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The Good News

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 News

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 News 👹

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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