib, a next‑generation SYK inhibitor for immune thrombocytopenia. The deal includes a $25 million upfront payment and up to $140 million in development, regulatory and commercial...
Akeso Reports Overall Survival Benefit for Ivonescimab in Phase III Lung Cancer Trial
Akeso, Inc. disclosed that its investigational antibody ivonescimab achieved a statistically significant overall survival advantage in the Phase III HARMONi-6 study of advanced squamous non‑small cell lung cancer. The data, presented on June 1, 2026, revive expectations for Summit Therapeutics,...
Immunocore Posts Positive Phase 1/2 Data for Brenetafusp in Advanced Cutaneous Melanoma
Immunocore Holdings plc announced positive Phase 1/2 data for its PRAME‑targeted immunotherapy Brenetafusp in 66 patients with advanced cutaneous melanoma. Presented at the 2026 ASCO meeting, the early‑stage results suggest activity where current options are limited.
Why Breakthrough Cell and Gene Therapies Still Fail at the Finish Line
Nearly half of cell and gene therapy submissions now receive FDA complete response letters, with 42% flagged for deficiencies. The analysis shows that most of these CRLs arise from manufacturing, chemistry, and controls (CMC) issues rather than safety concerns. Shifts...
Parkinson's Disease
Recent pre‑clinical studies show that capsaicin, the active component of chili peppers, can increase dopaminergic neuron numbers and tyrosine‑hydroxylase expression in mouse and rat models of Parkinson’s disease. The neuroprotective effect appears to be mediated by TRPV1‑dependent reductions in microglial...
Eli Lilly Highlights P-III (LIBRETTO-432) Trial Data on Retevmo for Early-Stage RET Fusion–Positive NSCLC at ASCO 2026
Eli Lilly presented data from its phase III LIBRETTO‑432 trial of selpercatinib (Retevmo) as adjuvant therapy in early‑stage RET‑fusion positive NSCLC. In 151 patients, the drug reduced the risk of disease recurrence or death by 83% versus placebo, with 24‑month...
Photosynthes-Eyes: Spinach-Based Therapy Offers Hope for Dry Eyes
Scientists at the National University of Singapore have engineered a nanosized eye‑drop called LEAF, derived from spinach thylakoid membranes, that generates NADPH when exposed to ambient light. The 400 nm particles boost antioxidant production, rapidly normalising reactive oxygen species in cultured...
Lynk Pharmaceuticals Receives NMPA Approval for Phase II Trial of LNK01004 Ointment
Lynk Pharmaceuticals received approval from China’s National Medical Products Administration to begin Phase II trials of its internally developed LNK01004 ointment for vitiligo and chronic hand eczema. The ointment is a skin‑restricted pan‑JAK inhibitor designed to minimize systemic exposure while targeting...
New Pancreatic Cancer Drug Earns Standing Ovation
I don’t usually talk about new drugs but it isn’t often we see a new one get a standing ovation like this. Pancreatic cancer took my dad and Steve Jobs so any breakthrough is worth cheering about.
Akeso Presents the P-III (HARMONi-6) Trial Data on Ivonescimab + CT in 1L Squamous NSCLC at ASCO 2026
Akeso’s global Phase III HARMONi‑6 trial compared ivodescimab plus chemotherapy with Tevimbra plus chemotherapy in 532 patients with first‑line squamous non‑small cell lung cancer. The study met its primary overall‑survival endpoint, showing a 34% reduction in death risk (median OS 27.9 months...
Wockhardt Marks Research Milestone with USFDA Approval for Novel Antibiotic Zaynich
Wockhardt has secured US FDA approval for Zaynich, an intravenous antibiotic combining cefepime and zidebactam, to treat complicated urinary tract infections in adults. The drug earned Qualified Infectious Disease Product and Fast Track designations and follows recent clearance by India’s...
Minghui Pharmaceutical and Qilu Pharmaceutical Co-Announces Updated Clinical Data of MHB088C (QLC5508) From Phase I/II Study in Heavily Pretreated mCRPC...
MHB088C, a B7‑H3‑targeted antibody‑drug conjugate from Minghui Pharmaceutical, presented updated Phase I/II data in heavily pretreated metastatic castration‑resistant prostate cancer (mCRPC) at the 2026 ASCO Annual Meeting. Among 59 enrolled patients, median radiographic progression‑free survival was not reached, with a...
ASCO26 HARMONi6 Updated – Plaudits, Pitfalls, and Pratfalls
Akeso Bio presented updated interim results from its HARMONi‑6 trial at ASCO 2026, eight months after the initial ESMO data. The new dataset, with longer follow‑up, revealed a modest overall response rate and emerging safety signals that fell short of...
Psychological Inoculation: With a Vaccine to Prevent HIV on the Horizon, Misinformation Is Soaring. What Can Be Done.
A new study examined psychological inoculation—pre‑bunking videos—to combat emerging HIV vaccine misinformation. Researchers produced 2.5‑minute TikTok‑style clips that presented false claims alongside factual rebuttals. In a trial of more than 2,000 South African women aged 18‑29, participants who viewed the...
Daily Pill Doubles Survival Time for Pancreatic Cancer Patients
A phase III trial of the oral KRAS inhibitor daraxonrasib showed median overall survival of 13.2 months for advanced pancreatic cancer patients, roughly double the 6.6 months achieved with standard chemotherapy. The study enrolled 500 participants across North America, Europe...
Kelun‑Biotech Shows 87% Response Rate for RET‑Fusion Lung Cancer in Phase II ASCO Data
Kelun‑Biotech reported pivotal Phase II results for its next‑generation RET inhibitor lunbotinib fumarate at ASCO 2026, revealing an 87.1% objective response rate in pre‑treated patients and a 30% intracranial complete‑response rate. The data prompted the Chinese regulator to accept a...
Sacituzumab Tirumotecan + Pembrolizumab Cuts Progression Risk 65% in First‑Line NSCLC
Sichuan Kelun‑Biotech reported that its antibody‑drug conjugate sacituzumab tirumotecan combined with pembrolizumab cut the risk of disease progression by 65% in a Phase III trial of PD‑L1‑positive non‑small cell lung cancer. The data, presented at ASCO and published in The Lancet,...
Dizal Reports Breakthrough EGFR and JAK1 Data at ASCO 2026
Dizal presented compelling Phase II/III data on its fourth‑generation EGFR inhibitor DZD6008 and the JAK1‑only agent golidocitinib combined with anti‑PD‑1 at the 2026 ASCO meeting. The studies showed high tumor‑shrinkage rates, durable progression‑free survival and promising activity against brain metastases,...
Daily Pill Doubles Pancreatic Cancer Survival, Cuts Toxicity
A daily pill extended median survival to 13.2 months in previously treated metastatic pancreatic cancer, compared with 6.7 months on more chemotherapy. The benefit came with fewer severe side effects, but not indefinitely. pancreaticcancer