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THE GOOD
Approvals & Labels

Journey Medical’s rosacea med Emrosi lands FDA approval
Small molecule, rosacea - Read more

THE GOOD
Business Development

Nektar Therapeutics sells manufacturing supply & PEGylation reageant facility to Ampersand Capital Partners for $90M total ($70M cash + $20M equity)
Facility sale, manufacturing, PEGylation - Read more

THE GOOD
Clinical Trials

Viking Therapeutics posts positive Ph1 data for experimental obesity pill
Small molecule, obesity - Read more
(But their stock also took a hit due to manufacturing cost concerns and competitor progress)

Novo Nordisk’s Wegovy may reduces all-cause hospital admission according to new Ph3 analysis
GLP-1, obesity, diabetes - Read more

AstraZeneca throws hat in the obesity ring with “promising” Ph1 data for AZD5004
Small molecule, obesity, GLP-1 - Read more

CinRx’s obesity hopefuls CIN-109 and CIN-110 both posted “promising” Ph1 data, both for tolerability and efficacy
Small molecule, synthetic peptide, obesity, weight-loss - Read more

OSE Immunotherapeutics touts “statistically significant” Ph2 data for lusvertikimab in ulcerative colitis
Monoclonal antibody, ulcerative colitis - Read more

Formosa Pharmaceuticals announces “successful” topline Ph3 results of APP13007 in reducing inflammation, pain after cataract surgery in Chinese patients
Small molecule, inflammation and pain following cataract surgery - Read more

Disc Medicine touts successful end of Ph2 FDA meeting for bitopertin in treating erythropoietic protoporphyria
Small molecule, erythropoietic protoporphyria - Read more 

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⬇️ More Good News ⬇️

THE GOOD
Earnings & Finances

BioNTech’s Q3 beats analysts estimates driven by COVID-19 vaccines sales, though 2024 outlook takes a cut
Vaccine, COVID-19 - Read more

THE GOOD
Fundraises

Tribe Capital files plans with SEC for nearly $50M healthcare fund
Venture capital, healthcare investing - Read more 

Neurogene $200M private funding via PIPE
Gene therapy, Rett syndrome - Read more

Lomond Therapeutics $44M private placement financing (and goes public via SPAC)
Small molecule, liquid tumor, cancer - Read more

CrossBridge Bio $10M raise
Antibody-drug conjugate, solid tumor, breast cancer - Read more

NeuroDawn “several hundred million” RMB Series C
Small molecule, depression, central nervous system diseases - Read more [Press Release in Chinese]

THE GOOD
Mergers & Acquisitions

NLS Pharmaceutics, Kadimastem agree on merger, focus on allogeneic cell therapies
Cell therapy, amyotrophic lateral sclerosis, diabetes - Read more

Boston Scientific to buy Cortex, catheter tech
Medical device, catheter - Read more

Relief Therapeutics, Renexxion agree on reverse merger to go public, focusing on GI mobility disorders
Small molecule, gastroparesis, delayed gastric emptying, reverse merger - Read more

For better or worse, European regulators will rule on Novo Holdings, Catalent acquisition by November 6th (tentatively)
CDMO, manufacturing - Read more

THE GOOD
Partnerships

Novo Nordisk partners with Ascendis Pharma, leveraging latter’s delivery tech for GLP-1s
GLP-1, obesity, drug delivery, platform technology - Read more

Integra Therapeutics partners with Caszyme for their Cas121 nucleases for €40 ($43.5M) biobucks + additional royalties
Gene-editing, CRISPR-Cas nuclease, platform - Read more

TCGFB (founded by The Column Group), Surrozen partner on antibody-focused drug discovery for idiopathic pulmonary fibrosis
Antibody, idiopathic pulmonary fibrosis - Read more

Y-mAbs Therapeutics, Nobelpharm partner on Japan development, commercialization of former’s Danyelza mAb
Monoclonal antibody, neuroblastoma, osteosarcoma, cancer - Read more

BigHat Biosciences, Synaffix partner on developing next-gen ADCs
Antibody-drug conjuugate, platform tech, drug discovery - Read more

THE GOOD
Regulatory

FDA making steps towards establishing Rare Disease Innovation Hub
Rare disease, regulatory guidance - Read more

FDA expanding accelerated review pilot to full approval applications (not just supplemental)
Drug approval process - Read more [Paywall]

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THE BAD
Lawsuits

Sun Pharma’s Leqselvi launch delayed as judge grants Incyte requested injunction on patent infringement allegations
Small molecule, alopecia areata, patent infringement - Read more

THE UGLY
Warnings Letters, Form 483s

Mark Cuban’s Cost Plus Drugs Dallas facility handed FDA Form 483 due to sterility, quality concerns
Drug compounding, quality, sterility - Read more [Paywall]

THE UGLY
Withdrawals & Recalls

Dr. Reddy’s Laboratories recalls over 300k cinacalcet bottles due to “presence of known carcinogen”
Small molecule, hyperparathyroidism - Read more

Fullerton Wellness compounded injectables (including some popular GLP-1s) get do-not-use warning from FDA due to sterility concerns
Injectables, sterility - Read more

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

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