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News For VVUS;JNJ;AZN;PFE From The Last 14 Days
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December 18, 2014
08:03 EDTPFEPfizer reports statistically significant results in Phase 3 pregabalin study
Pfizer announced top-line results from a double-blind Phase 3 study evaluating pregabalin controlled-release formulation in adult patients with postherpetic neuralgia. The results show that pregabalin CR resulted in a statistically significant positive effect compared to placebo in the primary endpoint, time to loss of therapeutic response in pain reduction. PHN is a type of peripheral neuropathic pain caused by nerve damage. Symptoms include continued burning or electric shock-like pain.1 This study is the final of three Phase 3 studies of the pregabalin CR formulation conducted to ascertain the potential use of pregabalin as a once-a-day therapy. The first study in adults with partial onset seizures with epilepsy did not meet its primary endpoint. In the second study in patients with fibromyalgia, pregabalin CR had a statistically significant positive effect compared to placebo in the primary endpoint, time to LTR in pain reduction. The objective of the Phase 3 double-blind, randomized, placebo-controlled study was to evaluate the safety and efficacy of pregabalin CR compared with placebo in the durability of effect for the treatment of pain associated with PHN among patients who initially respond to single-blind pregabalin.
07:28 EDTPFEPfizer shares poised to perform well in 2015, says Deutsche Bank
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December 17, 2014
09:04 EDTJNJHalozyme enters collaboration pact with Janssen for ENHANZE Technology
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09:02 EDTJNJHalozyme enters collaboration pact with Janssen for ENHANZE Technology
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08:06 EDTJNJInovio appoints Zane Yang as VP, Clinical Development, Oncology
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08:01 EDTPFEPfizer initiates Phase 2 PF-06252616 study
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December 16, 2014
07:20 EDTJNJGeron announces early HSR clearance for collaboration with Janssen
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December 15, 2014
18:32 EDTPFEPfizer announces Palbociclib PALOMA-1 data published in The Lancet Oncology
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12:09 EDTPFEPfizer increases dividend 8% to 28c per share
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10:40 EDTPFEOPKO Health deal with Pfizer removes financing overhang, says Ladenburg
Ladenburg views the agreement OPKO Health (OPK) signed with Pfizer (PFE) as a significant positive catalyst since the company is partnering with an established leader in short-acting hGH and because the large upfront payment removes near-term financing needs as an overhang on the stock. The firm reiterates its Buy rating and $14.50 price target on OPKO, but said it will re-examine its projections after the deal closes.
10:19 EDTPFEOPKO Health soars after entering hGP-CTP agreement with Pfizer
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09:03 EDTPFEBaxter to divest Vero cell vaccines platform to Nanotherapeutics
Baxter International (BAX) announced that it has entered into a definitive agreement to sell its proprietary Vero cell technology and related assets, including its production facility in Bohumil, Czech Republic, to Nanotherapeutics, Inc. Financial details were not disclosed. The agreement with Nanotherapeutics includes all assets related to the platform, including vaccines for H5N1, H1N1 and seasonal influenza. The agreement also includes investigational vaccine programs for Ross River virus, Chikungunya disease and West Nile virus. In recent weeks, the company has also completed the sale of its commercial vaccines business and related manufacturing facilities to Pfizer (PFE).
08:02 EDTPFEPfizer, OPKO Health enter into global agreement for hGH-CTP
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07:35 EDTVVUSApricus Biosciences appoints Barbara Troupin, M.D. as Chief Medical Officer
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07:33 EDTAZNAdvaxis announces FDA acceptance of INDA to commence clinical trials of ADXS-HPV
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December 12, 2014
14:01 EDTJNJGenOn Energy to receive $3M milestone payment in Janssen collaboration
Genmab announced it has reached a milestone in its DuoBody technology platform collaboration with Janssen Biotech (JNJ), triggering a $3M payment. The milestone payment is for pre-clinical progress with a DuoBody product candidate targeting cancer. Today's news will not impact Genmab's 2014 financial guidance.
December 11, 2014
16:03 EDTAZNAmgen, AstraZeneca to present results from Phase 3 plaque psoriasis study
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07:28 EDTAZNCBI to hold a summit
2nd Specialty Data Optimization Summit is being held in Philadelphia on December 11.
December 10, 2014
08:31 EDTPFETeva announces launch of first generic Celebrex capsules in the U.S.
Teva Pharmaceutical Industries (TEVA) announces the launch of the first FDA-approved generic equivalent to Celebrex Capsules in the United States. Teva is offering 50, 100, 200, and 400 mg strengths of Celecoxib Capsules. Celebrex Capsules, marketed by Pfizer (PFE) had annual sales of approximately $2.56B in the United States, according to IMS data as of October 2014.
