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THE GOOD
Approvals & Labels

Johnson & Johnson’s Spravato (NDMA receptor antagonist) nasal spray lands FDA approval as monotherapy for treatment-resistant depression in adults
Small molecule, treatment-resistant depression, nasal spray - Read more

Janssen-Cilag’s lung cancer combo of Lazcluze (EGFR inhibitor) plus Rybrevant (targeting EFGR, MET) handed marketing authorization by EC
Small molecule, lung cancer, bispecific antibody - Read more

Inflammatix's TriVerity diagnostic test receives FDA clearance to detect bacterial/viral infections and sepsis risk in emergency departments within 30 minutes
Diagnostic test, infectious disease, sepsis - Read more

THE GOOD
Clinical Trials

Ascletis Pharma's obesity hopeful ASC30 (GLP-1R agonist) shows promising safety and feasibility of once-a-day (or less) dosing
Small molecule, obesity - Read more

Verrica Pharmaceuticals' VP-315 delivers positive Ph2 results for treating basal cell carcinoma
Peptide, basal cell carcinoma, cancer - Read more

Valneva's IXCHIQ vaccine touts 98.3% immune response against chikungunya virus in Ph3 trial for adolescents one year after vaccination
Vaccine, chikungunya virus infection - Read more

InMed Pharmaceutical's touts positive long-term pre-clinical data in INM-901 Alzheimer’s trial; reduced neuroinflammation markers
Small molecule, Alzheimer’s disease - Read more

Disc Medicine's finalizes Ph3 trial structure for bitopertin (GlyT1 inhibitor) in erythropoietic protoporphyria, aiming for accelerated FDA approval
Small molecule, erythropoietic protoporphyria -  Read more

FDA lifts hold on Amylyx Pharmaceuticals' Ph1 trial of AMX0114 (targeting CAPN2) in treating ALS
Antisense oligonucleotide, amyotrophic lateral sclerosis - Read more

Sanofi's consumer healthcare division Opella receives FDA go-ahead to pursue over-the-country conversion for erectile dysfunction med Cialis (PDE-5 inhibitor)
Small molecule, erectile dysfunction - Read more

THE GOOD
Fundraises

Arctic Therapeutics €26.5M ($27.5M) Series A, developing treatments for familial dementia and Alzheimer’s disease
Small molecule, familial dementia, Alzheimer’s disease - Read more

Gesynta Pharma SEK 304M ($27.6M) Series B, developing novel endometriosis therapy vipoglanstat (targeting mPGES-1)
Small molecule, endometriosis - Read more

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⬇️ More Good News ⬇️

THE GOOD
Investments

Trump administration announces $500B AI infrastructure project with OpenAI, SoftBank, Oracle, with potential to “revolutionize healthcare” 
Infrastructure, public investment, AI - Read more

THE GOOD
IPOs

Chinese cancer drug developer Ascentage Pharma hoping for a $149M NASDAQ IPO
Small molecule, leukemia, cancer - Read more

THE GOOD
Marketing

HK inno.N and Roche Korea partner to promote Avastin, dividing marketing and research responsibilities
Drug promotion, cancer - Read more

THE GOOD
Partnerships

Eli Lilly, Merck & Co., Purdue University, form consortium to modernize drug manufacturing, including focus on innovative tech, AI; additional focus on US domestic drug manufacturing
Manufacturing innovation, biopharma manufacturing, AI -Read more

Alaya.bio, Columbia University expand collaboration to develop polymeric delivery platform for in situ CAR-T cell therapy
Cell therapy, drug delivery, in situ CAR-T, polymeric nanoparticle - Read more

SaponiQx, Probius, Ginkgo Bioworks partner to leverage quantum spectroscopy and AI to develop advanced vaccine adjuvants against biological threats
Vaccine adjuvant, AI, adjuvant development - Read more

Circio Holding, 4basebio partner to develop and test synthetic DNA vectors for genetic medicines using circVec technology
Gene therapy, cell therapy, drug delivery, DNA vector - Read more

Dermata Therapeutics, Revance Therapeutics partner to test needle-free delivery of Daxxify (botulinum toxin) using Xyngari (Spongilla powder) for hyperhidrosis treatment
Botulinum toxin, hyperhidrosis, drug delivery - Read more

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THE BAD
Clinical Trials

Atara Biotherapeutics' clinical aspirations hit with FDA clinical hold, due to compliance issues at the same third-party facility from last week’s CRL
Cell therapy, lymphoma, cancer, lupus, CAR-T - Read more

THE UGLY
Lawsuits

Federal judge allows states to renew legal challenge against FDA's approval of abortion drug mifepristone, following Supreme Court ruling
Small molecule, abortion - Read more

THE UGLY
Regulatory

Chinese authorities investigate quality concerns of (commonly domestically produced) bulk-purchased medicines after multiple doctors report “therapeutic inconsistencies”
Quality concerns, discount drugs - Read more

THE UGLY
Warning Letters, Form 483

FDA issues warning letter to Sanofi's Genzyme plant in Massachusetts for manufacturing quality issues after failed inspection
Active pharmaceutical ingredient, manufacturing, quality concerns - Read more

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

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