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Total 341 results found since Jan 2013.
AmerisourceBergen Specialty Group Pleads Guilty to Distributing Misbranded Drugs
On September 27, 2017, AmerisourceBergen Specialty Group (ABSG), a wholly-owned subsidiary of AmerisourceBergen Corporation, one of the nation’s largest wholesale drug companies, pled guilty to illegally distributing misbranded drugs. ABSG agreed to pay a total of $260 million to resolve criminal liability for its distribution of oncology supportive-care drugs from a facility that was not registered with the Food and Drug Administration (FDA). The guilty plea and sentencing took place before United States District Judge Nina Gershon.
As set forth in court records, between 2001 and 2014, two of ABSG’...
Source: Policy and Medicine - October 17, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Fight Aging! Newsletter, October 16th 2017
In this study, we have shown that the lipid chaperones FABP4/FABP5 are critical intermediate factors in the deterioration of metabolic systems during aging. Consistent with their roles in chronic inflammation and insulin resistance in young prediabetic mice, we found that FABPs promote the deterioration of glucose homeostasis; metabolic tissue pathologies, particularly in white and brown adipose tissue and liver; and local and systemic inflammation associated with aging. A systematic approach, including lipidomics and pathway-focused transcript analysis, revealed that calorie restriction (CR) and Fabp4/5 deficiency result ...
Source: Fight Aging! - October 15, 2017 Category: Research Authors: Reason Tags: Newsletters Source Type: blogs
Fight Aging! Newsletter, October 9th 2017
In this study, we investigated the Hippo pathway, which is known from my lab's previous studies to prevent adult heart muscle cell proliferation and regeneration. When patients are in heart failure there is an increase in the activity of the Hippo pathway. This led us to think that if we could turn Hippo off, then we might be able to induce improvement in heart function."
"We designed a mouse model to mimic the human condition of advanced heart failure. Once we reproduced a severe stage of injury in the mouse heart, we inhibited the Hippo pathway. After six weeks we observed that the injured hearts had recovered the...
Source: Fight Aging! - October 8, 2017 Category: Research Authors: Reason Tags: Newsletters Source Type: blogs
Towards the Recognition of Aging as a Treatable Medical Condition
In recent years numerous groups have made a start on the long road of changing the public view of aging, from considering it a normal state to considering it a pathological state. To have it recognized as a harmful medical condition that can in principle be treated - that medical technologies can be developed for this purpose soon enough to matter. This is a process of unofficial advocacy and persuasion on the one hand, to change minds and educate people, but on the other there is also a strong component of formalism, of working with regulatory definitions. Medical research and development is, sadly, heavily regulated. The...
Source: Fight Aging! - October 6, 2017 Category: Research Authors: Reason Tags: Activism, Advocacy and Education Source Type: blogs
Latest Legal Settlements Suggest Hazards of Making Pharmaceutical Regulation More Lenient, as is Apparently Favored by New FDA Leader
DiscussionAll the cases discussed above were of behavior that could have harmed patients. Many of the companies involved had records of previous ethical misadventures. While a few cases resulted in corporate guilty pleas (to misdemeanors), none resulted in monetary penalties that would have much impact on the companies ' finances, and none resulted in any negative consequences for people who enabled, authorized, directed or implemented the bad behavior.These, just the latest in the march oflegal settlements by large health care organizations, again demonstrate how often and how seriously pharmaceutical companie...
Source: Health Care Renewal - October 1, 2017 Category: Health Management Tags: adulterated drugs Celgene crime deception FDA impunity legal settlements market fundamentalism Novo Nordisk revolving doors thalidomide Source Type: blogs
The Science and Technology of Liquid Biopsies Improving Rapidly
I have blogged about liquid biopsies over the course of seven years (see, for example:Does the New Term"Liquid Biopsy" Make Any Sense?;Rapid Adoption of the Term"Liquid Biopsy" on the Web;"Liquid Biopsy" Used to Refer to Detection of Any Serum Cancer DNA). The procedure has the potential to revolutionize both the diagnosis and monitoring of malignant lessons. A recent article discussed the technology in detail (see:Going With the Flow: The Promise and Challenge of Liquid Biopsies). I offer below only a short excerpt from the article. Be sure to read the whole thing if you are interested....
Source: Lab Soft News - September 23, 2017 Category: Laboratory Medicine Authors: Bruce Friedman Tags: Clinical Lab Industry News Clinical Lab Testing Food and Drug Administration Lab Industry Trends Lab Processes and Procedures Medical Research Surgical Pathology Source Type: blogs
Caution Warranted As VA Incorporates ICER Value Assessments Into Formulary Management Process
The Department of Veterans Affairs (VA) Pharmacy Benefits Management Services and the Institute for Clinical and Economic Review (ICER) recently announced a collaboration in which the VA will use the ICER’s drug assessments as part of its formulary development and price negotiations. This type of relationship might be normal outside of the United States (for example, in the United Kingdom, Germany, and Australia), where input from governmental health technology assessment organizations is used in determining health care coverage decisions. However, in the United States—with our multipayer health care system coverin...
Source: Health Affairs Blog - September 18, 2017 Category: Health Management Authors: Robert Dubois Tags: Costs and Spending Drugs and Medical Innovation Insurance and Coverage Payment Policy Population Health Department of Veterans Affairs drug pricing Institute for Clinical and Economic Review pharmaceuticals quality of care Veterans' He Source Type: blogs
The $475,000 drug
The US Food and Drug Administration recently approved the first gene therapy, Kymriah, to treat B-cell acute lymphoblastic leukemia. It uses a lentivirus to modify the patient’s T cells to kill tumor cells.
