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News Breaks
May 10, 2013
11:48 EDTJNJ, AZN, GSK, LLY, SNY, RHHBY, MRK, BMY, PFEDrugmakers to face pressure on U.S. prices, Reuters says
Big pharmaceutical companies have enjoyed higher a premium on their drugs in the U.S. market when compared to Europe, but a report from Reuters says that President Obama's health reform bill will put downward pressure on drug prices over the next three to five years. Reference Link
News For JNJ;AZN;GSK;LLY;SNY;RHHBY;MRK;BMY;PFE From The Last 14 Days
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August 18, 2014
11:41 EDTJNJ, PFE, LLYCubist rises after report sparks takeover interest speculation
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08:01 EDTPFEPfizer announces submission of Palbociclib NDA to FDA
Pfizer announced it has completed the submission of a New Drug Application to the United States Food and Drug Administration for palbociclib. This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor positive, human epidermal growth factor receptor 2 negative advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients. Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Pfizer will communicate the Agency’s decision.
07:57 EDTBMY, PFE, MRK, AZNCambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
August 17, 2014
13:40 EDTRHHBYChugai makes statement denying media reports on Roche deal
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August 15, 2014
11:28 EDTRHHBYRoche in talks on $10B deal to buy remainder of Chugai, Bloomberg reports
Roche is in talks to purchase the 38% stake of Chugai Pharmaceutical that it doesn't already own, according to Bloomberg, citing people familiar with the matter. The potential deal is valued at approximately $10B. Though no financial decision has been made, the deal may be announced as early as next week, the sources added. Reference Link
11:02 EDTRHHBYRoche in talk on $10B deal to buy remainder of Chugai, Bloomberg says
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06:34 EDTGSKLawyer says GSK connected investigators to not appeal ruling, Reuters says
Defense lawyer Zhai Jian said GlaxoSmithKline connected corporate investigator Peter Humphrey and his American wife are not aiming to appeal a Chinese court's prison sentence ruling, according to Reuters, citing comments from Jian. Reference Link
06:12 EDTRHHBYGilead announced favorable ruling in arbitration against Roche
Gilead (GILD) announced that an arbitration panel determined that Roche (RHHBY) failed to establish any of their claims and ruled in favor of Gilead. As a result, Roche is not entitled to any damages or other relief. In March 2013, Roche initiated an arbitration against Gilead and Pharmasset, predecessor to Gilead Pharmasset, regarding a 2004 collaboration agreement between Roche and Pharmasset. In the arbitration demand, Roche asserted that it had an exclusive license to sofosbuvir pursuant to the collaboration agreement because sofosbuvir, a prodrug of a uridine monophosphate analog, is allegedly a prodrug of PSI-6130, a cytidine analog. Roche further claimed that, because it had exclusive rights to sofosbuvir, it also had an exclusive license to a patent covering sofosbuvir, and that we infringed that patent by selling and offering for sale products containing sofosbuvir.
August 14, 2014
17:05 EDTPFEPfizer says FDA accepted for review BLA for bivalent recombinant LP2086
Pfizer announced that the FDA has accepted for review the Biologics License Application,BLA, for bivalent recombinant LP2086, the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds. The FDA has also granted Priority Review designation for the BLA, providing an anticipated Prescription Drug User Fee Act, PDUFA, action date of February 14, 2015. “Pfizer has closely collaborated with the FDA since 2008 to develop our meningococcal B vaccine candidate with the intent to help prevent this devastating disease,” said Dr. Emilio Emini, senior vice president of Vaccine Research and Development for Pfizer. “Both the acceptance of Pfizer’s Biologics License Application today, and its Priority Review designation, are significant regulatory milestones that underscore the importance of our efforts to expedite the approval and subsequent availability of our meningococcal B vaccine for U.S. adolescents.”
16:02 EDTRHHBYFDA approves Genentech’s Avastin plus chemotherapy for cervical cancer treatment
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12:01 EDTAZNThird Point gives quarterly update on stakes
NEW STAKES: Rackspace (RAX), Finisar (FNSR), Amgen (AMGN), Ally Financial (ALLY), and AstraZeneca (AZN). INCREASED STAKES: Dollar General (DG) and Dow Chemical (DOW). DECREASED STAKES: FedEx (FDX), Hertz (HTZ), T-Mobile (TMUS) and Intrexon (XON). LIQUIDATED STAKES: Google Class A (GOOGL), Verizon (VZ) and Mondelez (MDLZ).
