Pharmafile

pharmafile | April 17, 2026 | News story | Research and Development |  RWS, kayentis Kayentis and RWS have announced a partnership aimed at improving confidence in clinical trial data for neuroscience and other complex trials. The collaboration combines Kayentis’ electronic Clinical Outcome Assessment (eCOA) platform with RWS’ rater training services, with a focus on reducing variability in clinician-reported outcomes.

pharmafile | April 13, 2026 | News story | |  Astellas Pharma, menopause Final draft NICE guidance has recommended Veoza (fezolinetant), made by Astellas Pharma, to treat moderate to severe menopausal hot flushes and night sweats, when hormone replacement therapy (HRT) is not suitable. Veoza, a non-hormonal treatment, is taken once a day as a 45mg tablet and blocks the nerve pathways in the brain that trigger hot flushes and night sweats.

pharmafile | April 15, 2026 | News story | Business Services | Ardena has announced that its new GLP bioanalytical laboratory in Somerset, New Jersey in the US is operational and supporting client studies. The 2,500 sq ft facility expands the specialist CDMO and bioanalytical CRO’s scientific capabilities in North America, providing bioanalytical services closer to client development programmes. The laboratory includes controlled sample storage, LC-MS/MS systems and immunochemistry platforms.

pharmafile | April 14, 2026 | News story | Research and Development |  Gesynta Pharma, endometriosis Gesynta Pharma has dosed the first patient in its phase 2 clinical proof-of-concept trial of vipoglanstat. The trial, NOVA, is randomised, double-blind and placebo-controlled, and will evaluate the efficacy and safety of two different doses of vipoglanstat. NOVA will enrol around 190 women aged 18 to 45 across the UK, Italy, Poland, Romania, Bulgaria, the Czech Republic and Hungary.

pharmafile | April 7, 2026 | News story | Research and Development | Kainova Therapeutics has announced that the first patient in the European expansion of its DOMISOL phase I/II clinical trial evaluating DT‑7012 has been dosed. Kainova focuses on breakthrough treatments in immuno-oncology and inflammation, and DT‑7012 is a proprietary Treg‑depleting anti‑CCR8 monoclonal antibody for patients with advanced solid tumours.

pharmafile | April 8, 2026 | News story | Manufacturing and Production | Trelleborg Medical Solutions will showcase its latest engineered polymer solutions for demanding medical, biotech and pharmaceutical applications at Medtec Japan from 21-23 April.

pharmafile | April 7, 2026 | News story | Research and Development | Eisai is to begin enrolling participants in its phase 2 study, Study 202, in patients with narcolepsy. The company registered the screening for Study 202, which will evaluate the safety, efficacy and tolerability of E2086, on ClinicalTrials.gov. Sites in Canada, China, Europe, Japan and South Korea are also planned.

pharmafile | April 9, 2026 | News story | |  Oncology The Japan Pharmaceuticals and Medical Devices Agency (PMDA) has accepted the updated prescribing information for Daiichi Sankyo’s Enhertu (trastuzumab), a specifically engineered HER2 directed DXd antibody drug conjugate (ADC). Following a review of the data from the DESTINY-Gastric04 phase 3 trial, Enhertu can now be used, in Japan as a second-line treatment for patients with HER2 positive unresectable advanced or recurrent gastric cancer.

pharmafile | April 9, 2026 | News story | |  Ear Nose & throat Sandoz has launched its azelastine and fluticasone fixed-dose-combination (FDC) nasal spray in Germany and Switzerland. In Germany the FDC over the-counter (OTC) nasal spray is used to treat the symptoms of moderate-to-severe seasonal allergic rhinitis in adults.

Lucy Batizovsky | April 2, 2026 | Appointment | |  Faron Pharmaceuticals Faron Pharmaceuticals, a clinical-stage biopharmaceutical company, has appointed Heikki Jouttijärvi as Chief Technical Officer (CTO). Jouttijärvi brings decades of experience to the role, having most recently been the Senior Vice President (SVP) of Commercial Business Operations at Adverum Biotechnologies. He has also previously held multiple global roles at Menlo Therapeutics and Santen Pharmaceutical Company.