News and Press Releases
FDA Grants OKYO Pharma Fast Track Designation to Urcosimod for Neuropathic Corneal Pain
1 May 2025 -- London, UK and New York, US -- OKYO Pharma Limited, an ophthalmology-focused bio-pharmaceutical company which is developing urcosimod (formerly called OK-101) to treat NCP, an ocular...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 1, 2025
PCI Pharma Services to Acquire US-based Aseptic Fill-Finish CDMO Ajinomoto Althea
Acquisition creates a world-class large-scale manufacturing hub in San Diego region with state-of-the-art aseptic facilities for prefilled syringes, cartridges and high potent formulations such as ADCs, complementing existing global sterile...
Category: Logistics, Manufacturing and Packing, Pharmaceutical
Posted: April 24, 2025
Fondazione Telethon Submits US Biological License Application for Etuvetidigene Autotemcel Gene Therapy for the Treatment of Wiskott-Aldrich Sydrome
11 March 2025 -- Milan, Italy -- Fondazione Telethon, an Italian biomedical charity focused on rare genetic diseases, announced that it has submitted the Biologics License Application (BLA) for the...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 11, 2025
OKYO Pharma Files for Fast Track Designation with FDA for Urcosimod to Treat Neuropathic Corneal Pain
10 March 2025 -- London, UK and New York, US -- OKYO Pharma Limited, a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain, a severe...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 10, 2025
Bioxodes obtains Orphan Drug Designation for hemorrhagic stroke therapeutic candidate in US and Europe
FDA, EMA grant BIOX-101 ODD status to treat intracerebral hemorrhagic stroke (ICH) ODD status may expedite drug candidate development and approvals BIOX-101 interim Phase 2a data in ICH imminent. 5...
Category: Drug Discovery, Other, Pharmaceutical
Posted: March 5, 2025
Tiziana Life Sciences Files Investigational New Drug Application with FDA for ALS Phase 2 Clinical Trial
4 March 2025 -- New York, US -- Tiziana Life Sciences, Ltd, a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 4, 2025
Tiziana Life Sciences 14/15 Conduit Street London W1S 2XJ United Kingdom
Boehringer’s nerandomilast meets primary endpoint in Phase III study FIBRONEER-ILD, in progressive pulmonary fibrosis
Topline data from FIBRONEER™-ILD show that the investigational compound nerandomilast met its primary endpoint, which was the absolute change from baseline in forced vital capacity [mL] at week 52 versus...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: February 10, 2025
ProBioGen Launches New Website to Enhance User Experience and Streamline Access to Expanded
February 04, 2025 – Berlin, Germany – Biotech Newswire / -- ProBioGen has launched its new, redesigned website to provide biotech and biopharma professionals with clear access to its expanded...
Category: Biotechnology
Posted: February 5, 2025
Rentschler Biopharma announces strategic realignment of its global business operations
30 January 2025 – Laupheim, Germany – Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, announced today a realignment of its global business operations...
Category: BioManufacturing
Posted: January 30, 2025
Spektus Pharma and Recipharm Announce Strategic Partnership to Develop and Supply CNS Medicines Using Flexitab™ Oral Drug Delivery Platform
22 January 2025 -- Montreal, Canada -- Spektus Pharma, an innovator in value added medicine development, and Recipharm, a leading global contract development and manufacturing organization, have entered into a...
Category: Drug Discovery, Other, Pharmaceutical
Posted: January 22, 2025
Opella reaches study milestone for Cialis
21 January 2025 -- Paris, France -- Opella, Sanofi’s Consumer Healthcare business, announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned actual...
Category: Clinical Trials, Other, Pharmaceutical
Posted: January 21, 2025
PureTech Receives FDA Fast Track Designation for LYT-200 in Acute Myeloid Leukemia (AML)
Single agent and combination data from Phase 1b AML/MDS trial presented at ASH 2024 showed potential of LYT-200 to serve broad range of patients across various lines of treatment LYT-200...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 9, 2025
Recipharm’s full range Oral Solid Dosage (OSD) capabilities meet growing industry demands
Full range OSD development and manufacturing capabilities from orphan drugs to blockbusters High potency manufacturing capabilities expansion Introduction of ReciPredict platform to accelerate product development and de-risk tech transfer API...
Category: Manufacturing and Packing
Posted: November 19, 2024
Bespak and Orbia Fluor & Energy Materials unite to accelerate transition to climate-friendly inhalers
Collaboration aims to speed the commercialisation of low global warming potential pMDIs utilising Orbia Fluor & Energy Materials’ Zephex® 152a propellant at Bespak’s Holmes Chapel site 6 November 2024 –...
Category: Drug Delivery, Manufacturing and Packing
Posted: November 6, 2024
53Biologics Awarded Best Company in Biotechnology Innovation at Farmaforum
This award acknowledges the company’s groundbreaking work in microbial expression systems and its ongoing commitment to delivering cutting-edge biotechnological solutions for the global market. 53Biologics, a Contract Development and Manufacturing...
Category: Biotechnology
Posted: October 30, 2024
