Sentences with phrase «not by drug companies»

Contrary to my paranoid suspicions, Mignot's study was funded not by drug companies but by two upstanding behemoths of American philanthropy, the Howard Hughes Medical Research Institute and the McKnight Foundation.

Not exact matches

The key is to avoid a company that has only a few drugs in the pipeline that one day may or may not be approved for use by the FDA.

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

That research will be crucial: An earlier effort by another company, Pathway Genomics, to create a «liquid biopsy» for cancer was greeted in September by a stern letter from the Food and Drug Administration (FDA) warning that the agency had «not found any published evidence that this test or any similar test has been clinically validated as a screening tool for early detection of cancer in high risk individuals.»

Celgene's patents likely won't be challenged by its rivals anytime soon — its three main patents expire in the 2020s, by which point the company will have made a considerable amount of money on the drugs.

The memory - eating disease, expected to afflict 15 million Americans by 2060 (and tens of millions more around the world as life expectancy increases), has no cure; a new drug for the condition hasn't been approved in well over a decade; initially promising experimental treatments seem to be failing with clockwork regularity; and there's not even a definitive consensus on what, exactly, biopharma companies should focus on while developing Alzheimer's medicines.

Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb isn't mincing words about kratom, the increasingly popular herbal substance that's been hawked as an alternative to painkillers and anti-depressants by companies promoting its ostensible curative properties (and supposedly innate safety as a «natural,» plant - based product).

A Wall Street Journal investigation earlier this year linked companies controlled by Canada Drugs through its wholesale division to a shipment of a fake cancer drug, though the FDA hasn't reached a conclusion.

By 2013, Bristol's five diabetes drugs were bringing in $ 1.6 billion in sales — not a huge amount, but enough to account for 10 % of the company's revenue.

Early in the decade the company had been dogged by R&D failures, most notably of Vanlev, a high - profile hypertension drug that had been hailed as a can't - miss blockbuster but then fell short of even getting FDA approval.

By bringing a drug that's been well - established as safe in other markets to the U.S. for the first time in order to treat a rare disease, the company doesn't just control its pricing destiny — it will also receive a coveted «priority review voucher» which it can hawk to another firm for tens (or even hundreds) of millions of dollars.

Not willing to call Twitter's bluff, the city offered a deal to the company, which now works out of space in the gritty but fashionable South of Market district where many Internet start - ups begin: move to a building in the even more gritty and decidedly less fashionable mid-Market neighborhood — on a section of Market Street that is marred by drug dealing, homeless encampments and shuttered storefronts — and get a payroll tax exemption.

Its claims about some of its products, the company says on its website, have not been evaluated by the Food and Drug Administration.

Bayer said in a statement that it doesn't control the cost for patients at the pharmacy, because copays are determined by insurers and pharmacy - benefit managers — an argument that pharmaceuticals companies have long made when facing criticism over drug prices.

He started MSMB Capital, a hedge fund company, in his 20s and drew attention for urging the Food and Drug Administration not to approve certain drugs made by companies whose stock he was shorting.

By August, the company, which sells thousands of drugs and says it fills one in every 13 American prescriptions, was making mea culpas and renewing its promise to «do what's right, not what's easy,» as the company's mission statement goes.

First, patents are often taken out to use as legal weapons by huge companies to fight off their competitors even if they do not plan on completing trials for the drug.

That cash doesn't include the money PhRMA's spending on the ongoing «Go Boldly» campaign, a series of TV, print and radio ads designed to polish the drug industry's image by reminding the public that drug companies do world - class research that brings disease cures to market to save lives.

This is a multi-million dollar process to get a product approved as a «drug» by the FDA, and no company will invest that kind of resources into a natural product they can not patent.

This China Food and Drug Authority approval (CFDA), expected within weeks, is significant for any number of reasons — not least being that the company has flagged it expects to land take - or - pay contracts, backed by bank guarantees, from Chinese counter-parties (the second milestone).

A former aide to Hillary ClintonHillary Diane Rodham ClintonTrump Jr. met with Gulf adviser who offered help to win election: report Voters Dems need aren't impressed by anti-waterboarding showboating After year of investigation, Trump can rightly claim some vindication MORE criticized Sen. Kirsten GillibrandKirsten Elizabeth GillibrandOvernight Health Care — Sponsored by PCMA — Trump hits federally funded clinics with new abortion restrictions Dem senators ask drug companies to list prices in ads Gillibrand to publish children's book about suffragists MORE on Thursday after the New York Democrat became the first of many senators to join a successful push to force the resignation of Sen. Al FrankenAlan (Al) Stuart Franken100 days after House passage, Gillibrand calls on Senate to act on sexual harassment reform Eric Schneiderman and #MeToo pose challenges for both parties Senate confirms Trump judicial pick over objections of home - state senator MORE (D - Minn.).

Besides weed does not do nearly the damage that the opioids produced by legal drug companies inflict on our communities!

«I think we understand some things happened that should not have happened,» said Senate Democratic Whip Dick DurbinRichard (Dick) Joseph DurbinOvernight Health Care — Sponsored by PCMA — Trump hits federally funded clinics with new abortion restrictions Dem lawmaker spars with own party over prison reform Dem senators ask drug companies to list prices in ads MORE (Ill.).

