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FDA Maintains Record-Breaking Approval Pace Despite Organizational Upheaval, Highlighting Three Breakthrough Therapies

Drug ApprovalOncology
  • The FDA has approved 84 drugs in 2025 so far, marking the second-highest total for this period despite major organizational changes including 3,500 staff layoffs.
  • Gilead's Yeztugo represents a potential game-changer for HIV prevention with 100% efficacy in phase 3 trials and twice-yearly dosing, though priced at $28,218 annually.
  • Daiichi Sankyo's ADC portfolio expansion continues with Datroway's lung cancer approval, while GSK's Blujepa becomes the first new urinary tract infection antibiotic in three decades.

Orano Med Expands Texas R&D Center to Advance Lead-212 Targeted Alpha Therapies

Oncology
  • Orano Med has inaugurated a $5 million expansion of its Plano, Texas R&D center, adding 11,000 square feet of laboratory and office space to advance lead-212 radioligand therapies.
  • The expansion doubles the facility's Good Manufacturing Practice production capacity for early clinical trials and accommodates a team that has doubled in size over four years.
  • The company's most advanced asset, AlphaMedix for GEP-NETs tumors, received FDA Breakthrough Designation in 2024, highlighting the clinical potential of targeted alpha-emitter therapy.
  • The facility now operates as the Drug Development and Preclinical Unit (DDPU) – George de Hevesy Center, supporting both internal programs and pharmaceutical partnerships.

Incyte Names Bill Meury as New CEO, Replacing 11-Year Veteran Hervé Hoppenot

Oncology
  • Incyte has appointed Bill Meury as its new CEO, effective immediately, replacing Hervé Hoppenot who led the cancer and blood disease drugmaker for 11 years.
  • Meury previously led Anthos Therapeutics, which sold to Novartis for nearly $1 billion, and Karuna Therapeutics, acquired by Bristol Myers Squibb for $14 billion in 2023.
  • Under Hoppenot's leadership, Incyte grew revenues from $355 million in 2013 to $4.2 billion today, though the company remains heavily dependent on Jakafi, which faces patent expiration in 2028.
  • Incyte shares rose more than 4% following the CEO announcement, with investors potentially viewing the company as an acquisition target given Meury's track record of successful exits.

Ontario Expands Public Coverage of XTANDI for High-Risk Prostate Cancer Patients

Oncology
  • Ontario's Drug Benefit Program now covers XTANDI (enzalutamide) for non-metastatic castration-sensitive prostate cancer patients with high-risk biochemical recurrence, making it the first androgen receptor pathway inhibitor reimbursed for this indication in the province.
  • The decision follows Health Canada's expedited approval of XTANDI for this indication in January 2024 through Project Orbis, providing faster access to promising cancer treatments.
  • XTANDI is now publicly reimbursed in Ontario for all of its approved prostate cancer indications, addressing a critical need as about 9 out of 10 men with high-risk biochemical recurrence develop metastatic disease.
  • The expanded access removes barriers for physicians to provide comprehensive care to prostate cancer patients, particularly important given that prostate cancer accounts for 76 new diagnoses daily among Canadian men.

TME Pharma Appoints Diede van den Ouden as New CEO to Advance Glioblastoma Drug Development

Oncology
  • TME Pharma shareholders unanimously approved the appointment of Diede van den Ouden as new CEO, succeeding Aram Mangasarian at the company's 2025 annual general meeting.
  • The leadership transition comes as TME Pharma has achieved significant clinical progress with NOX-A12 in glioblastoma, earning FDA fast track designation for the challenging brain cancer indication.
  • Van den Ouden, who is also a major shareholder, will focus on accelerating strategic initiatives for both NOX-A12 and NOX-E36 while securing funding and partnerships.
  • The company has strengthened its financial position with reduced cash burn and a secured 12-month runway as it advances multiple clinical programs targeting the tumor microenvironment.

Glioblastoma Treatment With Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients

NCT04121455Active, Not RecruitingPhase 1
TME Pharma AG
Posted 9/12/2019

Olaptesed With Pembrolizumab and Nanoliposomal Irinotecan or Gemcitabine/Nab-Paclitaxel in MSS Pancreatic Cancer

NCT04901741Not Yet RecruitingPhase 2
TME Pharma AG
Posted 1/1/2026

Exousia Pro Files Patent for Novel Exosome Loading Technology Targeting Multi-Billion Dollar Therapeutic Markets

Oncology
  • Exousia Pro filed a provisional patent for a groundbreaking method to load extracellular vesicles with therapeutic compounds, potentially enhancing drug delivery efficiency and stability.
  • The patented technology targets three major markets worth over $2.7 trillion combined: pharmaceuticals ($1.77 trillion), nutraceuticals ($500 billion), and cosmetics ($450 billion).
  • The clinical-stage biotech company plans to use the technology under its Exousia Health division to develop new products and is preparing trademark applications for multiple innovations.
  • Concurrent with the patent filing, Exousia Pro has initiated a Reg A offering to raise up to $4.985 million, with primary focus on funding glioblastoma IND trials.

Gilead and Kymera Partner on Novel CDK2 Molecular Glue Degrader for Cancer Treatment

Oncology
  • Gilead Sciences and Kymera Therapeutics have entered into an exclusive option and license agreement to develop novel molecular glue degraders targeting CDK2 for cancer treatment.
  • The collaboration focuses on CDK2-directed molecular glue degraders that selectively remove the CDK2 protein from cells rather than just inhibiting its function, potentially offering more precise cancer treatments.
  • Kymera is eligible to receive up to $750 million in total payments, including up to $85 million in upfront and potential option exercise payments, plus tiered royalties on net product sales.
  • The oral CDK2 degraders have demonstrated compelling preclinical profiles and target breast cancer and other solid tumors with high unmet medical need.

Bio-Thera Solutions Initiates Phase 3 Trial for BAT8006 ADC in Platinum-Resistant Ovarian Cancer

Oncology
  • Bio-Thera Solutions has dosed the first patient in a pivotal phase 3 trial for BAT8006, an antibody-drug conjugate targeting folate receptor α for platinum-resistant ovarian cancer treatment.
  • Early clinical data from 133 patients showed BAT8006 achieved a median progression-free survival of 7.63 months with a 40.7% objective response rate and no cases of interstitial lung disease or ocular toxicity.
  • The therapy has potential to treat the full spectrum of platinum-resistant ovarian cancer patients regardless of folate receptor α expression levels, addressing a significant unmet medical need.
  • BAT8006 represents one of the first folate receptor α-targeting ADCs in China to enter pivotal phase 3 testing, potentially offering a novel therapeutic option for this difficult-to-treat patient population.

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.

A First-in-Human Study of alpha1H in Patients With Non-muscle Invasive Bladder Cancer

NCT03560479Unknown StatusPhase 1
Hamlet Pharma AB
Posted 5/21/2018

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

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