Grifols

Roche acquires Poseida Therapeutics for up to $1.5B, expanding into CAR-T therapies. U.S. overdose deaths decline by 14.5% to 97,000 over 12 months. Arrowhead Pharmaceuticals licenses programs to Sarepta Therapeutics for $500M upfront and $325M in equity. Recordati and Angelini Pharma consider merger to form Europe's largest generics group. FDA approves BridgeBio's heart drug for transthyretin amyloidosis, challenging Pfizer's tafamidis. Novo Holdings expected to receive EU approval for $16.5B acquisition of Catalent Pharma Solutions. Amgen's obesity drug MariTide shows 20% weight loss in Phase II. Anavex Life Sciences submits MAA to EMA for Alzheimer's treatment. Biohaven's muscle drug fails in SMA study. embecta reports strong revenues of $1.12B, discontinues insulin patch pump. Axsome Therapeutics reports positive Phase 3 results for narcolepsy drug AXS-12. Kronos Bio to lay off 83% of workforce. PTC Therapeutics sells Rare Pediatric Disease Priority Review Voucher for $150M. EMA launches medicine shortages monitoring platform. Alector lays off 41 employees after Alzheimer's drug AL002 fails. Grifols seeks to refinance €1.4B in debt. Roche's cancer drug tiragolumab fails Phase 3 trial.

Cradle, an AI-powered protein engineering platform in Amsterdam, raised $73m in Series B funding, led by IVP with existing investors. The platform is used across pharmaceuticals, agriculture, and manufacturing, with clients like Novo Nordisk and Johnson & Johnson. Cradle emphasizes data security and IP protection, accelerating R&D timelines up to 12 times. The company aims to scale its technology and reach one million scientists globally.

GigaGen, a Grifols subsidiary, has started a Phase I trial for GIGA-2339, a recombinant polyclonal drug targeting chronic HBV infection. The drug, composed of over 1,000 anti-HBV antibodies, is designed to mimic natural immune responses and is claimed to be 2,000 times more potent than existing treatments, potentially offering a functional cure for HBV.

Biopharma layoffs continue into 4Q 2024, affecting companies like Thermo Fisher, Charles River, Pfizer, Evonik, Johnson & Johnson, Bayer, Bristol Myers Squibb, AGC Biologics, and others. These layoffs are part of restructuring initiatives, site closures, and focus shifts in strategic core growth areas.

The Pharmaceutical Contract Manufacturing Market is projected to exceed $155 billion in 2024, driven by high in-house drug development costs and varying regulatory requirements. CDMOs like Thermo Fisher Scientific and Samsung Biologics are expanding services to meet demand, offering end-to-end solutions from development to commercial-scale manufacturing. The market report provides revenue forecasts to 2034, regional and national market analyses, and profiles of leading companies.

Grifols' plasma-protein based fibrin sealant (FS) received FDA approval for pediatric patients in the U.S., extending its availability from Europe and adults. FS, marketed as VISTASEAL™ in the U.S. and Canada, and VERASEAL™ in Europe, promotes hemostasis and tissue sealing during surgery, reducing blood loss and complications. The FS solution is now available in 18 countries and combines fibrinogen and thrombin with Johnson & Johnson MedTech’s airless spray technology.

FDA approves Grifols' VISTASEAL fibrin sealant for surgical bleeding control in pediatric patients, achieving 95% efficacy and rapid hemostasis within 4 minutes, with comparable safety profiles to active control.

Grifols' plasma-protein based fibrin sealant (FS) received FDA approval for pediatric patients in the U.S., extending its availability from Europe and adults. FS promotes hemostasis and tissue sealing during surgery, reducing blood loss and complications. Commercialized as VISTASEAL™ in the U.S. and Canada, and VERASEAL™ in Europe, FS combines fibrinogen and thrombin with airless spray technology. A phase 3b study showed 95% efficacy in pediatric patients, with hemostasis achieved within four minutes.