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THE GOOD
Approvals & Labels

Novartis lands a FABulous FDA accelerated approval for IgA nephropathy complement inhibitor
Small molecule, IgA nephropathy, kidney disease - Read more

Citius Pharmaceuticals scores FDA approval for fusion protein cancer med
Fusion protein, lymphoma, cancer - Read more

Amneal Pharma retribution with FDA approving extended-release Parkinson’s med after June 2023 rejection
Small molecule, Parkinson’s disease - Read more

Purdue Pharma (yes, that Purdue Pharma) gains FDA approval for injectable opioid overdose treatment
Small molecule, auto-injector, opioid overdose - Read more

Big Health gets big win from FDA with approval for insomnia digital therapeutic
Digital therapeutic, chronic insomnia, sleeping disorder - Read more

THE GOOD
Business Development

Bavarian Nordic lands $156.8M BARDA contract for smallpox/mpox vaccine stockpile
Vaccine, mpox, monkeypox, smallpox - Read more

Conduit Pharmaceuticals buys license and development rights to three AstraZeneca small molecule assets
Small molecule, autoimmune, idiopathic male infertility - Read more

Evotec lands $25M payday in as they make progress in Bristol Myers Squibb strategic partnership
Neurodegenerative disease, platform technology, drug discovery - Read more

THE GOOD
Clinical Trials

Intellia Therapeutics’ angioedema CRISPR med hits all Ph2 primary and secondary endpoints
CRISPR, gene editing, hereditary angioedema - Read more

Sanofi notches Ph3 win with multiple myeloma antibody
Monoclonal antibody, multiple myeloma, cancer - Read more

Aldeyra Therapeutics’ once-rejected dry eye med succeeds in new Ph3 study
Small molecule, dry eye disease - Read more

Apellis Pharmaceuticals touts positive Ph3 data in
Polypeptide, C3 glomerulopathy, membranoproliferative glomerulonephritisa, kidney disease - Read more

Johnson & Johnson publishes positive Ph2 results for hemolytic disease prevention antibody
Monoclonal antibody, severe fetal anemia, severe hemolytic disease of the fetus and newborn (HDFN) - Read more

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⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Earnings & Finances

Eli Lilly had an absolutely smashing Q2, in contrast to obesity rival Novo Nordisk
GLP-1, obesity, diabetes - Read more

THE GOOD
Fundraises

Isotope manufacturer IONETIX scores additional financing from Eli Lilly
Radiopharma, isotope manufacturing - Read more

NovAliX lands investment from Bruker
CRO, contract research organization, drug discovery - Read more

THE GOOD
Mergers & Acquisitions

Pharma’s biggest AI bets gets even bolder with Recursion & Exscientia merger
AI-enabled biotech, drug discovery & development - Read more

Clinigen acquires Kinesys Consulting
Pharma consulting, biotech consulting, regulatory consulting - Read more

THE GOOD
Partnerships

WuXi Biologics signs T cell engager R&D partnership with Medigene
Monoclonal antibody, TCR-guided T cell engager, CDMO/CRDMO, cancer - Read more

SK pharmateco and Rznomics sign MOU regarding RNA-based gene therapy CDMO partnership
RNA-based gene therapy, drug development, manufacturing, CDMO - Read more

Coegin Pharma, University of Bradford sign commercialization pact
Peptide, pigmentation, skin condition - Read more

THE GOOD
Patient Access

Vertex Pharmaceuticals and UK’s NHS strike reimbursement agreement for Casgevy in transfusion-dependent beta-thalassemia, paving way for patient access
CRISPR/Cas-9, gene editing, beta-thalassemia - Read more

THE GOOD
Research

Aminoglycoside-induced hearing loss might be prevented with alkaloid from a Indian pepper plant; non-primate animal study
Small molecule, antibiotic-induced hearing loss - Read more 

THE GOOD
Strategic Plans

Roivant has upcoming “promising additions” to pipeline, one program to be unveiled next month
Small molecule, monoclonal antibody, autoimmune - Read more

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THE BAD
Business Development

Cullinan Therapeutics has buyer’s remorse after reviewing Ph1 data, hands back bispecific asset to Harbour BioMed
Bispecific antibody, solid tumor, cancer - Read more

THE BAD
Clinical Trials

Merck & Co. halts Ph3 lung cancer trial after hitting futility criteria and experiencing a higher rate of adverse events
Monoclonal antibody, lung cancer - Read more

Eli Lilly’s tau-targeting Alzheimer’s med handed a Ph2 L
Small molecule, Alzheimer’s disease - Read more

THE BAD
Company Shutdown

Entero Therapeutics faces loan default notice as obligations outstrip cash reserves
Recombinant protein, autoimmune, celiac disease - Read more

THE BAD
Earnings & Finances

Despite a surprising FDA approval, Sarepta Therapeutics’ earnings fall short of analyst expectations, stock tumbles
Gene therapy, Duchenne’s muscular dystrophy - Read more

As is the case with many CDMOs & CROs lately, Charles River Laboratories posts decreasing revenue numbers
CRO, contract research organization - Read more

Novavax earnings miss analyst expectations, as COVID-19 vaccine sales continue to tumble
COVID-19 vaccine - Read more

THE BAD
Layoffs

Ajinomoto Pharma to lay off 71 San Diego staffers by September - Read more [Paywall]

THE UGLY
Withdrawals & Recalls

Medtronic handed FDA Class 1 recall over nerve monitoring tech, 10 patient injuries reported
Medical device, vital nerve monitoring - Read more

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

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