Don Tracy, Associate Editor

Daniel Vitt, CEO, Immunic Therapeutics, discusses how the company is positioning itself to lead in the area of gastrointestinal diseases.

The application leverages existing clinical data for Uzedy along with prior FDA findings on the safety of Udezy in patients with bipolar I disorder.

The funding, led by existing and new investors, is expected to support Eikon’s efforts to integrate advanced computing, automation, and data science that drives innovation in drug development.

Daniel Vitt, CEO, Immunic Therapeutics, discusses how the safety and tolerabilities results from Phase I trials for IMU-856 influences further studies for gastrointestinal diseases moving forward.

Surgifort is the first FDA-approved human milk-based fortifier specifically designed for term infants recovering from gastroschisis surgery.

Keytruda demonstrated a statistically significant and clinically meaningful improvement in event-free survival and major pathological response in patients with resectable locally advanced head and neck squamous cell carcinoma.

Daniel Vitt, CEO, Immunic Therapeutics, discusses how IMU-856 could support the challenges of gluten-free diets and cross-contamination risks for celiac disease.

The BrainSense adaptive deep brain stimulation system personalizes therapy by dynamically adjusting stimulation based on real-time brain activity to improve Parkinson disease symptom control without manual adjustments.

Launching this month, Vaxitek HVT+IBD+H5 integrates COBRA technology to address the ongoing viral evolution challenges of avian influenza, as well as for the prevention of Marek disease and infectious bursal disease.

Under terms of the deal, Stoke will spearhead global development of zorevunersen, while Biogen will receive exclusive rights to commercialize the treatment outside of North America.

Valencia will seek to leverage the investment as well as Surek’s leadership experience to drive commercialization of its flagship eCoin system to develop minimally invasive treatments for urinary incontinence.

Led by Bosch Ventures, Applyo Jena’s Series A funding seeks to accelerate the development and commercialization of its advanced pharmaceutical technologies.

Under terms of the deal, Epitopea and Merck will work to identify Cryptigen tumor-specific antigens through Epitopea’s CryptoMap platform.

Ospomyv, a biosimilar to Prolia, is indicated for postmenopausal women and men at high risk of fracture, while Xbryk, a biosimilar to Xgeva, is indicated for preventing skeletal-related events in multiple myeloma and solid tumor bone metastases.

Vimkunya is the first FDA-approved vaccine for chikungunya in patients over 12 years of age.

Meilog marks the first rapid-acting insulin biosimilar to gain FDA approval for the treatment of diabetes.

Approval of Adcetris provides a new treatment option for patients with relapsed or refractory large b-cell lymphoma who are ineligible for autologous stem cell transplantation.

As part of the funding, Latent Labs aims to leverage generative artificial intelligence to computationally create novel therapeutic molecules, such as antibodies and enzymes, to improve molecular features.

Evrysdi is a non-invasive, disease-modifying option that can be swallowed whole or dispersed in water for patients with spinal muscular atrophy.

Acquisition includes abelacimab, a Factor XI-inhibiting monoclonal antibody in development for stroke prevention in patients with atrial fibrillation and cancer-associated thrombosis.

Funding was led by New Enterprise Associates, with participation from Foresite Capital and multiple other investors.

Approval makes Gomekli the first treatment to be approved for both adults and pediatric patients for neurofibromatosis type 1, a genetic disorder that causes noncancerous tumors to grow on nerves throughout the body.

PwC report identifies transformative trends impacting the pharma market this year and into the future.

Emblaveo marks the first and only fixed-dose intravenous monobactam/β-lactamase inhibitor combination antibiotic to be approved by the FDA for complicated intra-abdominal infections with limited treatment options.

Data from the Phase III FRONTIER3 trial found that 98% of caregivers prefer Mim8 for hemophilia A over other treatments.

Approval of Onapgo (apomorphine hydrochloride) marks the first and only subcutaneous apomorphine infusion device for managing motor fluctuations in adults with advanced Parkinson disease.

Legos will take over from Roger Dansey, who will begin transitioning to retirement.

The waveLINE-010 trial will compare zilovertamab vedotin, in combination with rituximab plus cyclophosphamide, doxorubicin, and prednisone against the current standard-of-care in patients with previously untreated diffuse large B-cell lymphoma.

Daniel Vitt, CEO, Immunic Therapeutics, discusses promising results from the Phase Ib trial of IMU-856 in celiac disease.

Clinical trials demonstrated that a single dose of Symbravo provides rapid migraine relief, sustains efficacy for up to 48 hours, and reduces the need for rescue medication.