09:11 EDTSNY, RHHBYOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Kohl's (KSS), up 2.5%... Plug Power (PLUG), up 10%... Perrigo (PRGO), up 4.5%. HIGHER: Aruba Networks (ARUN), up 3% after shares upgraded at Stifel... KaloBios (KBIO), up 7.9% after publication shows EphA3 as target for anticancer therapy... Supernus (SUPN), up 4.4% after receiving FDA fast track designation for SPN-810. DOWN AFTER EARNINGS: Noodles & Company (NDLS), down 22%... Vipshop (VIPS), down 5.8%. LOWER: ExOne (XONE), down 10.7%, Voxeljet (VJET), down 6.6%, after earnings reports. Peers in the 3D space are lower as well, with Stratasys (SSYS) down 1% and 3D Systems (DDD) down 0.2%... Enphase Energy (ENPH), down 2.6% after filing to sell common stock for holders... InterMune (ITMN), down 3% after downgraded at Goldman following yesterday's advance on Bloomberg report that the company received takeover bids from Sanofi (SNY), Roche (RHHBY).
August 13, 2014
18:02 EDTMRKMerck provides statement on role of PNEUMOVAX 23 in updated ACIP recommendations
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17:08 EDTSNYSanofi Pastuer annnounces positive results from trial of Fluzone
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16:52 EDTMRKMerck confirms FDA approval of BELSOMRA
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16:19 EDTRHHBY, GSK, SNYOn The Fly: Closing Wrap
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15:30 EDTMRKFDA approves Belsomra sleep drug
The Food and Drug Administration approved Belsomra tablets for use as needed to treat difficulty in falling and staying asleep. Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Belsomra will be dispensed with an FDA-approved patient Medication Guide that provides instructions for its use and important safety information. Belsomra is a controlled substance because it can be abused or lead to dependence. Belsomra is made by Merck, Sharpe & Dohme.
13:13 EDTRHHBY, GSK, SNYInterMune exploring sale after bids from Sanofi, Roche, Glaxo, Bloomberg says
InterMune (ITMN) is working with its financial advisers Goldman Sachs (GS) and Centerview Partners to evaluate takeover bids it has received from Sanofi (SNY), Roche (RHHBY), GlaxoSmithKline (GSK) and Actelion (ALIOF), said Bloomberg, citing people with knowledge of the matter. The report noted that one of the sources said Sanofi has so far shown the most interest in a deal for InterMune, whose shares are up more than 13% to $51.56 following the first headlines from the report. Reference Link
13:00 EDTRHHBY, SNYInterMune received takeover bids from Sanofi, Roche, Bloomberg says
08:31 EDTAZNAstraZeneca says Phase 3 trials of lesinurad for gout met primary endpoints
AstraZeneca announced top-line results from CLEAR1, CLEAR2 and CRYSTAL, the pivotal Phase III clinical trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor, as a combination therapy for the treatment of patients with symptomatic gout. Lesinurad is an investigational agent that inhibits the URAT1 transporter, increasing uric acid excretion and thereby lowering serum uric acid. In the CLEAR1 and CLEAR2 trials, both lesinurad 200mg and 400mg in combination with allopurinol met the primary endpoint, with a statistically significant higher proportion of patients reaching the target sUA goal of <6.0mg/dL at month 6 compared to allopurinol alone. In the CRYSTAL trial, lesinurad 400mg in combination with febuxostat met the primary endpoint, with a statistically significant higher proportion of patients reaching the target sUA goal of <5.0mg/dL at month 6 compared to febuxostat alone. Although lesinurad 200mg did not achieve statistical significance at month 6, this dose in combination with febuxostat, was superior to placebo plus febuxostat at all other time points. Results from these Phase III clinical trials will be submitted to a scientific meeting later in 2014. The company is proceeding with preparation of regulatory submissions for lesinurad 200mg combination therapy.
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