Sentences with phrase «of generic drugs for»

A spokesman on Monday said that its Kabi subsidiary, a maker of generic drugs for injection and infusion, would expand its existing business to reach that goal.

Not exact matches

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 FortuFor 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 Fortufor 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.
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 approvesdrug or treatment to be available as soon as the Food and Drug Administration approvesDrug Administration approves it.
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.
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.
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.
FORTUNE — For Indian generic - drug manufacturer Ranbaxy, the past five years have consisted of an escalating series of regulatory and legal woes.
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.
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.
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.
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.
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 SDrug 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 Sdrug 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.
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.
In Ontario, where the drug reforms began, reimbursements for all generics are down to 25 % of the branded price.
Pharmacies used to be able to charge 50 % or more of the price of a name - brand drug for its generic equivalent.
The two heavyweight CEOs were there — along with Jeff Watson, the president of Apotex, Canada's largest generic - drug producer — to present a plan calling for a vast expansion of the role pharmacists play in the Canadian health - care system.
WASHINGTON (AP)-- Some low - cost generic drugs that have helped restrain health care costs for decades are seeing unexpected price spikes of up to 8,000 percent, prompting a backlash from patients, pharmacists and now Washington lawmakers.
WASHINGTON (AP)-- The Supreme Court on Wednesday considered a drug company's fight to keep a generic version of its biotech drug off the market for an additional six months that would mean billions more in sales and higher costs to the public.
Bain and Cinven, who earlier this year took control of Germany's Stada, are hoping to use the Merck unit as a buy - and - build platform for Stada, which makes generic drugs and consumer care products and had annual revenues of more than 2 billion euros in 2016, the sources said.
While most of the attention on pharmaceutical prices has been on new drugs for diseases like cancer, hepatitis C and high cholesterol, there is also growing concern about huge price increases on older drugs, some of them generic, that have long been mainstays of treatment.
The FDA's action cuts off a vital supply line for the company, given that the plant reportedly makes about 70 % of the ingredients that Ranbaxy uses to make its U.S. drugs, including the generic version of Lipitor taken by millions of Americans.
Court documents made public late on Tuesday show that Fresenius (NYSE: FMS) dropped its acquisition of Akorn after uncovering evidence that the generic drug developer submitted fraudulent data to the U.S. Food and Drug Administration for at least six different drugs dating back to 2drug developer submitted fraudulent data to the U.S. Food and Drug Administration for at least six different drugs dating back to 2Drug Administration for at least six different drugs dating back to 2012.
The research behind a new drug is protected for a fixed number of years, after which competing firms can begin manufacturing generic forms.
The sale process for Mallinckrodt's generic drug business comes amid a wave of dealmaking in the sector.
The U.S. Food and Drug Administration's approval of Mylan N.V. (NASDAQ: MYL)'s generic version of Copaxone for the treatment of relapsing multiple sclerosis should be seen as a «clear negative» for Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA)'s Glatopa franchise, analysts at Baird said.
A federal judge in Delaware on Friday struck down key patents held by Acorda related to Ampyra, opening the doors for generic versions of the drug by companies including Mylan Inc (MYL.O) and Roxane Laboratories Inc..
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 versdrug 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 versDrug Administration's (FDA) stamp of approval, they must prove it is pharmaceutically equal to the name - brand version.
• PLIVA vs. Mensing: Ruled that makers of generic drugs can not be sued for failing to warn patients of new dangers or side effects.
Roche's drug, Valium, has been available on the market now for regarding forty five many years, and of course is currently in its generic variety, Diazepam.
Drugs cited in Tables 1 through 7 are listed in alphabetical order by generic name; brand names are available from the current Physicians» Desk Reference, 23 USP DI 2001: Drug Information for the Health Care Professional, Volume I, 24 and USP Dictionary of USAN and International Drug Names.25 The reference list is not inclusive of all articles published on the topic.
This prevented developing countries from producing generic versions of patented drugs, notably treatments for HIV / AIDS and malaria, which they maintained were being sold at unfair prices.
Drug maker Mylan said it will offer a generic version of the life - saving allergy treatment EpiPen for half the list price of the brand - name treatment after it became the center of a national controversy over skyrocketing drug priDrug maker Mylan said it will offer a generic version of the life - saving allergy treatment EpiPen for half the list price of the brand - name treatment after it became the center of a national controversy over skyrocketing drug pridrug prices.
«A civil war has broken out among the most powerful players in the pharmaceutical industry — including brand - name and generic drug makers, and even your local pharmacists — with each blaming others for the rising price of medicine.»
To avoid paying # 400 a month for private prescriptions of the brand - name drug Truvada, growing numbers are buying generic versions from online pharmacies in India and Swaziland for # 40 a month, through a UK website called I Want PrEP Now.
Generic low - cost versions of the drugs are available — Walmart sells a month's supply of low - dose lovastatin for $ 4 — but many consumers choose costlier brand name options.
After controlling for other factors, a generic drug in the highest marketing competition group was expected to see a decrease of 32 percent in price over the study period, while a generic drug in the lowest market competition was expected to see a price increase of 47 percent over the same period.
The rationale for using spironolactone - an inexpensive, generic, medication - stems from the pioneering research of Bertram Pitt, MD, University of Michigan School of Medicine, who showed the benefit of this class of drugs in patients with heart failure and reduced ejection fraction, and who also served as chair of the TOPCAT Steering Committee.
69 Percentage of prescriptions dispensed in the U.S. for generic drugs.
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 example, one of these generic drugs was ibuprofen, sold as gelatin capsules by one of the nation's largest grocery - store chains for months before the FDA received assurance they were saFor example, one of these generic drugs was ibuprofen, sold as gelatin capsules by one of the nation's largest grocery - store chains for months before the FDA received assurance they were safor months before the FDA received assurance they were safe.
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