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  • Biotech & Pharma Updates | December 16 - 17, 2024

Biotech & Pharma Updates | December 16 - 17, 2024

Sandoz pays $275M to settle generic price-fixing litigation, Pfizer forecasts a more stable & upbeat 2025, Akamis Bio's $60M raise fuels oncolytic gene therapy ambitions, The Big Apple gets a CGT manufacturing hub, PBMs (unsurprisingly) fight back against PBM reform + 26 more stories

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⬇️ The Good News ⬇️

THE GOOD
Approvals & Labels

Merck & Co.'s clesrovimab (anti-RSV F), targeting RSV infections in newbornws, expects FDA approval decision by June 2025
Monoclonal antibody, respiratory syncytial virus - Read more

THE GOOD
Business Development

Portage Biotech to sell subsidiary iOx Therapeutics, including lead clinical asset PORT-2 (iNKT engager), to Immunova
Small molecule, melanoma, lung cancer - Read more

THE GOOD
Clinical Trials

Actuate Therapeutics' elraglusib (GSK-3 beta inhibitor), improves survival in metastatic pancreatic ductal adenocarcinoma Ph1/2 trial in combo with gemcitabine/nab-paclitaxel
Small molecule, pancreatic cancer - Read more

Regeneron and Bayer's high-dose Eylea (vascular endothelial growth factor inhibitor) met Ph3 endpoint in macular edema following retinal vein occlusion, planning global filings
Fusion protein, macular edema following retinal vein occlusion - Read more

Teva Pharmaceuticals and Sanofi's duvakitug (targeting tumor necrosis factor-like ligand 1A) shows positive Ph2b results in ulcerative colitis and Crohn’s disease
Monoclonal antibody, ulcerative colitis, Crohn’s disease - Read more

Biomea Fusion's icovamenib (menin inhibitor) shows positive Ph2 results in Type 2 diabetes, improving HbA1c levels across multiple dosing regimens
Small molecule, type 2 diabetes - Read more

Affimed's AFM24 (targeting EGFR) combined with atezolizumab, shows positive Ph1/2a results in advanced non-small cell lung cancer
Bispecific antibody, lung cancer - Read more

Tenaya Therapeutics's TN-201 gene therapy in MYBPC3-associated hypertrophic cardiomyopathy delivers promising early Ph1 data
Gene therapy, hypertrophic cardiomyopathy - Read more

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⬇️ More Good News ⬇️

THE GOOD
Earnings & Finances

Pfizer’s aiming for a more upbeat 2025 - forecasts 2025 of $61B-$64B, matching 2024 expectations, with a potential 5% increase in 2025
Big pharma, earnings guidance - Read more

THE GOOD
Fundraises

Precision Neuroscience $102M Series C, advancing AI-powered brain implants and clinical research for brain-computer interface development.
Medical device, brain-computer interface - Read more

Akamis Bio $60M Series A, advancing NG-350A in Phase 1b trial for locally advanced rectal cancer using its T-SIGn platform.
Oncolytic gene therapy, rectal cancer - Read more

Indapta Therapeutics $22.5M funding, accelerating clinical development of allogeneic NK cell therapy for blood cancers and autoimmune diseases.
Cell therapy, liquid cancer, autoimmune, allogeneic NK cell - Read more

NeuroKaire $10M funding, treatment-optimizing personalized medicine solutions in psychiatric and neurological diseases
Personalized medicine, treatment selection - Read more

Reviva Pharmaceuticals $18M public offering, advancing R&D and corporate initiatives for CNS, inflammatory, and cardiometabolic disease therapies.
Small molecule, central nervous system, inflammation, cardiometabolic - Read more

CG Oncology closes $238M public offering, developing bladder cancer therapies
Oncolytic immunotherapy, bladder cancer - Read more

Candel Therapeutics closes $92M public offering, advancing cancer therapies, including pre-funded warrants for additional shares.
Viral immunotherapy, prostate cancer - Read more

THE GOOD
Investments

Roswell Park GMP Engineering and Cell Manufacturing Facility opens as New York's first cell and gene therapy hub, a $98M GMP facility to boost R&D and create new jobs
Cell therapy, gene therapy, manufacturing, research & development - Read more

THE GOOD
Lawsuits

Sandoz settles price-fixing litigation for $275M, resolving claims from 2009-2019 without admitting wrongdoing
Generic, drug pricing, price-fixing - Read more

THE GOOD
Mergers & Acquisitions

Merck KGaA's Life Science business to acquire HUB Organoids
Organoids, drug development, non-animal testing - Read more

Ultimovacs and Zelluna Immunotherapy announced merger, combining expertise in cancer immunotherapy
Cell therapy, solid tumor, cancer vaccine, allogeneic TCR-NK cell therapy - Read more

THE GOOD
Partnerships

Terray Therapeutics, Gilead Sciences AI-powered drug discovery partnership
Small molecule, drug discovery, AI - Read more

Scailyte, Visterra research collaboration to develop treatments for autoimmune diseases using AI-powered biomarker discovery and biologics expertise.
Antibody, autoimmune, AI, biomarkers - Read more

Silexion Therapeutics, Evonik ongoing collaboration to develop advanced siRNA formulation for KRAS-driven cancers using Evonik’s PLGA microparticles
siRNA, cancer, microparticles, drug delivery - Read more

Orexo, Abera Bioscience collaboration to develop mucosal vaccines using Orexo’s AmorphOX drug delivery technology and Abera's vaccine platform
Vaccine, mucosal vaccine, nasal vaccine, drug delivery - Read more

SK Biopharmaceuticals, ProEn Therapeutics research collab to advance preclinical radiopharmaceutical candidates and expand oncology pipeline by 2027
Radiopharm, cancer, drug development - Read more

THE GOOD
Politics & Policy

Pfizer CEO Albert Bourla has developed a “good relation” with incoming HHS head RFK Jr., as potential immunization policy changes loom with incoming Trump administration
Big pharma, vaccine, immunization policy - Read more

THE GOOD
Research

Researchers at Université de Montréal show that endocannabinoids in the brain, particularly in the nucleus accumbens, regulate body weight; mice studies
Small molecule, obesity, brain - Read more

A gene-edited pig kidney was transplanted into a third patient, marking xenotransplantation’s progress towards clinical trials
Gene-edited organs, xenotransplantation - Read more [Paywall]

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⬇️ The Bad News ⬇️

THE BAD
Clinical Trials

Merck & Co. discontinues vibostolimab (targeting TIGIT) and favezelimab (targeting LAG3) development after Ph3 failure in combination with Keytruda for non-small cell lung cancer
Monoclonal antibody, lung cancer - Read more

UCB's Novartis-partnered minzasolmin (targeting alpha-synuclein) flops in Parkinson's disease Ph2a trial
Small molecule, Parkinson’s disease - Read more

THE BAD
Politics & Policy

Pharmacy benefit managers fight back against PBM reform (and new transparency rules) included in US government’s “larger-than-anticipated“ end-of-year healthcare package
Pharmacy benefit manager, drug pricing - Read more

⬇️ The Ugly News ⬇️

THE UGLY
No Ugly News Today!

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

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