news
Oct 14, 2021
Bausch + Lomb’s LuxSmart Intraocular Lenses; Movair’s Luisa Life Supporting Ventilator; Cochlear’s Nucleus and Baha Systems; Laborie Acquires Pelvalon; Know Labs’s SARS-CoV-2 Research; Syntellix’s MAGNEZIX;
Syntellix obtains product approval for India On October 07, 2021, Syntellix obtained the license to bring five different product families of its revolutionary bioabsorbable magnesium-based implants to market from India's Central Drugs Standard Control Organisation (CDSCO) for the Indian market. With this approva...
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Oct 12, 2021
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
Brickell Plans to Submit New Drug Application to FDA for gel Brickell Biotech will request the FDA in mid-2022 to approve its gel for excessive underarm sweating after decreasing sweat production and disease severity in two pivotal trials. The gel achieved statistical significance in lessening the sever...
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Oct 07, 2021
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
Amber Implants VCFix® spinal system obtains US FDA Breakthrough designation On October 05, 2021, the US Food and Drug Administration (FDA) granted the Breakthrough Device Designation to VCFix® spinal system, a next-generation spinal implant for spinal injuries developed by Amber Implants, a Netherlands-bas...
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Oct 05, 2021
Pfizer tightens DMD trial criteria over safety concerns; Kytopen raises $30M; Eli Lilly taps Reify’s Care Access; Vensana Capital raises $325M
Pfizer tightens DMD patient criteria after serious adverse events in phase 3 gene therapy trial Pfizer is tightening up the criteria for Duchenne muscular dystrophy patients to partake in phase 3 clinical trials of its experimental gene therapy after three severe events were cropping up in ongoing studies. Th...
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Sep 30, 2021
RETINA-AI Health declares positive results; Medtronic’s Hugo robotic-assisted surgery system; Boston Scientific acquires Devoro Medical; Paige obtains first-ever FDA approval
RETINA-AI Health, Inc. declares positive pivotal study results for the RETINA-AI Galaxy™ autonomous Diabetic Retinopathy screening device On September 20, 2021, RETINA-AI Health, Inc. announced optimistic results from the pivotal study of the RETINA-AI Galaxy™, a multi-device compatible autonomous ...
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Sep 28, 2021
UNION Therapeutics-Innovent’s collaboration; Delix Therapeutics bags $ 70 M; Biohaven’s Verdiperstat clinical trial result; Intra-Cellular’s CAPLYTA Phase III study
Innovent, UNION Therapeutics Set to Advance Dermatology Market in China Innovent Biologics and UNION therapeutics have announced a strategic and licensing collaboration to develop and commercialize Orismilast, a next-generation PDE4 inhibitor for inflammatory dermatology conditions in China. Orismilast ...
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Sep 23, 2021
Boston Scientific pays $336M; Boehringer Ingelheim acquires Abexxa Biologics; Oncology, RNA biotech 858 Therapeutics inks $60M Series A; Novartis acquires Arctos Medical
Boston Scientific pays USD 336 Million to acquire blood clot medical device firm Boston Scientific Corp. is shelling out as much as USD 336 million to take over the rest of medical device firm Devoro Medical, which it has held a stake in since 2019. The payment comprises USD 269 million paid upfront for the 8...
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Sep 21, 2021
Biogen’s AMD Biosimilar Gets Approval; SmartLabs Series B Funding; BARDA, Partner Therapeutics in Sepsis Space; Synlogic to Explore Sepsis Market Domain
Win-win for Biogen as its Biosimilar Gets Approval for AMD Samsung Bioepis and Biogen's biosimilar drug, Byooviz, received USFDA approval for the treatment of vision loss, Age-related macular degeneration and has become the first biosimilar to Lucentis in the AMD market. The Lucentis copycat had also manag...
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Sep 16, 2021
FDA’s New Drug Application to ALS Drug; Approval to BeiGene’s Brukinsa; Roche, Temedica Forges Digital Companionship, Shares of Sage Therapeutics Rises
FDA’s Go-Ahead to Amylyx New Drug Application for ALS Drug Amylyx Pharmaceuticals has announced its plan to submit a New Drug Application (NDA) to the U.S. FDA for its drug, AMX0035 (sodium phenylbutyrate (PB) and Taurursodiol (TURSO)), for the treatment of Amyotrophic lateral sclerosis (ALS). A f...
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Sep 14, 2021
ADARx Raises $75M Series B; Fast Track Designation for Vor Biopharma’s drug; Ixaka’s cell therapy clears phase 3; Breakthrough Device Designation to NovoTTF-200T™ System
ADARx bags USD 75 Million to advance its RNA tech pipeline ADARx Pharmaceuticals, a biotechnology company developing RNA targeting therapeutics, announced the completion of a USD 75 million Series B financing to progress its drug development pipeline. SR One Capital Management and OrbiMed Advisors co-led Series ...
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