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Topic: Cephalon


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In the News (Tue 8 Dec 09)

  
  PharmaTimes WorldNews| Daily pharmaceutical news | Cephalon drops Sparlon after FDA says 'no'
Cephalon has decided to drop its Sparlon drug for attention-deficit hyperactivity disorder (ADHD) after the US Food and Drug Administration rejected its application to market the drug.
Cephalon supplied new data to try to back up Sparlon's safety profile, but was unable to sway the agency.
After the FDA advisory committee rejected its application in March, Cephalon said its 2006 sales would be reduced by $100 million to $1.45-$1.5 billion as a result of the delay to the Sparlon project.
www.pharmatimes.com /news/9358-Cephalon-Sparlon.aspx?src=PTDay   (199 words)

  
 Cephalon Comments
Cephalon's Sparlon had been disingenuously (and perhaps to their own ultimate disservice) proclaimed as an "important new drug", instead of seeking supplemental approval on the basis of what it really is, a label extension for Provigil.
Cephalon is hardly standing pat, besides hiring a platoon of attorneys, they are about to begin clinical trials with single-isomer modafinil, which preclinically appears to have longer-duration of activity.
Cephalon is adding mass rapidly, but would still (because of the positive and growing revenue flow) be an attractive acquisition target itself for a larger company in possession of a strong CNS sales force.
www.neuroinvestment.com /CEPHcom.html   (6252 words)

  
 Cephalon News
Cephalon Inc. shares fell today after the company said U.S. regulators will likely delay final approval of its drug Nuvigil for excessive sleepiness as the agency investigates a case of a serious rash with a...
Cephalon Inc. engaged in 'problematic' practices to promote and increase sales of its narcotic lollipop painkiller, Actiq, according to an investigation by the Connecticut attorney general.
Cephalon received several FDA approvals for its drugs this year and may get one more by the end of '06.The Frazer, Pa.-based firm makes prescription drugs for the treatment of sleep and neurological disorders,...
www.topix.net /com/ceph   (615 words)

  
 Earnings Preview: Cephalon - Boston.com
Cephalon canceled the development program for Sparlon after the FDA rejection and shares of its stock plummeted.
In August, Cephalon said it expects third-quarter profit between $1.25 and $1.35 per share, excluding charges, on revenue between $425 million and $440 million.
Cephalon also is awaiting an FDA decision from on its narcolepsy drug Nuvigil, expected by the end of the quarter.
www.boston.com /business/articles/2006/10/31/earnings_preview_cephalon   (365 words)

  
 Philadelphia Inquirer | 08/04/2006 | Cephalon's revenue soars with Provigil   (Site not responding. Last check: 2007-10-15)
Cephalon Inc. yesterday reported a 54 percent increase in second-quarter revenue on strong sales of its biggest-selling sleep-disorder drug, Provigil, beating analysts' expectations.
Cephalon's earnings also benefited in the second quarter from sales of the cancer-pain drug Actiq, which were up 87 percent to $172.3 million, mainly because of hefty price increases and "a strong sales effort to maintain" the level of prescriptions, Baldino said.
Cephalon recently announced a new copromotion agreement with Takeda Pharmaceuticals to copromote Provigil to primary-care physicians across the country.
www.philly.com /mld/inquirer/business/15193442.htm   (557 words)

  
 Cephalon, Inc. - CIVIL ACTION NO. 96CV-633 - CONSOLIDATED CLASS ACTION COMPLAINT
Cephalon's major drug is Myotrophin, a recombinant human insulin-like growth factor-1 (or "rhIGF-1"), which is a peptide that has been isolated from the hearts of hypertensive rats and from dilated cardio-myopathic human heart tissue.
Cephalon was conducting another clinical trial of Myotrophin in the treatment of ALS in Europe at approximately the same time as the North American trial.
Cephalon further stated that it hadn't been told exactly what worried the FDA, insisting that Myotrophin is safe and that the higher mortality rate in Myotrophin-treated patients "was not statistically significant".
securities.stanford.edu /1002/CEPH96/002.html   (10235 words)

