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IND

Orexo announces positive outcome from in vivo study of OX390

Orexo AB has announced positive data from a pre-clinical in vivo study on the nasal absorption of atipamezole when delivered with Orexo’s AmorphOX® drug delivery technology. The study results mark an important milestone in the development of OX390, an emergency treatment to...
IND

MEKanistic Therapeutics announces FDA clearance of IND for MTX-531, enabling phase 1 trials in advanced solid tumours

MEKanistic Therapeutics, a biotechnology company developing first-in-class precision medicines designed to overcome cancer resistance mechanisms, has announced that the US Food and Drug Administration has cleared the Investigational New Drug application for MTX-531, the company’s lead oncology candidate. With...
IND

Matter Bio files first IND for Lm-LLO-TT, advancing first-in-human phase 1/2a study in patients with pancreatic cancer

Matter Bio has submitted its first Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for Lm-LLO-TT, the company’s lead therapeutic candidate, for a first-in-human phase 1/2a clinical trial in patients with pancreatic ductal adenocarcinoma (PDAC). If...
Phase 1-2 trials

Myosin Therapeutics initiates phase 1/2 trial of MT-125 targeting non-muscle myosin II in newly diagnosed glioblastoma

Myosin Therapeutics, a clinical stage biotechnology company developing innovative therapies for oncology, has announced that the first patient has been dosed in its phase 1/2 study. The trial is designed to assess safety, tolerability, pharmacokinetics, and preliminary signals of...
Drug Discovery

New clinical study shows pasteurised Akkermansia muciniphila MucT supports weight loss maintenance

The Akkermansia company has announced the publication of a new randomised, placebo-controlled clinical trial in Nature Medicine demonstrating that supplementation with pasteurised Akkermansia muciniphila MucT®, the proprietary bacterial strain used in the company’s products, significantly improved weight loss maintenance in adults with overweight...
Phase 1-2 trials

Remepy reports strong clinical phase 2a results for Hybridopa, a first-in-class hybrid drug for Parkinson’s disease

Remepy, a pioneer in hybrid drugs, has announced that the phase 2a clinical trial of Hybridopa, a new hybrid drug for Parkinson’s disease, met its primary endpoint, delivering statistically significant improvements across motor and non-motor outcomes in Parkinson’s...
Phase 3 trials

BioMarin announces positive phase 3 pivotal study results for Voxzogo (vosoritide) in children with hypochondroplasia

BioMarin Pharmaceutical has announced that a phase 3 study evaluating treatment with Voxzogo® (vosoritide) in children with hypochondroplasia met its primary endpoint, demonstrating a statistically significant increase in the change from baseline at week 52 in annualised growth velocity...
Drug Discovery

Atossa Therapeutics announces acceptance of manuscript highlighting utrophin-modulation potential of (Z)-Endoxifen in Duchenne Muscular Dystrophy

Atossa Therapeutics, a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of significant unmet clinical need, has announced that a manuscript titled, â€˜(Z)-Endoxifen as a Potential Modulator of Utrophin Pathways in Duchenne Muscular Dystrophy: A Mechanistic...
Phase 3 trials

Eli Lilly’s triple agonist, retatrutide, delivered powerful weight loss in pivotal phase 3 obesity trial

Eli Lilly and Company, the maker of Zepbound (tirzepatide) and Foundayo (orforglipron), has announced positive topline results from a phase 3 clinical trial evaluating the efficacy and safety of retatrutide, an investigational, first-in-class GIP, GLP-1, and glucagon triple hormone...
Phase 3 trials

Kelun-Biotech announces phase 3 trial of Sacituzumab Tirumotecan versus chemotherapy as first-line treatment for advanced TNBC met primary endpoint of PFS

Kelun-Biotech Biopharmaceutical has announced that the Independent Data Monitoring Committee (IDMC) concluded that the phase 3 clinical study of the company’s trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan versus investigator’s choice of chemotherapy as first-line...
Finance, mergers and appointments

Eli Lilly announces three acquisitions to build infectious disease portfolio

Eli Lilly and Company has entered agreements to acquire three companies, Curevo Inc, LimmaTech Biologic, and Vaccine Company, to expand its research and development efforts into infectious disease. The transactions advance Eli Lilly’s strategy of investing in differentiated technology platforms to address significant...
Phase 3 trials

Positive topline results from a phase 3 trial for VGX-3100 in cervical dysplasia patients announced by ApolloBio, INOVIO’s partner in China

Inovio, a biotechnology company focused on developing and commercialising DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, has announced that its partner for VGX-3100 in China, ApolloBio, declared positive topline results...
Phase 1-2 trials

Innovent Biologics’ new bispecific fusion protein demonstrates robust survival benefits in long-term follow-up study in advanced immunotherapy-resistant non-small-cell lung cancer

