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FDA Calendar Updates: POZN, AZN, SNY, CEPH, APPY, CYTR POZN

73%

-24.46% in 134 days <> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <font> BioMedReports.com </font> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-st... Continue reading »

The FDA's approval of Treximet should lead to profitability in the second quarter. POZN

22%

-56.30% in 572 days Pozen and partner GlaxoSmithKline announced late this evening that the U.S. Food and Drug Administration (FDA) has approved Treximet for the acute treatment of migraine attacks with or without aura in adults. The news was as expected and results in a $20 million milestone from Glaxo ($10 million for approval and $10 million for the launch) to be recorded by Pozen in the second quarter of 2008. This should lead to profitability in the second quarter. We are maintaining our Buy rating and $18 near-term price target on the shares. We are buyers on this positive ne... Continue reading »

From the Blogosphere

Pozen Files For Approval of Vimovo

28%

By 2013 Pozen (POZN) should be posting revenues near $200 million, with high profitability. Continue reading »

Pozen Files For Approval of Vimovo

By 2013 Pozen (POZN) should be posting revenues near $200 million, with high profitability. Continue reading »

Morning Movers 1/29: Allstate (ALL) Lower Following Results, Credit Downgrade; Sepracor (SEPR) Up On Results/Guidance

StreetInsider.com Morning Movers: <>POZEN Inc. (NASDAQ: POZN) 30% HIGHER; Informed by FDA That Endoscopic Gastric Ulcer Incidence Continues to Be an Acceptable Primary Endpoint Lloyds Banking Group plc (NYSE: LYG) 25% LOWER; UK banks continue to see extreme volitility. DryShips, Inc. (Nasdaq: DRYS) 23% LOWER; filed to offer up to $500 million in common shares. Innovative Solutions and Support, Inc. (Nasdaq: ISSC) 24% LOWER; reports Q1 EPS of $0.11, 8 cents better than the analyst estimate of $0.03. Revenue for the quarter was $10.6 million, versus the consensus of $9.47 million. Innovative Sol... Continue reading »

Unusual 11 Mid-Day Movers 10/17: CIT, ICUI, MPEL, UAUA Higher; LBY, POZN, ING, PPC Lower

CIT Group (NYSE: CIT) 39.9% HIGHER; after reporting a Q3 loss of $1.13, shares of CIT fell about 36% yesterday. The stock appears to be correcting after yesterday's large slide. Libbey Inc. (NYSE: LBY) 37% LOWER; reports preliminary Q3 sales of $211.5 million, versus the consensus of $220.14 million. Sees FY08 sales in the range of $833-$843 million, versus the consensus of $876.25 million. POZEN Inc. (NASDAQ: POZN) 28.7% LOWER; today announced that the U.S. FDA has informed the Company that, as part of the FDA's on-going discussions with the Company and their review of both the Special Continue reading »

POZEN, Inc. (POZN) Chairman and CEO Presents Company Update at Conference

38%

<>At the Jefferies 2nd Annual Healthcare Conference in New York, Dr. John R. Plachetka, Chairman and CEO of POZEN presented in regards to the company’s main product Treximet???. POZEN has obtained commercialization and development alliances with GlaxoSmithKline for Treximet??? (sumatriptan and naproxen sodium), which was recently approved by the FDA for the acute treatment of migraine attacks in adults. Additionally, the company has an agreement with AstraZeneca for proprietary fixed dose combinations of naproxen with the proton pump inhibitor esomerprazole magnesium, designed specifically <><>< /><><>... Continue reading »

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