  
 Cephalon, Inc.   (Site not responding. Last check: 2007-10-15)
Today Cephalon is developing new products and drug delivery technologies that have the potential to generate a new era of growth, beginning in 2006.
Cephalon discovery research is focused on understanding and directing the molecular mechanisms of cell survival.
Cephalon employs hundreds of leading scientists who communicate and work across multiple disciplines, geographies and areas of expertise.
jobs.adsumo.com /jobseekerx/ViewCompanyProfile.asp?CompanyProfileID=98   (790 words)

  
 Cephalon Drug Gets Conditional OK
In addition, Cephalon is also developing modafinil for the potential treatment of sleep apnea [323039], fatigue associated with various neurological disorders, attention deficit hyperactivity disorder (ADHD), depression and circadian rhythm disorder [414510], [353372], [343435], [388926].
Cephalon received an approvable letter from the FDA in December 1997, for the treatment of excessive daytime sleepiness associated with narcolepsy [273272].
Cephalon is also planning to conduct pilot studies to evaluate the efficacy of modafinil in reducing daytime sleepiness associated with Parkinson's disease (PD), Alzheimer's disease (AD) and multiple sclerosis (MS), although it will not pursue FDA approval for all the indications.
www.ustc8312.com /drugnews/messages/79.html   (2302 words)

  
 PharmaTimes WorldNews| Daily pharmaceutical news | Cephalon's Fentora clears Phase III trial in back pain
Fentora (fentanyl), a novel painkiller that is dosed orally and delivers active drug via an effervescent lozenge that is held inside the cheek, was approved towards the end of September in the USA to treat chronic pain in patients with cancer.
Cephalon said in a statement that the results from the clinical trial showed that Fentora had a statistically significant effect in relieving lower back pain within 10 minutes of dosing, compared with placebo, and was also better at all subsequent timepoints tested out to 120 minutes.
Cephalon and Barr cut a deal earlier this year to keep the generic off the market until Fentora won approval, and Cephalon now manufactures fentanyl citrate for Barr while the Food and Drug Administration reviews the latter's own marketing application for the drug.
www.pharmatimes.com /news/9699-Cephalon-Fentora.aspx?src=PTDay   (329 words)

  
 Cephalon's Core Franchise Under Pressure - Forbes.com   (Site not responding. Last check: 2007-10-15)
The drugmaker's shares fell 13% in afternoon trading after Cephalon (nasdaq: CEPH - news - people) said late Wednesday that federal health regulators denied approval of the company's experimental attention deficit treatment for children.
Murphy views 2007 as a transitional year for Cephalon with limited upside for the stock due to sales erosion for cancer pain treatment Actiq and pending patent settlements.
In addition, the research analyst said fallout for Nuvigil due to the Sparlon rejection should be limited since the drug is for adults at lower doses and Provigil has been on the market for seven years with a clean safety record.
www.forbes.com /markets/equities/2006/08/10/cephalon-0810markets04.html   (431 words)

  
 Fool.com: Cephalon's Trials (Fool On The Hill) September 16, 1998
Cephalon's second drug, Provigil, is for use in the treatment of narcolepsy.
Some observers concurred with Cephalon's view that the European study wasn't large enough to attain statistical significance and that the patients on the therapy were sicker to begin with.
That hope was dashed yesterday when Cephalon announced it was withdrawing its application for marketing approval in Europe because a review committee there wasn't convinced the drug works.
www.fool.com /EveningNews/foth/1998/foth980916.htm   (1215 words)

  
 Cephalon Story
In 1987, a small team of pioneering young researchers launched Cephalon with the vision of building an integrated biopharmaceutical company with a presence in major markets around the world.
Today, Cephalon is poised for a new level of growth, with an expanded international presence, a diverse product portfolio, and drugs with even greater therapeutic potential.
From researching target molecules to advancing late-stage compounds, Cephalon is contributing to scientific understanding while preparing a new portfolio of therapies.
www.cephalon.com /our_business/cephalon_story.aspx   (240 words)

