In another stunning and surprising ruling to come out of the prosecution of Lauren Stevens, a former in-house counsel for GlaxoSmithKline, for obstructing an FDA investigation into off-label marketing, the […]
Geron Corp. has announced, as part of its landmark Phase I clinical trial, that a second patient has received an embryonic stem cell injection. The patient, who recently suffered a severe spinal cord injury, received the injection at Northwestern Memorial Hospital and will undergo rehabilitation at the Rehabilitation Institute of Chicago. In August, 2010, we reported that the U.S. Food and Drug Administration (FDA) announced the “go ahead” for the world’s first authorized human trial of an embryonic stem cell treatment.
The purpose of the trial is to establish the safety of the embryonic stem cells, in addition to establishing that the cells will effectively travel to the site of a recent spinal cord injury and help restore the damaged nerves. The team will look to see if the stem cells improve the patient’s control or sensation in the trunk or legs.
The first patient to undergo the procedure, over six months ago, has not had any serious side effects. However, it is still too early to determine whether the patient’s control or sensation has improved.
On May, 2, 2011, the United States District Court for the District of Columbia granted the FDA’s Motion to Dismiss a lawsuit brought by Mylan Pharmaceuticals (“Mylan”) seeking injunctive and declaratory relief for alleged violations of the Administrative Procedure Act (“APA”) by the FDA in the approval process of several Abbreviated New Drug Applications (“ANDA”) for the brand-name drug Lipitor.
The U.S. Food and Drug Administration (FDA) today issued the first rules under the FDA Food Safety Modernization Act (FSMA). As we previously reported, President Obama signed the FSMA in January of this year to help ensure the safety and security of foods in the United States.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-05-05 14:34:102025-12-09 14:14:44FDA Issues First New Rules under the Food Safety Modernization Act
We recently reported the U.S. Food and Drug Administration’s (“FDA’s”) announcement of its intent to remove approximately 500 unapproved cold, cough, and allergy drugs from the United States market.
The U.S. Patent and Trademark Office recently granted a patent (U.S. Patent No. 7,901,672) for a method of enriching a patient’s own fat with their own adipose derived stem and regenerative cells (ADRCs) to create a cell-enriched fat graft.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-05-02 07:44:122014-11-10 18:20:20U.S. Patent and Trademark Office Grants Patents for Methods of Making Stem and Regenerative Cell-Enriched Fat Grafts
Today, the United States Court of Appeals for the District of Columbia overruled, 2-1, a district court judges preliminary injunction on federal funding of research using embryonic stem cells (ESCs). […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-04-29 15:49:542025-12-09 14:15:09Sherley V. Sebelius: Federal Appeals Court Vacates Preliminary Injunction on NIH Funding for Embryonic Stem Cell Research
On April 26, 2011, the Office of Foreign Assets Control (“OFAC”) of the U.S. Department of the Treasury announced that it had reached a settlement with HCC Insurance Holdings, Inc. (“HCC”) over alleged violations of the Iranian Transactions Regulations (“ITR”). The ITR, which are found at 31 C.F.R. part 560, were promulgated pursuant to the International Emergency Economic Powers Act and are administered by OFAC. General information regarding economic sanctions against Iran can be found at OFAC’s website here.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-04-27 13:57:312014-11-10 18:20:33HCC Insurance Holdings, Inc. Reaches Settlement With OFAC Over Alleged Violations of Iranian Transactions Regulations.
On April 15, 2011, Judge Ellen Segal Huvelle of the United States District Court for the District of Columbia granted the FDA’s motion to dismiss a lawsuit brought by ViroPharma, Inc. (“ViroPharma”) under the Administrative Procedure Act (“APA”) challenging the FDA’s Abbreviated New Drug Application (“ANDA”) bioequivalent regulations. A copy of the Court’s opinion can be read here.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-04-27 08:28:002026-01-07 15:06:29Court Dismisses Drug Manufacturer’s Suit Against FDA Challenging Bioequivalence Regulations For Lack of Standing
During the first week in April, a federal judge granted the U.S. Food and Drug Administration (FDA) summary judgment in a federal case brought by dietary supplement manufacturers challenging good […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-04-26 15:35:572025-12-09 14:15:09FDA Modification to Dietary Supplement Qualified Health Claims Remanded by Federal Court
Former in-house counsel for GlaxoSmithKline acquitted
In another stunning and surprising ruling to come out of the prosecution of Lauren Stevens, a former in-house counsel for GlaxoSmithKline, for obstructing an FDA investigation into off-label marketing, the […]
Second Patient Receives Embryonic Stem Cell Treatment in Gerons Clinical Trial
Geron Corp. has announced, as part of its landmark Phase I clinical trial, that a second patient has received an embryonic stem cell injection. The patient, who recently suffered a severe spinal cord injury, received the injection at Northwestern Memorial Hospital and will undergo rehabilitation at the Rehabilitation Institute of Chicago. In August, 2010, we reported that the U.S. Food and Drug Administration (FDA) announced the “go ahead” for the world’s first authorized human trial of an embryonic stem cell treatment.
