Newron Pharmaceuticals bags up to €38 million to fuel Phase III ENIGMA-TRS program

A final tranche of €12 million will follow, contingent on positive pivotal study results, with the share price calculated according to an agreed formula

Worldwide Clinical Trials completes acquisition of Catalyst, boosting oncology & global reach

BridgeBio reports breakthrough results in Phase 3 achondroplasia trial

Achondroplasia is a genetic condition driven by FGFR3 that affects more than stature alone

Alteogen strikes $285M deal with GSK subsidiary for innovative cancer drug delivery

This deal marks a major step for Alteogen as it pushes its Hybrozyme platform deeper into the oncology market

InflaRx shifts focus to lead drug, cuts costs by 30% to extend cash runway

InflaRx is streamlining operations and largely discontinuing non-essential activities outside izicopan’s development

Prokaryotics and Basilea team up to tackle deadly fungal infections

The partnership aims to develop a first-in-class broad-spectrum antifungal to combat life-threatening invasive infections

Newron secures key European patent for schizophrenia drug Evenamide

This drug candidate, which is currently progressing through pivotal clinical studies, has the potential to become the first add-on therapy for schizophrenia patients who do not respond adequately

Subcutaneous Saphnelo cuts lupus disease activity in phase III trial

SLE remains a life-threatening autoimmune disease, with patients facing an elevated risk of early mortality and long-term organ damage

Medera doses final patient in high-dose HFpEF gene therapy trial

Heart failure affects an estimated 64.3 million people worldwide

Kelun-Biotech secures IND nod for innovative cancer therapy SKB105 in China

Kelun-Biotech and Crescent Biopharma forged a collaboration covering SKB105/CR-003 and SKB118, a PD-1 x VEGF bispecific antibody also known as CR-001

Savara resubmits FDA application for potential treatment in rare lung disease patients

The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer

Kashiv BioSciences secures Rs. 684 crore funding to build one of India’s largest biopharma facilities

The new single-use commercial facility will be among India’s largest, featuring advanced technologies to produce high-quality biologics and specialty pharmaceuticals

Ipsen acquires Simcere Zaiming’s innovative ADC SIM0613

The therapy targets the LRRC15 protein and is designed for enhanced tumor penetration and differentiated anti-tumor activity in solid tumors with the highest unmet needs.

Samsung Biologics strengthens U.S. presence with acquisition of GSK’s Human Genome Sciences or $280 million

Additional investments planned to expand the site’s capacity and capabilities to support growing manufacturing programs

FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease

$22 million BARDA project taps ProteoNic Tech to boost life-saving monoclonal antibody manufacturing

The multi-partner team will integrate new technologies across the entire mAb production workflow, from cell line development to purification

Croda strikes strategic deal with Amino to boost global supply of high-purity amino acids

The agreement pairs Croda’s global footprint and “smart science” approach with Amino’s precision manufacturing capabilities

Thermo Fisher opens Bioprocess Design Center in Hyderabad

Expands bioprocessing footprint across Asia

Halozyme wins German injunction blocking Merck’s Keytruda distribution

While Merck can appeal, Halozyme said it expects the order to hold

Aelis Farma gets EMA nod for phase 2B trial of AEF0217 in down syndrome

AEF0217 is a first-in-class CB1 receptor signaling-specific inhibitor