Don Tracy, Associate Editor

The approval of neffy marks the first major advancement in epinephrine delivery for patients over four years of age in more than 35 years.

Joint venture is expected to leverage Astellas' expertise in cell therapy R&D and Yaskawa’s robotics technology to enhance accuracy, reproducibility, and efficiency in cell manufacturing.

The acquisition is expected to enhance Jazz's oncology portfolio by adding dordaviprone, a novel small molecule therapy in development for H3 K27M-mutant diffuse glioma.

Submission is supported by positive results from the Phase III REGENCY trial, which demonstrated that nearly half of patients with lupus nephritis who received Gazyva/Gazyvaro plus standard therapy achieved a complete renal response.

New indication for Tevimbra in combination with platinum-containing chemotherapy as a first-line treatment addresses an unmet need for adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1.

Stoboclo, a biosimilar to Prolia, is indicated for postmenopausal women and men at high risk of fracture, while Osenvelt, a biosimilar to Xgeva, is indicated for preventing skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors.

Aliya Omer, VP, US franchise head, breast cancer, AstraZeneca, discusses how results of the trial compare with other treatments for gBRCAm HER2-negative high-risk early breast cancer.

In the SWIFT and ANCHOR trials, depemokimab demonstrated statistically significant reductions in nasal polyp size, obstruction, and asthma exacerbations compared to placebo.

Under terms of the deal, Gubra will receive an initial $350 million payment and could earn up to $1.875 billion more in development and sales milestones for the potential weight loss drug.

Ron Lanton, Partner, Lanton Law, discusses the legal and industry challenges posed by recent National Institute of Health budget cuts, diversity bans in clinical trials, and pharmaceutical supply chain disruptions due to tariffs.

FP008 is designed for patients with solid tumors that have not responded to existing immunotherapies targeting PD-1.

Results from a Phase III study in pediatric patients demonstrated that Odactra reduced the total combined rhinitis score by 22% compared to placebo.

Results from a Phase III registrational study suggest that ecopipam has potential as a first-in-class dopamine-1 receptor antagonist for patients with Tourette syndrome.

The Phase III SERENA-6 trial is the first global trial to use a circulating tumor DNA-guided approach to detect endocrine resistance before disease progression in HR-positive, HER2-negative advanced breast cancer.

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.