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Ocular Therapeutix’s dry eye disease insert fails in phase 2 trial Ocular Therapeutix declared that its OTX-CSI (cyclosporine intracanalicular insert) for dry eye disease (DED) has flunked to reach the primary endpoint in the phase 2 clinical trial. The company has conducted the US-based, randomised, double-m...

Hologic to acquire Bolder Surgical for USD160 Million, expanding its Surgical Franchise  On October 14, 2021, Hologic, Inc., a global player in women's health, signed a definitive agreement to acquire Bolder Surgical. This US-based company offers advanced energy vessel sealing surgical devices for approxima...

Biogen’s tofersen fails to meet the primary goal in the Phase III ALS trial Biogen has announced that its investigational antisense drug, tofersen (BIIB067), flunked to meet the primary goal of Phase III VALOR clinical trial in superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS) patients. Althou...

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...

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...

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...

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...

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 ...

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 ...

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...