Acute lymphoblastic leukemia, or ALL, is caused by uncontrolled growth of B cells, which normally produce antibodies to fight off infections. It is the most common cancer in children. The uncontrolled production of these cells by the bone marrow causes a shortage of blood cell production, leading to fever, increased risk of infection, and anemia. These B cells have on their surfaces a protein called B19 – wh...
Source: virology blog - September 15, 2017 Category: Virology Authors: Vincent Racaniello Tags: Basic virology Information ALL B cell B-cell acute lymphoblastic leukemia B19 CAR chimeric antigen receptor gene therapy Kymriah lentivirus viral viruses Source Type: blogs
Celgene Settles Whistleblower Suit for $280 Million
Late July 2017, Celgene Corp., a manufacturer of pharmaceuticals, agreed to pay $280 million to settle fraud allegations related to the promotion of two cancer treatment drugs for uses not approved by the United States Food and Drug Administration (FDA).
The settlement resolves allegations brought in a “whistleblower” lawsuit that Celgene promoted two cancer drugs – Thalomid and Revlimid – for uses that were not approved by the FDA and not covered by federal health care programs. The allegations included the use of false and misleading statements about the drugs, and paying kickbacks to physicians to induce them t...
Source: Policy and Medicine - September 8, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Cracks Down on Some Stem Cell Clinics for Unproven Treatments
The FDA is still working to protect the U.S. population from medical chicanery while some of the federal government is wasting money, frittering away time, and trying to harm people. The new target for the agency is stem cell clinics and purveyors of"regenerative medicine" (see:FDA cracks down on stem-cell clinics, including one using smallpox vaccine in cancer patients). Below is an excerpt from the article:The Food and Drug Administration...announced a crackdown on stem-cell clinics offering unproven and potentially dangerous treatments, including an operation in California that the agency said was using the sm...
Source: Lab Soft News - September 5, 2017 Category: Laboratory Medicine Authors: Bruce Friedman Tags: Food and Drug Administration Healthcare Business Lab Processes and Procedures Lab Regulation Lab Standards Medical Consumerism Medical Education Medical Ethics Medical Research Quality of Care Source Type: blogs
Oral Contraceptives Should be Free (From the Third-Party Trap)
An argument will soon erupt over the fate of the Affordable Care Act ’s mandate that requires health insurance to cover oral contraceptives at no direct out of pocket cost to the patient. This mandate was never explicitly listed in the ACA as one of the “essential health benefits.” Its inclusion was made at the discretion of the HHS Secretary. According to pres sreports, the Trump Administration is about to relax the requirement.The arguments made in favor of loosening the mandate mostly revolve around the employers ’ right to freedom of conscience. Meanwhile, some advocacy groups fear this will mean many women won...
Source: Cato-at-liberty - September 5, 2017 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs
Making Smoking Cessation Work For People With Mental Illnesses And Other Vulnerable Populations
The prevalence of cigarette smoking among adults is now at a modern low of 15 percent, and youth rates are also down for high school seniors, with only 3.4 percent smoking daily. Yet this is not a time to become complacent and move on to other public health problems. As many as 40 million people still smoke, and half of them will die prematurely as a result. Furthermore, smoking rates remain high among the most vulnerable populations, such as people with mental illnesses or substance use disorders, necessitating policies and strategies targeted specifically at them, as well as support for tobacco control at the federal, st...
Source: Health Affairs Blog - August 23, 2017 Category: Health Management Authors: Steven Schroeder Tags: Featured Health Equity Population Health Public Health Behavioral Health Mental Illness smoking cessation Substance Use Disorders vulnerable populations Source Type: blogs
Combination hormonal therapy boosts survival in men with aggressive prostate cancer
A standard approach for treating aggressive prostate cancer is to give therapies that block testosterone, a tumor-stimulating hormone. Should initial hormonal therapies fail, doctors can switch to other drugs that suppress testosterone in different ways. One of them, a drug called abiraterone, has been shown to significantly extend lifespans in men who have become resistant to other hormonal treatments.
But in June, two major studies reported simultaneously that abiraterone also prolongs life in men with aggressive prostate cancer that’s been newly diagnosed. One of the studies, a phase 3 clinical trial called LATITUDE, ...
Source: Harvard Health Blog - August 18, 2017 Category: Consumer Health News Authors: Charlie Schmidt Tags: Cancer Health Men's Health Prostate Health Source Type: blogs
To Speed Access To Compassionate Use, Look Beyond The FDA
In mid-July, the nonpartisan research arm of the federal government, the Government Accountability Office (GAO), released its long-awaited verdict on how the Food and Drug Administration (FDA) is handling compassionate use. As anyone who saw Dallas Buyers Club knows, compassionate use (also known as pre-approval access and expanded access) is when a drug company allows a patient who has no other treatment options to try a drug that is still in development and not FDA approved for use or sale. These patients are generally too sick to participate in a clinical trial—which has inclusion and exclusion criteria to try t...
Source: Health Affairs Blog - August 10, 2017 Category: Health Management Authors: Alison Bateman-House Tags: Drugs and Medical Innovation Population Health Quality Compassionate Use expanded access Food and Drug Administration right-to-try laws Source Type: blogs
FDA Issues Two Proposed Studies on Disclosures for Advertising
Last month, the FDA issued two proposed studies on disclosures for advertising: one for general advertising and another for oncology advertising. Both studies have comment periods that end on August 18, 2017.
For both proposals, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality,...
Source: Policy and Medicine - August 8, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
