After graduating with degrees in psychology and social work — both of which Witt says are extremely beneficial in real estate — she worked as a marketing coordinator
for generic drug maker Pharmascience, organizing activities for 40 sales reps.
For example, typical copayments are $ 20 for a doctor visit, $ 50 for an emergency room visit, and $ 10 to $ 40 for a prescription medication (depending if your prescription is
for a generic drug or a brand - name drug).
Many of the new user fee funds would come from new fees
for generic drug reviews and «biosimilars,» which aim to be generic versions of biologic drugs.
For a generic drug manufacturer to get the U.S. Food and Drug Administration's (FDA) stamp of approval, they must prove it is pharmaceutically equal to the name - brand version.
Stada's owners are also mulling bids
for the generic drug business being sold by Sanofi, the sources said, and might favor this combination over Merck as generic drugs are typically valued at a cheaper multiple.
That's an even rarer feat
for a generic drug maker such as Mylan, which makes most of its revenue not on brand - name drugs, but on cheaper, equivalent versions of other companies» branded medications.
«Shoppers tends to be a Top Five company, but last year was a low point for them with the fight
for generic drugs,» says Susan Quinn - Mullins, a senior adviser to the Research Institute.
Merritt cited a backlog among approval
for generic drugs at the FDA as one of the reasons that many drugs don't face generic competition just yet.
Provincial governments, strapped for cash and facing ballooning deficits, have been hacking away at the prices they pay
for generic drugs.
The provinces just find it way too easy to unilaterally lower reimbursement rates
for generic drugs, and will probably continue for a while yet.»
Prices
for some generic drugs have increased in recent years, adversely affecting patients who rely on them.
69 Percentage of prescriptions dispensed in the U.S.
for generic drugs.
Others received «Imotadil - LeniPharma Creme» — another fake, this time housed in a chintzier orange box resembling those typically used
for generic drugs.
It also put in place an expedited approval processes
for generic drugs.
Some newer plans have a prescription drug coverage option
for generic drugs not associated with a pre-existing condition.
Not exact matches
Not only is the science around them advancing quickly, but the
drugs are so complex that they are hard
for generic producers to copy — an attractive prospect
for big pharma.
The chairman of Apotex, the largest producer of
generic drugs in Canada, came under fire recently
for helping to organize a $ 500 - per - ticket pay -
for - access fundraiser
for the party.
For one thing, «There are a lot of good drugs on the market for heart disease right now that come in generic form,» says Neil Lesser, a principal at Deloitte who specializes in the life sciences, in an interview with Fortu
For one thing, «There are a lot of good
drugs on the market
for heart disease right now that come in generic form,» says Neil Lesser, a principal at Deloitte who specializes in the life sciences, in an interview with Fortu
for heart disease right now that come in
generic form,» says Neil Lesser, a principal at Deloitte who specializes in the life sciences, in an interview with Fortune.
Prices
for roughly 300
generic drugs at least doubled from 2010 to 2015.
The Hong Kong - listed company has two blockbuster
drugs on its roster — anlotinib
for lung cancer and tenofovir
for hepatitis B — and a few blockbuster
generics aiming
for approval before 2021.
The Food and
Drug Administration (FDA) under Commissioner Scott Gottlieb is continuing its quest to ramp up generic drug approvals, this time for complex generics that could compete with products such as Mylan's Epi
Drug Administration (FDA) under Commissioner Scott Gottlieb is continuing its quest to ramp up
generic drug approvals, this time for complex generics that could compete with products such as Mylan's Epi
drug approvals, this time
for complex
generics that could compete with products such as Mylan's EpiPen.
Last year, Chinese pharmaceuticals obtained U.S. Food and
Drug Administration approvals
for 38
generic drugs, up from 22 such approvals in 2016.
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.
For instance, a ProPublica analysis of Medicare's Part D prescription
drug program found that doctors who received more industry money were also more likely to prescribe brand name, rather than cheaper
generic,
drugs.
The plan also calls
for generic versions of any
drug or treatment to be available as soon as the Food and Drug Administration approves
drug or treatment to be available as soon as the Food and
Drug Administration approves
Drug Administration approves it.
The reason there's no
generic Viagra yet is because Pfizer, the company that makes it, holds two patents
for the
drug: the first
for Viagra's composition — which expired in 2012 — and the second
for what's called a «method of treatment,» meaning how the
drug is used.
