69 Percentage of prescriptions dispensed in
the U.S. for generic drugs.
Not exact matches
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.
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.
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 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.
In May
generic drug company Actavis Inc. agreed to buy Warner Chilcott PLC
for $ 8.5 billion in stock, creating the third - biggest specialty pharmaceutical company in the
U.S. market.
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
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.
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.
As it has
for its HIV
drugs, Gilead plans to provide patient assistance within the
U.S., to license the
drug (
for a fee) to select
generic manufacturers outside the
U.S., and to lower prices in low - and middle - income countries.
AES, the American Academy of Neurology and other professional societies had opposed patients substituting antiepileptic
generics for people with epilepsy without consent of the physician or patient out of concern that the
U.S. Food and
Drug Administration (FDA) was allowing room
for too much variability across formulations.
It should be noted that on February 17, 2017, the
U.S. Food and
Drug Administration announced the agency's approval
for the first
generic medication to treat heartworm disease in dogs.