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- Biotech & Pharma Updates | January 14 - 15, 2025
Biotech & Pharma Updates | January 14 - 15, 2025
Colossal Biosciences' $200M Series C furthers de-extinction ambitions, Eli Lilly's Omvoh lands FDA approval for Crohn's disease, Samsung Biologics considers building sixth plant to meet growing biologics demand, Pharma CEOs downplay IRA impacts on revenues as next round of CMS negotiations loom, FDA provides receipts on why they rejected Vanda Pharmaceuticals’ gastroparesis treatment hopeful tradipitant + 30 more stories

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⬇️ The Good News ⬇️
THE GOOD
Approvals & Labels
Eli Lilly's Omvoh (IL-23p19 inhibitor) lands FDA approval for Crohn's disease
Monoclonal antibody, inflammatory bowel disease, Crohn’s disease - Read more
Medtronic's adaptive deep-brain stimulation therapy with Percept neurostimulator receives EU approval for treating motor symptoms in Parkinson's disease
Medical device, deep-brain stimulation, Parkinson’s disease - Read more
Johnson & Johnson submits TAR-200, first intravesical drug release system, application to FDA for bladder cancer treatment
Small molecule, bladder cancer, drug delivery, extended release - Read more
THE GOOD
Business Development
Keylicon Biosciences acquires exclusive rights to Boston University's modified RNA technology, enabling longer protein expression and reduced immune response
RNA, drug development, platform technology - Read more
THE GOOD
Clinical Trials
OS Therapies' OST-HER2 (targeting HER2) delivers Ph2 win in osteosarcoma
Bioengineered bacteria, osteosarcoma, bone cancer - Read more
Inflammasome Therapeutics' K8 implant (targeting inflammasomes) shows 66% reduction in geographic atrophy lesion growth in Ph1 macular degeneration trial
Small molecule, geographic atrophy, dry age-related macular degeneration - Read more
Zai Lab's Tivdak (targeting TF receptors) delivered positive topline Ph3 data versus chemotherapy for recurrent/metastatic cervical cancer in China subpopulation
Antibody-drug conjugate, cervical cancer - Read more
Vistagen's PH284 nasal spray shows promising Ph2A results for treating appetite loss in cancer cachexia patients
Small molecule, appetite loss, cancer cachexia - Read more
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⬇️ More Good News ⬇️
THE GOOD
Earnings & Finances
Pfizer sells 700 million Haleon shares for £2.5B, reducing its stake in the consumer healthcare company
Consumer health - Read more
THE GOOD
Fundraises
Cephagenix €9M ($9.3M) Seed raise, developing KATP channel inhibitors as novel migraine therapies
Small molecule, migraine - Read more
Hinge Bio $30M Series A, developing trispecific antibodies targeting lupus and other diseases with high unmet need
Trispecific antibody, systemic lupus erythematosus - Read more
Conceivable Life Sciences $18M Series A, fertility biotech expanding Mexico pilot and planning 2026 US launch
Fertility, robotic surgery, AI, automation - Read more
Colossal Biosciences $200M Series C, fuelling genetic engineering tech for de-extinction but also “species preservation and human healthcare”
Genetic engineering, de-extinction, species preservation - Read more
Be Bio $92M Series C, develops engineered B Cell Medicines for hemophilia and genetic diseases
Cell therapy, hemophilia, hypophosphatasia, B cell medicine - Read more
Lophora $3M investment round, developing CNS drug LPH-5 for Phase I clinical trials and patents
Small molecule, psychedelic, central nervous system disorders - Read more
THE GOOD
Investments
Samsung Biologics considers building sixth plant to meet biologics demand, potentially increasing capacity to 964,000 liters following record contract signing
CDMO, manufacturing, facility expansion - Read more
THE GOOD
Lawsuits
Gilead Sciences and US government resolve patent dispute over HIV drugs Truvada and Descovy following Gilead's 2023 trial victory
Small molecule, drug patent, human immunodeficiency virus - Read more
THE GOOD
Mergers & Acquisitions
N-Power acquires Syapse Holdings, expanding clinical trial network and access to community-based trials,
Clinical trial recruitment, clinical research network, cancer - Read more
THE GOOD
Partnerships
Immuron, Monash University collaborate to develop new drugs targeting antimicrobial resistant pathogens
Research, drug development, antimicrobial resistance - Read more
Orna Therapeutics, Simnova Biotech expand partnership to develop BCMA-targeted RNA therapies using circular RNA technology
Cell therapy, RNA, cancer, drug development, in vivo cell therapy - Read more
Therazyne, Biorevert partner to discovery and develop novel protein-based anti-cancer therapies
Antibody, cancer, drug discovery, drug development - Read more
Daiichi Sankyo, BioMed X partner to develop multi-targeting antibody therapies for solid tumors
Antibody, solid tumor, cancer, research - Read more
GE Healthcare, University of California San Francisco partner to develop automated imaging solutions for cancer and neurological diseases
Imaging, cancer, neurological disease, automation - Read more
THE GOOD
Politics & Policy
Pharmaceutical CEOs downplay IRA impacts on revenues as CMS prepares to announce next round of drugs price negotiations
Inflation reduction act, drug pricing - Read more [Paywall]
THE GOOD
Product Launches
Perthera touts AI-powered chemotherapy effectiveness predictor for pancreatic cancer patients
Therapeutic predictions, pancreatic cancer, AI - Read more
THE GOOD
Public Health
GSK and Sanofi CEOs embrace transparency in vaccine discussions amid growing US anti-vaccine sentiment
Vaccine, public trust, anti-vaccine - Read more
THE GOOD
Research
Study finds inhaled xenon gas may help treat Alzheimer's by activating brain immune cells to reduce plaques and inflammation in mice
Element, Alzheimer’s - Read more [Paywall]
Researchers find cholesterol-blocking drug combination, including statins, could treat bladder cancer by targeting PIN1 protein in mice
Small molecule, bladder cancer - Read more
Gene-editing treatment reduces brain prion protein levels by 60%, extending lifespan in mice with prion disease by 50%
Gene-editing, prion disease - Read more
THE GOOD
Strategic Plans
Biogen CEO suggests more convenient dosing and blood-based diagnostics as potential remedies to Leqembi's sluggish uptake
Monoclonal antibody, Alzheimer’s disease, diagnostics, blood test - Read more
GSK's CSO outlines strategy focused on genetic disease partnerships and GI cancer development, following $1B IDRx acquisition earlier this week
Gastrointestinal cancer, rectal cancer, genetic disease - Read more
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⬇️ The Bad News ⬇️
THE BAD
Clinical Trials
Keros Therapeutics discontinues Ph2 trial of cibotercept (anti-MSTN, INHBA, GDF11) for pulmonary arterial hypertension due to safety concerns
Monoclonal antibody, pulmonary arterial hypertension - Read more
Neumora Therapeutics’ deeper data release on flopped navacaprant (kappa opioid receptors antagonist) Ph3 trial further depresses investors
Small molecule, depression - Read more
THE BAD
Regulatory
FDA spills the tea on why they rejected Vanda Pharmaceuticals’ gastroparesis treatment hopeful tradipitant (neurokinin 1 antagonist)
Small molecule, gastroparesis - Read more
⬇️ The Ugly News ⬇️
THE UGLY
Lawsuits
HHS rejects Vertex's fertility support program for Casgevy gene therapy patients, calling lawsuit challenge self-serving and potentially violating anti-kickback laws
Gene therapy, fertility, conditioning regimen - Read more
You’re all caught up on the latest Pharma & Biotech News!

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