The purpose of the trial is to establish the safety of the embryonic stem cells, in addition to establishing that the cells will effectively travel to the site of a recent spinal cord injury and help restore the damaged nerves. The team will look to see if the stem cells improve the patient’s control or sensation in the trunk or legs.
The first patient to undergo the procedure, over six months ago, has not had any serious side effects. However, it is still too early to determine whether the patient’s control or sensation has improved.
Court Dismisses Mylan Pharmaceuticals Lawsuit Over Lipitor Generic ANDAs On Standing and Ripeness Grounds
On May, 2, 2011, the United States District Court for the District of Columbia granted the FDA’s Motion to Dismiss a lawsuit brought by Mylan Pharmaceuticals (“Mylan”) seeking injunctive and declaratory relief for alleged violations of the Administrative Procedure Act (“APA”) by the FDA in the approval process of several Abbreviated New Drug Applications (“ANDA”) for the brand-name drug Lipitor.
FDA Issues First New Rules under the Food Safety Modernization Act
The U.S. Food and Drug Administration (FDA) today issued the first rules under the FDA Food Safety Modernization Act (FSMA). As we previously reported, President Obama signed the FSMA in January of this year to help ensure the safety and security of foods in the United States.
Two Pharmaceutical Companies File Lawsuits in Response to FDA’s DESI Decisions
We recently reported the U.S. Food and Drug Administration’s (“FDA’s”) announcement of its intent to remove approximately 500 unapproved cold, cough, and allergy drugs from the United States market.
U.S. Patent and Trademark Office Grants Patents for Methods of Making Stem and Regenerative Cell-Enriched Fat Grafts
The U.S. Patent and Trademark Office recently granted a patent (U.S. Patent No. 7,901,672) for a method of enriching a patient’s own fat with their own adipose derived stem and regenerative cells (ADRCs) to create a cell-enriched fat graft.
Sherley V. Sebelius: Federal Appeals Court Vacates Preliminary Injunction on NIH Funding for Embryonic Stem Cell Research
Today, the United States Court of Appeals for the District of Columbia overruled, 2-1, a district court judges preliminary injunction on federal funding of research using embryonic stem cells (ESCs). […]
HCC Insurance Holdings, Inc. Reaches Settlement With OFAC Over Alleged Violations of Iranian Transactions Regulations.
On April 26, 2011, the Office of Foreign Assets Control (“OFAC”) of the U.S. Department of the Treasury announced that it had reached a settlement with HCC Insurance Holdings, Inc. (“HCC”) over alleged violations of the Iranian Transactions Regulations (“ITR”). The ITR, which are found at 31 C.F.R. part 560, were promulgated pursuant to the International Emergency Economic Powers Act and are administered by OFAC. General information regarding economic sanctions against Iran can be found at OFAC’s website here.
Court Dismisses Drug Manufacturer’s Suit Against FDA Challenging Bioequivalence Regulations For Lack of Standing
On April 15, 2011, Judge Ellen Segal Huvelle of the United States District Court for the District of Columbia granted the FDA’s motion to dismiss a lawsuit brought by ViroPharma, Inc. (“ViroPharma”) under the Administrative Procedure Act (“APA”) challenging the FDA’s Abbreviated New Drug Application (“ANDA”) bioequivalent regulations. A copy of the Court’s opinion can be read here.
FDA Modification to Dietary Supplement Qualified Health Claims Remanded by Federal Court
During the first week in April, a federal judge granted the U.S. Food and Drug Administration (FDA) summary judgment in a federal case brought by dietary supplement manufacturers challenging good […]