Pfizer’s inclacumab trial failed to reduce vaso-occlusive crises in patients with sickle cell disease. • The antibody was supposed to prevent cell adhesion & pain crises but the trial didn’t show benefit vs placebo. Analysts now doubt that Pfizer’s $3B revenue target from its

Vaxart Oral COVID-19 Vaccine Trial Paused - HHS ordered Vaxart to stop screening and enrollment in its Phase 2 trial of an oral COVID-19 tablet, as the federal mRNA development program winds down. - Existing participants remain under observation, but no new volunteers will be

• Lonza's H1 core profit grew 23% (CHF 1.1B) thanks to strong contract drug manufacturing, which accounts for 86% of revenue. • The CDMO raised its 2025 sales growth outlook to 20–21% and expects an EBITDA margin of 30–31%; it plans to divest its capsules & health ingredients

Rocket Pharmaceuticals resumed its Phase II trial of RP-A501 gene therapy after the FDA lifted a clinical hold. The trial was halted in May after a patient died from capillary leak syndrome. The company recalibrated the dose and added an immunomodulatory regimen, aligning with

• ChemPartner is opening a 12,000 sq ft R&D Center of Excellence in Boston on Sept 10, offering discovery & preclinical services. The facility aims to support biologics discovery, pharmacology, and DMPK, accelerating programs from early discovery to IND. • The expansion meets

• Novartis may buy Avidity Biosciences. • Avidity’s muscular RNAi therapies, including del‑zota, could unlock multi‑billion opportunities and have shown a 25% boost in dystrophin. • Talks may not lead to a deal, but they reflect growing consolidation in RNAi. What could

• Confusion swirls around the U.S. tariff and 'most favored nation' drug pricing proposals. • Trade experts note that the U.S. remains a signatory to the 1994 WTO zero ‑ zero agreement eliminating pharmaceutical tariffs, yet current rhetoric and policies ignore that pact.

• FDA greenlights new rare disease therapies. Ionis’s antisense drug Dawnzera (donidalorsen) earned approval to prevent hereditary angioedema attacks after trials showed it cut monthly swelling episodes by 81%. • Viral immunotherapy breakthrough. Precigen’s Papzimeos became

• J&J doubles down on U.S. manufacturing. Johnson & Johnson plans to invest $2 B in a 160 000‑sq‑ft biomanufacturing facility in Holly Springs, NC, creating roughly 120 jobs amid looming U.S. drug‑import duties. • Big Pharma joins the onshoring push. Eli Lilly and

• Gilead pursues in vivo gene delivery. Gilead’s Kite Pharma is buying Interius BioTherapeutics for $350 M to acquire its in vivo CAR‑T gene‑delivery platform. Kite’s leadership believes combining Interius’ platform with its expertise will advance best‑in‑class therapies. •

• Medtech funding surges. Venture capital financing rebounded in 2025, with investors pouring cash into pulsed-field ablation and fluid-management systems for heart care. • Layoffs and optimism. Biopharma layoffs exceeded 13 000 by July—up 31% year‑on‑year—driven by patent

• 15% tariff cap sets new baseline. A U.S.–EU trade pact caps pharmaceutical import tariffs at 15%, far below earlier proposals of up to 250%. • Hidden costs. Tariffs on active ingredients add little to finished-drug costs, but duties on finished products or key components

• Hearing aids and dementia risk. A long-term study of nearly 3 000 participants from the Framingham Heart Study found that adults under 70 who used hearing aids had a 61% lower risk of dementia over about 20 years. • Timing matters. No significant dementia risk reduction was

New Episode! "Can We Say That? Dara Katcher Levy on the AdPromo Regulatory Landscape" In this episode of RealPharma, Ian Wendt and Na-Ri Oh sit down with Dara Katcher Levy, a regulatory attorney at … Player links & show notes: realpharma.co/e/140462504028…

GLP-1 pill wars heat up. Eli Lilly’s oral GLP-1, orforglipron, hit 10.5% mean weight loss in T2D in Phase 3 and met A1C targets. Oral manufacturing & storage advantages could be huge vs injectables. Filing planned this year. What does an oral option do to capacity, access, and

PBM reform watch: AMA backs H.R. 4317 (119th Congress) pushing transparency, clawback limits, and pharmacy choice in Medicare. If enacted, what shifts should biopharma plan for on rebating, formulary design, and specialty access? Sources: Congress.gov; AMA.

Argenx’s Vyvgart gets a boost. New ADAPT SERON trial data show Vyvgart (efgartigimod alfa) improved MG‑ADL scores in seronegative myasthenia gravis and was well tolerated. Filing with FDA this year could add ~11k patients to its label. With competition heating up among FcRn

MannKind grabs scPharmaceuticals in a $360M deal. MannKind will pay $5.35 per share plus a $1 CVR — a 31% premium — to acquire scPharmaceuticals and its Furoscix on-body infuser. FuroScix delivers subcutaneous furosemide for heart failure/CKD patients and drove 96% sales growth

New Episode! "Inside the CMC Black Box: A Deep Dive with Reza Oliyai" 🎙️ Episode Title: Inside the CMC Black Box: A Deep Dive with Reza Oliyai 🧾 Show Notes: What exactly is CMC — and why is it behin… Player links & show notes: realpharma.co/e/140559315176…

New Episode! "Building the Highway for AI in Pharma: A Conversation with Ilya Burkov" 🎙️ Episode Title: Building the Highway for AI in Pharma: A Conversation with Ilya Burkov 📍 Episode Summary In th… Player links & show notes: realpharma.co/e/140656014003…