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THE GOOD
Approvals & Labels

Autolus Therapeutics’ CAR-T Aucatzyl (obe-cel) lands FDA approval in acute lymphoblastic leukaemia
Cell therapy, lymphoblastic leukaemia, cancer, CAR-T - Read more

Moderna nabs Health Canada approval for RSV vaccines for over 60
Vaccine, respiratory syncytial virus - Read more

Johnson & Johnson submits submits both USA & European applications for Darzalex Faspro/Darzalex in multiple myeloma
Monoclonal antibody, multiple myeloma, cancer - Read more

THE GOOD
Clinical Trials

AstraZeneca, Amgen showcases Ph3 success for Tezspire in chronic rhinosinusitis
Monoclonal antibody, chronic rhinosinusitis with nasal polyps - Read more

IMUNON posts positive Ph1 data for IMNN-001 in ovarian cancer
DNA therapeutic, ovarian cancer, lipid nanoparticle - Read more

IO Biotech reports “promising” Ph2 data for off-the-shelf cancer vaccine IO102-IO103 with Keytruda (Merck & Co.) in metastatic lung cancer
Cancer vaccine, lung cancer - Read more

IASO Biotherapeutics publishes Ph1b/2 data for Fucaso cell therapy in multiple myeloma
Cell therapy, multiple myeloma, cancer, CAR-T - Read more

Paratek Pharmaceuticals positive top-line Ph2b for omadacycline in treating nontuberculous mycobacterial pulmonary disease
Small molecule, nontuberculous mycobacterial pulmonary disease, mycobacterium abscessus complex - Read more

THE GOOD
Fundraises

Healthier Capital applies to raise a $200M fund
Venture capital, healthcare, health tech - Read more

Parallel Fluidics $7M Seed, microfluidics development for life science tools and biomanufacturing
Microfluidics, manufacturing - Read more

Travere Therapeutics public offering, gross proceeds of $125M
Small molecule, IgA nephropathy, cystinuria - Read more

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THE GOOD
Market Reports

The tables turn as Bristol Myers Squibb, Gilead, Sanofi stocks climbed in Q3, while obesity stars Novo Nordisk, Eli Lilly fell; GlobalData reportt
Public markets, big pharma - Read more

THE GOOD
Mergers & Acquisitions

AlloVir attempts to come back from the brink by merging with Kalaris Therapeutics 
Fusion protein, neovascular age-related macular degeneration (AMD) - Read more

Tempus AI acquires Ambry Genetics for $600M
Hereditary cancer screening, diagnostics, precision medicine, AI - Read more

Maravai LifeSciences to acquires DNA, RNA businesses of Officinae Bio
DNA, RNA, drug design - Read more 

THE GOOD
Partnerships

Daiichi Sankyo, Alteogen partner on developing subcutaneous Enhertu formulation using latter’s technology
Antibody-drug conjugate, breast cancer, formulation development - Read more

Arctic Vision, Santen Pharmaceuticals ARVN001 commercial collab in China (excluding Hong Kong, Macau, Taiwan)
Small molecule, uveitic macular oedema, commercial partnership - Read more

Vaccinex signs partnerships with multiple pharmas, including Amgen, Chugai, Incyte, focused on antibody drug discovery
Antibody, drug discovery - Read more

THE GOOD
Research

Carisma Therapeutics, Moderna tout initial lung, liver tumor-shrinking results in mice for mRNA-driven macrophage therapy dubbed CAR-M
mRNA, lung cancer, liver cancer, in-vivo macrophage - Read more  

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THE BAD
Approvals & Labels

Neurotech Pharmaceuticals’ NT-501 FDA PDUFA date pushed back by three months
Encapsulated cell therapy, macular telangiectasia type 2, medical device - Read more 

THE BAD
Clinical Trials

Allogene Therapeutics’ ALLO-316 Ph1 data overshadowed by 3 (heavily pre-treated) patient deaths
Cell therapy, solid tumor, renal cell carcinoma, allogeneic CAR-T - Read more

THE BAD
Earnings & Finances

Eisai cut full-year Leqembi forecast to $279M (drop of $91M)
Monoclonal antibody, Alzheimer’s disease - Read more

Oaktree Capital Management accuses Indivior of “lack of focus” and “value destruction”, makes push for new board
Activist investor - Read more

THE BAD
Layoffs

Charles River Laboratories closing “15 smaller sites” which focus on dis­cov­ery, safe­ty, and reg­u­la­to­ry services
CDMO, CRO - Read more [Paywall]

THE BAD
Partnerships

Genentech terminates cancer vaccine development partnership with Nykode Therapeutics
Cancer vaccine, drug development - Read more

THE BAD
Politics & Policy

GSK leaves industry lobby group Biotechnology Innovation Organization (BIO)
Industry group, lobbying - Read more

NIH researchers feel unease about incoming Trump administration, fear funding cuts, politicization
Healthcare research, biomedical research - Read more [Paywall]

THE BAD
Strategic Plans

Athira Pharma beginss considering the dreaded “strategic alternatives” after fosgonimeton Ph2/3 failure in early September
Small molecule, Alzheimer’s disease - Read more

Dynavax drops Tdap vaccine due to “[in]sufficient differentiation” in unreleased Ph1 data
Vaccine, tetanus, diphtheria, acellular pertussis - Read more

Nkarta Therapeutics continues autoimmune pivot by dropping NKX019 CAR-NK program
Cell therapy, lymphoma, cancer, CAR-NK - Read more [Paywall]

NextCure makes deep pipeline cuts, focusing efforts on ADC LNCB74
Antibody-drug conjugate - Read more

THE UGLY
Regulatory

FDA puts Shandong Boyuan Pharmaceutical on no-import list after failure to provide documents demonstrating cGMP compliance
Active pharmaceutical ingredients, manufacturing, good manufacturing practices - Read more

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

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