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THE GOOD
Clinical Trials

Lundbeck's eptinezumab shows sustained efficacy in Ph4 trials for chronic migraine prevention with medication overuse headache
Antibody, neurological, monoclonal antibody, migraine, CGRP inhibitor, chronic migraine - Read more

Merck & Co.'s Capvaxive pneumococcal conjugate vaccine shows superior Ph3 immune response in at-risk children
Vaccine, infectious disease, pneumococcal conjugate vaccine, pneumococcal disease, pediatric population, high-risk patients - Read more

Affibody's IL-17A inhibitor izokibep meets Ph3 primary endpoint in hidradenitis suppurativa with strong safety profile
Protein therapy, autoimmune, IL-17A inhibitor, hidradenitis suppurativa, inflammatory disease - Read more

Bioxodes reports positive Ph2a results for BIOX-101 in intracerebral hemorrhage, shows reduced hematoma expansion
Protein therapy, neurological, peptide therapeutic, intracerebral hemorrhage, anticoagulant, anti-inflammatory - Read more

Vaxart reports positive Ph1 data for second-generation oral pill norovirus vaccine showing enhanced immune response
Vaccine, infectious disease, oral vaccine, norovirus, mucosal immunity, IgA response - Read more

Maze Therapeutics' MZE782 SLC6A19-targeting oral drug shows promising Ph1 results for phenylketonuria and chronic kidney disease
Small molecule, metabolic, chronic kidney disease, phenylketonuria, SLC6A19 inhibitor, amino acid transport - Read more

Zelgen's ZG006 (DLL3/CD3) and ZG005 (PD-1/TIGIT) show efficacy in small cell lung cancer Ph1 trials
Antibody, cancer, bispecific antibody, trispecific antibody, lung cancer, neuroendocrine carcinoma - Read more [Source in Chinese]

Revolution's RAS-inhibitor daraxonrasib advances to Ph3 after promising Ph1 data in pancreatic cancer
Small molecule, cancer, RAS inhibitor, pancreatic cancer, PDAC, monotherapy - Read more [Paywall]

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✅ More Good News ✅

THE GOOD
Company Launches

Medra launches with AI-powered robotics platform to automate lab experiments
AI/ML platform, lab automation, robotics, services, platform technology - Read more [Paywall]

THE GOOD
Fundraises

LB Pharmaceuticals raises $285M IPO for schizophrenia drug development
Neurological, schizophrenia, small molecule, bipolar disorder, clinical-stage - Read more

Cutiss raises CHF 56M ($70.2M) Series C for personalized skin tissue therapy development
Regenerative medicine, tissue therapeutics, clinical-stage, skin surgery, personalized therapy - Read more

Dianthus Therapeutics raises $288M in public offering for autoimmune disease treatment development
Autoimmune, antibody, complement therapeutics, clinical-stage, biotechnology - Read more

Avidity Biosciences raises $600M in public offering for RNA therapeutics development and commercialization
RNA therapeutics, antibody oligonucleotide conjugates, platform technology, clinical-stage - Read more

Actuate Therapeutics raises $17.25M public offering for GSK-3β inhibitors treating difficult cancers
Oncology, small molecule, cancer, clinical-stage, platform technology - Read more

THE GOOD
Lawsuits

AbbVie settles with generic makers, protecting Rinvoq's US exclusivity until 2037
Small molecule, autoimmune, strategic, regulatory, competitive - Read more

THE GOOD
Mergers & Acquisitions

GTCR (a PE firm) acquires former Sanofi generics unit Zentiva from Advent (another PE firm) for €4.1B, expanding European presence
Generics manufacturing, financial, major transaction, strategic acquisition - Read more

THE BAD
Lawsuits

FibroGen pays $1.25M to SEC over allegations former CMO manipulated roxadustat clinical data
HIF-PH inhibitor, anemia, regulatory, financial, data manipulation - Read more

Arrowhead Pharmaceuticals sues Ionis Pharmaceuticals over patent dispute involving plozasiran, potential FCS treatment rivaling Tryngolza
RNAi therapeutic, rare disease, patent litigation, competitive, regulatory - Read more

THE BAD
Market Reports

UK pharma & life science investment “falling behind”, trade group warns on heels of Merck & Co. $1.3 billion London lab exit and broader sector decline
Pharmaceutical industry, investment decline, strategic, financial, regulatory - Read more [Paywall]

THE BAD
Regulatory

FDA warns Hikal over metal contamination in APIs, potentially jeopardizing U.S. imports
API manufacturing, pharmaceutical ingredients, regulatory, operational, quality control, supply chain - Read more

FDA's Vinay Prasad reassumes chief medical officer role after controversial departure and return to biologics division
Gene therapy, regulatory, leadership, strategic, operational - Read more

THE UGLY
Regulatory

Sun Pharma's Gujarat facility faces FDA import ban due to persistent manufacturing violations
Small molecule, manufacturing, regulatory, operational, quality control - Read more

Intercept Pharmaceuticals withdraws liver drug Ocaliva from US market following FDA's safety concerns and deaths in PBC patients
Small molecule, liver disease, regulatory, safety concerns, market withdrawal - Read more

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

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