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THE GOOD
Business Development

Accord BioPharma (Intas Pharmaceutical specialty division) gains U.S. rights to Bio-Thera's Simponi biosimilar BAT2506 (targeting TNF-alpha; Simponi biosimilar, Janssen Biotech) for $21M upfront plus potential milestone payments
Monoclonal antibody, rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, severly active ulcerative colitis, biosimilar - Read more

Kineta sells Genentech and Merck & Co. deals to investors, and pain drug to Pacira, while preparing for TuHURA merger
Small molecule, amyotrophic lateral sclerosis, frontotemporal lobar dementia, cystic fibrosis, pain - Read more

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⬇️ More Good News ⬇️

THE GOOD
Clinical Trials

Boehringer Ingelheim's nerandomilast (PDE4B inhibitor) succeeds in Ph3 trials for progressive pulmonary fibrosis
Small molecule, progress pulmonary fibrosis - Read more

Caliway Biopharmaceuticals’ CBL-514 (targeting BAX, DYRK1B) meets Ph2b endpoints for localized fat reduction targeting abdominal fat
Small molecule, obesity, localized fat reduction - Read more

Orca Bio's Orca-T cell therapy hits Ph3 endpoint, showing improved survival in a range of blood cancers versus standard stem cell transplant
Cell therapy, acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, acute leukemia, T cell therapy, allogeneic cell therapy - Read more

Bristol Myers Squibb's Breyanzi (targeting CD19) succeeds in Ph2 trial for relapsed marginal zone lymphoma
Cell therapy, lymphoma, CAR-T - Read more

IVIEW Therapeutics' IVW-1001 (TRPM8 agonist) delivered via eyelid wipe, shows positive Ph1/2 results in treating dry eye disease
Small molecule, dry eye disease, drug delivery - Read more

AceLink Therapeutics touts positive Ph2 data for AL01211 (GCS inhibitor) in Fabry disease
Small molecule, Fabry disease - Read more

Grace Therapeutics' GTx-104 (Cav2.1 inhibitor) injectable beats oral nimodipine in aneurysmal subarachnoid hemorrhage Ph3 trial
Small molecule, aneurysmal subarachnoid hemorrhage, injectable, drug delivery - Read more

THE GOOD
Earnings & Finances

Incyte's topical Opzelura (JAK inhibitor) sales gew 50% to $508M, while company prepares for Jakafi (JAK inhibitor) patent expiration
Small molecule, atopic dermatitis, eczema, topical - Read more

THE GOOD
Fundraises

Alterity Therapeutics AUD 40M ($25.2M) placement, biotech developing treatments for neurodegenerative diseases
Small molecule, Parkinson's disease, neurodegenerative disease, multiple system atropy - Read more

Hexaell Biotechnologies raises RMB 200M ($27.4M) Series B+, developing bioartificial liver therapy for liver diseases
Cell therapy, liver disease, liver failure, bioartificial liver - Read more [Press release in Chinese]

THE GOOD
Investments

Novartis opens €40M viral vector facility in Slovenia, part of larger €3.5B investment in cell and gene therapy manufacturing.
Cell & gene therapy manufacturing, viral vector manufacturing, new facility - Read more

THE GOOD
IPOs

Ascentage Pharma raises $142.5M after underwriters partially exercise option to buy additional 935,144 ADSs at $17.25 each
Small molecule, leukemia, cancer - Read more

THE GOOD
Lawsuits

Axsome and Teva settle patent dispute; Teva's generic version of depression drug Auvelity (targeting NMDA) delayed until 2038
Small molecule, major depressive disorder, generic, drug patent suit - Read more

THE GOOD
Mergers & Acquisition

Merck KGaA reportedly in advanced talks to acquire SpringWorks Therapeutics for potential $3 billion deal ahead of US regulatory decision
Small molecule, neurofibromatosis type 1, cancer - Read more

Globus Medical to acquire Nevro and their chronic pain-targeting neuromodulation platforms for $250M, paying $5.85 per share in all-cash deal
Medical device, chronic pain, neuromodulation - Read more

MaxCyte acquires SeQure Dx to “broaden cell engineering offerings” with gene-editing assays relevant to CGT
Cell & gene therapy, gene-editing, on-target/off-target editing assay - Read more

THE GOOD
Partnerships

Eli Lilly, AdvanCell partner to R&D targeted alpha therapies for cancer using Pb-212 production technology
Radiopharm, cancer, alpha therapy, research & development, drug development - Read more

NecstGen, Galapagos partner to establish decentralized CAR-T cell manufacturing platform and production in Europe
CDMO, cell therapy, CAR-T, decentralized manufacturing, cell therapy manufacturing - Read more

PHC Corporation, CCRM partners to develop T-cell expansion processes focused on former’s under development cell expansion system
Instrumentation, cell therapy, gene therapy, cell culturing - Read more

THE GOOD
Politics & Policy

US district court judge blocks Trump administration's plan to cap medical research funding after 22 states sue, citing threats to public health
Federal research funding, Department of Health & Human Services, National Institutes of Health - Read more

Brand-name drugmakers and partnered manufacturers expect minimal impact from Trump's tariffs
Drug pricing, drug access, tariffs - Read more [Paywall]

THE GOOD
Research

AI discovers 25 new protein compounds, with two effectively treating bacterial and fungal infections in mice during tests
Peptide, antibiotic, antifungal, drug discovery, AI - Read more

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THE BAD
Business Development

Roche sells IPF drug Esbriet (targeting TGF-β, pro-inflammatory cytokines) and associated InterMune unit to Legacy Pharma, likely due to declining sales due to generic competition
Small molecule, idiopathic pulmonary fibrosis, generic competition - Read more

THE BAD
Clinical Trials

Roivant’s subsidiary Kinevant Sciences discontinues namilumab (anti-GM-CSF) development after Ph2 trial failure in pulmonary sarcoidosis
Monoclonal antibody, pulmonary sarcoidosis - Read more

THE BAD
Earnings & Finances

Neurocrine's Ingrezza (VMAT2 inhibitor) sales forecast disappoints investors, missing expectations amid concerns over competition in tardive dyskinesia market
Small molecule, tardive dyskinesia - Read more

THE BAD
Layoffs

Q32 Bio cuts staff and discontinues renal program to focus on alopecia drug bempikibart (anti-IL-7R), extending cash runway through 2026
Monoclonal antibody, alopecia areata - Read more

THE UGLY
Adverse Events

FDA expands warnings regarding BD's Rotarex atherectomy catheter after 4 deaths and 30 injuries from device fractures
Medical device, catheter - Read more

You’re all caught up on the latest Pharma & Biotech News!

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