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Hamlet BioPharma Receives FDA Clearance for Phase III Bladder Cancer Trial Following Successful Regulatory Meeting

Oncology
  • Hamlet BioPharma held its first in-person meeting with the FDA on June 24, 2025, receiving a clear pathway to Phase III trial initiation for Alpha1H in bladder cancer treatment.
  • The FDA provided positive feedback on the company's recently completed Phase II study data from December 2024, with the Alpha1H program being well-received by regulators.
  • The meeting resulted in helpful FDA guidance on Phase III trial design for non-muscle invasive bladder cancer (NMIBC) patients, which will support Alpha1H registration.
  • The company remains on track to initiate the Phase III trial following final protocol agreement and regulatory clearance, marking a key milestone toward market approval.

Sun Pharma's European Partner Withdraws Melanoma Therapy Application from EMA Due to Data Delays

Oncology
  • Sun Pharma's European biotech partner Philogen voluntarily withdrew the marketing authorization application for Nidlegy, an investigational melanoma therapy, from the European Medicines Agency.
  • The withdrawal was due to delays in providing essential Chemistry, Manufacturing and Controls data and additional clinical information needed to establish the therapy's benefit-risk profile.
  • Nidlegy is being developed as a neoadjuvant treatment for locally advanced, resectable melanoma and has been administered to over 450 patients with various skin cancers.
  • Philogen plans to resubmit an updated application after addressing EMA's regulatory requirements and remains committed to making the therapy available to melanoma patients.

Neoadjuvant L19IL2/L19TNF- Pivotal Study

NCT02938299RecruitingPhase 3
Philogen S.p.A.
Posted 7/1/2016

Biocon Biologics Partners with Malaysia's National Cancer Society to Launch Biosimilar Access Program

OncologyMonoclonal Antibody
  • Biocon Biologics has partnered with the National Cancer Society of Malaysia to launch a Patient Assistance Programme providing affordable oncology biosimilars to underserved cancer patients.
  • The program will initially focus on providing trastuzumab to patients facing treatment delays due to financial constraints, with plans to expand to pegfilgrastim and bevacizumab.
  • This collaboration builds on Biocon's previous success in Malaysia's diabetes care, where the company has served over 345,000 patients through affordable treatment programs.
  • The partnership combines Biocon's biosimilar expertise with NCSM's community outreach capabilities to enhance cancer care accessibility in Malaysia.

CytoDyn Initiates Phase II Trial of Leronlimab in Relapsed/Refractory Colorectal Cancer

Monoclonal AntibodyOncology
  • CytoDyn has dosed the first patient in a Phase II clinical trial evaluating leronlimab, a CCR5 antagonist, in patients with relapsed/refractory microsatellite stable colorectal cancer.
  • The study is being conducted across eight clinical sites in partnership with Syneos Health, with Dr. Ben Weinberg from Georgetown University serving as lead principal investigator.
  • The trial builds on prior research showing potential clinical benefit of leronlimab in relapsed colorectal cancer and promising survival rates in metastatic triple-negative breast cancer.
  • Colorectal cancer represents a significant global health burden with approximately 1.9 million new cases and over 900,000 deaths annually worldwide according to WHO data.

Bayer Extends 16-Year Research Partnership with Tsinghua University for Three More Years

Drug DiscoveryOncology
  • Bayer and Tsinghua University have extended their strategic research collaboration by three additional years, building on a 16-year partnership that has produced over 70 joint research projects and more than 10 publications in top international journals.
  • The extended agreement focuses on joint research targeting oncology, cardiovascular and renal diseases, neurology, rare diseases, and immunology, reinforcing Bayer's commitment to healthcare innovation in China's rapidly evolving pharmaceutical market.
  • The partnership has established a benchmark for collaboration between multinational pharmaceutical companies and Chinese academic institutions, with Bayer conducting more than 80% of its major multi-center clinical trials in China.
  • Bayer's broader China strategy includes two global R&D centers, four production facilities, and the recent launch of Bayer Co.Lab China, which aims to incubate 10-15 biotech startups focusing on cutting-edge therapeutic innovations.

