Not exact matches
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.
But at the same time
drug companies were
increasing prices for many
drugs, insurance plans have been going through their own transformation, leaving more families like the LePeres on the hook for far more of that cost.
The
company has responded with statements saying that it's not as dependent on
drug price
increases as critics have claimed; it has also pointed out that while attention has focused on changes in list prices for
drugs, those prices don't reflect the actual cost for insurers, governments and other group purchasers, which typically receive discounts that aren't publicly disclosed.
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.
A spokesperson for the
drug company told the Financial Times that revenue from
increased prices would go to investing in «schemes that ensured more patients could access the medicine.»
There's been a recent trend in biopharma where some
companies, led by Allergan (agn) CEO Brent Saunders» new «social contract» with patients, are voluntarily pledging to limit
drug price hikes and being more transparent about which products have seen price
increases.
Both
companies have since rolled back their price
increases, and experts say that while
drug prices will continue to rise the practice of hiking prices purely for profit may be on the wane.
His
company acquired the patent to a
drug used to treat malaria, cancer, and AIDS, and
increased its price from $ 13.50 to $ 750 a tablet — 5,455 percent.
Pfizer (pfe), and at least one major newspaper, got fooled by a fake press release claiming the
company would no longer
increase the prices of its
drugs.
Numerous
drug companies have been criticized for the
increased prices of some medications in the past few years.
The
company couldn't say whether its
drug price
increases have typically occurred before or after a generic version launches, but said that once a generic is available, it would expect to lose so much market share that it «needs to
increase the price to keep production of the
drug viable.»
«It's hard to know what incentives will work for the pharmaceutical
companies to
increase drug production,» said the University of Utah's Fox.
«
Drug Pricing
companies under scrutiny for prices
increases, such as Alexion, would benefit,» Golub wrote.
Add one more name to the new slew of pharma
companies trying to counteract the public backlash to big
drug price
increases: France's Sanofi, a $ 126 billion firm known for its flagship diabetes and vaccines units.
Yet the
company making the
drug, Sprout Pharmaceuticals, says this is enough of an
increase to make it available to women.
In late 2015 the
company acquired Cordis, naviHealth, and Harvard
Drug; it spent much of 2016 integrating them, with a 19 %
increase in annual revenue to show for it.
But you probably know Mr. Shkreli from his
company Turing Pharmaceuticals's outrageous
increasing of prices on a
drug that helps people with compromised immune systems fight parasitic infections.
The campaign also said that Prop 61 «would invalidate many
drug discount agreements the state has negotiated with pharmaceutical
companies,» which would
increase state prescription costs by tens of millions of dollars each year.
Two older mainstays among multiple - sclerosis
drugs, made by other
companies, have
increased prices to seven times their 1990s levels to catch up with the prices of newcomers, researchers reported in April in the journal Neurology.
Martin Shkreli, the Turing Pharmaceuticals LLC executive who drew criticism in August over a dramatic jump in a prescription
drug price, made headlines Thursday for a different kind of price
increase: a seven-fold surge in the shares of a microcap pharmaceutical
company.
Turing Pharmaceuticals LLC CEO Martin Shkreli discusses why the
company increased the price of a
drug from $ 13.50 to $ 750 a tablet.
WOONSOCKET, R.I. (AP)-- CVS Health Corp. reported better - than - expected third - quarter earnings Tuesday as
increased use of specialty
drugs helped offset missing sales of tobacco products, which the
company stopped selling this fall.
** A message from the Coalition for Affordable Prescription
Drugs (CAPD): Prescription drugs are often critically important to seniors» health, and yet drug companies continue to increase prices for the very drugs they rely on
Drugs (CAPD): Prescription
drugs are often critically important to seniors» health, and yet drug companies continue to increase prices for the very drugs they rely on
drugs are often critically important to seniors» health, and yet
drug companies continue to
increase prices for the very
drugs they rely on
drugs they rely on most.
This
increased survival rate places a high value on immunotherapy
drugs and the
companies that research and produce them.
Some investors argue that massive share - price
increases in 2014 mean that even future successes won't produce strong returns for shareholders buying in at today's prices, but the demand among top pharmaceutical
companies for promising
drug candidates to add to their pipelines shows few signs of slowing anytime soon, and that could bode well for the sector in the coming year.
Investments in fast - growing industries like the technology and healthcare sectors (which have historically been volatile) could result in
increased price fluctuation, especially over the short term, due to the rapid pace of product change and development and changes in government regulation of
companies emphasizing scientific or technological advancement or regulatory approval for new
drugs and medical instruments.
As
drug patents begin to roll off and scrutiny around
drug prices
increased over the summer, many pharmaceutical
company's struggled.
Regeneron prices its
drugs responsibly, and the
company has never initiated a price
increase.
