Pharmafile Logo

News and Press Releases

Heidelberg Pharma’s Lead ADC Candidate HDP-101 Granted Fast Track Designation by US FDA for the Treatment of Multiple Myeloma

Recognizes the potential of HDP-101 to address a serious or life-threatening condition with high unmet medical needs Enables more frequent engagement with FDA and eligibility for rolling review to support...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 23, 2025

Heidelberg Pharma
info@hdpharma.com
Gregor-Mendel-Straße 22 68526 Ladenburg Deutschland

Recipharm supports landmark trial of next generation pneumococcal vaccine developed by ImmBio and iiCON

Recipharm delivers cGMP manufacture of PnuBioVax® enabling progression to phase 2 clinical trials in Malawi Demonstrates Recipharm’s agility and flexibility, completing full tech transfer, scale-up and process optimisation within three...

Category: BioManufacturing, Drug Delivery, Manufacturing and Packing, Other, Pharmaceutical
Posted: October 15, 2025

Iksuda to present IKS014 Phase 1 data at ESMO

14 October 2025 -- Newcastle, UK -- Iksuda Therapeutics (Iksuda), the developer of class-leading antibody drug conjugates (ADCs), will present new data from its Phase 1 study of IKS014, a...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 14, 2025

Iksuda
The Biosphere, Draymans Way, Newcastle Helix Newcastle upon Tyne NE4 5BX

IAVI, Minapharm, and ProBioGen Announce Memorandum of Understanding to Progress Clinical Development, Manufacturing, Commercialization, and Access to Vaccines and Antibodies in Africa

Partners will advance end-to-end development of biologics for regionally prioritized diseases starting with Mpox and HIV 10 October 2025 -- Cairo, Egypt; Berlin, Germany; and New York, New York -- IAVI,...

Category: Biotechnology, Drug Delivery, Logistics, Manufacturing and Packing, Other, Pharmaceutical
Posted: October 10, 2025

ProBioGen
info@probiogen.de
Herbert-Bayer-Straße 8 13086 Berlin

Rezon Bio launches as a European biologics CDMO combining cost efficiency and digital innovation.

New brand with proven track record – EMA and FDA-audited mirrored-capability sites in Poland provide an accelerated path from development to commercialization 29 September 2025 -- Gdańsk, Poland -- Rezon...

Category: BioManufacturing, Logistics, Manufacturing and Packing, Other, Pharmaceutical
Posted: September 29, 2025

Rezon Bio
office@rezonbio.com
Trzy Lipy 3, Building A 80-172 Gdansk, Poland

eXmoor Pharma and Siam Bioscience form strategic partnership to establish leading Cell and Gene Therapy services in Southeast Asia

23 September 2025 -- Bristol, UK and Bangkok, Thailand -- eXmoor Pharma, the integrated cell and gene therapy CDMO with embedded consultancy expertise, and Siam Bioscience, a leading biopharmaceutical company...

Category: BioManufacturing, Manufacturing and Packing, Other, Pharmaceutical
Posted: September 23, 2025

eXmoor Pharma
info@exmoorpharma.com
Britannia Road, Patchway, Bristol, BS34 5TA

Terumo BCT and PwC Belgium Join Forces to Break Barriers in Access to Advanced Cell and Gene Therapies 

2 September 2025 -- Brussels, Belgium -- Terumo Blood and Cell Technologies, (Terumo BCT), a medical technology company, and PwC Belgium today announce a new collaboration focused on driving equitable...

Category: Biotechnology, Drug Discovery, Logistics, Manufacturing and Packing
Posted: September 8, 2025

Terumo Blood and Cell Technologies
Old Belfast Road Millbrook Larne BT40 2SH

Ryvu Therapeutics Announces Strategic Agreement to Support Clinical Trials for BioNTech’s Investigational Cancer Immunotherapies in Poland

Ryvu to support BioNTech in the acceleration of site activation and enrollment of patients for multiple of BioNTech’s priority oncology clinical programs in Poland Ryvu will leverage its clinical network to...