  
 Cephalon, Inc. - CIVIL ACTION NO. 96CV-633 - CLASS ACTION COMPLAINT
Defendant Cephalon is a corporation organized and existing under and by virtue of the laws of the State of Delaware.
On June 10, 1995, Cephalon presented the results of a Phase III clinical study of Myotrophin on 266 patients with ALS at eight medical centers in the United States and Canada at a session of the World Federation of Neurology Committee on Motor Neuron Diseases in Talloires, France.
Cephalon was quoted by the Dow Jones News Service on October 31, 1995, as stating: "[T]he drug appears to have an effect on survival." 45.
securities.stanford.edu /1002/CEPH96/001.html   (4085 words)

  
 With Conditions, FTC Allows Cephalon’s Purchase of CIMA, Protecting Competition for Breakthrough Cancer Pain Drugs
Cephalon also is developing a sugar-free Actiq formulation, which it expects to launch in 2005.
Specifically, it requires Cephalon to grant a third-party company, Barr, a fully paid, irrevocable license to make and sell a generic equivalent of Actiq in the United States that will be launched as soon as the FDA approves OVF, and in any event no later than February 2007.
First, Cephalon must transfer the know-how and intellectual property related to both the sugar and sugar-free versions of Actiq to Barr immediately, in accordance with a licensing and supply agreement.
www.ftc.gov /opa/2004/08/cimacephalon.htm   (1684 words)

  
 Cephalon - Wikipedia, the free encyclopedia
Cephalon, Inc. (NASDAQ: CEPH) is a biopharmaceutical company co-founded in 1987 by Dr. Frank Baldino, Jr.
The company's name relates to the Greek root word "cephalic" meaning "related to the head or brain," and it was established primarily to pursue treatments for neurodegenerative diseases.
Cephalon is a component of the SandP MidCap 400 stock index.
en.wikipedia.org /wiki/Cephalon   (492 words)

  
 Cephalon Receives Approvable Letter For FENTORA(TM) (fentanyl Buccal Tablet) For Management Of Breakthrough Pain In ...
Cephalon intends to submit a response to the FDA by the end of July.
Cephalon expects to deliver bulk units to Barr, and Barr will be responsible for all packaging and labeling of the product.
Approximately 50 million Americans suffer from chronic pain, a condition that consists of two distinct components: persistent pain, which is pain that is continuous throughout the day, and breakthrough pain, which is a transitory flare of moderate-to-severe pain in patients with otherwise stable persistent pain.
www.medicalnewstoday.com /medicalnews.php?newsid=46280   (988 words)

  
 PROVIGIL | Terms
Cephalon also owns a copyright in the Site as a collective work and/or compilation, and in the selection, coordination, arrangement, and enhancement of such content.
Please be aware that Cephalon actively and aggressively enforces its intellectual property rights to the fullest extent of the law.
Cephalon, Inc. may make changes to these materials at any time, without notice, and makes no commitment to update the information contained herein.
www.provigil.com /patient/terms.aspx   (1018 words)

  
 RFID Journal - Cephalon Announces Item-Level Pilot
Cephalon is working with RFID software vendor OATsystems and RFID hardware provider ADT Security Services to develop and execute the pilot.
While Cephalon did not provide a detailed timeline for the pilot, it did say it will begin by tagging and tracing dummy bottles containing pharmaceutically inert substances similar to those used as placebos.
Cephalon's Schedule II drugs are sold by Wal-Mart stores through a distributor that is responsible for applying RFID tags to comply with Wal-Mart's Schedule II drug-tagging mandate.
www.rfidjournal.com /article/articleprint/1796/-1/1   (739 words)

  
 deseretnews.com | Cephalon agrees to buy alcohol-treatment drug
Cephalon Inc., maker of the sleep-disorder drug Provigil, agreed to pay as much as $490 million to Alkermes Inc. for the development and U.S. commercial rights to Vivitrex, an experimental treatment for alcohol dependence.
Vivitrex is a once-a-month injection of naltrexone, a non-addictive agent that binds to opioid receptors in the brain and is believed to diminish the craving for alcohol, Cephalon said.
Cephalon will have the primary responsibility of marketing the medicine, with Alkermes contributing a specialized sales force.
deseretnews.com /dn/view/0,1249,600144016,00.html   (488 words)