Investments in fast - growing industries like the technology and health care sectors (which have historically been volatile) could result in
increased price fluctuation, especially over the short term, due to the rapid pace of product change and development and changes in government regulation of
companies emphasizing scientific or technological advancement or regulatory approval for new
drugs and medical instruments.
There is enough evidence that antidepressants cause
increased risk of suicide and violence for the U.S. Food and
Drug Administration and its Canadian counterpart to require that drug companies include a «black box» warning to that effect on their packa
Drug Administration and its Canadian counterpart to require that
drug companies include a «black box» warning to that effect on their packa
drug companies include a «black box» warning to that effect on their packages.
While the Food and
Drug Administration (FDA) did not require approval of cryotherapy because it is a non-invasive procedure, the
company believes that additional studies can help business with the added confirmation and explanation of benefits, as well as
increase exposure of cryotherapy to the mainstream.
Although the hierarchy at the Merck
drug company was aware that the pain killer Vioxx
increased the risk of death from heart attack and stroke, they marketed it anyway.
Choose an obstetrician or health care provider Interview potential doctors Contact health insurance
company about coverage Start and pregnancy and birth budget Discuss financial effects of pregnancy and baby with partner Stop smoking Stop drinking Stop using street
drugs Talk to your physician about any prescription medications Drink at least 8 glasses of water every day Visit the doctor at least once per month or every 4 weeks Do not dye or perm hair Stop drinking coffee and other caffeinated beverages Exercise daily Start taking prenatal vitamins Eat foods rich in folic acid Eat iron rich foods
Increase daily intake of whole grains, fruits and vegetables Nap as much as possible as fatigue is common Eat fish with low levels of mercury no more than 2 days per week Do not eat undercooked meats Do not eat unpasteurized dairy producs Do not eat cold cut deli meats Allow someone else to clean out the kitty litter, if applicable Limit exposure to chemicals Try to limit stress and tension Complete all prenatal tests — HIV, Chlamydia, Gonorrhea, Anemia, Blood Typing, Sickle Cell Anemia, Urine Screening and Rubella.
As the
company has progressed with its
drug trial, the market valuation has
increased significantly.»
But, although modern technologies are accelerating the number of compounds that
companies can produce and analyse, in Canada there has not been a dramatic
increase in the number of jobs created for
drug discovery scientists.
In September 2013 a report on the «crisis in cancer care» from the Institute of Medicine recommended offering
drug companies a patent extension of six months on new
drugs that have been tested in the elderly; a similar incentive has greatly
increased the testing of
drugs in children.
Other analysts have also noted that while research and development spending by pharmaceutical
companies has
increased dramatically, the number of new
drug approvals has remained flat.»
Most of the
increase — $ 601 million — would come from user fees charged to
drug, device, tobacco, and other
companies regulated by FDA, which have supplied FDA with billions of dollars in recent years.
Among the interesting topics covered in Pathways are: the changing role of the patient in the total health equation and the ways in which decentralized information is affecting their expectations and demands; the dearth of pipeline products among international pharmaceutical
companies against a backdrop of
increased research and development spending; the dynamics of emerging markets and their rising demand for therapies in chronic disease; the value of
drugs and biotechnology solutions within the context of global economic realities.
Most of the
increase — $ 601 million — would come from user fees charged to the
drug, device, tobacco, and other
companies regulated by FDA, which have supplied FDA with billions of dollars in recent years.
The microbes need to
increase output of thebaine by a factor of 100,000 for
drug companies to be interested in using them to make medicines.
Drug companies have shown an
increasing interest in incorporating CF3 compounds — which contain carbon and fluorine — in a range of pharmaceuticals.
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.
The White House has not specified the size of the U.S. Food and
Drug Administration's (FDA's) budget, but does propose a major increase in user fees, which are collected from drug and medical device companies submitting products for FDA rev
Drug Administration's (FDA's) budget, but does propose a major
increase in user fees, which are collected from
drug and medical device companies submitting products for FDA rev
drug and medical device
companies submitting products for FDA review.
The expense and effort are
increased by the FDA requirement that any
company applying for approval of a
drug targeted against a specific gene - driven abnormality must also produce a diagnostic test for that abnormality.
Other
companies, including the Swiss
drug giants Novartis and Roche, along with Boston's Paratek Pharmaceuticals, are developing ingestible small - molecule
drugs designed to
increase the inclusion of SMN2 «s exon 7.
Increased understanding of the developing brain and how deviations from normal development can
increase the risk of neurological and psychiatric diseases has created a rich landscape of opportunity for collaborations between leading academic medical centers and pharmaceutical and biotechnology
companies dedicated to identifying new
drugs and other interventions to help children.
Pharmaceutical
companies capitalize on this property by mixing or chemically binding
drug molecules to propylene glycol to
increase the
drug absorption rate (source).
Clinton has said
drug companies should have to explain price
increases and show what benefits and value have been added.
They have the balance sheet to buy another biotech
company in an effort to
increase their roster of promising new
drugs.