ReGen Biologics wins round in battle with the FDA over its MenaFlex knee implant | Medtech legal news for the week of October 6, 2014
ReGen Biologics Inc.
Appeals court vacates FDA’s rescission of ReGen’s MenaFlex implant
Inside stock traders gain jail time for Stryker case | Medtech legal news for the week of Apr. 14, 2014
ReGen Biologics appeals loss to FDA
ReGen Biologics’ long battle against the FDA entered a new phase this year, with the medical device company’s appeal in a lawsuit it filed against the watchdog agency, its top regulator and the secretary of the U.S. Health & Human Services Dept. over the FDA’s decision to rescind the clearance granted to ReGen’s Menaflex knee implant.
Bankrupt ReGen terminates its stock
ReGen Biologics Inc. (OTC:RGBO) terminated its common stock registration in connection with its bankruptcy proceedings connected to the FDA’s rescission of 510(k) clearance for the company’s Menaflex knee implant.
Earlier this month ReGen sued the FDA, it’s top regulator and the secretary of the U.S. Dept. of Health & Human Services, accusing them of overstepping their bounds in rescinding the clearance.
ReGen Biologics sues FDA over 510(k) rescission
ReGen Biologics Inc. sued the FDA, its top regulator and the secretary of the U.S. Dept. of Health & Human Services, accusing them of overstepping their bounds in rescinding a clearance for ReGen’s Menaflex knee implant earlier this year.
Judge rules no infringement in Medtronic patent spat with Boston Scientific | Legal Roundup
Bankrupt ReGen gets another cash infusion through investor | Funding roundup
Bankrupt ReGen Biologics Inc. (OTC:RGBO) took out a loan from a company affiliated with one of its investors. The new debt represents Regen’s second financing deal with the company since filing for Chapter 11 bankruptcy two weeks ago.
Regen Biologics files for bankruptcy
ReGen Biologics Inc. (PINK:RGBO) filed for Chapter 11 bankruptcy protection with the U.S. Bankruptcy Court for the District of Delaware.
FDA makes ReGen 510(k) rescission final
ReGen Biologics Inc. (OTC:RGBO) is weighing options for the Menaflex knee implant the FDA forced off the market last week.
The agency rescinded its 2008 510(k) clearance for the Hackensack, N.J.-based company’s embattled bio-absorbable knee implant last October. Last month ReGen rebuffed an offer from the FDA for a final hearing on the decision.
ReGen Biologics: We’re too broke to file our annual report
ReGen Biologics Inc. (PINK:RGBO) doesn’t have enough money to pay for its annual earnings filing with the Securities & Exchange Commission.
