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  • Biotech & Pharma Updates | February 4 - 5, 2025

Biotech & Pharma Updates | February 4 - 5, 2025

GSK raises 2031 revenue forecast by £2B (from £38B to £40B), Valneva's chikungunya virus vaccine lands MHRA (UK) approval, Harvard Medical School's personalized cancer vaccine delivers promising Ph1 data in renal cell carcinoma, Novo Nordisk's monlunabant falls flat in diabetic kidney disease Ph2, USDA discovers a new circulating H5N1 bird flu strain in Nevada dairy herds + 30 more stories

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⬇️ The Good News ⬇️

THE GOOD
Approvals & Labels

Valneva's Ixchiq, a live-attenuated vaccine targeting chikungunya virus, receives MHRA approval for disease prevention in adults
Vaccine, chikungunya virus infection - Read more

THE GOOD
Business Development

Basilea Pharmaceutica receives a CHF 1.2M ($1.3M) milestone payment from Asahi Kasei Pharma following strong Cresemba antifungal sales in Japan
Small molecule, antifungal, milestone payment - Read more

Klinge Biopharma and Lotus Pharmaceutical to commercialize aflibercept (Eylea biosimilar, Regeneron, Bayer) in select APAC countries, with Formycon supplying the finished product
Fusion protein, neovascular age-related macular degeneration (wet AMD), diabetic macular edema, myopic choroidal neovascularization, biosimilar - Read more

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⬇️ More Good News ⬇️

THE GOOD
Clinical Trials

EyePoint Pharmaceuticals touts positive Ph2 results for Duravyu (tyrosine kinase inhibitor) in diabetic macular edema
Small molecule, diabetic macular edema - Read more

Qlaris Bio showcases positive Ph2 data for QLS-111 (ATP-sensitive potassium channel modulator) in glaucoma and ocular hypertension
Small molecule, glaucoma, ocular hypertension - Read more

Spur Therapeutics' FLT201 (targeting lyso-Gb1) delivers positive Ph1/2 results in Gaucher disease type 1
Gene therapy, Gaucher disease type 1, AAV - Read more

SiteOne Therapeutics' touts positive Ph1 results for STC-004 (NaV1.8 inhibitor) as a non-opioid pain treatment
Small molecule, pain, cough, non-opioid - Read more

Kura Oncology, Kyowa Kirin's ziftomenib (menin inhibitor) delivers positive Ph2 data in NPM1-mutant acute myeloid leukemia
Small molecule, leukemia, cancer - Read more

Harvard Medical School touts promising Ph1 data for personalized vaccine targeting clear cell renal cell carcinoma; all 9 patients, following surgery and vaccine administration, remained cancer free for media of 40 months (data collection paused then)
Cancer vaccine, renal cell carcinoma, cancer - Read more

Ultragenyx's pulls back curtain on key data used in last December’s BLA application of their UX111 gene therapy in Sanfilippo syndrome type A
Gene therapy, Sanfilippo syndrome type A, AAV - Read more

Novo Nordisk plans Ph3 trial of obesity drug CagriSema (cagrilintide, dual amylin and calcitonin receptor agonist + semaglutide, GLP-1 agonist) testing higher doses for longer duration after mixed results in previous study
GLP-1, obesity, small molecule - Read more

Quantum Biopharma's unbuzzd supplement delivers statistically significant accelerated Blood Alcohol Concentration (“BAC”) reduction and intoxication, hangover symptoms reduction in clinical study
Supplement, alcohol intoxication, hangover - Read more

THE GOOD
Earnings & Finances

GSK raises 2031 revenue forecast to £40B ($50B), citing strong pipeline progress in respiratory, immunology, oncology and HIV treatments
Big pharma earnings, respiratory disease, immunology, cancer, HIV (human immunodeficiency virus) - Read more

Novo Nordisk reports strong 2024 growth led by Wegovy, but forecasts slower expansion in 2025 with 16-24% sales growth expected
Big parma earnings, GLP-1, obesity - Read more

