Gastric cancer

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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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Eli Lilly’s Jaypirca Approval; Novartis’ Adakveo EMA Review; Janssen’s CARTITUDE-4 Study of CARVYKTI; Negative Review on Ipsen’s Palovarotene; Gilead Sciences and Kite’s Yescarta NICE Recommendations; Daiichi Sankyo and AstraZeneca’s Enhertu EU Approval

FDA Approves Eli Lilly’s Jaypirca for Relapsed Mantle Cell Lymphoma Eli Lilly has received FDA approval for Jaypirca, a non-covalent BTK inhibitor, in relapsed mantle cell lymphoma (MCL) patients who have relapsed after treatment with other drugs in the class. Adult MCL patients who have previously received at l...

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ENHERTU’s Journey in Cancer Treatment and Management

ENHERTU is an antibody-drug conjugate composed of an anti-HER2 antibody and a cytotoxic topoisomerase I inhibitor. Three components make up this ADC:  A topoisomerase inhibitor that is covalently linked to, Humanized anti-HER2 IgG1 monoclonal antibody (mAb) via, Tetrapeptide-based cleavable linker Rec...

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MedTech Updates for Ibex and Senseonics
CE Mark to Ibex’s Gastric Cancer Detection System; Senseonics’s Eversense E3 Continuous Glucose Monitoring System; NEUSPERA’s NUVELLA SYSTEM; Conformal Medical Initiates CONFORM Pivotal Trial; Meridian Launches New qPCR Master Mixes for Stool Samples; Sentinel Diagnostics Launches SENTiFIT 800

Conformal Medical Announces Launch of CONFORM Pivotal Trial On June 17, 2022, Conformal Medical Inc, is a medical device company manufacturing devices to avoid strokes in patients with non-valvular atrial fibrillation and developing next-generation LAAO technology. Its exclusive technology is intended to make le...

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Pharma News For Sanofi, Bayer, Innoviva
PTC Therapeutics’ Gene Therapy Upstaza; Sanofi and Regeneron’s Dupixent; Bayer CAR-T Collaboration with Atara; FDA Accepts Biohaven’s Zavegepant; AbbVie Files FDA Approval for ABBV-951; Innoviva to Acquire Entasis; FDA Orphan Drug Designation to XMT-2056; FDA Approves Azacitidine for Juvenile Myelomonocytic Leukemia

EU Recommends Approval for PTC Therapeutics’ Gene Therapy Upstaza Upstaza, a gene therapy developed by PTC Therapeutics for patients with the genetic condition AADC deficiency, has been recommended for EU approval, putting another test of gene therapy's commercial prospects in the union. Upstaza (eladocagene exu...

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Pharma News and Updates for Coherus, Keymed, Roche, Vicore, Cassiopea
Coherus Biosciences’ Toripalimab; Keymed’s CMG901; Biogen Alzheimer’s Drug Aduhelm; Vicore’s Digital Therapeutics Study; Cassiopea’s Acne Treatment Winlevi; Samsung Biologics Acquires Samsung Bioepis; Roche’s Giredestrant; Ashai Kasei Acquires Bionova

FDA Grants Orphan Drug Designation to Coherus Biosciences’ Toripalimab for Small Cell Lung Cancer The FDA granted orphan drug status to Coherus Biosciences’ Toripalimab (TuoYi) based on data from the phase 3 JUPITER-08 study in patients with extensive-stage Small-cell Lung Cancer (ES-SCLC). Patients in the curre...

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Algernon’s NP-120 (ifenprodil); Pieris’s cinrebafusp alfa (PRS-343) clinical trial; Gaumard Scientific’s multidisciplinary patient simulator HAL S5301; Hekka Labs’s decentralized healthcare ecosystem

Algernon receives positive FDA feedback on Phase IIb chronic cough trial The US Food and Drug Administration (FDA) has given positive feedback for Algernon Pharmaceuticals’ Phase IIb clinical trial of NP-120 (ifenprodil) for chronic cough treatment.  A receptor antagonist of N-methyl-D-aspartate (NMDA), ifenp...

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Adagio Raises $336 M; Lyndra’s Schizo Trial; BMS Opdivo for Gastric Cancer; Anixa Ovarian Cancer CAR-T Therapy

Adagio Raises $336 Million to Advance Covid-19 Antibody Treatment An antibody startup Adagio Therapeutics announced the completion of a $336 million Series C financing round. The proceedings from the financing round will be used to augment the development of the company’s lead program developing treatments for C...

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