Upfront Briefing Big-picture today: the FDA loses its longtime oncology power center as Richard Pazdur heads for the exit, even as the agency moves to lighten non-human primate use for monoclonal antibodies. At the same time, the Pentagon is turning up the heat on China-linked outsourcing, with WuXi AppTec staring at a potential military list designation. Around the edges, biotech stocks lag broader indices, gene editing deal-making rolls on (Regeneron–Tessera), GLP-1 pricing by Lilly and Novo keeps reshaping the cardiometabolic opportunity set, and a New York court just revived a multibillion-dollar Celgene earnout fight. In other words: calm tape, noisy rulebook. Market Moves | Instrument | Last close | 1D % | YTD % | | S&P 500 (^GSPC) | 6,829.37 | 0.25% | 16.11% | | Nasdaq 100 (^NDX) | 25,555.86 | 0.84% | 21.62% | | Russell 2000 (^RUT) | 2,464.98 | -0.17% | 10.53% | | SPDR S&P Biotech (XBI) | 118.46 | -1.16% | 31.53% | | Nasdaq Biotechnology Index (^NBI) | 5,653.72 | -0.67% | 31.16% | Top 3 Headlines | 1 | FDA Drug Czar Richard Pazdur to Retire Amid Agency Turmoil | Richard Pazdur, a key FDA drug regulator, is set to retire, signaling internal conflict and raising concerns about future drug approvals and regulatory stability. Why it matters: Pazdur's unexpected exit from a key FDA role signals significant internal conflict, raising concerns about future drug approvals and regulatory stability. Source: Endpoints News More: BioCentury · BioSpace All News · BioPharma Dive | | 2 | FDA to Reduce Animal Testing for Monoclonal Antibodies | New FDA guidance aims to reduce or eliminate monkey testing for monoclonal antibodies, potentially streamlining drug development and reducing costs for biopharma companies. Why it matters: New FDA guidance aims to reduce or eliminate monkey testing for mAbs, potentially streamlining development and reducing costs for biopharma. Source: Endpoints News More: BioPharma Dive | | 3 | WuXi AppTec Faces Potential Pentagon Military List Designation | The Pentagon is reportedly considering adding WuXi AppTec to a military list, a move that could significantly impact the company and broader US-China biopharma collaborations. Why it matters: Pentagon's move to add WuXi AppTec to a military list could significantly impact the company and broader US-China biopharma collaborations. Source: Endpoints News | More Headlines - Regeneron–Tessera partner on gene editing for AATD — BioCentury
- Janux shares halve despite still-strong Phase I data — BioCentury
- New UK–US trade deal eases industry rebate burden and secures tariff-free exports — BioCentury
- Lilly and Novo GLP-1 pricing plans may clear the runway for future cardiometabolic competitors — BioSpace All News
- Durso succeeds Garg as Altimmune CEO — BioCentury
- Hospitals challenge 340B rebate pilot program in Maine federal court — Endpoints News
- NY judge revives $6.7B Bristol Myers–Celgene deal dispute — Endpoints News
- Pfizer culls Phase 1 ulcerative colitis candidate in ongoing pipeline adjustments — Endpoints News
- Imvax heads to FDA with glioblastoma therapy after survival gain despite endpoint miss — BioSpace All News
Deal Flow M&A - No notable M&A in the last 24 hours.
VC & Private Financings - Kazia Therapeutics Announces Pricing of $50.0 Million Private Placement of Equity Securities — Yahoo Finance
IPOs & Follow-Ons - No notable IPOs or follow-on offerings in the last 24 hours.
Academic Corner - Liraglutide in mild to moderate Alzheimer’s disease: a phase 2b clinical trial — Nature Medicine
| | That’s your daily dose of regulators, rebate schemes, and GLP-1 ripple effects — enough moving parts to keep any pipeline team busy. This content is for information only and is not investment or medical advice. | |