Revolution Medicines Secures $2 Billion Funding Deal with Royalty Pharma for RAS Cancer Drug Development

Targeted TherapyOncology
  • Revolution Medicines partnered with Royalty Pharma on a $2 billion flexible funding agreement to support global development and commercialization of its RAS(ON) inhibitor portfolio for cancer treatment.
  • The funding comprises up to $1.25 billion in synthetic royalty monetization on daraxonrasib sales and up to $750 million in corporate debt, with $1.25 billion available at the company's discretion.
  • Revolution Medicines retains full strategic control of product development and commercialization while removing its cash runway guidance, enabling independent global operations.
  • The agreement includes milestone-based payments tied to FDA approval and sales targets, with royalty rates decreasing as sales increase and reaching zero above $8 billion annually.

Glenmark Launches Tevimbra, First Immuno-Oncology Drug in India for Lung and Esophageal Cancer Treatment

Monoclonal AntibodyDrug ApprovalOncology
  • Glenmark Pharmaceuticals has launched Tevimbra (tislelizumab), marking the company's first entry into immuno-oncology in India following CDSCO approval.
  • The anti-PD-1 monoclonal antibody is indicated for first-line treatment of locally advanced or metastatic NSCLC in combination with chemotherapy and second-line treatment as monotherapy.
  • Tevimbra is already approved in 46 countries including the US and EU, with over 1.5 million patients treated globally and worldwide sales of $625 million in 2024.
  • The drug targets NSCLC, which represents over 80% of lung cancer cases, and ESCC, the most common esophageal cancer subtype in India.

Psychedelic Therapy Expands Beyond Cancer Care as Multi-Center Studies Launch

Oncology
  • Sunstone Therapies has conducted over 150 MDMA sessions through expanded access programs, demonstrating the drug's relational properties that facilitate therapeutic conversations and empathy.
  • The group therapy model pioneered for cancer patients using simultaneous psilocybin administration is being adapted for active duty military PTSD treatment using MDMA in a Department of Defense study.
  • Major cancer centers including Dana-Farber Cancer Institute have completed psilocybin studies, with upcoming multi-center trials comparing psilocybin to ketamine in cancer patients.
  • Long-term group integration sessions continue for over three years post-treatment, with participants from multiple cohorts meeting monthly and showing sustained benefits.

Moleculin Biotech Raises $5.9 Million to Advance Annamycin Through Phase 3 AML Trial

Oncology
  • Moleculin Biotech completed a $5.9 million public offering to fund advancement of its lead drug candidate Annamycin through clinical development.
  • The company is conducting the MIRACLE Phase 3 trial evaluating Annamycin combined with cytarabine for relapsed or refractory acute myeloid leukemia.
  • Annamycin is designed as a next-generation anthracycline that avoids multidrug resistance and lacks the cardiotoxicity of current anthracyclines.
  • The funding will also support development of the company's broader pipeline including WP1066 for brain tumors and WP1122 for viral infections.

Onco360 Partners with Deciphera to Distribute QINLOCK for Advanced GIST Patients

Oncology
  • Onco360, the nation's leading independent specialty pharmacy, has been selected as a national pharmacy partner for QINLOCK (ripretinib), an FDA-approved treatment for advanced gastrointestinal stromal tumors.
  • QINLOCK is indicated for adult patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib, based on the Phase III INVICTUS study.
  • The INVICTUS trial demonstrated significant efficacy with median progression-free survival of 6.3 months for ripretinib versus 1.0 month for placebo in 129 patients with relapsed or refractory GIST.
  • Ripretinib is a tyrosine kinase inhibitor targeting KIT and PDGFRA kinases, including wild type, primary, and secondary mutations, with generally well-tolerated safety profile.
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