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Missed the Biotech/Pharma updates from December 19th to 31st? 

Since TLDR Biotech was on break for the last bit of December, there’s a bunch of news that we missed including in these newsletters.

But not to worry - all the news from December 19th to 31st is available in a downloadable spreadsheet, categorized by Good/Bad/Ugly and news types (no tags though, sorry).

If you want access (free of charge), just reply to this email with the word “Holiday List”.

(If you’re reading this newsletter on the web and want access, you’ll need to be subscribed to TLDR Biotech. Once subscribed, reply to your welcome email with “Holiday List” for access.)

THE GOOD
Approvals & Labels

Bristol Myers Squibb's Opdivo (PD-1 inhibitor) lands another FDA approval for subcutaneous delivery in solid tumors
Monoclonal antibody, solid tumor, cancer - Read more

SIGA Technologies' Tepoxx (VP37 inhitor) nabs Japanese PMDA approval to treat orthopoxvirus infections
Small molecule, orthopoxvirus infection, antiviral - Read more

GSK's Nucala (targeting IL-5) lands Chinese NMPA approval as add-on therapy for chronic rhinosinusitis with nasal polyps
Monoclonal antibody, chronic rhinosinusitis with nasal polyps - Read more

Innovent’s Dovbleron (ROS1 tyrosine kinase inhibitor) lands Chinese NMPA approval in China in advanced non-small cell lung cancer patients.
Small molecule, lung cancer - Read more

Novartis’ Fabhalta (factor B inhibitor) gets FDA adcomm date of February 24th, related to C3 glomeru­lopa­thy approval bid
Small molecule, C3 glomeru­lopa­thy - Read more (Paywall)

Capricor Therapeutics submits BLA for deramiocel, a cell therapy targeting Duchenne muscular dystrophy cardiomyopathy
Cell therapy, Duchenne muscular dystrophy cardiomyopathy, allogeneic cell therapy - Read more

THE GOOD
Business Development

Roche in-licenses Innovent's ADC IBI3009 (targeting) DLL3 for up to $1 billion, including $80 million upfront payment
Antibody-drug conjugate, lung cancer - Read more

Chia Tai Tianqing gains exclusive Chinese market rights to Naldemedine (opioid antagonist) for treating opioid-induced constipation
Small molecule, opioid-induced constipation - Read more (Press release in Chinese)

Radius Pharmaceuticals grants Pharmanovia exclusive commercialization rights to abaloparatide (targeting parathyroid hormone 1) across ten Asia Pacific markets, including China
Synthetic peptide, osteoporosis - Read more

iBio in-licenses IBIO-600 (myostatin inhibitor) from AstralBio, with goals of muscle-preserving weightloss
Bispecific antibody, obesity - Read more

Eton Pharmaceuticals acquires new commercial product in Galzin, adding Wilson disease treatment to rare disease portfolio
Small molecule, Wilson disease - Read more

Hutchmed sells its 45% stake in cardiovascular prescription med joint venture Shanghai Hutchison Pharmaceuticals (with Shanghai Pharmaceuticals)
Small molecule, cardiovascular, divestment, antibody-drug conjugate, cancer - Read more

THE GOOD
Clinical Trials

Zhaoke Ophthalmology's TAB014 (anti-VEGF) shows superior visual acuity over Lucentis (Genentech) in Ph3 trial for wet age-related macular degeneration.
Monoclonal antibody, wet age-related macular degeneration - Read more

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⬇️ More Good News ⬇️

THE GOOD
Company Launches

General Proximity launches with $16M to develop platform targeting previously "undruggable" disease-linked proteins
Small molecule, drug discovery, cancer, cardiometabolic disease - Read more

THE GOOD
Earnings & Finances

The who’s-who of big pharma plan price increases on 250 branded drugs in 2025, though percentage increases are lower than in years’ previous
Drug pricing, price increases - Read more

THE GOOD
Fundraises

CEL-SCI $5M public offering, funding further clinical development of squamous cell carcinoma hopeful Multikine
Interleukin, squamous cell carcinoma, head & neck cancer - Read more

