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News Breaks
March 18, 2014
07:28 EDTRHHBY, ABT, JNJ, LH, DHR, DGXCLFS review potential negative for Quest, LabCorp, says Piper Jaffray
Piper Jaffray views the Centers for Medicare & Medicaid Services' plan to revalue Clinical Lab Fee Schedule test codes as a potential negative for Quest Diagnostics (DGX) and LabCorp (LH) as well as diagnostic manufacturers like Abbott (ABT), Danaher (DHR), Johnson & Johnson (JNJ) and Roche (RHHBY). Piper says Quest and LabCorp both have around 12% of revenue exposure to CLFS, which it feels presents risk for additional reimbursement pressure in FY15. The review follows an Office of Inspector General report that found CMS paid between 18%-30% higher for 20 high volume/high expenditure tests than state and federal plans.
News For DGX;LH;ABT;DHR;JNJ;RHHBY From The Last 14 Days
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December 16, 2014
05:46 EDTRHHBYRoche launches PCR molecular diagnostic system for point of care environment
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December 15, 2014
10:10 EDTLHHigh option volume stocks:
High option volume stocks: RVBD AGCO FRO CRUS UBNT LH PAY PETM OREX KOS
05:24 EDTRHHBYExelixis announces Genentech files NDA for cobimetinib, vemurafenib combination
Exelixis (EXEL) announced its collaborator Genentech, a member of the Roche Group (RHHBY), has completed the filing of its New Drug Application, or NDA, with the FDA for cobimetinib, a specific MEK inhibitor discovered by Exelixis, in combination with vemurafenib for previously untreated patients with unresectable locally advanced or metastatic melanoma harboring a BRAF V600 mutation. Cobimetinib has received Fast Track designation by the FDA. Roche submitted a Marketing Authorization Application for the combination to the European Medicines Agency in September of this year. The NDA is based on data from the coBRIM trial, a phase 3 pivotal trial conducted by Genentech in 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma.
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.
11:19 EDTABTAbbott board increases quarterly dividend to 24c from 22c
The board of Abbott increased the company's quarterly common dividend to 24c per share from 22c per share. The cash dividend is payable Feb. 13, 2015, to shareholders of record at the close of business on Jan. 15, 2015.
09:16 EDTDHRDanaher price target raised to $93 from $85 at RW Baird
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07:19 EDTDHRDanaher priced target raised to $94 from $88 at BofA/Merrill
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05:52 EDTRHHBYRoche announces retirement of Genentech research head
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December 11, 2014
06:04 EDTDHRDanaher sees FY15 adjusted EPS $4.35-$4.45, consensus $4.01
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06:02 EDTDHRDanaher backs Q4 EPS view of $1.00-$1.04, consensus $1.02
05:24 EDTABTAbbott IRIDICA now available in Europe
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December 9, 2014
15:31 EDTLHLabCorp management to meet with Craig-Hallum
Meeting to be held in Baltimore on December 10 hosted by Craig-Hallum.
13:45 EDTDHRDanaher to host investor and analyst meeting
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12:22 EDTRHHBYPiper 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.
07:44 EDTRHHBY, DGXAmerican 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
07:53 EDTDHRDanaher price target raised to $100 from $89 at Jefferies
Jefferies raised its price target for Danaher shares to $100 ahead of the company's investor day and keeps a Buy rating on the name. It expects an initial 2015 organic growth outlook of 3% and earnings guidance of $3.95 and ex-amortization $4.40. Jefferies keeps a Buy rating on the stock.
December 7, 2014
14:54 EDTJNJIMBRUVICA data suggests promise in multiple myeloma
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