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THE GOOD
Approvals & Labels

BridgeBio Pharma, Bayer's Beyonttra lands EU approval for cardiac amyloidosis with cardiomyopathy in adults
Small molecule, transthyretin amyloidosis with cardiomyopathy (ATTR-CM) - Read more

SpringWorks Therapeutics' Gomekli (MEK inhibitor) receives FDA approval for inoperable plexiform neurofibromas in neurofibromatosis type 1 patients
Small molecule, neurofibromatosis type 1 (NF1), symptomatic plexiform neurofibromas (PN) - Read more

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⬇️ More Good News ⬇️

THE GOOD
Business Development

Ellipses Pharma in-licenses GENA-104 (targeting CNTN4 protein) from Genome & Company to treat “cancer patients who do not respond to existing checkpoint inhibitor“
Monoclonal antibody, cancer, drug development - Read more

THE GOOD
Clinical Trials

Pfizer's accidental early release of positive Ph1 data for mevrometostat (EZH2 inhibitor) combined with Xtandi (androgen receptor antagonist) in metastatic castration-resistant prostate cancer
Small molecule, prostate cancer, combo therapy - Read more

IN8bio touts “promoting” Ph1 data for INB-100 gamma-delta T cell therapy in leukemia patients following stem cell transplant
Cell therapy, leukemia, gamma-delta T cell therapy, allogeneic cell therapy - Read more

Lipella Pharmaceuticals showcases positive Ph2 data for LP-310 in treating oral lichen planus
Small molecule, lichen planus, liposome, drug delivery - Read more

Spinogenix touts Ph2 success for SPG601 (targeting large-conductance, calcium-activated potassium channels) in reducing abnormal brain activity in men with Fragile X syndrome
Small molecule, Fragile X syndrome - Read more

Ashvattha Therapeutics' subcutaneous Migaldendranib shows positive Ph2 results in wet AMD and diabetic macular edema
Nanomedicine, wet AMD, diabetic macular edema - Read more

Pfizer and Astellas' deliver Ph3 win in Padcev (targeting nectin-4) plus Keytruda (targeting PD-1) in urothelial cancer
Antibody-drug conjugate, urothelial cancer, monoclonal antibody, drug combo - Read more

THE GOOD
Earnings & Finances

Gilead Sciences' stock rises after Q4 results exceed expectations, with revenues of $7.57B and earnings per share of $1.90
Big pharma earnings - Read more

THE GOOD
Fundraises

Harrison.ai $112M Series C, medical AI company expanding US operations and global product development
Medical device, healthtech, diagnostics, AI - Read more

Eli Lilly $6.5B bond sale, raising capital to acquire $2.5B cancer drug from Scorpion Therapeutics
Small molecule, breast cancer - Read more

Levee Medical $10M Series B, developing surgical scaffold device for prostate cancer patients
Medical device, prostate cancer - Read more

THE GOOD
Investments

Bio X Cell expands globally, opens Beijing distribution center to complement existing facilities in Germany and New Hampshire
Antibody, facility build, biomanufacturing - Read more

THE GOOD
IPOs

Sionna Therapeutics raised $219.2M in upsized IPO, selling 12.2M shares at $18 each to advance cystic fibrosis treatments
Small molecule, cystic fibrosis - Read more

THE GOOD
Marketing

Invizyne Technologies announces corporate rebranding to eXoZymes, Inc., with new NASDAQ ticker "EXOZ" starting February 2025
Biomanufacturing, name change, instrumentation - Read more

Cannabinoid biotech Oxford Cannabinoid Technologies rebrands as Octavian Therapeutics after delisting, aims to develop treatments as private company
Small molecule, diabetic peripheral neuropathy, chemotherapy-induced peripheral neuropathy, irritable bowel syndrome (IBS), name change - Read more

THE GOOD
Mergers & Acquisition

Novartis buys back blood thinner abelacimab (targeting Factor XI, Factor XIa) by acquiring Anthos Therapeutics for up to $3.1B
Monoclonal antibody, anticoagulation, stroke, atrial fibrillation, cancer-associated thrombosis - Read more

THE GOOD
Patient Access

Vertex aims to secure broad insurance coverage and minimal prescription barriers for its new non-opioid pain medication Journavx
Small molecule, pain, non-opioid, drug access - Read more

THE GOOD
Politics & Policy

New bill proposes allowing FDA-approved AI systems to prescribe medications if authorized by individual states
Drug prescription, AI - Read more

THE GOOD
Product Launches

Tasso launches new at-home blood collection technology combining Tile-T20 cartridge with Tasso Mini for clinical trials and anti-doping testing
Blood collection tech - Read more

THE GOOD
Research

Researchers successfully remove liver tumor using immunotherapy and targeted radiation in high-risk patient (liver cirrhosis)
Immunotherapy, radiation, solid tumor, cirrhosis - Read more

THE GOOD
Strategic Plans

Insilico Medicine reveals performance data from 22 AI-designed drug candidates and expands into obesity, muscle-wasting, and pain treatments
Drug design, lung fibrosis, obesity, muscle-wasting disease, non-opioid pain, drug development, AI - Read more

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THE BAD
Clinical Trials

Voyager Therapeutics halts development of VY9323 (targeting SOD1) amyotrophic lateral sclerosis due to off-target effects in primates
Gene therapy, amyotrophic lateral sclerosis (ALS), siRNA, AAV - Read more

THE BAD
Layoffs

Inventiva cuts workforce by 50% and halts research programs to focus solely on lanifibranor (PPAR agonist) development for MASH treatment
Small molecule, metabolic dysfunction-associated steatohepatitis (MASH) - Read more

Third Harmonic Bio cuts workforce by 50% to push urticaria hopeful THB335 (KIT inhibitor) into Ph2, whilst halting all R&D and “[evaluating] a full range of strategic transactions and/or business combinations
Small molecule, chronic spontaneous uriticaria - Read more

THE BAD
Partnerships

Incyte terminates immuno-oncology partnership with Agenus after ending LAG-3 and TIM-3 antibody programs
Antibody, cancer, drug development - Read more

THE UGLY
Public Health

Uganda reports nine Ebola cases with one death; 265 people under quarantine as outbreak monitoring continues
Infectious disease, Ebola, low- and middle-income countries - Read more [Paywall]

THE UGLY
Warning Letters, Form 483

FDA issues warning letters to Chinese companies Nuowei Chemistry and Innovation Pharmaceutical over API quality control issues
Active Pharmaceutical ingredient (API), quality concerns - Read more

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

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