Innovent Biologics has announced updated data from the phase 1 clinical study of its first-in-class PD-1/IL-2α-bias bispecific fusion protein IBI363 in the treatment of advanced immunotherapy (IO)-resistant non-small cell lung cancer (NSCLC). Updated data from this study conducted in China,...
Phase 3 trials

US FDA IND clearance for localised fat reduction candidate, a second global phase 3 study of Caliway’s CBL-514

The Investigational New Drug (IND) application for CBL-0302 (Supreme-02), Caliway’s second multi-country pivotal phase 3 study for its localised fat reduction candidate CBL-514, has successfully passed the FDA’s 30-day review period. Both global pivotal phase 3 studies, CBL-0301 and...
Phase 1-2 trials

Inhibrx provides clinical update on ozekibart in late line colorectal cancer

Inhibrx Biosciences, a clinical-stage biopharmaceutical company focused on developing novel biologic therapeutic candidates, has released updated interim data from its phase 1/2 study evaluating ozekibart (INBRX-109) in combination with Folfiri in patients with locally advanced or metastatic, unresectable...
Finance, mergers and appointments

US$ 8.5 million investment in malaria and other R&D projects planned among pharma giants

The global health innovative technology (GHIT) fund has announced a total investment of approximately JPY 1.37 billion (US$ 8.5 million) in five R&D projects for the development of drugs for malaria and neglected tropical diseases (NTDs). Investment of around...
Phase 1-2 trials

Positive phase 1 data for RAG-17 in amyotrophic lateral sclerosis patients with mutations in the superoxide dismutase 1 gene

Ractigen Therapeutics, a clinical-stage biopharmaceutical company focused on developing next-generation RNA-based medicines, has announced positive preliminary data from the single ascending dose (SAD) phase 1 portion of its ongoing Phase I/II clinical trial of RAG-17. RAG-17 is a novel...
CRO

New non-compromise early-phase progression accelerator launched

CARBOGEN AMCIS introduces Sprint for early-phase development, a new, phase-appropriate approach designed to accelerate early-phase progression while maintaining scientific rigour. Sprint has been designed to deliver faster, more efficient progression to clinical phases without compromising scientific rigour. As pressure on...
Phase 3 trials

AbbVie announces positive CHMP opinion for Maviret (glecaprevir/pibrentasvir) for the treatment of acute Hepatitis C infection

AbbVie has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Maviret(glecaprevir/pibrentasvir), an oral pangenotypic direct-acting antiviral (DAA) therapy for the treatment of acute hepatitis...
Finance, mergers and appointments

Neuvoir awarded Smart:Scotland grant to advance AI feasibility work for NHS generic medicines access

Neuvoir Pharmaceuticals has been awarded over £99,000 in Smart:Scotland funding from Scottish Enterprise to support the development of Pharmoris®, its AI-enabled medicines intelligence and deployment programme. The funding will support a nine-month feasibility study exploring how artificial intelligence can...
CDMO

Oxford University scaling doses of Ebolavirus candidate vaccine

In response to the current Bundibugyo Ebolavirus outbreak in the Democratic Republic of the Congo, the Oxford Vaccine Group (OVG) is working urgently with Oxford’s own clinical biomanufacturing facility and the Serum Institute of India, to rapidly produce...
Approvals

Lupin receives China approval for Oseltamivir phosphate oral suspension

Global pharma major Lupin has announced that China's National Medical Products Administration has approved its abbreviated new drug application for oseltamivir phosphate, in partnership with Yabao Pharmaceuticals, a leader in China's paediatric medicine market. This marks Lupin's first product...
Approvals

Ojemda approved in the European Union as the first targeted therapy in relapsed or refractory paediatric low-grade glioma

the treatment of patients six months of age and older with paediatric low-grade-glioma harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies. This EC decision applies across...
Finance, mergers and appointments

Amneal to acquire Kashiv BioSciences to create global biosimilar leader

Amneal Pharmaceuticals, a diversified, global biopharmaceutical leader focused on expanding access to affordable and innovative medicines, has entered into a definitive agreement to acquire 100% of Kashiv BioSciences, in a transaction with consideration that includes $375 million of...
IND

Rznomics reports interim clinical data for RZ-001 in hepatocellular carcinoma, demonstrating encouraging efficacy and favourable safety profile

Rznomics has presented interim clinical data from its ongoing study of RZ-001, an RNA editing-based investigational anticancer therapy, in patients with hepatocellular carcinoma (HCC) during an oral presentation at the AACR 2026 (American Association for Cancer Research Annual Meeting)...
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Drug Discovery & Development (DDD) is dedicated to advancing scientific innovations into active medical solutions. Its aim is to accelerate breakthroughs in medicine, addressing human disease and improving global health outcomes.

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