07:38 EDTPFEMylan launches generic version of Pfizer's Celebrex capsules
Mylan (MYL) announced the U.S. launch of its Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg, one of the first available generic versions of Pfizer's (PFE) Celebrex Capsules, indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. Celecoxib Capsules had U.S. sales of approximately $2.5B for the 12 months ending September 30, 2014.
December 9, 2014
12:22 EDTPFEPiper Jaffray biopharm analyst holds an analyst/industry conference call
Senior Research Analyst Schimmer, along with Biopharmaceuticals Analyst Breazzano, discuss gene therapy for hemophilia on an Analyst/Industry conference call to be held on December 11 at 10 am.
10:32 EDTPFEPfizer says in talks with FDA on path forward for Mylotarg
Pfizer announced the presentation of encouraging early- and late-stage data from clinical studies across several hematologic malignancies, including acute myeloid leukemia, acute lymphoblastic leukemia and chronic myeloid leukemia. Among the highlights are results from several investigator-led, large, randomized studies evaluating the antibody-drug conjugate MYLOTARG in select adult AML populations. Research was presented at the 56th Annual Meeting of the American Society of Hematology in San Francisco, December 6-9. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology, said “In particular, we are encouraged by the significant clinical evidence emerging from large randomized trials, such as AML-19 and ALFA-0701, demonstrating a positive impact of MYLOTARG when added to standard first-line treatment for patients with acute myeloid leukemia. We are engaging in discussions with the U.S. FDA and other health authorities to determine the best path forward for MYLOTARG. In addition, we plan to initiate an expanded access protocol for the therapy by the end of 2014 in the United States in patients with relapsed or refractory acute myeloid leukemia for whom there are no other treatment options.”
09:10 EDTAZNARIAD takeover rumors rekindled, Independent says
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08:02 EDTAZNMoventig approved in EU for opioid-induced constipation
Nektar (NKTR) reported partner AstraZeneca (AZN) announced that MOVENTIG has been granted Marketing Authorisation by the European Commission for the treatment of opioid-induced constipation in adult patients who have had an inadequate response to laxative. MOVENTIG is the first once-daily oral peripherally-acting mu-opioid receptor antagonist to be approved in the European Union.
07:44 EDTPFE, AZNAmerican Association for Cancer Research to hold a symposium
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05:50 EDTJNJPharmacyclics data demonstrates safety, durability response
New, 27-month IMBRUVICA median follow-up data announced by Pharmacyclics (PCYC) support the use of IMBRUVICA over longer periods of time in patients with relapsed/refractory mantle cell lymphoma, or MCL, an aggressive type of lymphoma. More than 30% of IMBRUVICA patients remained progression-free after two years with no new or unexpected adverse events occurring during that time. Nearly half of the 111 patients treated were still living at the time of the data analysis. A second Phase II trial looked at IMBRUVICA's efficacy and safety as a single-agent treatment for MCL patients who previously had received rituximab combination therapy and at least two cycles of bortezomib. IMBRUVICA combination therapy resulted in an 88% overall response rate in MCL patients with a complete response rate of 40%. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of Johnson and Johnson (JNJ).
05:43 EDTJNJPharmacyclics reports IMBRUVICA data shows 84% PFS rate at one year
Pharmacyclics (PCYC) announced new, longer term data in IMBRUVICA patients with relapsed/refractory chronic lymphocytic leukemia, or CLL, including high-risk CLL patients with deletion 17p. Results from the Phase III RESONATE trial demonstrated an 84% progression-free survival, or PFS, rate in all patients with previously treated CLL or small lymphocytic lymphoma, or SLL, who received IMBRUVICA and a 94% PFS rate in patients who received only one prior therapy at 12 months. Separately, follow-up data was reported from Phase II RESONATE-17, or PCYC-1117, the largest prospective trial dedicated to studying CLL or SLL patients with del 17p. The data showed that IMBRUVICA was associated with an 83% overall response rate, or ORR, at a median follow up of 11.5 months. At 12 months, the estimated PFS was 79%. These results and additional data were presented here at the 56th American Society of Hematology, or ASH, Annual Meeting, highlighting IMBRUVICA's sustained efficacy in relapsed/refractory patients who have received at least one prior therapy. IMBRUVICA combination therapy resulted in an 88% overall response rate in MCL patients with a complete response rate of 40%. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of Johnson and Johnson (JNJ).
