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Hematological Disorders

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

IMFINZI’s AEGEAN Phase III Trial Data for Treating Resectable NSCLC; Ipsen and Day One’s Exclusive Agreement to License and Market Tovorafenib Outside the US; Alzheimer’s Drug LEQUEMBI Rejected by EU; EU Apporves Pfizer’s Gene Therapy DURVEQTIX; CHMP Approves SPEVIGO’s New Indications

The FDA Advisory Committee Considers the AEGEAN Phase III Trial Data in their Review of IMFINZI for Treating Resectable NSCLC The FDA's Oncologic Drugs Advisory Committee (ODAC) acknowledged that AstraZeneca’s IMFINZI (durvalumab) achieved the primary endpoint of event-free survival (EFS) in resectable non-small cell lung cancer (NSCLC) based on the AEGEAN Phase III trial. This trial involved adult patients with early-stage (IIA-IIIB) NSCLC treated with Imfinzi and neoadjuvant chemotherapy before surgery, followed by Imfinzi as adjuvant monotherapy. The FDA accepted the supplemental Biologics License Application (sBLA) for this indication in September 2023, with re...

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X4 Pharmaceuticals’ XOLREMDI FDA Approval; ONO to Acquire Deciphera Pharmaceuticals; Johnson & Johnson’s SIRTURO CHMP Approval; BeiGene’s Tislelizumab EC Approval; Sanofi’s Rilzabrutinib LUNA 3 Phase III Trial

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Roche’s Columvi Phase III STARGLO Trial; Novartis’ Fabhalta Latest Data; Vertex’s Alpine Immune Sciences Acquisition; Telix Pharmaceuticals’ TLX101-CDx Fast Track Designation; NovelMed’s NM5072 Orphan Drug Designation

medtech-news-for-carl-zeiss-abbott-medtronic-edwards

Carl Zeiss Meditec AG’s Acquisition of Dutch Ophthalmic Research Center; Johnson & Johnson’s Shockwave Medical Acquisition; Biora Therapeutics’ BT-600 Positive Results; Medtronic’s Single-Shot Mapping Ablation Catheter Positive Data; Abbott’s TriClip FDA Approval; Abbott’s Whole Blood Rapid Test FDA Clearance

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AstraZeneca and Daiichi Sankyo’s Enhertu US Approval; Basilea’s ZEVTERA FDA Approval; Genmab’s ProfoundBio Acquisition; Rocket Pharmaceuticals’ RP-L102 EMA Approval; Alexion’s Ultomiris and Soliris AAN 2024 Data

pharma-news-for-bms-astrazeneca-astellas-akebia

AstraZeneca’s Voydeya FDA Approval; Akebia’s Vafseo FDA Approval; Bristol Myers Squibb’s Phase III YELLOWSTONE Trial Update; Astellas’ IZERVAY FDA Approval; AstraZeneca’s Truqap and Faslodex MHLW Approval

medtech-news-for-tela-bio-stryker-livanova-c2dx

TELA Bio Launched Hernia Mesh Fixation Devices; Stryker Acquisition of SERF SAS; FDA 510(k) Clearance for RedDrop Dx’s Blood Collection Device; FDA 510(k) Clearance for Next Generation Shaw Scalpel; LivaNova’s Sleep Apnoea Device Trial; Nanodropper’s Positive Impact on Glaucoma Treatment

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Regeneron’s Odronextamab BLA; Novo Nordisk’s Cardior Pharmaceuticals Acquisition; Novartis’ Fabhalta CHMP Approval; Idorsia’s TRYVIO FDA Approval; AbbVie’s Landos Biopharma Acquisition

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Giant-Cell Arteritis Treatment Beyond Glucocorticoids: Exploring Horizons

crovalimab-for-pnh-treatment

Will Roche’s Crovalimab An Answer to AstraZeneca PNH Treatment Drugs?

Pharma News for GSK, Gilead, CSL, CymaBay

GSK Receives FDA Fast Track Designation for Bepirovirsen; Gilead to Acquire CymaBay Therapeutics; CSL Announces Top-line Results from the Phase III AEGIS-II Trial; Ruxoprubart Scores FDA Orphan Drug Designation for PNH Treatment; CymaBay Announces FDA Acceptance of NDA and Priority Review for Seladelpar; Biogen Received European Commission Approval for SKYCLARYS

MedTech News for Dexcom, Philips, Toku, Carthera

Cerenovus Launched Next-Gen Stroke Revascularization Catheter; Dexcom Launched New ONE+ CGM System; Philips Received the US FDA Nod for Latest Intellivue Patient Monitor Software; Toku Obtained CE and UKCA Marks for AI Cardiovascular Risk Assessments; Genesis MedTech Completed Enrollment in TAVR Trial; Carthera’s Ultrasound Drug Delivery Trial

Pharma News for Merck, BMS, Sanofi, Juvena

Merck’s KEYTRUDA as Adjuvant Therapy for RCC Patients; BMS Receives Positive CHMP Opinion for CAR T Cell Therapy Abecma for Multiple Myeloma; FDA Approves Dupixent for Eosinophilic Esophagitis; Juvena Receives FDA Orphan Drug Designation for JUV-161; European Commission Authorizes GSK’s Omjjara; ENHERTU Granted Priority Review in the US for for metastatic HER2-positive Solid Tumors

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AstraZeneca Strengthens Presence in PNH Treatment with Voydeya in Japan: World’s First Approval

Pharma News for Exelixis, AstraZeneca, Kyverna

BMS, and Exelixis’s Opdivo + CABOMETYX in First-Line Advanced Renal Cell Carcinoma; AIRSUPRA Now Available as the First and Only FDA-approved Anti-inflammatory Rescue Option for Asthma; AstraZeneca’s Voydeya Receives First-ever Regulatory Approval; EMA Grants ODD to GC Biopharma’s Sanfilippo Syndrome (Type A) Treatment; FDA Approves NRx Pharma’s IND Application of NRX-101; FDA Fast Track Designation to Kyverna’s KYV-101

A Glance at Key Insights From 42nd J.P. Morgan Annual Healthcare Conclave

expanding-market-of-complement-inhibitor

The Expanding Market of Complement Inhibitors

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