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Infectious Diseases

Pharma News for Nexcella, Janssen, Alentis

Notizia - Recent Pharma, Healthcare and Biotech Happenings

FDA Approves BMS’s Reblozyl for MDS; FDA Awards Orphan Drug Designation to NXC-201; Janssen Submits Supplemental NDA for Full Approval of BALVERSA; FDA Grants Fast Track Status to ALE.C04; FDA Orphan Drug Designation to Faron’s Bexmarilimab; FDA Clears IND Application for AHB-137

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Pharma News for Amgen, AstraZeneca, Sanofi, Anavex, Sensorion, GSK

Amgen’s Olpasiran Candidate; GSK’s Novel Antibiotic for Urinary Tract Infections; AstraZeneca and Sanofi’s Beyfortus Approval; FDA Orphan Designation to Anavex’s Anavex2-73; FDA Rare Pediatric Disease Designation to Sensorion’s OTOF-GT; GSK’s Blenrep Fails in Phase III Trial in R/R Multiple Myeloma

Pharma News for Actinium, Santhera, Gilead, Seres, BMS, Boehringer

Actinium Announces SIERRA Trial Results; Santhera Seeks FDA Review for Vamorolone; Seres Announces BLA Submission for SER-109; BMS Announces Results of COMMANDS Trial; Boehringer’s PDE4B Moves Late-stage Clinical Testing; FDA Rejects Gilead’s Hepcludex; Approval to J&J’s BCMAxCD3 Bispecific Antibody for Multiple Myeloma; Syncona to Acquire AGTC

MedTech News for NeuroLogica, Medtronic, and Pfizer

Biosense Webster’s HELIOSTAR Radiofrequency Balloon Ablation Catheter; Philips’s ClarifEye Augmented Reality Surgical Navigation Solution; NeuroLogica’s Elite Mobile Computed Tomography Devices; Medtronic’s Natural Conduction System for Heart; Pfizer & BioNTech’s Omicron BA.4/BA.5-Adapted Bivalent Booster Trial; Castle Biosciences’s TissueCypher® Barrett’s Esophagus Test

Pharma News and Updates for Takeda, Gilead, and Odyssey

CHMP Reviews Takeda’s Qdenga; FDA Sets Date for Gilead’ Trodelvy Review; Odyssey’s Announces $ 168 Million Series B Financing; Tavros and Vividion Signs Agreement; Pharming Submits Leniolisib for Approval in the EU; FDA Fast Track Designation to Mereo’s Alvelestat

Pharma News Merck, AstraZeneca, and GSK

Merck’s Sotatercept Trial Result; PARP Rivals Closing in on AstraZeneca and Merck’s Lynparza; FDA Clears GSK’s Boostrix for Pertussis; Fast Track Designation to Nanoscope Therapeutics’s MCO-010; FDA Awards Fast Track Designation to Eftilagimod Alpha Plus Pembrolizumab; Solid Biosciences to Acquire AavantiBio

Pharma News and Updates for Akero Chiesi Pfizer

AstraZeneca’s Danicopan Trial; CHMP Recommends Sanofi/AstraZeneca’s nirsevimab; Akero’s NASH Drug Trial; FDA Grants Orphan Drug Status to SY-5609; BMS’s Opdivo Trial Results; Pfizer to File for FDA Approval for Meningitis Vaccine; EMA Orphan Drug Designation to CAN-2409; FDA Starts Priority Review of Chiesi ‘s velmanase alfa

Pharma News for Aktis, Alcon and Takeda

Aktis’s Novel Targeted Alpha Radiopharmaceuticals; Koye Partners with Sonde Health; Novartis to Spin Off Sandoz Business; Alcon to Buy Aerie Pharma; Fast Track Designation to Merck’s MK-2060; FDA Approves Ibrutinib for Chronic GvHD; French Authorities Clears BrainVectis’s Clinical Trial; Takeda’s Dengue Vaccine TAK-003 Gets Approval in Indonesia

Pharma News for Cidara, Merck, Gilead

EMA to review Cidara Therapeutics’ Rezafungin; EU Approves Gilead Sciences’ Sunlenca; FDA Approves Axsome’s Auvelity; EU Marketing Authorisation to Oncopeptides’s Pepaxti; Merck Signs $ 3.5 B Deal with Orna; FDA to review AstraZeneca and Merck’s Lynparza; FDA Approval to Bluebird’s Zynteglo; FDA Decision Date for GSK’s Momelotinib

Latest MedTech News for CereVasc and Nanopath

CereVasc’s eShunt System Study; FDA Approves NGS-Based CDx for Trastuzumab Deruxtecan; Nanopath Secures $10 Million Funding; BD, Accelerate Diagnostics Announce Collaboration; Avails Medical’s Clinical Trials for eQUANT; Movano Ring Exceeds Accuracy Targets for SpO2 & Heart Rate Monitoring

Pharma News for Sarepta and Ionis

Bristol-Myers Squibb’s Opdivo & Yervoy Combo Trial; Sarepta’s Gene Therapy SRP-9001 for DMD; Ionis’s End-Stage Renal Disease Drugs; FDA Approves Arcutis’s Zoryve Cream; Gilead’s Biktarvy for HIV and Hepatitis B; FDA to Review Biogen’s ALS Therapy Tofersen

MedTech News Updates for Renovia and Zsquare

Zsquare ENT-Flex Rhinolaryngoscope Receives FDA Clearance; ClearMind Biomedical’s Completion of Least Invasive ICH Treatment; Bruker Launched Tool for ‘Long COVID’ Multi-Organ Risk Assessment; EarlySign, Roche Signed Strategic Deal; FDA Clearance for Leva® Pelvic Health System; NeuroOne’s Evo® sEEG Electrode

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MedTech News and Updates for GenScript, Biomerics, MedAlliance, Filterlex

GenScript Enters Distribution Agreement with EUROIMMUN; Biomerics’s New Facility in Galway (Ireland); MedAlliance’s SELUTION SLR DEB; OmniGuide’s RevoLix HTL Hybrid Thulium Laser; Filterlex’s CAPTIS Full-Body Embolic Protection Device; Orthofix’s M6-C Artificial Cervical Disc

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