BioSpace News Archive

Abiomed (NASDAQ: ABMD) announces new PROTECT III study data that demonstrates reduced rates of MACCE (composite of death, stroke, myocardial infarction and repeat procedures) when Impella is used to achieve a more complete revascularization in a single setting for high-risk percutaneous coronary intervention (PCI) patients. PROTECT III is an ongoing, prospective, single-arm FDA post-approval study for the PMA approval

Agilent Technologies Inc. (NYSE: A) today announced that the Agilent Vaya Raman raw material identity verification system has received a 2020 R&D 100 Award in the Analytical/Test category. The worldwide competition, held by R&D World , recognizes R&D pioneers and their revolutionary contributions to science an

Tenax gains developmental and commercial rights for a fully-developed oral levosimendan formulation in the U.S. and Canada Oral formulation expected to be used in upcoming Phase 3 registration trial

Consistent and robust benefit seen in post hoc exploratory analyses of patients with a history of PCI across the hierarchy of endpoints prespecified for the full study cohort

DaVita Inc. (NYSE: DVA), announced today that it will hold its quarterly conference call to discuss third quarter results on Thursday, October 29, 2020 , at 5:00 p.m. Eastern Time . The company plans to release its results after market close the same day. This call is also being webcast and can be accessed at the DaVita IR web pa

- Today, the U.S. Food and Drug Administration (FDA) reissued the Emergency Use Authorization (EUA) for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH).

- After consultation with the FDA, the company can conduct a hybrid registration trial that allows for the use of matched external controls for two-thirds of control arm - - The design sets a new precedent for GBM clinical trials, allowing robust OS analysis and significantly reduces the number of trial participants randomized to standard of care therapies - - Reduced enrollment requirements in the control arm can substantially lower trial costs and expedite timelines for regulatory approval

ProCure Proton Therapy Center in Somerset, New Jersey, passed another celebratory achievement with the graduation of its 5,000th patient to complete treatment, in this case for prostate cancer.

Conformal Medical, Inc. , a privately held medical device company developing next generation left atrial appendage closure (LAAC) technology, today announced positive clinical data from First-in-Human studies pe

On September 24 , 111, Inc. (NASDAQ: YI) (the “Company” or “111") and Hainan Huluwa Pharmaceutical Group Co., Ltd. (SH: 605199) (“Huluwa Pharmaceutical”) signed a strategic partnership agreement in Shanghai . Mrs. LIU Jingping, Chairperson of Huluwa Pharmaceutical, and Dr. YU Gang, Co-founder and Executive Chairman of 111, attended