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THE GOOD
Approvals & Labels

Astellas nabs European Commission approval for Padcev, in combo with Keytruda (Merck & Co., MSD) for urothelial cancer
Antibody-drug conjugate, urothelial cancer, bladder cancer - Read more

THE GOOD
Business Development

Bora Pharmaceuticals buys 30.5% stake in Tanvex BioPharma
CDMO, biomanufacturing - Read more

Chugai Pharmaceutical to transfer Oxarol for injection business in Japan to LTL Pharma
Small molecule, secondary hyperparathyroidism - Read more

THE GOOD
Clinical Trials

Novartis’ touts positive Ph3 Leqvio data, aims for FDA approved expanded label
siRNA, atherosclerotic cardiovascular disease, cholesterol - Read more

Hyundai Bioscience charts Ph3 COVID-19 trial Xafty in high risk groups who cannot take Paxlovid (Pfizer)
Small molecule, antiviral, COVID-19 - Read more

Aesthetics biotech Jeuene Aesthetics (Krystal Biotech subsidiary) posts promising Ph1 interim data for KB301
Biologic, lateral canthal lines, dynamic wrinkles - Read more

Egetis Therapeutics Ph2b post-hoc analysis provides slightly positive evidence towards Emcitate use in rare disease MCT8 deficiency
Small molecule, monocarboxylate transporter 8 (MCT8) deficiency - Read more

THE GOOD
Fundraises

UK government launches £400M ($527M) public-private investment program to accelerate patient access, strength clinical trials, improve UK-based medicine manufacturing
Public-private partnership, biopharma investment, clinical trials - Read more

Noetik $40M Series A
AI-native biotech, drug development, machine learning, cancer - Read more [Paywall]

Curio Digital Therapeutics “double digit” fundraise (amount undisclosed)
Digital therapeutics, postpartum depression, women’s mental health - Read more

UCLA lands $120M gift to seed California Institute for Immunology and Immunotherapy
Medical research, donation - Read more

Mestag Therapeutics lands £1.5M ($2.0M) grant from Innovate UK’s £10M ($13.2M) cancer innovation fund
Bispecific antibody, solid tumor, cancer - Read more

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⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Investments

Curi Bio signs 7-year lease on bigger Seattle lab space
CRO, preclinical translational research - Read more

THE GOOD
Lawsuits

GSK’s Zantac appeal upheld, Delaware Supreme Court to review state’s Superior Court decision to allow expert expert testimony before jury
Small molecule, heartburn, cancer - Read more

THE GOOD
Partnerships

Pfizer and Flagship Pioneering’s Quotient Therapeutics partner on developing new cardiovascular and renal disease meds
Drug discovery & development - Read more

Bayer, NextRNA partner on next-gen small molecule cancer meds; up to $547M total (biobucks + undisclosed upfront payment)
Small molecule, drug development, cancer - Read more

Novartis, Lindy Biosciences partner to create self-administered versions of existing biologics; up to nearly $1B in upfront + biobucks
Biologics, drug delivery, “microglassifiction suspension technology“ - Read more

Advanz Pharma, Enzene Biosciences partner on commercializing undisclosed biosimilar
Biologics, biosimilar, commercialization - Read more

Unravel Biosciences, CSNK2A1 Foundation partner on drug discovery for ultra-rare genetic disease
In-silico drug discovery, RNA transcriptomics, Okur-Chung neurodevelopmental syndrome - Read more

THE GOOD
Research

NIH launches $270M anti-overdose research program focused on Native American population
Substance-use disorder, addiction, overdose research & prevention - Read more [Paywall]

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THE BAD
Clinical Trials

Neurocrine Biosciences presents disappointing Ph2 schizophrenia data for NBI-1117568
Small molecule, schizophrenia - Read more 

THE BAD
Lawsuits

Regeneron sues Sandoz over alleged patent infringement related to Enzeevu approval (Eylea biosimilar)
Fusion protein, wet age-related macular degeneration (wet AMD), biosimilar - Read more

THE BAD
Layoffs

Genentech to lay off 93 staffers at San Francisco site - Read more

THE BAD
Politics & Policy

PBMs continue to be in the crosshairs, as House Oversight Committee demands them to "correct the record" on alleged false statements during July hearing
Pharmacy benefit manager, drug pricing - Read more

THE UGLY
Warnings Letters, Form 483

EyePoint Therapeutics handed FDA warning letter for Watertown, MA facility, citing “batch discrepancies, lackluster written procedures and more”, mainly focused on eye implant Yutiq
Small molecule, chronic non-infectious uveitis, drug delivery device - Read more 

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

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