Category: BioManufacturing, Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 2, 2025

Ryvu Therapeutics
ryvu@ryvu.com
R&D Center for Innovative Drugs Leona Henryka Sternbacha 2 30-394 Kraków, Poland

Upperton Pharma Solutions Advancing Oral Vaccines Delivery with Oxford’s Pandemic Sciences Institute

14 August 2025 -- Nottingham, UK -- Upperton Pharma Solutions, a leading UK-based contract development and manufacturing organisation (CDMO), has been awarded a grant as part of the first VaxHub Sustainable Platform Funding...

Category: Biotechnology, Drug Delivery, Drug Discovery, Other, Pharmaceutical
Posted: August 14, 2025

Upperton Pharma Solutions
contact@upperton.com
Albert Einstein Centre, Nottingham Science Park, Nottingham, UK, NG7 2TN

Iksuda Therapeutics receives FDA IND clearance for IKS014

FDA decision will enable Iksuda to expand its ongoing clinical trial in the US, Australia and Singapore Preliminary data from an ongoing dose-escalation study of IKS014 has shown meaningful clinical activity across...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: July 1, 2025

Iksuda
The Biosphere, Draymans Way, Newcastle Helix Newcastle upon Tyne NE4 5BX

At BIO Show in Boston, PCI Pharma Services to Provide Updates on New Manufacturing Facility at Nearby Bedford, NH Campus

For leading CDMO, qualification activities for plant’s state-of-the-art sterile fill-finish and lyophilization line are underway, with GMP production commencing summer 2025 6 June 2025 -- Pennsylvania, US -- PCI Pharma Services, a world...

Category: BioManufacturing, Logistics, Manufacturing and Packing, Other, Pharmaceutical
Posted: June 6, 2025

PCI Pharma Services
talkfuture@pci.com
3001 Red Lion Road, Philadelphia, PA 19114, USA

Heidelberg Pharma to Present Promising New Clinical Data on its Lead ATAC Candidate HDP-101 at EHA 2025

• HDP-101 demonstrated complete response in one female patient from cohort 5• R&D Webinar to be hosted on 17 June 2025. 15 May 2025 -- Ladenburg, Germany -- Heidelberg Pharma...

Category: BioManufacturing, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 15, 2025

Heidelberg Pharma
info@hdpharma.com
Gregor-Mendel-Straße 22 68526 Ladenburg Deutschland

ProQR Announces Upcoming Scientific Presentations at ASGCT and TIDES Conferences

12 May 2025 -- Leiden, the Netherlands and Massachusetts, US -- ProQR Therapeutics NV (ProQR), a company dedicated to changing lives through transformative RNA therapies based on its proprietary Axiomer™...

Category: BioManufacturing, Drug Discovery, Other, Pharmaceutical
Posted: May 15, 2025

ProQR Therapeutics
info@proqr.com
Zernikedreef 9 2333 CK Leiden The Netherlands

Medable Releases New Digital Oncology Trial Offering to Reduce Complexity for Sites, Sponsors, Patients, and Caregivers

Integrated solution with self-service capabilities simplifies trial experience for all 13 May 2025 -- California, US -- Medable Inc., a leading provider of clinical development and eCOA technology, today announced...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 13, 2025

Medable
media@medable.com
525 University Ave Suite A70 Palo Alto, CA 94301

iOnctura commences randomized Phase I/II study in non-small cell lung cancer

First patient dosed in study investigating roginolisib + dostarlimab +/- docetaxel in patients with NSCLC who have progressed on prior immunotherapy/chemo Study will evaluate safety of the combination and explore...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 8, 2025

iOnctura
enquiries@ionctura.com
Campus Biotech Innovation Park Avenue Sécheron 15
 1202 Genève
 Switzerland