Plus, a handful of companies will typically all get approved to make a
generic at once, which ideally creates competition in the marketplace and can sometimes result in even lower prices
for those
drugs.
Daiichi Sankyo's press release comes in the wake not only of Ranbaxy's highly unusual criminal guilty plea and $ 500 million in fines and penalties — the largest ever against a
generic -
drug maker — but also a lengthy Fortune article that exposed
for the first time the depth and extent of the fraud charges leveled at the company and the knowledge of senior company executives.
The epic inside story of long - term criminal fraud at Ranbaxy, the Indian
drug company that makes
generic Lipitor
for millions of Americans.
And that applies
for drugs under patent, which are typically more expensive to begin with, and
generic drugs.
Nothing about the
drug has changed in that time, and the fact that it's
generic flies in the face of the argument that lack of
generic competition is the reason
for drastic price hikes.
Nonetheless, Pessina said it remains a «challenging market
for pharmacies,» with increasing margin pressure on
generic drugs.
FORTUNE —
For Indian
generic -
drug manufacturer Ranbaxy, the past five years have consisted of an escalating series of regulatory and legal woes.
He suggested coming up with a faster approval timeline
for generics coming to market to take on
drugs with high prices.
PARIS, April 17 - French healthcare group Sanofi is in exclusive talks to sell its Zentiva European
generics drugs arm to private equity firm Advent International
for 1.9 billion euros, the companies said on Tuesday.
But Slavitt's letter noted that EpiPen, since the fourth quarter of 1997, has been incorrectly reported by its sellers as a
generic drug for the rebate program.
After all, patients and doctors who choose Valeant's
drugs when an identical
generic version is available are already volunteering to pay extra
for the brand name.
Revenue growth has slowed as many companies sink more resources into developing the next blockbuster
drug; what's more, the «patent cliff»
for the last round of megabillion - dollar
drugs — when
generics firms typically see a sales spurt — happened a few years ago.
Given its areas of specialization, Gilead wouldn't benefit as much from consolidation as, say, a
generic -
drug company would, but it still faces pricing pressure: To appease Medicaid and other insurers, Gilead is already steeply discounting its hep - C
drugs, which can cost more than $ 80,000
for a 12 - week course.
Contrary to Clinton's assertion that the patient «has to take a brand - name
drug,» the patient has
for the last 16 years had the option to take a much cheaper
generic version of it.
Often it turns out that the price increases by Valeant and Turing that have provoked the most criticism have been on
drugs that are off - patent — meaning
generic competitors are free to enter the market, typically bringing the price that most people pay
for the
drugs way down.
Here's how it went: Shortly before 9 a.m. New York time (and before U.S. markets opened),
generic drug giant Teva Pharmaceutical (TEVA) confirmed its unwelcome bid to acquire rival Mylan (MYL)
for $ 40 billion.
Advisory panels to the Food and
Drug Administration (FDA) this week gave unanimous recommendations
for so - called biosimilars of Humira and Enbrel developed by Amgen and Novartis (nvs)
generics unit Sandoz, respectively.
In Africa,
for example, some smaller pharmaceutical companies have profitably sold
generic drugs and commercially developed local products.
Generic drug giant Teva really is going to cut tens of thousands of jobs in a gigantic restructure
for the struggling and debt - laden pharmaceutical — in fact, the 14,000 planned layoffs announced Thursday actually surpass initial reports.
JERUSALEM — Israeli
generic drug maker Teva Pharmaceutical Industries on Thursday said first - quarter earnings surged over 80 percent and raised its outlook
for the rest of the year, citing progress in an aggressive restructuring plan.
Still, he's taken on market inefficiencies, called
for expanding access to biosimilars, is approving
generics at a record pace and trying to bring down
drug prices.
These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues
for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement
for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding
for state AIDS
Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the S
Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of
generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new
drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the S
drug applications
for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all,
for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).
The son of pharmaceutical tycoon Leslie Dan — once one of Canada's richest men — the younger Dan was stuffing envelopes
for Novopharm, the family's
generic drug empire, by the time he was five.
But it won't be nearly enough to make up
for the money lost as
generic -
drug prices are capped, she says.