  
 Cephalon UK | neurological disorders | diseases of the nervous system and brain | sleep disorders and cancer
Founded in 1987, Cephalon Inc is a research based pharmaceutical company located in Pennsylvania.
Cephalon seeks to discover, develop and market innovative products to treat neurological disorders (diseases of the nervous system and brain), sleep disorders and cancer.
The company is committed to providing patients and the medical community with novel therapies to treat unmet medical conditions through its proprietary research programs and by acquiring promising products for clinical development and commercial sale.
www.cephalon.co.uk   (81 words)

  
 Cephalon UK | Careers
A leading innovator in pharmaceutical and drug delivery, discovery and development, Cephalon is creating novel therapies to treat neurological disorders, sleep disorders and cancer.
It is a stimulating, multi-disciplinary scientific community where your talents and ideas are inspired by the excitement of discovery.
Join us at Cephalon and realise the true potential of your mind and your career.
www.cephalon.co.uk /careers/index.html   (109 words)

  
 Ambit Biosciences announces collaboration first with Cephalon   (Site not responding. Last check: 2007-10-15)
The deal will allow Cephalon to see not only how their drugs interact with target kinases, but also with other kinases that could be causing side effects.
Under the terms of the agreement Ambit's KinomeScan-driven discovery capabilities will be combined with Cephalon's chemistry, discovery and development capabilities, significantly compressing typical timelines for discovery and development of small molecule pharmaceutical products.
Ambit will also have the opportunity to utilise Cephalon library compounds to discover and develop products that are effective inhibitors of certain undisclosed kinases.
www.drugresearcher.com /news/ng.asp?n=71887-cephalon-ambit-kinases   (725 words)

  
 Cephalon, The specialist in Neuro and fMRI applications - Neuroimaging, aEEG-Monitor, Neuromonitor, digitalt EEG, ...
Cephalon are located with offices in Sweden, Denmark and Finland.
Cephalon announces this years technical training course for the nEEG (Nervus) EEG / NeuroMonitor system.
Cephalon carries full range of Nonin oximeter and sensors
www.cephalon.dk   (229 words)

  
 [No title]
Shares of Cephalon rose $3.19, or 6.1 percent, to $55.28 in midday trading on the Nasdaq at more than three times their average volume.
In November, Cephalon announced it expected a generic version of Provigil to enter the market in 2006.
Cephalon said it expects 2005 sales of Provigil to total $500 million to $525 million, slightly less than half its overall sales for the year.
www.ynetnews.com /articles/0,7340,L-3182256,00.html   (242 words)

  
 Cephalon Announces Results from GABITRIL(R) Clinical Program in Generalized Anxiety Disorder - PipelineReview.com | ...
Cephalon will conduct a complete analysis of the data to assist in its evaluation of future clinical development plans for GABITRIL in other therapeutic areas.
Cephalon currently employs approximately 3,000 people in the United States and Europe.
Cephalon's European headquarters are located in Maisons-Alfort, France.
www.pipelinereview.com /joomla/content/view/4780/109   (555 words)

  
 Cephalon, Inc.
Cephalon - one of the world's fastest growing biopharmaceutical companies with more than $1 billion in annual revenue - is dedicated to the discovery, development and marketing of innovative drugs to treat and manage neurological diseases, sleep disorders, cancer and pain.
To balance the risks inherent in drug discovery and development, Cephalon pioneered a balanced risk business model that combines acquiring and marketing innovative, high-growth products with strong in-house research and development capabilities.
Cephalon is collaborating with Alkermes to commercialize VIVITREX® (naltrexone long-acting injection), therapy for alcohol dependence.
www.biospace.com /company_profile.aspx?CompanyID=1335   (374 words)

  
 Cephalon initiated with "buy" | newratings.com
NEW YORK, October 17 (newratings.com) – Analyst Louis C Webb of WR Hambrecht initiates coverage of Cephalon (CEPH.NAS) with a "buy" rating.
Shares of Cephalon, a company that develops neurological and oncology drugs, are currently trading at $47.33.
Cephalon also has several new proprietary drugs in the pipeline in neurology and oncology, the analysts observe.
www.newratings.com /new2/beta/article.asp?aid=343727   (311 words)

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