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Pharma News and Updates for Coherus, Keymed, Roche, Vicore, Cassiopea

Notizia - Recent Pharma, Healthcare and Biotech Happenings

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 current randomized, double-blind trial are getting toripalimab, a PD-1 inhibitor, plus a platinum-based chemotherapeutic such as cisplatin or carboplatin, and etoposide as first-line therapy for ES-SCLC, as opposed to placebo plus the same chemotherapy backbone. The trial is estimated to enroll 420 patients who will get a toripalimab or placebo injection paired w...

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Neurent Medical’s NEUROMARK; Brain Navi NaoTrac received European CE Mark approval; Theradaptive receives Breakthrough Medical Device Designation; HAGAR GWave awarded Breakthrough Device Designation; Fujifilm launches ColoAssist PRO

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TecTraum’s pro2cool receives Breakthrough Device Designation; Vektor Obtains FDA Clearance for vMap; Medtronic’s TMVR system; Sight Sciences’s PRECISION Trial; Alcon to buy Ivantis; Philips to acquire Cardiologs

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Smith+Nephew’s LEGION CONCELOC; Renew Bioscience’s Cerezen; Perimeter Medical’s ATLAS AI Project; SAGA Diagnostics-AZ’s Deal; Magnus Receives Breakthrough Device Designation; ReValve’s Transeptal Mitral Valve Replacement

An in-depth Assessment of the Top Drugs Launched by Leading Global Companies in the First Half of 2021 (H1)

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Biogen’s ALS drug Tofersen (BIIB067); Phathom’s erosive esophagitis drug trial; Vertex’s islet cell therapy; Natera launches lung DNA test

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Brickell to Submit New Drug Application to FDA; Twin Health Raises $140M; BMS’ Deucravacitinib; Lando Biopharma’s LABP-104 gets Approval; NIH Grant of $ 3 M to Amydis; FDA Grant to GenSight’ GS030

Evaluating the Role of Digital Therapeutics as an Alternative to Conventional Therapies for Depression

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Amber Implants VCFix spinal system; iotaMotion’s iotaSOFT Insertion System; Boston Scientific acquires Baylis; ReCor’s Paradise Ultrasound Renal Denervation; Boston Scientific’s Ranger Drug-Coated Balloon; Natera’s Prospera

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RETINA-AI Health declares positive results; Medtronic’s Hugo robotic-assisted surgery system; Boston Scientific acquires Devoro Medical; Paige obtains first-ever FDA approval

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UNION Therapeutics-Innovent’s collaboration; Delix Therapeutics bags $ 70 M; Biohaven’s Verdiperstat clinical trial result; Intra-Cellular’s CAPLYTA Phase III study

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FDA’s New Drug Application to ALS Drug; Approval to BeiGene’s Brukinsa; Roche, Temedica Forges Digital Companionship, Shares of Sage Therapeutics Rises

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Ascendis’s SKYTROFA; MicroTransponder’s VNS System (Vivistim); BioMarin’s Voxzogo; Zimmer-Canary’s Smart Knee Implant; COVID-19 impact on Solid Organ Transplants

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Sanofi bets $3.2B on mRNA; Marinus signs $30M deal with Orion; Mestag with $45M seed; Moderna secures fast track designation

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Amgen acquires Teneobio for $2.5B; Signifier scores $35M; Biogen-Ionis’ drug meets a goal; AbbVie hits go on $1B re-upped Calico deal

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MedTech Market Industry: Approval of Devices, Therapy Address Market Needs | Clinical Outcomes Create New Value

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Insilico Medicine raises $255M; Sanofi & Translate Bio initiate trial; Medtronic gains expanded FDA approval; Blackstone, Cellex & Intellia form CAR-T startup

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