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  • Biotech & Pharma Updates | September 17 - 18, 2024

Biotech & Pharma Updates | September 17 - 18, 2024

Novo Nordisk’s $600M biobucks deal with NanoVation Therapeutics, Roivant sells derm division to Organon, Merck’s Keytruda nabs another indication, BMS and Novartis both boast long term MS data, Brenus Pharma $25M Series A for cancer vaccines, Insilico Medicines' dubious clinical efficacy data, Guardant Health CEO calls cap on Exact Science’s blood-based colon cancer test, Novo Nordisk accused of excessive Ozempic price gouging

All the top Biotech & Pharma news in one daily newsletter.

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⬇️ The Good News ⬇️

THE GOOD
Approvals & Labels

Merck & Co.’s Keytruda adds another indication, FDA accelerated approval for front-line mesothelioma
Monoclonal antibody, mesothelioma, cancer - Read more

AstraZeneca’s Fasenra lands FDA approval for rare, immune-mediated vasculuar disorder
Monoclonal antibody, eosinophilic granulomatosis with polyangiitis - Read more

Applied Therapeutics’ stock jumps as FDA cancels planned govorestat adcomm
Small molecule, cassic galactosemia - Read more

GE Healthcare’s amyloid imaging software lands FDA clearance
Medical image analysis, PET scan, Alzheimer’s disease - Read more

THE GOOD
Clinical Trials

Bristol Myers Squibb touts positive long-term Zeposia data for MS
Small molecule, multiple sclerosis - Read more

Novartis also showcases long-term Kesimpta data for MS
Monoclonal antibody, multiple sclerosis - Read more

GSK posts positive Ph3 data in Arexvy, Shingrix vaccine co-administration
Vaccine, respiratory syncytial virus, shingles - Read more

Purple Biotech’s positive Ph2 interim data for CM24 in pancreatic cancer
Monoclonal antibody, pancreatic cancer - Read more

Innovent Biologics touts positive IBI363 Ph1 response in colorectal cancer
Fusion protein, colorectal cancer - Read more

THE GOOD
Fundraises

EpicentRx receives US DoD translational reward for RRx-001
Small molecule, radioprotector, chemoprotector, neurodegeneration - Read more

Brenus Pharma $25M Series A
Cancer vaccines, colorectal cancer - Read more

Syntax Bio funding (undisclosed amount)
Stem cell differentiation, CRISPR, platform technology - Read more

PRESENTED BY ENMORE BIO
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Key topics will include cell and gene therapy, antibody drugs, and vaccines, with exhibits featuring pharmaceutical and biotech upstream suppliers, including CROs and CDMOs.

⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Mergers & Acquisitions

Roivant’s dermatology subsidiary Dermavant sold to Organon for $175M upfront + $1B in potential milestones
Dermatology, plaque psoriasis, atopic dermatitis, eczema - Read more

THE GOOD
Partnerships

Novo Nordisk’s $600M biobucks deal with NanoVation Therapeutics, partnering on genetic medicine delivery beyond the liver
Drug delivery, lipid nanoparticle, base-editing therapy - Read more

Ori Biotech deepens partnership with Charles River Laboratories after formers’ recent automated CGT manufacturing platform announcement
Cell & gene therapy manufacturing, automated manufacturing, CDMO - Read more

Axcelead Drug Discovery Partners, Eli Lilly partner on (you guessed it) drug discovery
Small molecule, drug discovery, AI - Read more

THE GOOD
Politics & Policy

US Fed cuts rates; what it means for biotech and VC
Interest rate, biotech funding, venture capital - Read more [Paywall]

Oregon lawmakers mull PBM regulations to support dwindling number of independent pharmacies
Pharmacy benefit managers - Read more

“Greater action is needed” in bolstering US biopharma supply chains with manufacturing tech; US Senators comment
Supply chain, manufacturing tech - Read more [Paywall]

THE GOOD
Research

Ichnos Sciences, Glenmark Innovations trispecific antibody bests Johnson & Johnson’s Tecvayli in shrinking multiple myeloma tumors in mice
Trispecific antibody, multiple myeloma, cancer - Read more

Hoth Therapeutics’ take on anti-nausea agent aprepitant reduced astrocytes, improved cognitive function in Alzheimer’s mouse models
Small molecule, Alzheimer’s disease - Read more

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⬇️ The Bad News ⬇️

THE BAD
Clinical Trials

Insilico Medicine posts promising ISM001-055 Ph2a safety data, though doubts swirl regarding efficacy data
Small molecule, idiopathic pulmonary fibrosis - Read more

THE BAD
Patient Access

Theratechnologies’ telegraph early 2025 Engrifta SV supply shortage due to third-party CMO facility shutdown
Peptide, HIV-associated lipodystrophy, contract manufacturing, CMO - Read more

THE BAD
Politics & Policy

Sparks fly between policy experts & lawmakers at Inflation Reduction Act hearing
Inflation reduction act (IRA), drug pricing - Read more

⬇️ The Ugly News ⬇️

THE UGLY
Opinions

Guardant Health CEO calls cap on Exact Science’s blood-based colon cancer test, makes public wager
Blood test, diagnostics, colon cancer screening - Read more [Paywall]

THE UGLY
Politics & Policy

HRSA threatens Johnson & Johnson with fines, termination from 340B program over “unapproved [340B] rebate proposal“
340 discount pharmacy program, drug rebates - Read more

Novo Nordisk again draws Senator Bernie Sanders’ ire, latter claims former can manufacture Ozempic for <$100/month
GLP-1, obesity, drug pricing - Read more

THE UGLY
Strategic Plans

Everyone decides to jump off the bridge at 23andme, as entire independent board of directors resigns
Genetic testing - Read more

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

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