Articles
🇪🇺 EuropeExpert insights, opinion pieces, and in-depth analysis on pharmaceutical trends and EMA regulations.
ASCO26: AstraZeneca's Camizestrant Data Aims to Sway FDA Approval
AstraZeneca is presenting new data for its oral selective oestrogen receptor degrader (SERD), camizestrant, at ASCO26, hoping to bolster its case for FDA approval. The drug demonstrated a 56% reduction in the risk of disease progression or death in recent trials.
MaaT Pharma Q1 2026 Update: Financials, Business Progress, and Strategic Outlook
MaaT Pharma reported EUR 0.8 million in Q1 2026 revenues following its transition to selling MaaT013 (Xervyteg®) to Clinigen for European distribution. The company highlighted a 19% year-over-year increase in MaaT013 revenues on a like-for-like basis.
Naldemedine Approved in China for Opioid-Induced Constipation: A New Option for Cancer Supportive Care
Naldemedine has been approved in China by the NMPA for the treatment of opioid-induced constipation (OIC), marking a significant advancement in supportive care for cancer patients. This approval by Sino Biopharmaceutical introduces a new therapeutic option to address a common and debilitating side effect of opioid analgesics.
OS Therapies' OST-HER2 Nears FDA Accelerated Approval for Osteosarcoma Amidst ASCO Data Presentation
OS Therapies is advancing OST-HER2, an immunotherapy for osteosarcoma, towards FDA accelerated approval. The company anticipates presenting crucial survival data at ASCO 2026, aligning with its planned 2026 Biologics License Application (BLA) submission.
ENYO Pharma Appoints Jeff George as Chairman to Bolster Growth and Phase 3 Readiness for Vonafexor
ENYO Pharma has appointed Jeff George as its new Chairman, a strategic move to support the company's next phase of growth. This appointment coincides with ENYO's preparations for the pivotal Phase 3 program of its drug Vonafexor, targeting Alport Syndrome.
Eli Lilly's 340B Policy Shift: Impact on Hospital Networks and Pharma Strategy
Eli Lilly's recent five-day ultimatum for hospitals to submit 340B claims data highlights a strategic shift in how pharmaceutical companies are managing compliance and discounts. This move places increased burden on hospital networks and signals a broader trend in the industry.
Karyopharm's Selinexor Plus Ruxolitinib SENTRY Trial Data to be Presented at EHA 2026
Karyopharm's Phase 3 SENTRY trial evaluating selinexor in combination with ruxolitinib for myelofibrosis has been selected for a late-breaking oral presentation at EHA 2026. This presentation will feature results from the randomized, double-blind, placebo-controlled study.
EMA's CHMP Recommends Oral Wegovy Approval, Expanding Obesity Treatment Options in Europe
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of an oral formulation of Wegovy for weight management. This recommendation signifies a crucial step towards increased accessibility of GLP-1 receptor agonist therapies for obesity in Europe.
FDA Approves AstraZeneca's Imfinzi-BCG Combination for High-Risk NMIBC
The FDA has approved AstraZeneca's Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). This marks the first immunotherapy-based combination therapy approved for this indication.
ASCO26: Summit, Akeso claim OS victory for ivonescimab in pivotal Chinese study
Structured plan for ASCO26: Summit, Akeso claim OS victory for ivonescimab in pivotal Chinese study
Medscape's AI Integration in Hematology: A Catalyst for Change at EHA 2026
Medscape is bringing AI to the forefront of hematology discussions at EHA 2026, signaling a significant shift in how clinical data and treatment options will be accessed and utilized. This move is poised to influence oncology research and clinical practice, presenting new opportunities and challenges for the pharmaceutical industry.
OS Therapies Publishes Four Articles on OST-HER2 and Osteosarcoma, Signaling Clinical Progress
OS Therapies has announced the publication of four articles focusing on its lead asset OST-HER2 and osteosarcoma in Drug Discovery World. This news coincides with the company's upcoming presentation of Phase 2b clinical trial data at the ASCO Annual Meeting and its plans for a BLA filing.
EMA celebrates diversity and inclusion in science and healthcare
Structured plan for EMA celebrates diversity and inclusion in science and healthcare
Navigating the Future of GMP: Reliance, Annex 1, and AI
The pharmaceutical industry is at a crossroads, with evolving regulatory landscapes and emerging technologies like AI demanding a modernization of Good Manufacturing Practices (GMP). This article examines the impact of increased regulatory reliance, the implementation of EU GMP Annex 1, and the integration of Artificial Intelligence on future compliance strategies.
Arrowhead Pharmaceuticals June 2026 Events
Arrowhead Pharmaceuticals is set to participate in several key industry events throughout June 2026. These appearances provide a crucial opportunity for analysts, strategy, and business development teams to gain insights into the company's pipeline advancements and strategic direction.
BioCryst Presents New HAE Data for ORLADEYO® and Navenibart at EAACI 2026
BioCryst Pharmaceuticals will present new hereditary angioedema (HAE) data for its oral therapy ORLADEYO® (berotralstat) and its investigational therapy navenibart at the 2026 European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting. This presentation highlights BioCryst's ongoing commitment to advancing HAE treatment and understanding.
Intellia Therapeutics to Report Additional Phase 3 HAELO Data for Lonvoguran Ziclumeran (lonvo-z) in Late-Breaking Oral Presentation at EAACI 2026
Structured plan for Intellia Therapeutics to Report Additional Phase 3 HAELO Data for Lonvoguran Ziclumeran (lonvo-z) in Late-Breaking Oral Presentation at EAACI 2026
European Commission Opens 2026 Joint Scientific Consultation Submission Window
The European Commission has announced the opening of the third 2026 submission window for Joint Scientific Consultations (JSCs), a critical step for health technology developers under the new EU HTA Regulation. This provides an opportunity for early alignment with EU HTA bodies.
Eisai's Leqembi Sales Forecast: Projecting Blockbuster Status in Alzheimer's
Eisai projects significant growth for its Alzheimer's treatment, Leqembi, with sales forecasts indicating a strong path toward blockbuster status. This analysis explores the drivers behind this projection and its strategic implications for the pharmaceutical industry.
ImmunityBio's Anktiva Expansion: Navigating FDA Decision Dates and Regulatory Hurdles
ImmunityBio is navigating a complex regulatory landscape for its bladder cancer therapy, Anktiva. This article provides insights into upcoming FDA decisions and their impact on the pharmaceutical industry.
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