«But we have to be honest and say that, based on all the evidence, including data presented by the drug companies themselves, our experts have concluded that these drugs do not make enough of a difference for us to recommend their use for treating all stages of Alzheimer's disease.

Although these facts do not mean that the results are invalid, a 2003 study published in the British Medical Journal suggests that trials funded by drug companies are more likely to report favorable results about their products than are trials funded by independent organizations.

Little coverage is given to such grim statistics by governments or pharmaceutical companies, so patients and their doctors are not primed to be as vigilant as they should be, and adverse drug reactions (ADRs) remain seriously under - recognised and under - reported.

Blood transfusions used for this purpose do not require approval by the US Food and Drug Administration, and some American companies are already charging hefty fees for transfusions of blood from young people.

David Ozonoff, an epidemiologist at the Boston University School of Public Health, says that the reports «smear» the scientists involved in pandemic planning by «insinuating» that they would have offered different advice had they not had a relationship with drug companies.

She did a little research and learned that the company was working on a related drug that had not yet come up for approval by the U.S. Food and Drug Administratdrug that had not yet come up for approval by the U.S. Food and Drug AdministratDrug Administration.

Any decisions about assigning metrics like letter grades to drugs — a step floated by FDA personnel in the past to indicate the quality of different manufacturers and pressure companies to improve — was not part of the plan.

An American who buys golf clubs abroad and doesn't want to declare them can send them via a company that packs them in a shipping container, which then slips them into port without ever being seen by customs agents; the ability of drug dealers to bypass even the most elaborate border controls is a well - known problem.

In an effort to strengthen her bones, Rubin gave her a growth factor called IGF - I — donated by a drug company because her insurance would not cover it — but the experiment had almost no measurable benefit.

The plan is to predict very early which drugs are likely to succeed and which are not, and promote the winners rapidly to larger (phase III) trials, which most likely would be run by private companies, without data sharing.

The frequency and growth of diabetes has not gone unnoticed by pharmaceutical companies — at least 20 firms are feverishly searching for remedies, and at least 40 new drugs are being tested.

Studying how genes affect different drugs manufactured by different companies gives Poirier greater influence on future drug development, he feels, which would not be possible if he was employed at any one pharmaceutical research lab.

By revealing skin sensitisation or an adverse reaction that may not be identified by use of an animal or computer model, the assay can provide vital information which will allow a drug company to make informed decisions earlier saving significant development costBy revealing skin sensitisation or an adverse reaction that may not be identified by use of an animal or computer model, the assay can provide vital information which will allow a drug company to make informed decisions earlier saving significant development costby use of an animal or computer model, the assay can provide vital information which will allow a drug company to make informed decisions earlier saving significant development costs.

Today's proposal to increase those fees by $ 1 billion may not sound ominous in itself, but it implies an impending, equivalent cut to federal funding, says Steven Grossman, deputy executive director at the Alliance for a Stronger FDA in Washington, D.C.. That's an unrealistic expectation, he adds, because drug companies have already gone through negotiations and reached an agreement with FDA on user fee increases.

That's part of the reason that most drugs that work in animals don't work in people — only 11 % of oncology compounds that show promise in mice are ever approved for humans — despite billions of dollars spent by pharmaceutical and biotech companies.

The cancer biology project was inspired by reports from two companies that when they tried to follow up on dozens of papers pointing to potential new drugs, they could not replicate as many as 89 % of the studies.

Equally important, by securing access to the best drugs from multiple companies, CRI is able to conduct clinical trials of novel combinations that might not otherwise be conducted.

There are hundreds of drug companies who would love to relieve you of your money (but not your symptoms) by giving you synthetic progesterone.

It is unlikely that any drug company will invest the millions for FDA approval studies when the drug in question is a natural substance such as a bioidentical hormone that can not be protected by a patent.

It has only just dawned on us that menstruation, pregnancy, and childbirth are not diseases; now we need to realize that menopause is not a disease despite millions in advertising dollars spent by drug companies to convince us otherwise.

Because essential oils are entirely natural, they can not be patented, which means they are not tested by drug companies.

It won't happen with the drug companies or the conventional mainstream doctors because there's — they're too entrenched with the pharmaceutical model and too funded by it.

Not only has the information we have been given about fitness been untrue, most of it has been fabricated by greedy processed food manufacturers and drug companies in order to keep up us sick, sad, stupid and FAT.

While companies must comply with industry standards called Good Manufacturing Practices (GMP's), a 2012 audit found that nearly 70 % of companies audited by the FDA were not in compliance with major issues including failure to test products, the presence of contaminants, non-approved dietary ingredients, and pharmaceutical drugs

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Whether or not the driver remains in your employ will be determined by your company's drug and alcohol testing policy since terminations are not a regulatory issue.

Apparently, the drug company she was affiliated with didn't list the correct warnings by failing to mention the drug was never approved for pregnant women with a severe type of morning sickness called hyperemesis gravidarum.