BC Week In Review | Jun 6, 2011
Company News

ReGen Biologics musculoskeletal news

ReGen filed suit against FDA in the U.S. District Court for the District of Columbia claiming that the agency's decision to reclassify ReGen's Menaflex collagen meniscus implant as a class III device from a class...
BC Week In Review | Mar 28, 2011
Clinical News

Menaflex collagen meniscus implant regulatory update

ReGen said it declined FDA's offer to conduct a hearing before formalizing a decision to rescind marketing clearance of ReGen's Menaflex collagen meniscus implant. ReGen said its experience with FDA "makes it clear that any...
BC Extra | Mar 23, 2011
Company News

ReGen declines FDA offer for Menaflex hearing

ReGen Biologics Inc. (Pink:RGBO) said it declined FDA's offer to conduct a hearing before formalizing a decision to rescind marketing clearance of ReGen's Menaflex collagen meniscus implant . ReGen said its experience with FDA "makes it...
BioCentury | Jan 10, 2011
Politics, Policy & Law

After Sharfstein

Principal Deputy Commissioner Joshua Sharfstein's unexpected exit from FDA has prompted Commissioner Margaret Hamburg to launch a 60-day organizational review. Drug developers will want to see whether Commissioner Hamburg is really going to tackle the...
BioCentury | Jan 3, 2011
Finance

Trickle-down effect

Although companies in the $1-$1.9 billion market cap range were the big winners for 2010 with a 28% gain, last quarter saw gains migrate into lower rungs of the market cap ladder. Small caps with...
BC Week In Review | Oct 18, 2010
Clinical News

Menaflex collagen meniscus implant regulatory update

FDA said it will rescind marketing clearance for ReGen's Menaflex collagen meniscus implant. In March, an agency panel said there was insufficient evidence that the device reinforces and repairs soft tissue injuries. FDA released a...
BioCentury | Oct 18, 2010
Finance

Regulatory milestones

Alkermes Inc. (NASDAQ:ALKS) was off $1.12 to $14.80 last week after FDA approved an sNDA to extend the label of Vivitrol naltrexone to prevent relapse to opioid use in opioid-dependent patients following opioid detoxification. The...
BC Extra | Oct 15, 2010
Company News

FDA to rescind clearance for collagen implant

FDA said it will rescind marketing clearance for Menaflex collagen meniscus implant from ReGen Biologics Inc. (OTCBB:RGBO). In March, an agency panel said there was insufficient evidence that the device reinforces and repairs soft tissue...
BioCentury | Jul 12, 2010
Regulation

Cacophony won't Help

The Avandia rosiglitazone mess epitomizes some of FDA 's biggest problems: internecine warfare; a toxic political and media atmosphere; and consequent lack of public trust. The advisory committee meeting on Avandia on Tuesday and Wednesday...
BC Week In Review | Mar 29, 2010
Clinical News

Menaflex regulatory update

FDA's Orthopedic and Rehabilitation Devices Panel said ReGen's Menaflex collagen meniscus implant was safe, but said there was insufficient evidence the device reinforces and repairs soft tissue injuries. The panel said that patient follow-ups, further...
Items per page:
1 - 10 of 39
BC Week In Review | Jun 6, 2011
Company News

ReGen Biologics musculoskeletal news

ReGen filed suit against FDA in the U.S. District Court for the District of Columbia claiming that the agency's decision to reclassify ReGen's Menaflex collagen meniscus implant as a class III device from a class...
BC Week In Review | Mar 28, 2011
Clinical News

Menaflex collagen meniscus implant regulatory update

ReGen said it declined FDA's offer to conduct a hearing before formalizing a decision to rescind marketing clearance of ReGen's Menaflex collagen meniscus implant. ReGen said its experience with FDA "makes it clear that any...
BC Extra | Mar 23, 2011
Company News

ReGen declines FDA offer for Menaflex hearing

ReGen Biologics Inc. (Pink:RGBO) said it declined FDA's offer to conduct a hearing before formalizing a decision to rescind marketing clearance of ReGen's Menaflex collagen meniscus implant . ReGen said its experience with FDA "makes it...
BioCentury | Jan 10, 2011
Politics, Policy & Law

After Sharfstein

Principal Deputy Commissioner Joshua Sharfstein's unexpected exit from FDA has prompted Commissioner Margaret Hamburg to launch a 60-day organizational review. Drug developers will want to see whether Commissioner Hamburg is really going to tackle the...
BioCentury | Jan 3, 2011
Finance

Trickle-down effect

Although companies in the $1-$1.9 billion market cap range were the big winners for 2010 with a 28% gain, last quarter saw gains migrate into lower rungs of the market cap ladder. Small caps with...
BC Week In Review | Oct 18, 2010
Clinical News

Menaflex collagen meniscus implant regulatory update

FDA said it will rescind marketing clearance for ReGen's Menaflex collagen meniscus implant. In March, an agency panel said there was insufficient evidence that the device reinforces and repairs soft tissue injuries. FDA released a...
BioCentury | Oct 18, 2010
Finance

Regulatory milestones

Alkermes Inc. (NASDAQ:ALKS) was off $1.12 to $14.80 last week after FDA approved an sNDA to extend the label of Vivitrol naltrexone to prevent relapse to opioid use in opioid-dependent patients following opioid detoxification. The...
BC Extra | Oct 15, 2010
Company News

FDA to rescind clearance for collagen implant

FDA said it will rescind marketing clearance for Menaflex collagen meniscus implant from ReGen Biologics Inc. (OTCBB:RGBO). In March, an agency panel said there was insufficient evidence that the device reinforces and repairs soft tissue...
BioCentury | Jul 12, 2010
Regulation

Cacophony won't Help

The Avandia rosiglitazone mess epitomizes some of FDA 's biggest problems: internecine warfare; a toxic political and media atmosphere; and consequent lack of public trust. The advisory committee meeting on Avandia on Tuesday and Wednesday...
BC Week In Review | Mar 29, 2010
Clinical News

Menaflex regulatory update

FDA's Orthopedic and Rehabilitation Devices Panel said ReGen's Menaflex collagen meniscus implant was safe, but said there was insufficient evidence the device reinforces and repairs soft tissue injuries. The panel said that patient follow-ups, further...
Items per page:
1 - 10 of 39