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Clinical Trial News

A.forall Launches Direct Commercialization of Sodium Acetate Injection to Address U.S. Drug Shortage

  • A.forall announced the direct commercialization and launch of Sodium Acetate Injection 2mEq/mL through its U.S. subsidiary Milla Pharmaceuticals Inc.
  • The injectable solution is available in 20mL, 50mL, and 100mL vials and is indicated for preventing or correcting hyponatremia in patients with restricted oral intake.
  • The company has been supplying Sodium Acetate in the U.S. for four years during ongoing shortages and now addresses the shortage directly through its own commercial organization.
  • This milestone represents A.forall's continued investment in serving the U.S. marketplace, particularly for products experiencing shortages.

CSL Behring's Australian Plasma Facility Wins Global Manufacturing Excellence Award for Advanced Automation

  • CSL Behring's $900 million plasma fractionation facility in Broadmeadows, Victoria, has been named 2025 Facility of the Year in the Pharma 4.0 category by the International Society for Pharmaceutical Engineering.
  • The facility represents the world's largest plasma fractionation facility of its kind, processing over 10 million liters of plasma annually and increasing CSL Behring's local capacity ninefold.
  • The award recognizes the facility's full-scale integration of robotics, automation technologies, and digital twin technology that enhances safety, reduces waste, and improves operational efficiency.
  • The facility produces plasma-derived therapies for treating immunodeficiencies, neurological disorders, shock, burns, and supports transplant, surgical, and cancer patients globally.

Biocon Biologics Expands Nepexto Biosimilar to Australian Market for Autoimmune Disease Treatment

  • Biocon Biologics has launched Nepexto, a biosimilar to Enbrel (etanercept), in Australia through partnership with Generic Health to expand patient access.
  • Nepexto targets multiple autoimmune diseases including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis.
  • The biosimilar has demonstrated broad adoption across Europe since receiving EU marketing authorization in 2020.
  • This launch represents part of Biocon Biologics' strategic global expansion following their 2022 acquisition and vertical integration of the biosimilars business.

Syntellix Secures NMPA Approval for Bioabsorbable Metallic Implants in China, Unlocking 1.4 Billion Patient Market

  • Syntellix AG received product approval from China's NMPA for its MAGNEZIX® bioabsorbable metallic implants, marking the company's most significant regulatory milestone and opening access to over 1.4 billion potential patients.
  • The Singapore-based manufacturing subsidiary now holds approvals in countries representing more than 5.5 billion inhabitants across 73 countries and regions on five continents, with China representing the largest single market opportunity.
  • The company's bioabsorbable metallic orthopedic implants have been documented in over 50 medical publications as "advantageous" and "clinically superior" to conventional titanium implants, with tens of thousands of successful surgeries completed globally.
  • Syntellix plans to leverage its Singapore production facility as an Asia-wide sales hub and is preparing for an IPO on the Singapore Exchange following this strategic market entry.

Kidney Cancer Research Consortium Advances Novel Combination Therapies Through Multi-Institutional Collaboration

  • The Kidney Cancer Research Consortium, a DoD-funded program led by Dr. Eric Jonasch, includes 7 institutions collaborating on hypothesis-testing clinical trials for novel kidney cancer therapeutic strategies.
  • The consortium has developed a portfolio of 10 clinical trials that combine established immune-modulating agents like nivolumab plus ipilimumab with novel therapeutic agents including LAG3 inhibitors and lutetium-177 girentuximab.
  • Researchers can conduct more mechanistic and scientifically driven investigations while collecting correlative samples including circulating tumor DNA, tissue samples, and quality of life data to acquire more information from fewer patients in less time.

Avalyn Pharma Raises $100M to Advance Inhaled Pulmonary Fibrosis Therapies

  • Avalyn Pharma secured $100 million in an oversubscribed Series D financing round to advance inhaled formulations of existing pulmonary fibrosis drugs pirfenidone and nintedanib.
  • The company is developing AP01 (inhaled pirfenidone) for Phase IIb trials and AP02 (inhaled nintedanib) for Phase II studies, aiming to reduce systemic side effects while maintaining efficacy.
  • Only 30% of the 300,000 U.S. pulmonary fibrosis patients take current oral medications due to severe gastrointestinal side effects including diarrhea, indigestion, and vomiting.
  • The inhaled delivery approach targets the lungs directly at lower doses, potentially improving tolerability for a disease with a median survival of 3-5 years.

FDA Approves First 3D-Printed Epilepsy Drug for Feeding Tube Administration

Drug Approval
  • The FDA has approved Spritam (levetiracetam), the world's first 3D-printed medication, for administration via nasogastric and gastrostomy tubes, making it the only levetiracetam formulation with this approval.
  • The drug uses Aprecia's proprietary ZipDose Technology Platform to create rapidly disintegrating tablets that can be dispersed in minimal liquid volumes for enteral administration.
  • This approval provides critical access for epilepsy patients who cannot take oral medications, particularly those with swallowing difficulties or requiring enteral feeding support.
  • Spritam is indicated for treating partial-onset seizures in patients 4 years and older, myoclonic seizures in juvenile myoclonic epilepsy patients 12 years and older, and generalized tonic-clonic seizures in patients 6 years and older.

Pacira BioSciences Partners with Johnson & Johnson to Expand Zilretta Access for Osteoarthritis Knee Pain

  • Pacira BioSciences has entered a strategic co-promotion agreement with Johnson & Johnson MedTech to expand distribution of Zilretta, the first FDA-approved extended-release intra-articular therapy for osteoarthritis knee pain.
  • The collaboration will leverage Johnson & Johnson's specialized sales team to target broader physician specialties including sports medicine, pain management, and rheumatology beyond traditional orthopedic practices.
  • Zilretta provides extended pain relief for up to 16 weeks and could potentially reach a significant portion of the seven million intra-articular knee injections administered annually in the U.S.
  • The partnership aligns with Pacira's 5x30 growth strategy and Johnson & Johnson's mission to advance orthopaedic care with non-opioid pain management solutions.

Stanford Researchers Develop Radiation-Free Stem Cell Transplant Protocol for Fanconi Anemia Patients

Monoclonal AntibodyRare Disease
  • Stanford Medicine researchers successfully conducted stem cell transplants in three Fanconi anemia patients using the anti-CD117 antibody briquilimab, eliminating the need for toxic radiation or busulfan chemotherapy.
  • All three pediatric patients achieved nearly 100% donor cell engraftment after two years, far exceeding the initial 1% target, with no graft rejection or major complications.
  • The innovative protocol addresses donor shortage by allowing transplants from half-matched donors like parents through alpha/beta T-cell depletion techniques.
  • Researchers are now conducting phase 2 trials and exploring applications for other genetic diseases including Diamond-Blackfan anemia and elderly cancer patients.

STRIDE Immunotherapy Achieves Unprecedented 19.6% Five-Year Survival Rate in Advanced Liver Cancer

  • A new exploratory analysis of the HIMALAYA phase III trial shows that 19.6% of patients with unresectable hepatocellular carcinoma treated with STRIDE immunotherapy remained alive after five years, compared to 9.4% with sorafenib.
  • STRIDE represents the first phase III study to report five-year overall survival data in advanced liver cancer, establishing a new survival benchmark for this devastating disease.
  • The combination therapy demonstrated sustained survival benefits across all clinically relevant patient subgroups with manageable safety and no new late-onset serious side effects.
  • These findings represent a clinical breakthrough that was considered unimaginable just a few years ago and will inform treatment decisions for years to come.

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

NCT03298451Active, Not RecruitingPhase 3
AstraZeneca
Posted 10/11/2017

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