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Lilly’s Morphic Acquisition; IDEAYA’s IDE397 Positive Phase II Trial Result; XPOVIO (selinexor) Approval in China; Roche to Reintroduce Susvimo in the US; Dupixent EU Approval

Lilly Strengthens IBD Treatment Portfolio with Morphic Acquisition Eli Lilly and Company and Morphic Holding, Inc. announced a definitive agreement for Lilly to acquire Morphic, a biopharmaceutical company developing oral integrin therapies for serious chronic diseases. Lilly will initiate a tender offer to acqu...

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Eisai Announces Solo Development of Farletuzumab Ecteribulin (FZEC); Johnson & Johnson’s Nipocalimab Phase III Trial; Merck’s WINREVAIR  EU CHMP Recommendation;  Verona Pharma’s  Ohtuvayre FDA Approval; AstraZeneca’s Lynparza and Imfinzi EU Approval

Eisai Announces Solo Venture for Farletuzumab Ecteribulin (FZEC) Antibody Drug Conjugate Eisai Co., Ltd. announced the termination of its global strategic collaboration with Bristol Myers Squibb for the co-development and co-commercialization of farletuzumab ecteribulin (FZEC), previously known as MORAb-202, an ...

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Alcon’s 510(k) Clearance From the FDA; Globus Medical Received FDA Clearance; UK Pioneers First Skull-Mounted Epilepsy Device for Child; The Initiation of a Significant Clinical Trial of 3d Printed Models; Esaote Unveiled the Cutting-Edge Mylab™E80 @Sirm Ultrasound Device For 2024; Medasense Unveiled a Transformative Partnership With Nihon Kohden Corporation

Alcon's Newest Technological Marvels, Unity VCS, and Unity CS, Achieved 510(k) Clearance From the U.S. FDA, Paving the Way for New Advancements  On June 24, 2024, Alcon, the foremost name in eye care with a mission to help people see brilliantly, revealed that the U.S. Food and Drug Administration (FDA) had...

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Alnylam’s HELIOS-B Phase III Study of Vutrisiran; Bristol Myers Squibb Secures FDA Nod for KRAZATI and Cetuximab; Daichii Sankyo’s EZHARMIA® Receives Japan Approval; Vertex’s Phase I/II VX-880 Trial; argenx’s VYVGART Hytrulo FDA Approval

Alnylam's HELIOS-B Phase III Study of Vutrisiran Shows Positive Results, Meeting All Primary and Secondary Endpoints Alnylam Pharmaceuticals, Inc. reported encouraging topline outcomes from its HELIOS-B Phase III study of vutrisiran, an experimental RNAi therapy being developed to treat ATTR amyloidosis with car...

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Takeda Showcase Phase III Results for Soticlestat; Imfinzi and Chemotherapy Combination Gains US Approval; Nipocalimab Shows Notable Efficacy in Phase II Study; Bristol Myers Squibb’s Augtyro FDA Approval; AstraZeneca’s Farxiga FDA Approval

Takeda Reveals Phase III Results for Soticlestat (TAK-935) in Dravet and Lennox-Gastaut Syndromes Takeda revealed topline results from its SKYLINE and SKYWAY studies. SKYLINE (TAK-935-3001) was a multicenter, randomized, double-blind Phase III trial assessing soticlestat (TAK-935) plus standard care against plac...

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Moderna’s Phase III Trials for Dual Influenza and COVID-19 Vaccine; Almirall’s Klisyri FDA Approval; Lilly’s Tirzepatide MASH Trial; Cycle Pharmaceuticals Acquisition of Vanda Pharmaceuticals; Ipsen’s Iqirvo FDA Approval

Moderna Reports Successful Phase III Trials for Dual Influenza and COVID-19 Vaccine Moderna, Inc. has reported that its Phase III trial for mRNA-1083, an experimental combination vaccine targeting both influenza and COVID-19, achieved its main objectives by generating a stronger immune response than the approved...

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Stryker’s LIFEPAK 35 Monitor/Defibrillator; Qiagen’s QIAstat-Dx Respiratory Panel; Evolution Optiks’s 510(k) Clearance; Microbot Medical Endovascular Surgical Robot Trial; Nexalin’s Insomnia and Anxiety Therapy Headset Clinical Trial; KORU Medical Systems’ Study With Commercialized Oncology Biologics

Stryker Released LIFEPAK 35 Monitor/Defibrillator  On June 04, 2024, Stryker, a global leader in medical technologies, announced the launch of the LIFEPAK 35 monitor/defibrillator. This latest addition to their monitor/defibrillator lineup features advanced technology and is designed on an intuitive, modern...

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Moderna’s mRESVIA(R) FDA Approval; Novartis Scemblix® Phase III Data; Kite’s Tecartus for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia; Astellas’ Zolbetuximab Biologics License Application; CHMP Recommends AstraZeneca’s Tagrisso

FDA Greenlights Moderna's RSV Vaccine mRESVIA(R) Moderna, Inc. has announced that the FDA has approved mRESVIA (mRNA-1345), an mRNA-based vaccine for respiratory syncytial virus (RSV), to protect adults aged 60 and over from lower respiratory tract infections caused by RSV. This approval, granted under a breakth...

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AstraZeneca’s Tropion-Lung01 Phase III Trial Positive Outcomes; Biogen’s LEQEMBI South Korea Approval; AltruBio’s $225M Series B Funding; GSK’s Depemokimab Positive Phase III Severe Asthma Results; Roche’s Inavolisib FDA Breakthrough Therapy Designation

The Tropion-Lung01 Phase III Trial Reveals that Datopotamab Deruxtecan Significantly Enhanced Overall Survival in Advanced Nonsquamous NSCLC Patients Compared to Chemotherapy The high-level overall survival (OS) results from the TROPION-Lung01 Phase III trial, which had previously met the dual primary endpoint o...

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Laborie’s Enhanced Gastrointestinal Diagnostics; Carestream’s Image Suite MR 10 Software Launch; Implicity’s Heart Failure Algorithm FDA 510(k) Approval; AngioDynamics’ AlphaVac F1885 System CE Mark Approval; HeartBeam’s Artificial Intelligence Algorithm for Arrhythmias; Onward ARC-EX Nerve Stim Hit Pivotal Trial

Laborie Launched Solar Compact System and Solar Anorectal Manometry Catheter for Enhanced Gastrointestinal Diagnostics On May 20, 2024, Laborie Medical Technologies Corp., launched the Solar Compact System and Solar Anorectal Manometry Catheter, the first disposable HRAM catheter on the market. These devices sig...

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