Sentences with phrase «compassionate use»

Despite some small scale programmes for compassionate use of new life - saving drugs such as bedaquiline and delamanid, there is no widespread access in India meaning these drugs remain unavailable to patients who need them most.

Still, an exception was once made for compassionate use of an Ebola therapy.

As the outbreak in West Africa worsened, debates intensified among scientists, government officials, and company executives about bringing some of these unapproved products to Africa on a so - called compassionate use basis — after all, «something is better than nothing,» Ollman Saphire says.

«Much more ethical work needs to be done to create a sound infrastructure for compassionate use in humanitarian emergencies, «Caplan writes.

The remainder of the litigation, against the United States government for the alleged involvement of federal employees in administering plaintiff's compassionate use protocol, was ultimately dismissed a couple of months ago on grounds of sovereign immunity.

As the outbreak worsened, debates intensified among scientists, government officials, and company executives about bringing some of these unapproved products to Africa on a so - called compassionate use basis.

We also treat other cases under compassionate use.

In particular, the Council of State found that patients may be enrolled in compassionate use programmes or supplied with a medicine listed in the so - called 648 List after the product has obtained a marketing authorization, at least until the company starts to commercialize it in Italy.

In 2014, she revealed the agonizing decision - making behind Compassionate Use of unapproved drugs, and in 2016, she reported extensively on drug pricing controversies and the impact of politics on development of new medicines.

What it really needed was a patient who was dying of a multi-drug resistant infection, that antibiotics no longer worked for so that compassionate use approval could be obtained from the FDA.

Long - term compassionate use of oclacitinib in dogs with atopic and allergic skin disease: safety, efficacy and quality of life.

-- Left to Right: Jeffrey Schaffer, DVM Director Vet Professional Services VetStem Biopharma Senior Practice Manager Sioux Sciacca Jennifer Steiger, DVM Stem Cell Therapy Compassionate Use Certified

Mike is highly knowledgeable about the Illinois Compassionate Use of Medical Cannabis Pilot Program Act and the medical and recreational cannabis laws of many other states.

In any event, Ward is a stark reminder that litigants will sue over anything, even the most benignly intended programs like compassionate use / RTT if they think there's a buck to be made in damages.

MB - 003 and ZMAb were early formulations used in proof - of - principle trials that led to the more advanced formulation, ZMapp, currently in development and authorized for compassionate use in the West African Ebola outbreak response.

Chan emailed the twins» mother, who told him what to do to get Galya on the treatment, and then asked Wang if he'd be willing to apply on his daughter's behalf for compassionate use of cyclodextrin.

The relief of human suffering, of whatever kind, the liberation of human beings from fear, ignorance and evil, the compassionate use of human talents and personality — all these are shown to be of the highest importance.

«We said to pharmaceutical companies that we needed access to their drugs on the grounds of compassionate use,» she says.

Jacobson views the FDA's efforts to extend the compassionate use policy as the better way to handle the issue.

(One of Hempel's daughters suffered a stroke after ICV administration of cyclodextrin, although not as part of the NIH trial; it was being administered separately under a compassionate use protocol approved by the Food and Drug Administration.)

But Chan and Turner wondered if the agency might grant a «compassionate use» exception for patients who couldn't be cured with antibiotics.

Some experts say any treatments should not be given on a compassionate use basis, but should be part of a carefully conducted clinical trial, so as to learn as much about a compound's efficacy as possible.

But the source told ScienceInsider that FDA approved its use in the two patients after a request from a physician at Emory University in Atlanta who used the expanded access rules, which allow the emergency use of unapproved medicines on a «compassionate use» basis.

Currently, the toxins are still available on a «compassionate use» basis in nine countries, including Germany and the Bahamas; one clinic in the United States also uses a preparation based on Coley's toxins.

The Wikipedia page also linked to stories about twin 5 - year - old girls who in 2009 had become the first Americans to fight NPC with an experimental treatment called cyclodextrin — but only after their parents had spent years pressing for «compassionate use» of the investigational drug outside of a clinical trial.

Kobinger said he had no idea whether the antibodies had any effect on viral load in these patients, as they were given the experimental ZMapp on a «compassionate use» basis.

«It is important that the committee affirmed the morality of compassionate use,» writes Arthur Caplan, a bioethicist at New York University in New York City, in an e-mail.

«They also concluded that «there is a moral obligation to collect and share all data generated, including from treatments provided for compassionate use «and «a moral duty to evaluate these interventions (for treatment or prevention) in the best possible clincial trials under the circumstances.»

The availability of ZMapp is a critical issue for the growing number of people who want access to it on a compassionate use basis.

The children were resistant to other anti-epileptic drugs and participated in this study through a compassionate use, off - label program.

As part of a compassionate use program, 104 post-liver transplant patients with recurring HCV who had exhausted all treatment options and had poor clinical prognoses, received sofosbuvir (SOF) and ribavirin (RBV) with pegylated interferon (PEG) included at the physicians» discretion for up to 48 weeks.

In the current study, the researchers report the success of the BASILICA procedure in seven gravely ill patients who qualified for compassionate use of the technique — then untested in humans — because no other care options were available.

Eli Lilly is the sponsor of the compassionate use program.

We've had one promising result in a compassionate use patient with pancreas cancer that we treated with this approach.

Compassionate Use of Sorafenib in Primary Resistant Severely Progressed FLT3 - ITD Positive AML in a Young Woman - A Danish Case Report

Though the therapy has not been approved by the FDA, Art was treated through a compassionate use request.

I think it's too early to speculate about expanded access or compassionate use - first we need to figure out whether the drug works and if so, try to get it licensed as quickly as possible.

«The compassionate use of a VSVΔG - ZEBOV vaccine in a case exposed to Ebola allowed very detailed monitoring of the effects of this vaccine on immune responses and its side effects.

Compassionate use of antipruritic therapy is palliative and an important part of patient care.

Our veterinarians would love to talk with you if you have questions about any of these conditions or would like to submit your pet for a compassionate use trial.

The Compassionate Use of Medical Marijuana Pilot Program, which became effective in 2013, allows individuals who are diagnosed with certain debilitating conditions or terminal illnesses to apply for a medical cannabis registry identification card.

It wouldn't take many suits like Ward to convince drug manufacturers that, simply to avoid litigation expense, they should have nothing to do with compassionate use or RTT.