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News Breaks
December 19, 2012
17:54 EDTPFE, BMY, JNJFDA says Pradaxa not safe for use on patients with mechanical heart valves
The U.S. Food and Drug Administration ,FDA, is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves. A clinical trial in Europe (the RE-ALIGN trial)1 was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users. Boehringer Ingelheim's is the manufacturerof Pradaxa. Note that Pradaxa competitors include: Eliquis, from Bristol-Myers Squibb (BMY) and Pfizer (PFE), Xarelto from Johnson & Johnson (JNJ) and Coumadin, an older drug from from Bristol-Myers Squibb.
News For BMY;PFE;JNJ From The Last 14 Days
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December 9, 2014
16:35 EDTBMYBristol-Myers raises dividend to 37c per share from 36c per share
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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.”
08:25 EDTBMYBristol-Myers data positive, says BMO Capital
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07:44 EDTPFEAmerican 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 EDTBMY, PFEPfizer, 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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05:53 EDTBMYStocks with implied volatility movement; BSX BMY
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December 7, 2014
14:54 EDTJNJIMBRUVICA data suggests promise in multiple myeloma
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14:10 EDTBMYAmerican Society of Hematology to hold a meeting
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13:06 EDTBMYBMY announces positive results in Phase 1b trial evaluating Opdivo
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December 5, 2014
10:22 EDTPFE, BMYBristol-Myers call activity attributed to takeover speculation
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10:05 EDTPFE, BMYBristol-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 EDTBMY, PFERumor: Bristol-Myers strength attributed to takeover speculation
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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 EDTPFEAbbVie 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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