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THE GOOD
Approvals & Labels

Neurocrine Biosciences’ Crenessity (CRF1 antagonist) approved to treat congenital adrenal hyperplasia in patients aged 4 and older.
Small molecule, congenital adrenal hyperplasia - Read more

THE GOOD
Business Development

Innoviva Specialty Therapeutics signs exclusive U.S. distribution deal with Basilea for Zevtera (cephalosporin antibiotic)
Small molecule, antibiotic, infectious disease - Read more

Bavarian Nordic signs manufacturing deal with Serum Institute of India to produce MVA-BN for India
Vaccine, mpox, smallpox - Read more

KYORIN buys worldwide rights to Bayer’s potential OSA treatment BAY2925976 (ADRA2C receptors antagonist)
Small molecule, obstructive sleep apnea - Read more

Innovent and Eli Lilly announce distribution agreement for Jaypirca (BTK inhibitor) in Mainland China for mantle cell lymphoma treatment
Small molecule, mantle cell lymphoma, cancer - Read more

Mochida Pharmaceutical grants exclusive South Korean commercial rights for Epadel to Kuhnil Pharm
Small molecule, hyperlipidemia, arteriosclerosis obliterans - Read more

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⬇️ More Good News ⬇️

THE GOOD
Clinical Trials

Biohaven’s BHV-1300 (ASGR1 modulator, IgG inhibitor) demonstrated promising Ph1 safety and efficacy in lowering targeted IgG
Small molecule, protein degrader, lowering IgG - Read more

PureTech Health’s deupirfenidone (targets pro-inflammatory mediators) showed significant efficacy in Ph2b trial in idiopathic pulmonary fibrosis
Small molecule, idiopathic pulmonary fibrosis - Read more

Viridian Therapeutics’ veligrotug (anti-IGF1R), meets Ph3 primary/secondary endpoints in chronic thyroid eye disease
Monoclonal antibody, chronic thyroid eye disease - Read more

Edgewise Therapeutics’ sevasemten (keletal myosin inhibitor) reduced creatine kinase in Ph2 trial for Becker muscular dystrophy
Small molecule, Becker muscular dystrophy - Read more

Reviva Pharmaceuticals’ brilaroxazine (dopamine-serotonin modulator) reduced schizophrenia symptoms in Ph3 trial
Small molecule, schizophrenia - Read more

Menarini Group and NewAmsterdam Pharma's obicetrapib (targeting atherogenic lipoproteins) touts positive Ph3 results in heterozygous familial hypercholesterolemia and atherosclerotic cardiovascular disease
Small molecule, heterozygous familial hypercholesterolemia, atherosclerotic cardiovascular disease - Read more

THE GOOD
Company Launches

Promise Bio launches with $8.3M seed investment to develop AI-driven precision medicine for autoimmune diseases
Drug discovery, autoimmune, epiproteomics, AI, precision medicine - Read more

THE GOOD
Fundraises

Concinnity Genetics £3M Seed, focused on developing AI-driven RNA-based control systems to enhance the safety of gene therapies
Gene therapy, RNA, AI, drug safety - Read more

Fluid Biomed $27M Series A, developing bioabsorbable stents like ReSolv™ to treat vascular diseases and brain aneurysms
Medical device, bioabsorbable stent, vascular disease, brain aneurysm - Read more

Nintx $10M Series A, developing treatments for multifactorial diseases using Brazil’s biodiversity and human microbiome
Multifactorial diseases, microbiome - Read more

bit.bio $30M financing, leading provider of cell programming technology, to accelerate human cell supply for research and drug discovery
Cell therapy, cell programming, drug discovery, research - Read more

Trevi Therapeutics $50M public offering, developing Haduvio™ for chronic cough in idiopathic pulmonary fibrosis and refractory chronic cough
Small molecule, chronic cough in idiopathic pulmonary fibrosis, refractory chronic cough - Read more

THE GOOD
Mergers & Acquisitions

Goldman Sachs Asset Management is set to acquire Dutch pharmaceutical company Synthon for €2B from current owner BC Partners
Generic, manufacturing, cancer, high blood pressure - Read more

With FTC go-ahead cinched after the same from EU antitrust regulators, Novo Holdings set to finalize their $16.5B acquisition of Catalent
CDMO, contract manufacturing, antitrust scrutiny - Read more

Pharming acquires Swedish biotech Abliva for $66.1M to advance KL1333 (NAD+ modulator) in type of mitochondrial disease
Small molecule, primary mitochondrial disease - Read more

THE GOOD
Partnerships

Candid Therapeutics signs on three research collaborations with EpimAb Biotherapeutics, Nona Biosciences, and Ab Studio for bispecific antibodies in autoimmune diseases
Bispecific T-cell engager, autoimmune, drug design - Read more

THE GOOD
Politics & Policy

US Congress nears deal to regulate pharmacy benefit managers, extend telehealth, and fund public health programs in funding package
Pharmacy benefit manager, telehealth - Read more [Paywall]

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THE BAD
Approvals & Labels

AstraZeneca's Andexxa, an anticoagulant reversal drug, doesn’t land full FDA approval after concerns over supporting data
Recombinant coagulation factor, bleeding reversal - Read more [Paywall]

FDA rejects Johnson & Johnson's subcutaneous Rybrevant (targeting epidermal growth factor receptors, mesenchymal-epithelial transition proteins) for EGFR-mutated non-small-cell lung cancer due to manufacturing facility issues
Bispecific antibody, lung cancer - Read more

THE BAD
Clinical Trials

Foghorn Therapeutics discontinues FHD-286 (SMARCA4/SMARCA2 ATPase inhibitor) and decitabine (methylation inhibitor) for relapsed/refractory AML due to insufficient response rates in Phase 1 trial
Small molecule, acute myeloid leukemia - Read more

Roche discontinues development of Spark Therapeutics’ Ph3 hemophilia A gene therapy dirloctocogene samoparvovec (SPK-8011)
Gene therapy, hemophilia A - Read more

PepGen handed FDA clinical hold for PGN-EDO51 (DMD exon 51 modulator, dystrophin expression stimulant) in Ph2 Duchenne muscular dystrophy trial
Antisense oligonucleotide, Duchenne muscular dystrophy, drug delivery - Read more

THE BAD
Layoffs

Outlook Therapeutics lays off 23% of staff after wet AMD antibody misses endpoint in FDA-requested clinical trial
Monoclonal antibody, wet age-related macular degeneration - Read more

THE BAD
Partnerships

Bristol Myers Squibb cuts cell therapy R&D partnership with both Immatics and Century Therapeutics as part of cost-cutting spree
Cell therapy, research & development - Read more

THE BAD
Patient Access

AI and ML-enabled medical devices show gaps regarding pediatric patients, with only 149 of 876 FDA-approved for children
Medical device, pediatric - Read more [Paywall]

THE BAD
Politics & Policy

HRSA orders Sanofi to halt 340B rebate proposal, citing violation of statutory obligations and potential penalties
340B drug pricing, 340B rebate, Health Resources and Services Administration -Read more

THE UGLY
Adverse Events

Danish Medicines Agency to review Novo Nordisk’s Ozempic's link to rare eye disease after 19 reported cases
GLP-1, obesity, diabetes, non-arteritic anterior ischemic optic neuropathy - Read more

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