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Quick Thoughts from the Author
Today’s TLDR Biotech Vibe Check

The big story over the weekend is the incoming HHS head RFK Jr. - the noted vaccine skeptic, fluoride naysayer, and source of whatever the fresh hell this was is slated to be at the helm of US’s penultimate health department.

Time will tell if RFK’s mandate of “Make America Healthy Again” will do just that.

I’m testing adding in a few sentences here on any outstanding trends, stories, or whatever else I feel like commenting on in the biotech/pharma space.
Let me know if you’re a fan (or not) of this segment addition - send me an email or DM me on LinkedIn.

THE GOOD
Approvals & Labels

Azurity Pharmaceuticals feels full after Danziten scores FDA approval in chronic myeloid leukemia (Tasigna, Novartis formulation that doesn’t require strict fasting
Small molecule, chronic myeloid leukemia, cancer - Read more

Syndax’s Revuforj snags FDA approval in acute leukaemia
Small molecule, acute leukaemia, cancer - Read more

Knight Therapeutics’ Jornay lands Health Canada approval for treating ADHD in children
Small molecule, attention-deficit hyperactivity disorder - Read more

Sanofi’s Sarclisa recommended by EU CHMP for transplant-ineligible newly diagnosed multiple myeloma
Monoclonal antibody, multiple myeloma, cancer - Read more

Merck & Co. nabs positive EU CHMP opinion for Keytruda + chemotherapy as first-line therapy for form of mesothelioma
Monoclonal antibody, pleural mesothelioma, cancer - Read more

InflaRx scores positive EU CHMP opinion for Gohibic in adults with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS)
Monoclonal antibody, COVID-19, acute respiratory distress syndrome - Read more

Philips’ radiotherapy scanner snags FDA ok
Radiation oncology, spectral CT - Read more

THE GOOD
Business Development

OrbiMed buys rights to Neurelis’ Neffy for $208M
Small molecule, anaphylaxis, nasal spray - Read more

THE GOOD
Clinical Trials

Amgen showcases slate of rare disease clinical updates, including Uplizna & Krystexxa
Monoclonal antibody, immunoglobulin G4-related disease, enzyme, gout - Read more

Boston Pharmaceuticals’ efimosfermin alfa delivers the Ph2 goods in MASH and improving related fibrosis
Fusion protein, metabolic dysfunction-associated steatohepatitis (MASH) - Read more

Immutep touts positive Ph2 data for efti (+ radiotherapy + Keytruda) in soft tissue sarcoma
Fusion protein, soft tissue sarcoma, cancer - Read more

Levicept showcases positive Ph2 data for LEVI-04 in osteoarthritis
Fusion protein, osteoarthritis - Read more

Janssen-Cilag (Johnson & Johnson) touts Ph2 nipocalimab data that demonstrates “significant clinical improvement” in Sjögren’s disease
Monoclonal antibody, Sjögren’s disease - Read more

89bio presents additional pegozafermin Ph2 data analyses in MASH
Growth factor, metabolic dysfunction-associated steatohepatitis (MASH) - Read more

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⬇️ More Good News ⬇️

THE GOOD
Fundraises

Mithrl $4M Seed raise, AI-powered drug discovery software
Drug discovery, research & development, software, next generation sequencing, AI - Read more

Sunthetics $4M Seed raise, machine learning-powered R&D software
Small molecule, drug discovery, research & development, machine learning - Read more

Alector $50M credit facility
Monoclonal antibody, Alzheimer’s disease, dementia - Read more

Sparian Biosciences $19.5M grant from NIH
Small molecule, opiate use disorder, and opiate withdrawal syndrome - Read more

THE GOOD
Investments

Orano Med plans €250M ($263M) radioligand manufacturing facility in Germany
Radiopharm, radiotherapy, manufacturing, new site - Read more

Avantor opens new life science R&D facility
Research & development, bioprocess development, manufacturing - Read more

THE GOOD
Mergers & Acquisitions

Evotec share get boost on unsolicited takeover bid from Halozyme Therapeutics
Drug delivery tech platform, drug discovery - Read more

SciSafe acquired by 1315 Capital from BioLife Solutions
Logistics, cold chain, specialized storage - Read more

SAI MedPartners acquires IDEA Pharma
Consulting, pharmaceutical go-to-market strategy, commercialization - Read more

THE GOOD
Partnerships

Kaken Pharmaceutical and Numab Therapeutics partner on pre-clinical IBD asset drug development
Multispecific antibody, inflammatory bowel disease, drug development - Read more

Flashpoint Therapeutics $50M partnership with The King Abdullah International Medical Research Center
Structural nanomedicine, Merkel cell carcinoma, cancer - Read more

THE GOOD
Research

Arc Institute published new CRISPR system AI model dubbed “Evo”
CRISPR, synthetic biology, AI, drug discovery - Read more [Paywall]

Innate Pharma published animal studies for IPH6501 tetraspecific
Tetraspecific antibody, lymphoma, cancer - Read more

“Worst imaginable” diffuse intrinsic pontine gliomas may have met their match with CAR-T
Cell therapy, glioma, cancer, CAR-T - Read more [Paywall]

Unexpected death of genetically-modified pig-kidney transplant recipient was not caused by the organ (no signs of rejection), instead by an “unexpected cardiac event”
Organ transplant, genetically modified organ, pig-to-human organ transplant - Read more

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THE BAD
Business Development

Vitalli Bio to return licensing rights of DWP213388 to Daewoong Pharmaceutical
Small molecule, autoimmune - Read more

THE BAD
Clinical Trials

Eyenovia faces dreaded “strategic alternatives” after Optejet drug-device combo flops in Ph3
Small molecule, paediatric progressive myopia, drug-device combo - Read more

Nuvectis Pharma’s NXP800 Ph1b data sends stock cratering
Small molecule, ovarian cancer - Read more

THE BAD
Company Shutdown

TFF Pharmaceuticals winds down
Drug delivery, rapid freezing - Read more

THE BAD
Earnings & Finances

Vaccine makers facing uncertain times ahead, stocks take hit on incoming RFK Jr.-led HHS
Vaccine, policy, market impacts - Read more

Bavarian Nordic’s disappointing Q3 mpox/smallpox vaccine performance sinks stock
Vaccine, smallpox, mpox (monkeypox) - Read more

Hims & Hers drops 30% in a week with Amazon encroaching on it’s prescription business
Pharmaceutical prescriptions, consumer health, erectile dysfunction, hair loss - Read more

THE BAD
Lawsuits

Eli Lilly joins the 340B discount lawsuit party
Drug pricing, 340B drug discount program - Read more

Illumina wants to dismiss shareholder lawsuit alleging secret $800M stake in Grail
Sequencing, securities lawsuit - Read more [Paywall]

THE BAD
Layoffs

Adaptimmune plans 33% headcount reduction
Cell therapy, cancer, T cell therapy - Read more

THE BAD
Strategic Plans

Omega Therapeutics stops development of sole-clinical stage asset OTX-2002 in strategic pivot
mRNA, hepatocellular carcinoma, cancer, solid tumor - Read more

THE UGLY
No Ugly News Today!

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

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