They visited: Sonny's Enterprises, largest car wash manufacturer in the United States; City Furniture, one million square foot corporate headquarters and distribution center; Sprout Loud and Rex 3, largest commercial printer in South Florida - high growth internet company; Marine Association of South Florida (MASF), 7 billion dollar industry in South Florida - Tour of Roscioli and Water Taxi on New River (view existing working Marinas); Mario Portillo - Actavis (soon to be Teva), largest
generic drug manufacturer in the world; and Broward Health - Cora E. Braynon Family Center, health care professions.
Paul, Weiss client Nichi - Iko Pharmaceutical Co., Ltd., the largest
generic drug manufacturer in Japan by sales, announced that it has agreed to acquire Sagent Pharmaceuticals, Inc. in an all - cash tender offer followed by a second - step cash merger, for a total consideration of approximately $ 736 million.
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.
According to the GAO report, 71 percent of all
generic injectable cancer
drugs sold
in 2008 were produced by just three
manufacturers, while 91 percent of the market share of injectable nutrients and supplements was held by just three pharmaceutical firms.
Leave all medications and
drugs in their original, labelled containers with the name of either the pharmacy that dispensed the medication or the
manufacturer of the medication, and have on hand a copy of the original prescription, with both the
generic and trade names of the
drug.
But Gilead's latest agreement with the Medicines Patent Pool aims to have new
drugs ready for
generic manufacturers as soon as they are available
in high - income countries.
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.
* Eliminate «pay - for - delay» strategies
in which a pharmaceutical company with a brand name
drug shares profits on that
drug with a
generic drug manufacturer for the remainder of a patent period, effectively eliminating a patent challenge and competition.
For example, sofosbuvir's
manufacturer, Gilead Sciences Inc. of Foster City, California, sells the
drug to Egypt at a discount and allows
generic manufacturers in India to produce and sell
in 91 poorer countries.
And because
generics are available only for
drugs whose patent has run out, the competition
in the marketplace among
manufacturers drives the price down.
CVS has also engaged
in a joint venture with
drug distributor Cardinal Health Inc. to combine their purchases of
generic drugs to extract a larger discount from
manufacturers, which is generating higher margins.
Examples include the 2015 acquisitions of Cordis (a
manufacturer and distributor of interventional cardiology devices and endovascular solutions) and Harvard
Drug (a distributor of
generic and over-the-counter
drugs); the 2013 acquisition of AssuraMed (distributor of home health care products); and the 2010 acquisitions of Kinray (distributor to independent pharmacies) and Yong Yu (a leading distributor
in China).
Once a patent expires, other
manufacturers can create
generic drugs but must scientifically prove that their medications perform
in the same way as the branded
drug to get FDA approval.
On an issue of first impression, however, the California Court of Appeals
in Conte v. Wyeth, Inc. rejected this traditional view and held that a brand - name
manufacturer's duty to warn extends to patients whose prescriptions are filled with the
generic version of the
drug.
In other
generic drug injury news, the U.S. Food and Drug Administration has suggested a new rule that would allow manufacturers of generic meds to independently include new side effect information to the labels of their medicat
drug injury news, the U.S. Food and
Drug Administration has suggested a new rule that would allow manufacturers of generic meds to independently include new side effect information to the labels of their medicat
Drug Administration has suggested a new rule that would allow
manufacturers of
generic meds to independently include new side effect information to the labels of their medication.
In cases involving the Hatch - Waxman Act and issues involving the expiration of pharmaceutical patents and competition between branded
drug companies and
generic manufacturers, our antitrust litigation graphics can illuminate a complicated industry and a complex regulatory scheme as below:
Pay - for - delay («PFD») agreements are agreements that are intended to delay the market entry of
generic manufacturers with
generic drugs in exchange for payments made by original pharmaceutical producers (i.e., holders of patents for an original branded
drug).
Specifically,
in Rafferty v. Merck & Co., Inc., [4] the SJC held that plaintiffs who ingest the
generic form of a
drug may bring failure to warn claims against the brand - name
manufacturer of the
drug if the brand - name defendant acted recklessly by «intentionally fail [ing] to update the label on its
drug while knowing or having reason to know of an unreasonable risk of death or grave bodily injury associated with its use.»
Balancing these competing interests, the court held that, «a brand - name
manufacturer that controls the contents of the label on a
generic drug owes a duty to consumers of that
generic drug not to act
in reckless disregard of an unreasonable risk of death or grave bodily injury.»
Mr. Simon also recently represented a
generic brand
drug company
in an individual case alleging that the brand name
manufacturer had filed false citizens petitions to delay the entry of the
generic drug unto the market.
Now, the justices are trying to decide whether
generic drug manufacturers can be sued
in state court for design defects - especially when the
generic version is an exact copy of its brand - name counterpart that the federal government had already approved.
[10] Prior to 2006, the price at which
manufacturers could apply to list
generic drugs in the Formulary was capped by regulations under the Actsat effectively 63 % of the price of the brand - name
drug.
Patent holders previously made such claims
in order to delay the onset of competition from
generic drug manufacturers, by preventing or delaying FDA approval of a generic manufacturer's Abbreviated New Drug Application (AN
drug manufacturers, by preventing or delaying FDA approval of a
generic manufacturer's Abbreviated New
Drug Application (AN
Drug Application (ANDA).
We have represented clients
in numerous other congressional investigations and oversight hearings, including a major internet services company
in an investigation of its practices abroad, a chemical
manufacturer in an investigation of the safety of its products, an insurance company
in a hearing on the federal long term care insurance program, a financial services company
in an investigation of credit card terms, and
drug companies
in investigations concerning such matters as payments to doctors, marketing practices,
generic approvals,
drug importation, and
drug safety.
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generic drugs from all top
manufacturers to their worldwide customers.We always believe
in customer satisfaction.