05:27 EDTJNJPharmacyclics IMBRUVICA Phase II combination data shows positive profile
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December 8, 2014
13:32 EDTPFEPfizer, Bristol-Myers announce results of human study on Eliquis
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced results of the first human study evaluating the reversal of the anticoagulant effect of Eliquis by 4-factor prothrombin complex concentrates in healthy subjects. The study results demonstrated that both PCCs, Sanquin’s Cofact and CSL Behring’s Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis in several coagulation assessments, including endogenous thrombin potential. The full data will be presented today during the Antithrombotic Therapy: Anticoagulant Therapy session at the 56th annual meeting of the American Society of Hematology in San Francisco, CA. The study was an open label, randomized, placebo-controlled, three-period crossover study in 15 healthy, adult subjects. Within each period, subjects received Eliquis 10 mg twice daily. On day four, three hours after Eliquis administration, subjects received a 30-minute infusion of 4-factor PCCs, either 50 IU/kg Cofact or Beriplex P/N, or an equivalent volume of saline solution. The effect of Cofact and Beriplex P/N on the pharmacodynamics of Eliquis was based upon changes in endogenous thrombin potential, a measure of thrombin-mediated coagulation. Treatment periods were separated by an 11-day washout, after which the alternate treatment was administered. In this study, no serious adverse events, bleeding-related events or signs of thrombosis were reported with Eliquis administration with or without PCC treatment. Overall, these data demonstrate that Cofact and Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis as measured by ETP and support further evaluation of PCCs in the management of patients treated with Eliquis who require reversal of its anticoagulant effect.
08:03 EDTPFEPfizer announces agreement with Spark Therapeutics to develop SPK-FIX
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07:05 EDTAZNInnocoll appoints Tony Zook as CEO
Innocoll AG (INNL) announced that Tony Zook, formerly executive vice president, Global Commercial Operations, at AstraZeneca (AZN), has been appointed CEO effectively immediately. Michael Myers, will continue with the company as head of Portfolio Operations.
December 7, 2014
14:54 EDTJNJIMBRUVICA data suggests promise in multiple myeloma
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December 5, 2014
10:22 EDTPFEBristol-Myers call activity attributed to takeover speculation
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10:05 EDTPFEBristol-Myers jumps 2% amid talk of potential Pfizer bid
Shares of Bristol-Myers (BMY) are up in early trading amid chatter of a potential takeover bid from Pfizer (PFE). The stock is up $1.26 to $60.15. Bristol's market capitalization stands around $99B, less than twice that of Pfizer's $200B. A Jefferies analyst last week called Mylan (MYL) the most likely takeover target for Pfizer. Pfizer is "highly motivated" to buy a foreign company using its overseas cash and Mylan looks like the most likely target, Jefferies analyst Jeffrey Holford wrote.
09:56 EDTPFERumor: Bristol-Myers strength attributed to takeover speculation
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09:49 EDTAZNUBS European pharmaceuticals analysts holds analyst/industry conference call
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December 4, 2014
11:23 EDTJNJAppeals court reverses patent ruling in favor of J&J unit over Covidien
Ethicon Endo-Surgery, a Johnson & Johnson (JNJ) company, appealed a district court judgment regarding certain asserted patent claims of Tyco Healthcare. The appeals court affirmed-in-part, reversed-in-part, and vacated-in-part the prior judgment, because the lower court’s 102(g) findings were correct, but its 103 determination was improper, "including its decision to exclude the 102(g) prior art from the obviousness analysis," the court stated. In 2007, Tyco Healthcare changed its name to Covidien (COV). Reference Link
09:01 EDTJNJVA negotiated $594 per dose price for Gilead HCV treatment
A Veterans Health Administration official told a Senate committee yesterday that Veterans' Affairs has "moved rapidly to deploy new, more effective, less toxic HCV treatments and has been able to negotiate significant discounts for these newer therapies." The agency negotiated a price of $594 per dose for Gilead's (GILD) Hepatitis C virus drug Sofosbuvir, below the commercial price of $1,000 per dose, VHA Chief Consultant for Pharmacy Benefits Management Michael Valentino told the Senate's Committee on Veterans' Affairs. The agency also received a $413 per dose price for Johnson & Johnson's (JNJ) Simeprevir, below the commerical price of $790. The VA has approximately 174,000 veterans in care with HCV, making it the largest single HCV provider in the U.S., Valentino pointed out. He added, "Like the rest of the country, VA has treated only a portion of Veterans for HCV because treatment and cures have been difficult to achieve due to low efficacy and high toxicity of standard drug therapies." Reference Link
08:45 EDTAZN, PFEAbbVie price target raised to $80 from $72 at Jefferies
Jefferies raised its price target for AbbVie shares to $80 while calling the company one of its top five global pharma picks for 2015. The firm's top U.S. pick is Pfizer (PFE) and its top Europe pick is Novartis (NVS). Bayer (BAYRY) and AstraZeneca (AZN) round out the top five. Jefferies thinks AbbVie's "strong momentum" will continue into the first half of 2015 and keeps a Buy rating on the name.
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