Matters of legal in nature including licensing, intellectual property, and lawsuits.
Qualitative Test for the Detection of Nucleic Acid From SARS-CoV-2 IRVINE, Calif., (May 12, 2020) — Zymo Research announced today that the US Food and Drug Administration (FDA) has approved its Quick SARS-CoV-2 rRT-PCR Kit (R3011) for Emergency Use Authorization (EUA) for the detection of SARS-CoV-2, the virus that causes COVID-19. The kit is a qualitative test for the... Read more
Post-hoc analysis from 6 years of Phase III open-label extension studies showed OCREVUS treatment reduced the risk of needing a walking aid (EDSS≥6) by 49% in relapsing multiple sclerosis (RMS) patients compared with patients who switched from interferon beta-1a two years later Separate analysis showed OCREVUS slowed thalamic volume loss in patients with RMS and... Read more
FIREFISH Part 2 study met its primary endpoint by demonstrating a significant increase in motor milestones in infants aged 1-7 months after 12 months of treatment Large, pivotal global study confirms clinically meaningful efficacy seen in the dose-finding Part 1 of the trial Safety was consistent with the safety profile observed to date and no... Read more
Thermo Fisher Scientific adds Cefiderocol and Imipenem/Relebactam to manual and automated Antimicrobial Susceptibility Testing Platforms including ARIS HiQ New FDA-cleared Microbroth Dilution Susceptibility Plates offer immediate testing options to microbiology laboratories providing the most up-to-date therapy for critically ill patients BASINGSTOKE, England, April 27, 2020 /PRNewswire/ — The antimicrobials Cefiderocol and imipenem/relebactam are now available on... Read more
Biotech manufacturer recommended for continued certification to ISO 9001:2015 and ISO 13485:2016 Madison, WI USA. (April 17, 2020) Promega Corporation announced today it successfully completed its first ever fully remote quality surveillance assessment and is recommended for continued certification to ISO 9001:2015 and ISO 13485:2016. Due to COVID-19 restrictions, the British Standards Institution (BSI) completed its six-day... Read more
CHELMSFORD, Mass., April 8, 2020 /PRNewswire/ — Brooks Automation, Inc. (Nasdaq: BRKS) announced today that company management will participate in the 19th Annual Needham Virtual Healthcare Conference on Tuesday, April 14, 2020 at 10:40 a.m. ET. The 40-minute session will be webcast live via the Brooks investor relations website at www.brooks.investorroom.com/events. About Brooks AutomationBrooks (Nasdaq: BRKS)... Read more
U.S. Food and Drug Administration (FDA) extends review time for risdiplam following agreed submission of additional data, including SUNFISH Part 2 Roche has submitted filing applications for risdiplam in seven countries with submission in China imminent Risdiplam is being investigated in infants, children and adults with Type 1, 2 or 3 SMA Basel, 07 April... Read more
Thermo Fisher Scientific Continues Investments to Accelerate Biopharma Commercialization Capabilities and capacity now available to help customers of all sizes meet increasing demand for new biologics, cell and gene therapies, and drug products NEEDHAM, Mass., March 23, 2020 /PRNewswire/ — For biopharma companies faced with increasing demand for new biologics, cell and gene therapies, and drug... Read more
MENLO PARK, Calif., March 18, 2020 (GLOBE NEWSWIRE) — Pacific Biosciences of California, Inc. (Nasdaq:PACB), a leading provider of high-quality sequencing of genomes, transcriptomes and epigenomes, announced that the jury verdict in the U.S. District Court for the District of Delaware was not overall favorable for Pacific Biosciences, but mixed in terms of its findings.... Read more
The Roche Annual General Meeting 2020 will be held under conditions of the COVID-19 Ordinance 2 of the Federal Council To comply with regulatory requirements, voting at the AGM will be by independent proxy Shareholders who are physically present will be able to cast their votes through the proxy, but will not be admitted to... Read more