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Apozeal Pharmaceuticals Secures $4.1M Investment to Expand Generic Drug Manufacturing in Pennsylvania

FDA Approval
  • Apozeal Pharmaceuticals will invest $4.1 million to expand its drug manufacturing operations in Bucks County, Pennsylvania, with $1.1 million in state support.
  • The expansion will create 70 new jobs and retain 22 existing positions over three years while adding new production lines to manufacture seven additional FDA-approved generic drugs.
  • The company currently holds 11 FDA-approved Abbreviated New Drug Applications and aims to produce 100% of its products domestically in the United States.
  • Pennsylvania's life sciences sector employs over 100,000 people across nearly 3,100 companies and is expected to create 6,500 new jobs over the next decade.

LISCure BioSciences Achieves World's First FDA NDI Notification for Hair Health Probiotic Mobiome®

FDA ApprovalOrphan Drug
  • LISCure BioSciences received the world's first FDA New Dietary Ingredient (NDI) notification for Mobiome®, a proprietary hair health probiotic targeting hair follicle health.
  • Clinical trials demonstrated statistically significant improvements in hair gloss and elasticity (p<0.05, 95% CI) through multiple mechanisms including enhanced antioxidant activity and hair follicle cell proliferation.
  • The FDA NDI notification represents a critical regulatory milestone that strengthens LISCure's competitive position for global expansion in North America, Europe, and Asian markets.
  • Beyond hair health applications, LISCure is advancing a pharmaceutical pipeline including LB-P8 for primary sclerosing cholangitis with FDA Orphan Drug and Fast Track designations.

CS Diagnostics Submits Patent Application for CS-Protect Hydrogel Organ Spacer Device

FDA Approval
  • CS Diagnostics Corp. has submitted a patent application for its CS-Protect Hydrogel organ spacer medical device to support its FDA application process.
  • The company partnered with German intellectual property law firm Paul & Albrecht Patentanwälte PartG mbB to secure patent protection in the US market.
  • CS-Protect Hydrogel is described as an advanced organ spacer technology with versatile applications across multiple pathologies.
  • The patent submission represents a strategic milestone in the company's regulatory pathway toward FDA approval for the medical device.

FDA Clears Clinical Trial for Pig Kidney Transplants as Second Patient Achieves Dialysis-Free Life

FDA Approval
  • Bill Stewart, a 54-year-old New Hampshire man, successfully received a genetically engineered pig kidney transplant on June 14 and no longer requires dialysis after being discharged from Massachusetts General Hospital.
  • Tim Andrews, the first patient in the eGenesis study, continues to live dialysis-free seven months post-transplant, setting a new record for the longest-lasting gene-edited pig organ transplant at 130+ days.
  • The FDA has approved eGenesis to begin a clinical trial evaluating EGEN-2784 pig kidneys in 30 patients with end-stage kidney disease, marking a significant milestone in xenotransplantation research.
  • More than 100,000 Americans are on the transplant waiting list, with thousands dying while waiting for organs, highlighting the critical need for alternative solutions like genetically modified pig organs.

Locate Bio Receives FDA IDE Approval to Expand RESTORE Clinical Study of LDGraft Bone Graft Substitute to US

FDA Approval
  • Locate Bio received FDA Investigational Device Exemption approval to expand its RESTORE clinical study of LDGraft bone graft substitute to the United States.
  • LDGraft is an investigational product that encapsulates recombinant human Bone Morphogenetic Protein-2 to provide dose shielding during early inflammatory phases of bone healing.
  • The prospective, multi-center study evaluates LDGraft's safety and performance in patients undergoing single-level anterior lumbar interbody fusion procedures.
  • US clinical sites are expected to begin patient enrollment later this year, expanding beyond the existing Australian study locations.

Zydus and Synthon Partner to Launch Generic Multiple Sclerosis Drug in $637 Million US Market

FDA Approval
  • Zydus Lifesciences Global FZE has entered into an exclusive licensing and supply agreement with Netherlands-based Synthon BV to commercialize generic Ozanimod capsules for multiple sclerosis treatment in the US market.
  • Synthon has received tentative FDA approval as one of the first filers and will handle regulatory approval and manufacturing, while Zydus manages US commercialization of the generic version of ZEPOSIA.
  • The collaboration targets a total addressable market opportunity of approximately $637 million for Ozanimod capsules in the US, with the product eligible for shared 180-day exclusivity upon market entry.

Arecor Receives FDA Approval for Phase 2 Trial of Ultra-Concentrated Insulin AT278 in Automated Delivery Systems

FDA Approval
  • Arecor Therapeutics received positive FDA feedback for its Phase 2 clinical study design of AT278, an ultra-concentrated (500 U/mL) and ultra-rapid acting insulin for use with automated insulin delivery systems.
  • The first-of-its-kind study will use Time-in-Range as the primary efficacy endpoint, enabling faster development with a 6-week dosing period compared to the standard 12-week HbA1c assessment.
  • AT278 is the only insulin in development with potential to enable longer-wear for high daily insulin users and future insulin pump miniaturization, addressing unmet needs in diabetes treatment.
  • The Phase 2 crossover study will compare AT278 with NovoLog in less than 100 subjects with type 1 and type 2 diabetes, with enrollment planned for mid-2026.

Predicine Initiates FDA Premarket Approval Application for Bladder Cancer Companion Diagnostic

FDA ApprovalPrecision Medicine
  • Predicine has submitted the first module of a premarket approval application to the FDA for PredicineCARE, a urine cell-free DNA next-generation sequencing assay for use as a companion diagnostic in bladder cancer.
  • The comprehensive cfDNA assay targets variants in over 152 genes and can analyze DNA from blood, urine, and tissue samples with a 10-day turnaround time for results.
  • PredicineCARE received breakthrough device designation from the FDA in August 2022 and is being developed in collaboration with Janssen, a Johnson & Johnson company.
  • Additional modules of the PMA application will be submitted following completion of the registrational trial, with the foundational submission designed to support future companion diagnostic development.

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

NCT04191499Active, Not RecruitingPhase 2
Hoffmann-La Roche
Posted 1/29/2020

Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

NCT03822117TerminatedPhase 2
Incyte Corporation
Posted 10/17/2019

Shanghai Henlius Biotech Receives FDA Approval for Two Denosumab Biosimilars for Osteoporosis Treatment

Drug ApprovalFDA Approval
  • Shanghai Henlius Biotech has received FDA approval for two denosumab biosimilars, BILDYOS and BILPREVDA, marking the company's sixth overseas product approval.
  • The biosimilars are approved for eight indications related to osteoporosis and bone conditions, specifically targeting postmenopausal women at high risk for fractures.
  • FDA approval was based on comprehensive comparative studies demonstrating similarity to the reference product Prolia in quality, safety, and efficacy.
  • The products will be commercialized outside China through a partnership with Organon LLC, expanding the company's global market reach.

FDA Accepts First Non-Invasive Surrogate Endpoint for MASH Clinical Trials

FDA Approval
  • The FDA has accepted Echosens' Letter of Intent to qualify liver stiffness measurement by FibroScan® as the first non-invasive surrogate endpoint for MASH clinical trials.
  • This milestone could replace invasive liver biopsies for patient enrollment and treatment response assessment in MASH drug development programs.
  • The acceptance is supported by over 5,600 peer-reviewed publications and endorsements from major pharmaceutical companies including Eli Lilly, Boehringer Ingelheim, and Novo Nordisk.
  • The development has the potential to accelerate drug development by improving trial recruitment and patient retention while reducing patient burden.

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