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THE GOOD
Approvals & Labels

FDA approves Apellis' complement C3 inhibitor Empaveli for adolescent and adult complement 3 glomerulopathy and IC-MPGN
Protein therapy, autoimmune, complement inhibitor, kidney disease, C3G, IC-MPGN - Read more

Taiwan approves Ono Pharmaceutical’s Opdivo-Yervoy combination for first-line treatment of unresectable hepatocellular carcinoma, following successful Ph3 trial
Antibody, cancer, monoclonal antibody, hepatocellular carcinoma, immunotherapy, PD-1 inhibitor, combination therapy - Read more

Alteogen's EYLUXVI (aflibercept biosimilar) receives CHMP positive opinion for wet age-related macular degeneration treatment
Protein therapy, ophthalmological, biosimilar, aflibercept, wet AMD, VEGF inhibitor - Read more

CHMP recommends BeOne's TEVIMBRA (PD-1 inhibitor) for resectable non-small cell lung cancer in neoadjuvant/adjuvant setting
Monoclonal antibody, non-small cell lung cancer, immunotherapy, neoadjuvant/adjuvant therapy - Read more

EMA committee recommends Moderna's updated COVID-19 vaccine targeting LP.8.1 variant for European approval
mRNA vaccine, infectious disease, regulatory, operational - Read more

THE GOOD
Business Development & Partnerships

Boehringer Ingelheim, Re-Vana partner on long-acting eye disease treatments; potential $1B+ deal including milestones
Licensing deal, ophthalmology, drug delivery, milestone payments, R&D - Read more

Arrowhead Pharmaceuticals, Sarepta Therapeutics: $100M milestone payment due in 60 days for RNA therapy trial enrollment in DM1 partnership
Milestone payments, rare disease, RNAi therapeutic, licensing deal, neurological - Read more

Adaptimmune sells Tecelra and two late-stage cancer therapies to US WorldMeds for up to $85M amid financial struggles
Acquisition, cell therapy, oncology, asset sale, milestone payments - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Celcuity's gedatolisib PI3K inhibitor achieves Ph3 success in hormone receptor-positive breast cancer, setting stage for FDA filing
Small molecule, cancer, breast cancer, HR+/HER2-, PI3K pathway, combination therapy - Read more

Roche's trontinemab shows 90%+ amyloid clearance in Ph1b/2a trial for Alzheimer's disease, Phase III planned
Antibody, neurological, monoclonal antibody, Alzheimer disease, amyloid target, blood-brain barrier penetration - Read more

Alterity's ATH434 shows positive Ph2 results reducing progression in multiple system atrophy by targeting α-synuclein pathology
Small molecule, neurological, multiple system atrophy, alpha-synuclein, iron modulation, disease-modifying - Read more

Celcuity's gedatolisib, PAM inhibitor, achieves Ph3 success in hormone receptor-positive metastatic breast cancer
Small molecule, cancer, breast cancer, PI3K/AKT/mTOR inhibitor, combination therapy, HR+/HER2 - Read more

AIM ImmunoTech reports positive Ph2 data for Ampligen-Imfinzi combination targeting pancreatic cancer
Small molecule, cancer, immunotherapy, pancreatic cancer, checkpoint inhibitor, combination therapy - Read more

Alfasigma's Jyseleca (filgotinib) meets Ph3 primary endpoint for axial spondyloarthritis, targeting JAK1 pathway
Small molecule, autoimmune, JAK inhibitor, axial spondyloarthritis, oral therapy - Read more

THE GOOD
Fundraises

MapLight raises $372.5M Series D, advancing phase 2 competitor to BMS's schizophrenia drug Cobenfy
Neurological, small molecule, schizophrenia, Alzheimer disease, clinical-stage - Read more

Clarity raises $203M institutional placement, advancing radiopharmaceuticals for cancer treatment
Radiopharmaceutical, oncology, cancer, clinical-stage, therapeutic - Read more

VelaVigo raises $60M Pre-A+ to advance antibody and ADC drugs into global clinical trials
Oncology, antibody, ADC, multispecific antibody, autoimmune, clinical-stage - Read more

MaaT Pharma secures €37.5M ($44.1M) loan from EIB, advancing hemato-oncology clinical programs
Microbiome, hemato-oncology, oncology, clinical-stage, immune modulation, platform technology - Read more

LenioBio receives €3.7M ($4.35M) EU4Health grant to scale protein expression platform for medicine production
Protein expression platform, biomanufacturing, platform technology - Read more

Nurocor raises $1M investment, cloud software platform for pharma clinical development efficiency
Software platform, clinical trial platform, services, data analytics, pharmaceutical - Read more

NOBO Medicine raises $21M Series C, advancing Multi-TEC inhibitor for hematologic oncology
Oncology, hematologic oncology, precision medicine, clinical-stage, small molecule - Read more

Can-Fite raises $15.0M public offering for cancer and inflammatory disease drug development
Small molecule, inflammatory disease, cancer, clinical-stage - Read more

THE GOOD
Investments

Simtra BioPharma Solutions buys Indiana land for commercial-scale ADC manufacturing, becoming first U.S. CDMO for this capability
Antibody-drug conjugate, oncology, operational, manufacturing, capacity expansion - Read more

THE GOOD
Mergers & Acquisitions

Bavarian Nordic accepts $3B private equity buyout from Nordic Capital and Permira
Vaccine, infectious disease, major transaction, strategic, financial - Read more

THE GOOD
Regulatory

AMA urges HHS Secretary Kennedy to retain Preventive Services Task Force amid reported dissolution plans
Preventive healthcare, HIV, regulatory, strategic, healthcare policy - Read more

FDA allows Sarepta to resume Elevidys shipments for ambulatory Duchenne muscular dystrophy patients after safety pause
Gene therapy, rare disease, regulatory, safety concerns - Read more

EMA promotes new approach methodologies to reduce animal testing in drug development assessments
Non-clinical testing, regulatory, operational, animal welfare - Read more

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THE BAD
Clinical Trials

Recognify Life Sciences' GABA-B modulator inidascamine fails Ph2b trial for schizophrenia, prompting atai Life Sciences to shift focus
Small molecule, neurological, GABA-B modulator, schizophrenia, neurocognitive function, psychedelic therapy - Read more

THE BAD
Politics & Policy

EU-US trade deal imposes 15% tariff on pharmaceuticals crossing the Atlantic starting August 1
Trade policy, pharmaceutical manufacturing, regulatory, tariff implementation, competitive, financial impact - Read more

THE UGLY
Regulatory

RFK Jr. potentially restructuring USPSTF panel, threatening HIV PrEP coverage for Gilead and GSK
Small molecule, infectious disease, regulatory, strategic, policy impact - Read more

FDA investigates Brazilian boy's death after Elevidys treatment; Sarepta and Roche denies link
Gene therapy, rare disease, regulatory, safety concern, competitive impact - Read more

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

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