Apheris €20.1M ($20.9M) Series A, computational platform enabling secure life sciences collaboration networks
Life science data, secure collaboration, data sharing - Read more

GenKOre KRW 10 billion ($6.9M) bridge investment, developing ultra-small “gene scissors”
Gene-editing, gene therapy - Read more

Cyclacel Pharmaceuticals $3.1M private investment from incoming interim CEO, (temporarily) averting backruptcy
Small molecule, solid tumor, lymphoma, cancer - Read more

THE GOOD
IPOs

Ascentage Pharma plans $100M Nasdaq IPO under symbol AAPG
Small molecule, myeloid leukemia, cancer - Read more

THE GOOD
Lawsuits

BioNTech agrees to pay NIH and UPenn royalties for COVID-19 vaccine Comirnaty, including $791.5 million to NIH
Vaccine, COVID-19 - Read more

THE GOOD
Marketing

Veeda Group rebrands as Veeda Lifesciences, unveiling new logo and expanding services into the CDMO realm
CRO, CDMO, contract research, contract manufacturing - Read more

THE GOOD
Mergers & Acquisitions

HOOKIPA Pharma plans to merge with Poolbeg Pharma, giving the latter 55% ownership
Arenaviral immunotherapy, cancer, small molecule, immunotherapy-induced cytokine release syndrome prevention - Read more

Regeneron acquires Oxular, gaining specialized ocular drug delivery technology with implications for “future potential ocular gene therapies”
Ocular drug delivery, small molecule, gene therapy - Read more

THE GOOD
Partnerships

Atavistik Bio, Pfizer partner to discover novel allosteric therapeutics using AMPS platform for two targets
Small molecule, drug discovery, cancer - Read more

THE GOOD
Research

Io Therapeutics' drug IRX4204 shows multiple sclerosis in mouse studies, resorting mobility and myelin nerve coatings
Small molecule, multiple sclerosis - Read more

Chinese scientists use AI to identify potential new drugs to treat glaucoma via targeting RIPK3
Small molecule, drug discovery, glaucoma, AI - Read more

Study reveals specific brain cell types and regions in mice that change with age, offering insights into brain aging
Brain aging - Read more

Scientists develop automated system to detect emerging infectious variants, enabling faster responses to disease outbreaks and better vaccine development
Infectious disease, vaccine development, antibiotic resistance - Read more

AI models outperform human experts in detecting ovarian cancer through ultrasound imaging (implications in addressing ultrasound expert shortage)
Cancer detection, ovarian cancer - Read more

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THE BAD
Clinical Trials

Neumora's navacaprant (kappa opioid receptor antagonist) fails Ph3 trial for major depressive disorder, sending stock spiralling down over 80%
Small molecule, major depressive disorder - Read more

THE BAD
Lawsuits

Eli Lilly wants in on lawsuit focused on GLP-1-producing compounding pharmacies and their ire over tirzepatide shortage removal, stating that “FDA will not ‘adequately represent [Lilly’s] interest[s]’.”
GLP-1, obesity, compounding - Read more

Instead of (or in addition to?) selling cars, Braman Motors joins lawsuit against Eli Lilly, Novo Nordisk, and Sanofi over high insulin prices
Insulin, diabetes, drug pricing - Read more (Paywall)

THE BAD
Patient Access

Novo Nordisk petitions FDA to prevent compounding pharmacies from producing Victoza (liraglutide)
GLP-1, type 2 diabetes, compounding - Read more

THE UGLY
Patient Access

In­de­pen­dence Blue Cross won't cover most treatments granted FDA accelerated approvals for at least 18 months after approval (excluding cancer therapies and mandated medicines)
Accelerated approval, health insurance - Read more (Paywall)

THE UGLY
Withdrawals & Recalls

Astellas and Endo (respectively) recall drugs due to empty capsules and unapproved ingredients concerns
Small molecule, immunosuppressant, vasoconstrictor - Read more

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

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