EU – Talk Bio

Spotlight On: It’s Raining AI Devices as Regulatory Storm Reshapes Digital Health

2 days ago talkbio0Tagged 2025, Accountability, AI-enabled, clinical oversight, digital health regulation, digital mental health devices, draft guidance, EU, EU AI Act health, Generative AI, Health care facility, Medical Devices, Regulation, Software as a Medical Device, United States Food and Drug Administration

AI-enabled medical devices; digital health regulation 2025; FDA AI draft guidance; EU AI Act health; generative AI in healthcare; SaMD regulation; clinical oversight of AI; AI accountability in healthcare; digital mental health devices

Mindpeak Secures First Patent for Advanced AI Method in Digital Pathology

3 days ago talkbio0Tagged AI model, AI-powered, cell classification, Diagnostics, digital pathology, EU, Histopathological aspects, Legal patent, Mindpeak, oncology diagnostics, Pathology, Precision - temporal, Training Programs, United Kingdom, Validation

Mindpeak; digital pathology; AI-powered pathology; oncology diagnostics; cell classification; histopathology; EU patent; United Kingdom validation; AI model training; precision diagnostics

Dupixent Gains EU Approval as First Targeted Therapy for Chronic Spontaneous Urticaria in Over a Decade

2 weeks ago talkbio0Tagged Approved, Chronic Spontaneous Urticaria, Dupixent, EU, Interleukin-13, interleukin-4, Monoclonal Antibodies, Regeneron, sanofi, type 2 inflammation

Dupixent; chronic spontaneous urticaria (CSU); EU approval; Sanofi; Regeneron; monoclonal antibody; IL-4; IL-13; CUPID phase 3 trials; type 2 inflammation

Roche Bags EU Nod for SC Formulation of Lunsumio, Re-Igniting Bispecific Battle with Tepkinly

3 weeks ago talkbio0Tagged Antibodies, Bispecific, Approved, Clinical Research, Conditional, EU, GO29781, Lunsumio, Lymphoma, Follicular, marketing authorisation, Relapsed/Refractory, Roche (company), subcutaneous, Tepkinly

Roche; Lunsumio; subcutaneous; EU approval; conditional marketing authorisation; follicular lymphoma; bispecific antibody; Tepkinly; CD20xCD3; relapsed/refractory; GO29781 study

Trump Locks in 15% Pharmaceutical Tariff Rate for EU, Generic Drugs Exempted

4 months ago talkbio0Tagged 15%, brand-name drugs, EU, Evaluation, Generic Drugs, Sectioning technique, tariff, tariff exemption, TNFRSF19 gene, transatlantic trade, Trump administration

15% tariff; pharmaceuticals; EU; Trump administration; generic drugs; trade deal; tariff exemption; brand-name drugs; transatlantic trade; Section 232 investigation

Trump’s Most Favored Nation Policy and EU Generics: Recent Developments

4 months ago talkbio0Tagged drug price, EU, generics, Nation, Pharma, Policy, tariffs, Transplant Registry Unified Management Program

Trump; Most Favored Nation policy; EU generics; drug pricing; tariffs; pharma

AstraZeneca’s Calquence Combo Approved for First-Line CLL in EU

6 months ago talkbio0Tagged Amplify trial, Approved, AstraZeneca, BTK inhibitor, Calquence, Chronic Lymphocytic Leukemia, EU, First line treatment, obinutuzumab, venetoclax

AstraZeneca; Calquence; EU approval; chronic lymphocytic leukaemia; first-line treatment; venetoclax; obinutuzumab; BTK inhibitor; Amplify trial

Regeneron Secures EU Approval for Bispecific Antibody Lynozyfic, Positioning for Competition Against J&J and Pfizer

8 months ago talkbio0Tagged Antibodies, Bispecific, Approved, EU, J&J, Lynozyfic, Multiple Myeloma, Neoplasms, Pfizer, Regeneron

Regeneron, Lynozyfic, Bispecific Antibody, Multiple Myeloma, EU Approval, J&J, Pfizer, Oncology

Sanofi, Novartis CEOs lambast EU price control as Trump reportedly weighs drug cost parity with other nations

8 months ago talkbio0Tagged CEOs, EU, Financial cost, Investments, Market, nations, Novartis, Parity, Pharma, Prices, sanofi, Transplant Registry Unified Management Program, U.S.

EU, Novartis, CEOs, Transplant Registry Unified Management Program, Financial cost, Parity, sanofi, Investments, Prices, Pharma, Market, nations, U.S.

UPDATE: With looming Trump tariffs, pharma companies demand changes to stay in EU

8 months ago talkbio0Tagged drug price, EU, Industry, Investments, Pharma, Policy, Transplant Registry Unified Management Program, United States

EU, Pharma, Industry, Transplant Registry Unified Management Program, Policy, Investments, United States, drug price