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News For MRK;PFE;GSK;JNJ;BMY;NVS;SHPG;ABT;CELG;SNY From The Last 14 Days Check below for free stories on MRK;PFE;GSK;JNJ;BMY;NVS;SHPG;ABT;CELG;SNY the last two weeks. |
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| May 13, 2013 |
| 09:44 EDT |  | SNY | Several companies reportedly interested in buying Adcock Ingram, Globes says
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| 07:30 EDT |  | SNY | TechConnect to host a summit
2013 National Innovation Summit is being held in Washington, D.C. on May 12-16. |
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| 05:44 EDT |  | GSK | Elan provides additional information on Elan/Theravance agreement
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| 05:35 EDT | | GSK | Theravance, Elan enter into $1B royalty participation agreement
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| May 10, 2013 |
| 16:29 EDT |  | PFE | On The Fly: Closing Wrap
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| 12:42 EDT | | GSK | GlaxoSmithKline, Theravance confirm FDA approval of Breo Ellipta
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| 12:31 EDT | | PFE | On The Fly: Midday Wrap
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| 11:48 EDT | | SNY, JNJ, BMY, MRK, GSK, PFE | Drugmakers to face pressure on U.S. prices, Reuters says
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| 11:15 EDT | | GSK | FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease
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| 10:00 EDT |  | SHPG | On The Fly: Analyst Downgrade Summary
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| 09:21 EDT | | PFE | On The Fly: Pre-market Movers
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| 08:08 EDT | | PFE | Pain Therapeutics discloses Pfizer reassessing continued Remoxy partnership
Pain Therapeutics (PTIE) disclosed a letter its CEO was sent from partner Pfizer (PFE) in which the drug maker said it is reassessing its endorsement of the Remoxy program "given the years of delay, additional cost incurred to bring the program to this point and development work left in the program." Pfizer said it will be reaching out to Pain Therapeutics "shortly" to have a confidential discussion about the terms of the companies' contractual agreement over the pain drug. Pfizer that it appears there is a regulatory pathway forward for Remoxy, but that the company does not expect to respond to submit a Complete Response letter for Remoxy to the FDA before mid-2015. Pfizer added in its letter to Pain Therapeutics "no final decision has been made at this time" on how it will proceed with the Remoxy development program. Shares of Pain Therapeutics fell 47% to $2.81 in pre-market trading following the disclosure of the correspondence. |
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| 07:46 EDT | | PFE | DURECT says additional clinical studies needed for Remoxy
DURECT (DRRX) announced that Pfizer (PFE) has provided an update on Remoxy in a regulatory filing. Pfizer's disclosure included: "We have been working to address the issues raised in the letter, which primarily relate to manufacturing. We met with the FDA in March 2013 to discuss our plan to address the June 2011 "complete response" letter. We received written guidance from the FDA in May regarding required next steps, including additional clinical studies, to address the letter. Based on this guidance, we are considering our options with respect to Remoxy. If we elect to continue development of Remoxy, we would not expect to submit a response to the 'complete response' letter before mid-2015." DURECT said it understands from Pfizer that additional clinical studies are necessary and include, in part, a pivotal bioequivalence study with the modified formulation to bridge to the clinical data conducted with the original formulation, as well as an abuse potential study with the modified Remoxy formulation. Remoxy is based on DURECT's ORADUR technology. Shares of Pfizer's Remoxy partner Pain Therapeutics (PTIE) are down 56% in pre-market trading, while shares of DURECT are down 13%, or 20c, to $1.39. |
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| 06:53 EDT | | MRK, GSK | GlaxoSmithKline, Merck to discount cancer vaccine in poor nations, NY Times says
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| 06:16 EDT | | JNJ | Obesity surgery booming in India, Bloomberg reports
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| 05:42 EDT | | SHPG | Shire downgraded to Neutral from Overweight at JPMorgan
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| 05:42 EDT | | NVS | Novartis drug Ilaris approved by FDA
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| May 9, 2013 |
| 17:09 EDT | | JNJ | Johnson & Johnson deal to settle sales practices probe stalls, WSJ reports
Johnson & Johnson's $2.2B settlement with the Justice Department related to its promotion of certain drugs is on hold as the company is looking to avoid language in the agreement that could make it vulnerable to private lawsuits, reports The Wall Street Journal, citing people familiar with the talks. Reference Link |
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| 12:24 EDT | | SHPG | Shire unit wins patent trial against Watson regarding LIALDA
Shire (SHPG), announces that its subsidiary, Shire Development, has prevailed in its litigation against Watson Pharmaceuticals, Watson Laboratories-Florida, Watson Pharma. and Watson Laboratories in connection with their Abbreviated New Drug Application for a generic version of Shire's LIALDA delayed release tablets for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. Following a five day bench trial in the Southern District of Florida, Judge Middlebrooks issued a ruling upholding the validity of the patent covering LIALDA, US Patent No. 6,773,720, and holding that the proposed ANDA formulation infringes the claims of that patent. Accordingly, Judge Middlebrooks confirmed that Shire is entitled to an injunction, which he will issue separately, which prohibits the FDA from approving the ANDA formulation until the expiration of the '720 patent. |
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| 10:17 EDT | | BMY, PFE, SHPG | Shire trades higher in London amid takeover chatter, Guardian says
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