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The Good News

THE GOOD
Approvals & Labels

Pfizer's Ibrance (palbociclib) wins FDA label expansion for HR-positive, HER2-positive metastatic breast cancer based on Ph3 data
Small molecule, cancer, CDK4/6 inhibitor, breast cancer, HER2-positive, combination therapy - Read more

NICE recommends MSD's Keytruda (pembrolizumab) with chemoradiotherapy for Ph3-backed locally advanced cervical cancer
Antibody, cancer, monoclonal antibody, cervical cancer, PD-1 inhibitor, combination therapy - Read more

FDA approves Gilead's Trodelvy (sacituzumab govitecan) and Merck & Co.'s Keytruda combo for first-line triple-negative breast cancer
Antibody-drug conjugate, cancer, triple-negative breast cancer, TROP-2, combination therapy, PD-L1 - Read more

FDA approves Ionis Pharmaceuticals' Tryngolza (olezarsen) label expansion for severe hypertriglyceridemia following Ph3 success
Antisense oligonucleotide, metabolic, small molecule, hypertriglyceridemia, apolipoprotein C-III, pancreatitis - Read more

THE GOOD
Business Development & Partnerships

Boehringer Ingelheim, Immunai partner on AI-driven T-cell target discovery for cancer and autoimmune diseases, up to $15M
Research collaboration, oncology, autoimmune, AI/ML, drug discovery, milestone payments - Read more

Ionis Pharmaceuticals, Recordati strike ex-US licensing deal for zilganersen, $30M upfront plus tiered royalties
Licensing deal, rare disease, neurological, antisense oligonucleotide, milestone payments, royalties - Read more

NurExone Biologic, ExoLyra sign binding MOU for naïve exosome distribution in Mexico
Distribution agreement, exosome therapy, regenerative medicine, commercialization, milestone payments - Read more

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More Good News

THE GOOD
Clinical Trials

Otsuka's (centanafadine) Ph3b trial succeeds in adults with attention-deficit/hyperactivity disorder and comorbid anxiety
Small molecule, neurological, ADHD, reuptake inhibitor, comorbid anxiety - Read more

HUTCHMED's (fanregratinib) Ph2 data presented at ESMO GI, supporting NMPA priority review for FGFR2-fusion intrahepatic cholangiocarcinoma
Small molecule, cancer, FGFR inhibitor, cholangiocarcinoma, FGFR2 fusion - Read more

THE GOOD
Company Incubation

Parexel launches biotech incubator, partners with Cape Fear BioCapital to support early-stage therapeutics companies
Biotech incubator, early-stage therapeutics, clinical development, regulatory strategy, venture capital - Read more

THE GOOD
Fundraises

Absci prices $100M underwritten offering, advancing AI-designed anti-PRLR antibody program
Generative AI, antibody, clinical-stage, dermatology, endometriosis - Read more

eXoZymes awarded $2M NIH SBIR grant to advance cannabinoid analogs for drug discovery
Cell-free platform, drug discovery, cannabinoids, small molecule, preclinical - Read more

Oblenio Bio raises $62M Series B, advancing tri-specific autoimmune T-cell engager to trials
Autoimmune, T-cell engager, tri-specific, preclinical, B-cell depletion - Read more

Anodyne Nanotech closes $12.6M Series A to advance once-weekly GLP-1 obesity patch
Transdermal delivery, obesity, GLP-1, peptide therapeutics, clinical-stage, platform technology - Read more

THE GOOD
Mergers & Acquisitions

Merck KGaA to acquire Bio-Techne Corporation for $11.3B in largest deal since 2015 Sigma-Aldrich purchase
Life sciences tools, strategic, major transaction - Read more

Remix Therapeutics goes public via reverse merger with Passage Bio, raising $100M in private financing
Small molecule, oncology, major transaction, strategic - Read more

THE GOOD
Regulatory

FDA hiring 2,200 staff to rebuild workforce after DOGE cuts eliminated 3,000 employees
FDA, regulatory affairs, operational, workforce - Read more

BIO CEO Crowley, DOD's Overton emerge as top FDA commissioner candidates per RBC analysis
Rare disease, regulatory, strategic - Read more

THE GOOD
Strategic Plans

REGENXBIO plans accelerated approval BLA filing for Duchenne gene therapy RGX-202 amid shifting FDA stance
Gene therapy, rare disease, regulatory, accelerated approval - Read more

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The Bad News

THE BAD
Regulatory

FDA flags Pinnacle Biologics for misleading Photofrin videos that obscure cancer drug indications
Photodynamic therapy, oncology, regulatory, operational - Read more

FDA issues warning letter to Jubilant HollisterStier over mold investigation delays and quality unit failures
Contract manufacturing, sterile manufacturing, operational, quality compliance - Read more

👹 The Ugly News 👹

THE UGLY
No Ugly News Today!

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