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  • Biotech & Pharma Updates | February 11 - 12, 2023

Biotech & Pharma Updates | February 11 - 12, 2023

🧬 Novo Nordisk plans Ireland facility expansion to produce Wegovy pill for overseas markets beyond US, CARsgen Therapeutics signs agreements for RMB370M CAR-T manufacturing base expansion in Shanghai's Jinshan District, Evommune announces $125M private placement - advancing clinical programs for inflammatory diseases, Astellas settles Myrbetriq patent litigation with Lupin and Zydus for $210 million combined upfront payments, Nxera Pharma + Centessa Pharmaceuticals milestone triggers $1.8M payment for orexin receptor agonist ORX489

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✅ The Good News ✅ 

THE GOOD
Approvals & Labels

Agilent's PD-L1 diagnostic wins FDA approval alongside Merck & Co.'s Keytruda for ovarian cancer patient identification
Antibody, cancer, monoclonal antibody, ovarian cancer, PD-L1 target, companion diagnostic - Read more

FDA approves Novocure's Optune Pax wearable device for locally advanced pancreatic cancer treatment
Device therapy, cancer, tumor treating fields, pancreatic cancer, combination therapy - Read more

THE GOOD
Business Development & Partnerships

Nxera Pharma, Centessa Pharmaceuticals milestone triggers $1.8M payment for orexin receptor agonist ORX489
Research collaboration, neurological, small molecule, milestone payments - Read more

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 More Good News 

THE GOOD
Clinical Trials

Lundbeck's bocunebart (PACAP-targeting antibody) meets Ph2 primary endpoint for migraine prevention in treatment-resistant patients
Monoclonal antibody, neurological, migraine prevention, PACAP target, treatment-resistant patients - Read more

BridgeBio Pharma's infigratinib FGFR3 inhibitor shows impressive Ph3 results in achondroplasia, enabling regulatory filing
Small molecule, rare disease, FGFR3 inhibitor, achondroplasia, pediatric population - Read more

THE GOOD
Company Incubation

European Life Sciences Coalition launches in Brussels to strengthen Europe's biotechnology venture capital investment ecosystem
Investment ecosystem, strategic, financial, venture capital - Read more

THE GOOD
Earnings & Finances

Alnylam Pharmaceuticals achieves first-ever profitability with $314M net income despite disappointing Amvuttra Q4 revenue
RNAi therapeutics, cardiovascular, financial, profitability milestone - Read more

THE GOOD
Fundraises

LEON raises undisclosed financing for global LNP manufacturing scale-up systems
Platform technology, CDMO, manufacturing, RNA therapeutics - Read more

OKYO Pharma raises $20M public offering, developing therapies for neuropathic corneal pain
Ophthalmology, clinical-stage, neuropathic pain, inflammatory diseases - Read more

Evommune announces $125M private placement, advancing clinical programs for inflammatory diseases
Clinical-stage, autoimmune, chronic inflammatory diseases - Read more

Coherus Oncology raises $50.1M public offering, commercializing LOQTORZI and clinical development
Oncology, antibody, clinical-stage, commercialization - Read more

THE GOOD
Investments

Novo Nordisk plans Ireland facility expansion to produce Wegovy pill for overseas markets beyond US
Small molecule, obesity, strategic, investment - Read more

CARsgen Therapeutics signs agreements for RMB370M CAR-T manufacturing base expansion in Shanghai's Jinshan District
CAR-T, oncology, strategic, major transaction, operational - Read more

THE GOOD
Lawsuits

Astellas settles Myrbetriq patent litigation with Lupin and Zydus for $210 million combined upfront payments
Small molecule, urological, strategic, major transaction, patent settlement - Read more

Samsung Bioepis, Regeneron settle Eylea biosimilar patent dispute, enabling US launch January 2027
Licensing deal, ophthalmology, biosimilar, antibody - Read more

THE GOOD
Market Reports

Novo Nordisk's oral Wegovy attracts 36% new GLP-1 patients since December approval, expanding market access
GLP-1 agonist, obesity, strategic, market expansion - Read more

THE GOOD
Product Launches

Terray Therapeutics debuts EMMI Predict:TerraBind AI model with 20% better accuracy than leading competitors
Small molecule, AI drug discovery, operational, competitive - Read more

THE GOOD
Regulatory

FDA removes boxed warnings from six menopausal hormone therapy products after comprehensive scientific review
Hormone therapy, women's health, regulatory, operational - Read more

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❌ The Bad News

THE BAD
Earnings & Finances

CSL replaces CEO after net profit plummets from $2B to $384M amid restructuring costs
Iron replacement therapy, kidney disease, financial, operational, strategic - Read more

THE BAD
Lawsuits

AbbVie sues HHS and CMS alleging Botox wrongly included in drug price negotiation program as plasma-derived product
Botulinum toxin, neurological, regulatory, pricing pressure - Read more

THE BAD
Layoffs

Seres Therapeutics lays off 30% workforce, pauses SER-155 phase 2 trial amid funding constraints
Microbiome therapy, infectious disease, operational, cost reduction - Read more

THE BAD
Regulatory

PTC Therapeutics withdraws FDA application for Translarna (ataluren) in nonsense mutation Duchenne muscular dystrophy
Protein therapy, neurological, nonsense mutation Duchenne muscular dystrophy, protein restoration therapy, ataluren - Read mode

👹 The Ugly News 👹

THE UGLY
Earnings & Finances

Icon shares plummet 37% after CRO launches accounting investigation, withdraws 2025 guidance over revenue overestimates
CRO services, financial, operational, major transaction - Read more

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

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