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THE GOOD
Approvals & Labels

FDA accepts narrowed Nucala (IL-5 antagonist) application from GSK, sets target review date of May 7, 2025
Monoclonal antibody, chronic obstructive pulmonary disease - Read more

Innovent Biologics fruquintinib (VEGFR inhibitor) lands China NMPA approval in endometrial cancer
Small molecule, endometrial cancer - Read more

THE GOOD
Business Development

FivepHusion buys rights to solid tumor drug delivery tech ResectAssist from the University of Wollongong
Drug delivery, solid tumor, pancreatic cancer - Read more

MS Pharma lands licensing and supply deal to commercialize Formycon’s FYB202 (targeting IL-12, IL-23; Stelara biosimilar, Janssen Biotech) in the Middle East and North Africa
Monoclonal antibody, Crohn's disease, ulcerative colitis, psoriasis, autoimmune - Read more

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⬇️ More Good News ⬇️

THE GOOD
Clinical Trials

GSK showcases positive Blenrep (targeting BCMA) Ph3 interim data in multiple myeloma, head-to-head study against Darzalex (targeting CD38; Johnson & Johnson)
Antibody-drug conjugate, multiple myeloma, cancer - Read more

Innovent Biologics touts updated Ph1 data for IBI343 (anti-CLDN18.2) in
Antibody-drug conjugate, pancreatic cancer - Read more

Merck & Co. showcases 100% complete response rate from zilovertamab vedotin (anti-ROR1) Ph2 in lymphoma
Antibody-drug conjugate, lymphoma, cancer - Read more

AstraZeneca touts first set of Ph1 data from ADZ0486 (CD3, CD19 targeting) bispecific T cell engager in two kinds of lymphoma
Bispecific antibody, lymphoma, cancer - Read more [Paywall]

Amgen touts “practice-changing” 3-year data from Blincyto (CD3, CD19 targeting) Ph3 in lymphoblastic leukemia
Bispecific antibody, leukemia, cancer - Read more

Roche showcases positive Ph3 comparability data for intravenous and subcutaneous formulations of Lunsumio (CD3, CD20 targeting) in follicular lymphoma
Bispecific antibody, lymphoma, cancer - Read more

Genmab, Abbvie touts new data analyses for epcoritamab (CD3, CD20 targeting) in lyphoma; Ph2 monotherapy and Ph1b/2 with R-CHOP drug combo
Bispecific antibody, lymphoma, cancer - Read more

Incyte touts detailed Ph3 data for Zynyz (PD-1 inhibitor) in lung cancer
Monoclonal antibody, lung cancer - Read more

Merck & Co.’s Keytruda (PD-1 inhibitor) combo with Lynparza (PARP inhibitor) meets primary Ph3 endpoint, though misses secondary overall survival endpoint
Monoclonal antibody, ovarian cancer, small molecule - Read more

Enanta Pharmaceuticals’ topline Ph2 data from zelicapavir (N-protein inhibitor) in treating RSV infection
Small molecule, respiratory syncytial virus, antiviral - Read more

Kura Oncology, Kyowa Kirin tout positive Ph1a interim data for ziftomenib (menin inhibitor) in myeloid leukemia
Small molecule, leukemia, cancer - Read more

AbbVie showcases positive topline Ph3 data for tavapadon (partial D1/D5 receptor agonist) in Parkinson’s disease
Small molecule, Parkinson’s disease - Read more

Secura Bio touts new Ph2 data for duvelisib (phosphoinositide-3 kinase δ/γ inhibitor) peripheral T-cell lymphoma
Small molecule, T-cell lymphoma, cancer - Read more

Novo Nordisk showcases “promising” etavopivat (erythrocyte pyruvate kinase activator) Ph2 data in sickle cell disease
Small molecule, sickle cell disease - Read more

THE GOOD
Criminal Acts

Suspect arrested and charged with murder in UnitedHealthcare CEO slaying
Health insurance, shooting - Read more

