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Going out a bit later than expected today since I was traveling (in Suzhou, China to attend BIOCHINA2025).

THE GOOD
Approvals & Labels

AstraZeneca and Ionis' Wainzua (targeting TTR) lands EU approval in hereditary transthyretin-mediated amyloidosis with polyneuropathy
Antisense oligonucleotide, transthyretin amyloidosis - Read more

THE GOOD
Business Development

Tonix Pharmaceuticals receives MCDC grant to develop TNX-801, a single-dose vaccine candidate for mpox and smallpox
Vaccine, Mpox (monkeypox), smallpox - Read more

Syngene International buys $36.5M US biologics facility from Emergent BioSolutions, operational by second half of 2025
CDMO, CRO, biomanufacturing, facility sale - Read more

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⬇️ More Good News ⬇️

THE GOOD
Clinical Trials

Beam Therapeutics' BEAM-302 delivers promising Ph1/2 data in correcting SERPINA1 gene mutation in alpha-1 antitrypsin deficiency
Gene-editing, alpha-1 antitrypsin deficiency, lipid nanoparticle - Read more

Trevi Therapeutics’ Haduvio (targeting KAMA receptors) reducses 24-hour cough frequency by 67% in Ph2a trial for refractory chronic cough
Small molecule, refractory chronic cough - Read more

Arrowhead Pharmaceuticals' ARO-C3 (targeting C3) was well tolerated in Ph1/2a trial for IgA nephropathy
RNAi, IgA nephropathy - Read more

Mineralys Therapeutics' lorundrostat (aldosterone synthase inhibitor) hits primary endpoints in pair of clinical trials (Ph2 & Ph3) for uncontrolled hypertension
Small molecule, hypertension - Read more

Amgen and Kyowa Kirin's rocatinlimab (anti-OX40) delivers positive efficacy in Ph3 trial for moderate to severe atopic dermatitis
Monoclonal antibody, atopic dermatitis - Read more

Eli Lilly touts post-marketing data for Egblyss (IL-13 inhibitor) in atopic dermatitis, complete skin clearance in 50% of patients
Monoclonal antibody, atopic dermatitis - Read more

Eli Lilly and Incyte's Olumiant (JAK1/2 inhibitor) delivers significant hair regrowth in Ph3 trial for adolescents with severe alopecia areata
Small molecule, alopecia areata - Read more

Agomab Therapeutics' AGMB-129 (ALK5 inhibitor) successfully targeted intestinal fibrosis in Ph2 trial for fibrostenosing Crohn's disease, meeting safety and efficacy endpoints
Small molecule, Crohn's disease - Read more

Incyte's Opzelura (JAK1/2 inhibitor) delivers positive itch reduction data in prurigo nodularis Ph3 trial
Small molecule, prurigo nodularis - Read more

Immunocore's IMC-M113V delivers promising Ph1/2 data on quest for HIV “functional cure”
Bispecific T-cell receptor, human immunodeficiency virus (HIV) - Read more

CervoMed's neflamapimod (targeting p38α) delivers positive results for dementia with Lewy bodies Ph2b trial
Small molecule, dementia with Lewy bodies - Read more

Q32 Bio's bempikibart (anti-IL-7Rα) delivers durable responses in Ph2a trial for alopecia areata
Monoclonal antibody, alopecia areata - Read more

THE GOOD
Company Launches

Flagship Pioneering launches Lila Sciences with $200M to develop AI for autonomous research labs and "scientific superintelligence"
Laboratory automation, autonomous research lab, AI - Read more

THE GOOD
Fundraises

Valo Therapeutics secures €19M ($20.8M) to develop cancer immunotherapy PeptiCRAd in clinical trials
Oncolytic virus, solid tumor, cancer - Read more

BVI Medical $1B strategic capital raise, ophthalmic device maker to expand global operations and launch new products
Medical device, ophthamology - Read more

THE GOOD
Marketing

UK industry group to lift Novo Nordisk's suspension for misleading promotion of obesity drug; critics want more transparency
Drug marketing, obesity - Read more [Paywall]

THE GOOD
Mergers & Acquisition

Sun Pharma acquires financially troubled Checkpoint Therapeutics for $355 million upfront, gaining Unloxcyt (targeting PD-L1) for advanced skin cancer treatment
Monoclonal antibody, squamous cell carcinoma, cancer - Read more

Roquefort Therapeutics to sell Oncogeni divsion to The Nations Trust for up to $12 million in strategic asset-development deal
Undisclosed modality, cancer - Read more

THE GOOD
Partnerships

Daiichi Sankyo, Johnson & Johnson, Nosis Bio partner on RNA delivery technology for non-liver diseases
RNA, siRNA, drug delivery development, drug delivery - Read more [Paywall]

THE GOOD
Regulatory

FDA bars product reviewers and facility inspectors from accepting HHS's $25,000 buyout offer, ensuring the FDA doesn’t completely fall apart
Regulatory structure - Read more [Paywall]

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THE BAD
Clinical Trials

Novo Nordisk's CagriSema delivers weight-loss below investor expectations in Ph3, at 15.7% weight loss in obesity
GLP-1, peptide, obesity - Read more

THE BAD
Earnings & Finances

BioNTech stock falls as 2025 revenue forecast disappoints despite better-than-expected quarterly results, reflecting declining COVID-19 vaccine sales
Vaccine, COVID-19, big pharma earnings - Read more

THE BAD
Partnerships

Johnson & Johnson, Genmab end development of next-generation anti-CD38 antibody successor to Darzalex cancer drug
Monoclonal antibody, cancer, drug development - Read more

THE UGLY
Warning Letters, Form 483

Dexcom received FDA warning letter for manufacturing issues at two plants
Quality concerns - Read more

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

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