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 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.
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.
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 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.
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 2
drug developer submitted fraudulent data to the U.S. Food and
Drug Administration for at least six different drugs dating back to 2
Drug 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 vers
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 vers
Drug 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 pri
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 pri
drug 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 sa
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 sa
for months before the FDA received assurance they were safe.