THE GOOD
Earnings & Finances

ICER gives “slightly” cost-saving verdict to Vertex Pharmaceuticals non-opioid pain med suzetrigine (selective Na_v1.8-dependent pain-signaling pathways inhibitor)
Small molecule, pain management - Read more

THE GOOD
Fundraises

Dimension $500M second fund, investing at the “interfaces of life science and technology”
Venture capital, biotech investing, techbio investing - Read more

Citryll €85M ($89.5M) Series B, inflammatory disease treatments by targeting neutrophil extracellular traps
Monoclonal antibody, rheumatoid arthritis, hidradenitis suppurativa, autoimmune - Read more

VIVEbiotech lands strategic investment from Ampersand Capital Partners
CDMO, cell therapy, gene therapy, viral vector manufacturing - Read more

Alveron Pharma €5M ($5.3M) Seed extension, synthetic anticoagulant and platelet inhibitor reversal agent
Small molecule, anticoagulant, platelet inhibitor reversal - Read more

Cala Health $50M raise, wearable hand tremor-control device
Medical device, tremors - Read more

52North £4.72M ($6M) raise, urgent care pathways in oncology
Cancer, diagnostics, blood test, point-of-case, sepsis - Read more

Rowan $2.1M Pre-seed raise, molecular design and simulation tools
Machine learning, molecular simulation, drug design, computational chemistry - Read more

Abselion £6.6M ($8.4M) Series A, at-line protein quantification instrumentation
Instrumentation, protein quantification, drug development, analytical - Read more

THE GOOD
Mergers & Acquisitions

Kester Capital acquires EMAS Pharma from Bionical Emas
CRO, contract research - Read more

THE GOOD
Partnerships

Johnson & Johnson exclusively licenses undisclosed target as part of Mestag Therapeutics drug discovery collaboration
Antibody, drug discovery, cancer, inflammatory - Read more

THE GOOD
Politics & Policy

US Eighth Circuit Court upholds Arkansas’s 340B Drug Pricing Nondiscrimination Act, rejecting PhRMA’s constitutional challenge
Drug pricing, 340B drug pricing program - Read more

THE GOOD
Research

Unsurprisingly, starting multiple myeloma treatment earlier (at “smoldering” precancerous stage) results in better patient outcomes
Cancer treatment, multiple myeloma - Read more [Paywall]

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THE BAD
Clinical Trials

Vivoryon Therapeutics varoglutamstat (glutaminyl cyclase inhibitor) fails in second Ph2 trial in Alzheimer’s disease
Small molecule, Alzheimer’s disease - Read more

THE BAD
Lawsuit

Oxford NanoPore files confidential information suit against BGI
Genomic sequencing, confidential information, trade secrets - Read more [Paywall]

THE BAD
Layoffs

Carisma Therapeutics lays off 34% of staff
Cell therapy, cancer, fibrosis - Read more

Belharra Therapeutics cut 40% of staff
Small molecule, cancer, immunology - Read more [Paywall]

Zevra Therapeutics announces “organizational changes” as part of rare disease pivot, eliminating CMC & clinical development roles + closing labs in Iowa and Virginia
Small molecule, rare disease - Read more

THE BAD
Patient Access

Uptake of sickle cell gene therapies (from Vertex and bluebird bio) remains sluggish
Gene therapy, sickle cell disease, gene-modified cell therapy - Read more

THE BAD
Strategic Plans

Relmada Therapeutics in the dreaded “strategic alternatives” phase as it discontinues REL-1017 (N-methyl-D-aspartate receptor blocker) Ph3 trial in major depressive disorder
Small molecule, major depressive disorder - Read more

THE UGLY
Adverse Events

Agios Pharmaceuticals’ stock dips 21% on disclosure of liver injuries related to “very safe” mitapivat (pyruvate kinase activator) in thalassemia
Small molecule, thalassemia - Read more

THE UGLY
Public Health

President-elect Trump reiterates discredited potential link between autism and vaccines, says RFK Jr. to investigate as incoming HHS chair
Vaccine, autism - Read more

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

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