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Judge temporarily halts Illinois regs' equal benefits provision

Illinois may not require industrial staffing firms at this time to provide temporary workers with benefits equal to directly employed workers, judge rules.

Illinois , United-states , American , Thomas-durkin , Staffing-services-association-of-illinois , Labor-services , American-staffing-association , Daily-newsview-all , Illinois-general-assembly , Illinois-day , Temporary-labor-services , Staffing-services-association

Judge rejects NLRB joint-employment rule

A federal judge in Texas rejected a new joint-employment rule put forth by the National Labor Relations Board. The rule was previously stayed until March 11.

Texas , United-states , J-campbell-barker , Lauren-mcferran , Fiona-coombe , Littler-mendelson , National-labor-relations-board , Associated-press , Daily-newsview-all , Regulatory , Oint-employment ,

Beijing's 'broker butcher' sparks state-driven stock rally

Wu Qing, the new head of the China Securities Regulatory Commission, had been in the job for less than a month when he took to the stage for a high-profile...

Hong-kong , China , Beijing , Shenzhen , Guangdong , Shanghai , Wu-qing , Tianjin , Chinese , Kinger-lau , Yi-huiman , Fraser-howie

Biosense Webster continues PFA approval trend, nabs CE mark for Varipulse

Continuing the spate of regulatory approvals for pulsed field ablation (PFA) devices around the world, Johnson & Johnson’s Biosense Webster Inc. unit secured CE mark for the Varipulse platform for treatment of symptomatic, drug-refractory recurrent paroxysmal atrial fibrillation.

Johnson-biosense-webster-inc , Biosense-webster , Bioworld-medtech , Biosense-webster-inc- , Us- , Ce-mark , Johnson-amp , Boston-scientific-corp- , Medtronic-plc , Farapulse-inc- , Varipulse

The need for principle-based regulatory practice

DEALING with government agencies is one of the pain points that many Filipinos struggle with because of the historical difficulty (and for some notoriety) of government offices. It is nothing new for Filipinos to see long lines (actual or virtual), slow or delayed processing, repetitive or redundant requirements, and condescending government employees at times.

Philippines , Filipinos , The , Need , For , Principle-based , Regulatory , Practice ,

Teva, Alvotech land approval with edge in Humira biosimilar race

Abbvie Inc.’s blockbuster drug Humira is getting a 10th challenger that could give all the other adalimumab biosimilars a run for their money – depending on pricing and formulary coverage, of course. After delays caused by the COVID-19 pandemic and manufacturing issues, the U.S. FDA approved Simlandi, previously known as AVT-02, as a Humira biosimilar and interchangeable Feb. 23.

Abbvie-inc , Humira , Abbvie-inc- , Adalimumab , Simlandi , Interchangeable , Teva-pharmaceutical-industries-ltd- , Alvotech-holdings-sa , Bioworld , Regulatory , Us-

Virtual Incision's miniature robotic surgery device gets FDA nod

The U.S. FDA granted Virtual Incision Corp. de novo marketing authorization for its miniaturized in vivo robotic assistant for use in colectomy procedures in adults. The two-pound device offers portability and quick setup, eliminating the need for specialized operating rooms or arrangements to accommodate robotics.

Virtual-incision-corp , Virtual-incision , Bioworld-medtech , Virtual-incision-corp- , Coloectomy- , Miniaturized-in-vivo-robotic-assistant , Mira , Robotic-surgical-systems , Intuitive-surgical-inc- , Momentis-surgical-ltd- , Medtronic-plc

Finmin, RBI to look at ownership change in fintech cos for compliance

The finance ministry and RBI will focus on ownership change of listed fintech companies to ensure regulatory compliance. Virtual meetings, workshops,

India , Paytm-payments-bank , Department-for-promotion-of-industry , Paytm-payments-banks , Internal-trade , Startup-companies , Regulatory , Rbi , Ownership-change , Innovative-solutions , Fintech-companies

Zimmer Biomet wins new FDA clearance of Rosa robotic shoulder system

Zimmer Biomet Holdings Inc.’s Rosa robotics surgical assistant snapped up its fourth application with the U.S. FDA’s 510(k) clearance for use in shoulder replacement surgery. Over the past five years, the system has built a portfolio that includes partial and total knee replacement and total hip replacement.

Zimmer-biomet-holdings-inc , Zimmer-biomet-holdings , Bioworld-medtech , Zimmer-biomet-holdings-inc- , Shoulder-arthroplasty , Robotic-assisted-surgery , Rosa-surgical-assistant , Rosa-shoulder , Video-interventionelle-médicale-scientifique-sas , Vims-sas , Orthopedics

FDA issues CRL for Venatorx's antibiotic combo in UTIs

The good news is that the U.S. FDA’s complete response letter (CRL) for Venatorx Pharmaceuticals Inc.’s intravenous antibiotic combination, cefepime-taniborbactam, in complicated urinary tract infections (cUTIs) requested no additional clinical testing. The bad news is the inevitable delay for a drug Venatorx and partner Melinta Therapeutics Inc. are aiming to position as a much-needed option for the fight against drug-resistant gram-negative infections.

Melinta-therapeutics-inc , Venatorx-pharmaceuticals-inc , Venatorx-pharmaceuticals , Melinta-therapeutics , Complicated-urinary-tract-infections , Cuti , Cefepime-taniborbactam , Crl , Complete-response-letter , Venatorx-pharmaceuticals-inc- , Bioworld