Women in STEM: Unique Impacts in Rare Disease Development
Klaudia Lechowska, a business‑development specialist at Mabion Biologics, highlighted how STEM education equips women with both technical and commercial skills essential for biotech careers. She noted that women comprise about 60% of the pharma workforce but hold only a quarter of senior roles, underscoring a leadership gap. Mabion’s biosimilar MabionCD20 recently earned FDA orphan‑drug designation for membranous nephropathy and autoimmune hemolytic anemia, illustrating the company’s focus on rare‑disease therapeutics. Lechowska also emphasized emerging innovations in advanced biologics and personalized medicine as the industry pivots toward quality and safety.
Fresenius Kabi and Phlow Corp. Enter First US End-to-End Manufacturing Collaboration
Fresenius Kabi and Phlow Corp. have launched the United States’ first end‑to‑end domestic manufacturing collaboration for epinephrine injection, pairing Phlow’s new API production facility in Virginia with Fresenius Kabi’s existing formulation and fill sites. The partnership includes an FDA‑filed Drug...
FDA Grants Priority Review For Pfizer’s Marstacimab for Hemophilia A or B
The FDA granted priority review for Pfizer’s marstacimab, marketed as HYMPAVZI, to broaden its label to patients aged six and older with inhibitors and to children 6‑11 without inhibitors. Marstacimab is a weekly subcutaneous anti‑TFPI antibody, the first of its...
How CDMO Alliances Can Provide End-to-End Service that Reduces Drug Development Time and Costs
Integrated CDMO networks are reshaping drug development by offering end‑to‑end expertise, especially for complex modalities such as antibody‑drug conjugates (ADCs). Partnerships between specialist CDMOs allow small and mid‑size biopharma firms to access high‑potency handling, bioconjugation, and lyophilization capabilities without building...
Hovione’s Strategy for Complexity, Speed, and Regional Supply Chains
Marcio Temtem, Hovione’s VP of Strategic Business Management, highlighted three industry shifts: growing small‑molecule complexity, faster development cycles driven by AI, and the regionalization of supply chains. Hovione counters these pressures with its amorphous solid dispersion platform, continuous flow and...
Drug Digest: Outsourcing Partnerships Fuel Global Biopharma Discovery and Scale-Up
Strategic outsourcing is reshaping biopharma by linking discovery, formulation, and early‑clinical manufacturing through specialized external partners. In a Drug Digest interview, iOrganBio CEO Daniel Delubac explains how risk‑focused partner selection and integrated data flows accelerate cell, gene, and RNA therapies...
WEF Welcomes ACG Shirwal as First Pharma Packaging Site in Global Lighthouse Network
The World Economic Forum has added ACG’s Shirwal facility to its Global Lighthouse Network, making it the first pharmaceutical packaging site to receive the honor. The plant leverages AI, machine learning, IoT and digital twins to slash defects by 71%...
Women in STEM: Cultivating Scientific Confidence
Elisabeth Gardiner, CSO of Tevard Biosciences, warned that women remain vastly under‑represented in pharmaceutical STEM roles, occupying only 20‑30% of such positions despite comprising half of the U.S. workforce. She highlighted a "confidence paradox" where girls' interest in STEM has...
Shaping the Future of Microbial Development: From Gene to GMP
Fujifilm Biotechnologies is hosting a free webinar titled “Shaping the Future of Microbial Development: From Gene to GMP.” The session, led by Steve Loftus, PhD, will showcase proven strategies and emerging technologies that accelerate microbial fermentation, scale‑up, and regulatory readiness....
Behind the Headlines Episode 32: AI’s Power, NVIDIA & Lilly, Revolution Medicine
In the latest Behind the Headlines episode, NVIDIA and Eli Lilly announced a $1 billion, five‑year AI co‑innovation lab aimed at fusing wet‑lab experiments with continuous‑learning computational models. Panelists highlighted AI’s growing role in lowering drug‑development costs and accelerating clinical‑trial timelines, moving...
Women Leading Biotech: Advancing Treatments for Ovarian Cancer
IMUNON, a clinical‑stage biotech, is advancing a DNA‑mediated IL‑12 immunotherapy for advanced ovarian cancer into Phase 3 trials. The therapy uses the company’s TheraPlas nanoparticle platform to deliver an IL‑12 plasmid directly into the tumor microenvironment, converting “cold” tumors to “hot”...
Bristol Myers Squibb and Johnson & Johnson Launch Educational Program for Thromboembolic R&D
Bristol Myers Squibb and Johnson & Johnson have launched the “Change the Target. Change What’s Possible” educational initiative focused on Factor XIa inhibition for thromboembolic disease. The program highlights FXIa’s potential to prevent harmful clots while preserving normal hemostasis, addressing the...
The Role of Standards in Sustainability
Sustainability has moved from a niche environmental concern to a core business driver for pharmaceutical manufacturers. The United States Pharmacopeia (USP), whose standards are adopted by more than 22,000 facilities in 140 countries, is leveraging its reach to embed ecological...
EMA Recommends Rezurock for Chronic Graft-Versus-Host Disease
The European Medicines Agency has issued a recommendation for conditional marketing authorization of Sanofi Winthrop’s Rezurock (belumosudil) to treat chronic graft‑versus‑host disease in patients aged 12 and older. In an open‑label study, 73% of participants achieved a response, with 44%...
Women in STEM: Inspiration From Innovators in Pharma
PharmTech interviewed Katy MacLellan, Technical Team Leader at Symbiosis, about her journey from a Scottish island to senior roles at Pfizer, Eli Lilly, CSL Seqirus and now Symbiosis. She highlights how female mentorship and visible STEM programs propelled her career and how companies...
