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9 Best Application Lifecycle Management Solutions for MedTech
Key Takeaways
• Since the FDA's QMSR took effect on February 2, 2026, design control evidence has to sit inside an ISO 13485-aligned quality system, not beside it.
• Orcanos is the top pick, purpose-built for medical devices. It combines full...
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6 AI Tools That Stress-Test Research Arguments
Most research does not fail because of a typo or a formatting error. It fails because an argument does not hold: a conclusion reaches further than the data allow, a key assumption goes unstated, a contradicting study is missing...
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Hazardous Drug Compounding: The Safety Standards Behind Every Prescription
Quick Answer
Hazardous drug compounding is the careful preparation of medications that can harm the people who handle them, such as chemotherapy or hormone treatments. It follows strict safety standards that control the air, equipment, and protective gear used during...
Business & Industry
Hengrui Pharma and Novo Nordisk Sign Licensing Deal for Oral GLP-1/GIP Dual Agonist HRS-1596
Hengrui Pharma has entered into a licensing agreement with Novo Nordisk for HRS-1596, a phase I-ready glucagon-like peptide-1 receptor (GLP-1R) and gastric inhibitory polypeptide receptor (GIPR) dual agonist with potential for once-weekly oral dosing, in a deal valued at...
Business & Industry
US Details Eligibility for Section 232 Specialty Pharmaceutical Tariff Exemptions
The Trump administration has released detailed guidance regarding specialty pharmaceutical tariff exemptions for products including orphan treatments, nuclear medicines, cell and gene therapies, and antibody-drug conjugates (ADCs). Effective September 29, 2026, these rules allow specific drug classes to enter...
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Top Small Molecule API Partners for 2026
Choosing a small-molecule API manufacturing partner affects cost and timelines. It also affects regulatory outcomes for years after the contract is signed.
The stakes are rising alongside the market itself. The global small molecule API CDMO market reached an estimated...
Business & Industry
Roche and Earendil Forge $1.5 Billion Bispecific Antibody Discovery Deal
Roche-owned Genentech has entered into a major collaboration with Earendil Labs to discover and develop bispecific antibodies targeting oncology, in a deal valued at up to $1.5 billion.
Deal Structure and Financial Terms
Under the terms of the agreement, Earendil will...
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