Pharmaceuticals & Biopharmaceuticals

AdJane Details Plan to Add Mucosal Booster to mRNA Vaccine Regimens

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AdJane Details Plan to Add Mucosal Booster to mRNA Vaccine Regimens

Delft – September 16, 2026 -- AdJane Biosciences has published a White Paper outlining a strategy to add a proprietary intranasal booster to existing intramuscular respiratory vaccines, targeting the mucosal immunity gap left by current mRNA shots.

Phase I data show intranasal booster induced significant nasal IgA responses in mRNA-primed subjects

In a post-hoc subset of participants from AdJane's completed Phase I study who had previously received Pfizer and/or Moderna COVID-19 mRNA vaccines, a subsequent intranasal dose of an Nm-nOMV vaccine displaying SARS-CoV-2 Spike was well tolerated and generated significant nasal IgA responses. AdJane says this provides initial human evidence for a heterologous prime-boost approach: systemic priming via existing intramuscular vaccines followed by a mucosal Nm-nOMV booster delivered intranasally.

AdJane Unveils Mucosal Booster Strategy for Respiratory Vaccines

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AdJane Unveils Mucosal Booster Strategy for Respiratory Vaccines

Delft – September 16, 2026 -- AdJane Biosciences has published a white paper outlining a strategy to add mucosal immune stimulation to existing intramuscular respiratory vaccine regimens, using its clinically validated Nm-nOMV platform derived from Neisseria meningitidis outer membrane vesicles.

AdJane targets the mucosal gap left by intramuscular respiratory vaccines

Current intramuscular respiratory vaccines induce strong systemic immunity and protect against severe disease, but generate limited protection at the respiratory mucosa, the point where pathogens first enter the body. The company's white paper, titled 'Boosting mRNA: Mucosal Immunity and a Platform Beyond It,' argues that mucosal IgA responses can reduce transmission at the point of entry, a target public health bodies are pursuing alongside severe-disease prevention.

CordenPharma Invests €80M to Hit 500M Sterile Injectable Units Yearly

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CordenPharma Invests €80M to Hit 500M Sterile Injectable Units Yearly

Basel, Switzerland – September 16, 2026 -- CordenPharma has committed a multi-year €80 million investment to expand sterile injectable manufacturing at its FDA & EMA-approved Caponago site near Milan, Italy, targeting a total production capacity of 500 million units per year.

CordenPharma finalizes €13 million land and building acquisition to expand Caponago footprint by over 50%

The company completed the purchase of an 11,000 m2 commercial building and 26,000 m2 of adjacent land on 28 July 2026, adjacent to its existing late-stage aseptic fill & finish area. The new space can accommodate at least four aseptic fill & finish lines, four visual inspection lines and four packaging lines, with room for customer-owned lines, large-scale lyophilization and auto-injector assembly.

Insilico Doses First Patient in Phase III Trial of AI-Discovered IPF Drug

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Insilico Doses First Patient in Phase III Trial of AI-Discovered IPF Drug

Cambridge – – September 16, 2026 -- Insilico Medicine (HKEX: 3696) has dosed the first patient in GENESIS-IPF-3, a Phase III trial of Rentosertib, marking what the company calls the world's first late-stage clinical study of a drug candidate discovered and developed using generative AI.

Peking and Shanghai hospitals simultaneously enroll first patients

The dosing occurred at Peking Union Medical College Hospital, with Shanghai Pulmonary Hospital enrolling its own first patient on the same day. Professor Zuojun Xu of Peking Union Medical College Hospital serves as Leading Principal Investigator, with Academician Nanshan Zhong and President Chang Chen of Shanghai Pulmonary Hospital as Co-Leading PIs.

Seismic Pharma Doses First Patient in Phase 3 Cardiogenic Shock Trial

Durham – September 16, 2026 -- Seismic Pharmaceuticals has enrolled the first patient in RESCUE HF-CS, a global Phase 3 trial testing istaroxime as a potential first-ever approved drug for heart-failure-related cardiogenic shock, a condition with no FDA-approved treatment.

Trial to enroll 600 patients across four continents

The study will recruit approximately 600 patients at clinical sites in the United States, Europe, China and South America. It builds on four completed Phase 2 trials that enrolled more than 350 patients.

Cardiogenic shock carries high mortality despite critical care advances

The condition occurs when the heart cannot pump enough blood to meet the body's needs, cutting oxygen delivery to vital organs. It often complicates acute heart failure or other serious cardiac events, and no pharmacologic therapy has been developed specifically to treat it.

DisposeRx Launches Medication Stewardship Series on Unsafe Drug Disposal

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DisposeRx Launches Medication Stewardship Series on Unsafe Drug Disposal

Southern Pines, N.C. – September 16, 2026 -- DisposeRx, Inc. has launched a new monthly editorial series, the DisposeRx Medication Stewardship Center, aimed at reshaping how healthcare providers, pharmacists and caregivers manage the end stage of a prescription's life cycle.

DisposeRx CEO frames disposal as a patient safety issue, not just an environmental one

"This is not simply a conversation about medication disposal. It is a conversation about Medication Safety and completing the prescription journey," said William Simpson, CEO of DisposeRx. He said the starting point for the discussion is the household medicine cabinet, where unused prescriptions commonly accumulate.

Seismic Pharma Launches Phase 3 Trial for Cardiogenic Shock Drug

Durham – September 16, 2026 -- Seismic Pharmaceuticals has commenced a global Phase 3 trial of Istaroxime, aiming to deliver the first-ever approved drug for cardiogenic shock, a condition with no currently FDA-approved treatments.

Trial to enroll 600 patients across three continents

The study, named Rescue HF CS, will recruit approximately 600 patients at clinical sites in the United States, Europe and South America. It builds on four completed Phase 2 trials in which more than 340 patients received Istaroxime.

Ambit RD Sold to Danforth Health in Avesi-Backed Life Sciences Deal

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Ambit RD Sold to Danforth Health in Avesi-Backed Life Sciences Deal

Washington – – September 16, 2026 -- Clearsight Advisors served as exclusive sell-side advisor to Ambit RD, Inc. on its acquisition by Danforth Health, Inc., a portfolio company of Avesi Partners, in a deal announced by the firms.

Ambit brings patient-identification technology to Danforth's life sciences platform

Ambit RD specializes in commercial strategy, advanced analytics, and patient identification solutions for rare and specialty biopharma markets, operating through three service lines: Strategic Services, Analytics & Data Services, and Patient ID Services. The company helps biopharmaceutical organizations locate patients, speed therapy adoption, and engage healthcare providers across the clinical and commercial continuum.

Fibryga Cuts Blood Transfusions 19% in Cardiac Surgery Subgroups

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Fibryga Cuts Blood Transfusions 19% in Cardiac Surgery Subgroups

Paramus, N.J. – – September 15, 2026 -- A prespecified secondary analysis of the landmark FIBRES trial found that Octapharma's fibryga (fibrinogen [human]) cut 24-hour allogeneic blood-product transfusion requirements by 19% versus cryoprecipitate in two overlapping patient subgroups, according to findings published in the Journal of Cardiothoracic and Vascular Anesthesia.

Non-critical and elective surgery patients showed the sharpest transfusion reductions

Among 634 patients classified as non-critical before surgery -- 86% of the primary trial population -- those receiving fibryga required 13.6 blood-product units on average versus 16.2 units for cryoprecipitate recipients, a 19% relative reduction. In the 466-patient elective-surgery subgroup, representing 63% of the primary population, fibryga patients received 11.7 units compared with 14.4 units for cryoprecipitate, matching the 19% relative reduction.