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

SOM Biotech secures clear registrational path for SOM3355 in Huntington’s disease after FDA End‑of‑Phase 2 Meeting

20 October 2025 -- Barcelona, Spain -- SOM Biotech, a clinical-stage company dedicated to the discovery and development of innovative therapies for rare central nervous system disorders, announces today that it...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 20, 2025

SOM Biotech
Baldiri Reixac, 4 (08028) Barcelona, Spain

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

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

Pharming Group announces U.S. FDA acceptance and Priority Review of supplemental New Drug Application forleniolisib in children with APDS aged 4 to 11 years

If approved, leniolisib will be first and only treatment indicated for children with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS), a rare primary immunodeficiency Decision based on positive data from...

Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: October 1, 2025

Pharming Group NV
info@pharming.com
Pharming Group N.V. Vondellaan 47 2332 AA Leiden The Netherlands

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

Sanofi’s SAR402663 earns fast track designation in the US for neovascular age-related macular degeneration

Designation earned for a one-time intravitreal gene therapy with the potential to eliminate treatment burden for people living with neovascular age-related macular degeneration Neovascular or “wet” age-related macular degeneration can...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: September 11, 2025

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

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

SolasCure receives FDA Fast Track Designation for Aurase Wound Gel to treat calciphylaxis ulcers

Recognises the potential of Aurase Wound Gel to improve outcomes for individuals with calciphylaxis ulcers, a rare and life-threatening condition Represents a new indication for Aurase Wound Gel, currently in...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: June 16, 2025

SolasCure
wellington house East Rd, Petersfield, Cambridge CB1 1BH

University of Oxford and ReciBioPharm expand strategic collaboration in fight against malaria

Expands the collaboration to manufacture two malaria vaccine candidates (R78C and RH5.1) for Phase 1/2 clinical trials Delivers the sixth malaria vaccine candidate for the University of Oxford Provides drug...

Category: Biotechnology, Clinical Trials, Logistics, Manufacturing and Packing, Pharmaceutical
Posted: June 9, 2025

Recipharm

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

Bionova Scientific Licenses ATUM’s Proprietary Transposon-Based Gene Delivery Technology to Accelerate & De-Risk Cell Line Development

7 May 2025 -- California, US and Düsseldorf, Germany -- Bionova Scientific, an Asahi Kasei boutique commercial-scale biologics contract development and manufacturing organization (CDMO), today announced it has licensed ATUM’s...

Category: Biotechnology, Drug Discovery, Manufacturing and Packing, Pharmaceutical
Posted: May 7, 2025

Bionova Scientific
3288 Laurelview Ct. Fremont, CA 94538

Part of $1 Billion Investment Strategy, PCI Pharma Services Completes Acquisition of Ajinomoto Althea, Enhancing US Drug Product Manufacturing for Aseptic Filling of Prefilled Syringes & Cartridges

Along with PCI’s own robust infrastructure expansions, acquisition furthers CDMO’s recent growth in sterile fill-finish, advanced drug delivery systems like prefilled syringes and cartridges, and biologics – including high potent assets for antibody-drug...

Category: Manufacturing and Packing, Pharmaceutical
Posted: May 1, 2025

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