Amgen exceeds Q4 expectations with $5.31 EPS and $9.1B revenue, showing strong growth above analyst forecasts
Big pharma earnings - Read more

Boston Scientific's Farapulse ablation system exceeds $1B in first-year sales following FDA approval, driving significant revenue growth
Medical device, pulsed-field ablation - Read more

Amgen's biosimilar business grows significantly, reaching $2.2B in 2024 sales, up 16% from previous year
Big pharma earnings, biosimilar - Read more

THE GOOD
Fundraises

Zafrens $31M Series A, biotech platform enabling mass testing of potential medicines
Drug discovery, mass testing, multi-omics - Read more

iVeena $3M Series B-2, developing pediatric myopia treatment drug IVMED-85
Small molecule, pediatric myopia - Read more

Glucotrack $3M public offering, developing long-term implantable continuous blood glucose monitoring systems for diabetes patients
Medical device, diabetes, continuous glucose monitoring - Read more

THE GOOD
Mergers & Acquisition

Crown Laboratories completes tender offer for Revance Therapeutics, acquiring 82% of shares at $3.65 per share
Aesthetics, skin care - Read more

Teladoc Health acquires Catapult Health for $65M to expand chronic disease care services and increase member engagement
Virtual care, telehealth, chronic disease, at-home testing - Read more

THE GOOD
Partnerships

Eva Pharma, DNA Script, Quantoom Biosciences partner to develop digital mRNA vaccine platform in Egypt targeting 100M doses annually
mRNA, saRNA, vaccine, platform technology, vaccine access - Read more

Algernon NeuroScience, Validcare sign CRO partnership for upcoming Phase 2a DMT trial in stroke patients in Europe
Small molecule, stroke, psychedelic - Read more

THE GOOD
Politics & Policy

NIH resumes grant review meetings after Trump administration's two-week pause, allowing experts to evaluate research funding proposals
National Institute of Health, research & develop, public funding - Read more

THE GOOD
Product Launches

Solstice Health launches AI platform to streamline biopharma marketing content review and regulatory compliance processes
Life science marketing, drug marketing, AI - Read more

THE GOOD
Research

Experimental drug GL-II-73 (positive allosteric α5GABAA receptors modulator) shows promise in restoring memory and reversing brain damage in Alzheimer's disease mouse studies
Small molecule, Alzheimer’s disease - Read more

THE GOOD
Strategic Plans

GSK goes all in on hep B hopeful bepirovirsen (targeting hepatitis B virus mRNA), aiming for “functional cure”
Small molecule, hepatitis B infection - Read more

GSK CEO confirms focus on acquisitions in cancer, respiratory, and inflammation indications
M&A strategic, cancer, respiratory disease, inflammatory - Read more

⬇️ The Bad News ⬇️

THE BAD
Clinical Trials

FDA places clinical hold on Amgen's AMG 513 obesity drug in Ph1 trial, though CEO confident it “[isn’t] related to the drug“
Small molecule, obesity, clinical hold- Read more

Novo Nordisk's monlunabant (CB1 receptor blocker) fails Ph2 trial in diabetic kidney disease patients
Small molecule, diabetic kidney disease - Read more

THE BAD
Layoffs

Frontier Medicines conducts undiclosed number of layoffs to “streamline operations”
Small molecule, solid tumor, cancer - Read more

⬇️ The Ugly News ⬇️

THE UGLY
Lawsuits

Doctors sue federal agencies for removing vital health data and information from government websites used by medical professionals
Medical information - Read more

Families and LGBTQ+ organizations sue Trump administration over executive order blocking federal funding for youth gender-affirming healthcare
Executive order, LGBTQ+, gender-affirming care - Read more

THE UGLY
Public Health

USDA discovers new H5N1 bird flu strain in Nevada dairy herds, complicating efforts to control virus spread among cows
Bird flu (H5N1) - Read more [Paywall]

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

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