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THE GOOD
Business Development

Samsung Biologics secures $1.4B manufacturing contract with unnamed European pharma company
CDMO, manufacturing - Read more

Idorsia sells Agamree royalty rights to R-Bridge Healthcare Fund for $30M
Small molecule, Duchenne muscular dystrophy - Read more

World Medicine lands Turkey commercial rights for Biothera’s BAT2206 (Stelara biosimilar, Janssen)
Monoclonal antibody, plaque psoriasis, psoriatic arthritis, Crohn's disease, biosimilar - Read more [Press release in Mandarin]

Handa Therapeutics acquires Phyrago (kinase inhibitor), originally developed by Nanocopoeia
Small molecule, leukemia, cancer - Read more

Shionogi lands a $375M government contract from the US’s Administration for Strategic Preparedness and Response to develop a long-acting preventative COVID-19 drug for immunocompromised patients
COVID-19, pre-exposure prophylaxis, immunocompromised - Read more

THE GOOD
Clinical Trials

Outlook Therapeutics' ONS-5010 (targeting VEGF) matches ranibizumab (targeting VEGF-A) in Ph3 trial for wet age-related macular degeneration treatment
Monoclonal antibody, wet age-related macular degeneration - Read more

Avacta Therapeutics's AVA6000, targeting FAP-positive tumors, touts “compelling” Ph1a trial data in salivary gland cancer
Peptide-drug conjugate, salivary gland cancer - Read more

Kodiak Sciences' KSI-101 (targeting VEGF, IL-6) delivers vision improvements in Ph1b trial for inflammatory macular edema
Bispecific antibody, inflammatory macular edema - Read more

Ocugen doses first patient in Ph1 trial of OCU200 (targeting integrin receptors) in diabetic macular edema
Fusion protein, diabetic macular edema - Read more

Chromatin Bioscience and EsoBiotec advance ESO-T01, an in vivo CAR-T therapy (targeting BCMA), into clinical trials for multiple myeloma
Cell therapy, multiple myeloma, CAR-T, in vivo cell therapy - Read more

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⬇️ More Good News ⬇️

THE GOOD
Earnings & Finances

Sanofi's CEO touts Altuviiio's growth in hemophilia A market, challenging Roche's Hemlibra
Fusion protein, hemophilia A - Read more

THE GOOD
Fundraises

Micron Biomedical $16M Series A extension, needle-free dissolvable drug delivery tech
Medical device, drug delivery, micro-array, vaccine administration - Read more

Granata Bio $15M Series A+, reproductive health biotech focused on women’s health and addressing infertility
Fertility, reproductive health, in-vitro fertilization - Read more

THE GOOD
Lawsuits

Appeals court temporarily blocks MSN Pharmaceuticals' generic Entresto launch, protecting Novartis' $6 billion heart failure drug from competition
Small molecule, heart failure, generic - Read more

THE GOOD
Mergers & Acquisitions

GSK acquires organoid biotech Cellphenomics 
Organoid, tumor modelling, cancer - Read more

Serina Therapeutics sells UniverXome Bioengineering subsidiary to Juvenescence, eliminating $11.2M in debt
Small molecule, Parkinson’s disease, drug delivery, antiaging - Read more

THE GOOD
Partnerships

Yooyoung Pharmaceutical, Kangstem Biotech partner on stem cell-based osteoarthritis drug OSCA for clinical development and commercialization
Cell therapy, osteoarthritis, stem cell, drug development - Read more [Press release in Korean]

Lyndra Therapeutics, Thermo Fisher Scientific partner on manufacturing and clinical research for long-acting oral drugs
Small molecule, long-acting drugs, research, manufacturing - Read more

Servier, Google Cloud extend 5-year AI partnership to accelerate drug R&D and enhance data capabilities
Drug development, research, AI - Read more

THE GOOD
Patient Access

The Pan American Health Organization partners with the Argentinian government, Pfizer, and Sinergium to produce pneumococcal vaccine locally, improving access across Americas
Vaccine, pneumococcal disease, equitable access - Read more

THE GOOD
Regulatory

DEA proposes three-tier registration system for remote controlled substance prescribing, extending COVID telehealth flexibilities through 2025
Drug prescription, controlled substance, telehealth - Read more

THE GOOD
Strategic Plans

As Xarelto LOE reaches “full swing” in 2025, Bayer’s pharma business unit head remains upbeat on revenue growth based on label expansions and new key drug roll-outs
Small molecule, atrial fibrillation - Read more

Takeda highlights six pipeline drugs (oveporexton, zasocitinib, rusfertide, fazirsiran, mezagitamab, and elritercept) with potential combined peak sales of $10-20B, as flagship Entyvio will face biosimilar competition come 2031
Monoclonal antibody, ulcerative colitis, Crohn’s disease - Read more

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THE BAD
Approvals & Labels

Atara Biotherapeutics' Ebvallo (tabelecleucel) rejected by FDA (handed CRL) due to third-party manufacturing facility concerns
Cell therapy, post-transplant lymphoproliferative disease, allogeneic cell therapy, manufacturing facility - Read more

THE BAD
Clinical Trials

Boehringer Ingelheim's schizophrenia hopeful iclepertin (GlyT1 inhibitor) flops in three Ph3 trials, planned long-term extension study scrapped
Small molecule, schizophrenia - Read more

THE BAD
Lawsuits

Appeals court judge not convinced that FDA is in the right for denying Vanda Pharmaceuticals a hearing on its recently rejected Hetlioz (targeting MT1, MT2) label expansion application, citing legal requirements for said hearing when experts dispute
Small molecule, sleep-wake disorder, jet lag disorder - Read more

THE UGLY
Lawsuits

HHS argues Boehringer Ingelheim's voluntary Medicare negotiations participation undermines their legal challenge against drug pricing process
Inflation reduction act, drug pricing - Read more [Paywall]

Novartis sues HHS for rejecting its proposed 340B drug discount rebate model, joining four other pharmaceutical companies in legal action
340 drug pricing program, drug pricing - Read more

Teva Pharmaceuticals sues CMS over drug price negotiation program, claiming it violates IRA guidelines and threatens pharmaceutical innovation
Inflation reduction act, drug pricing - Read more

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