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News Breaks
January 29, 2013
06:39 EDTBMY, SNY, PFE, TEVA, MRK, JNJ, AZN, AMGN, GSK, LLY, RHHBY, ACTBiotech companies pushing states to restrict generic drugs, NY Times says
Large biotech companies are lobbying state legislators around the country to pass laws that would limit the use of generic drugs, according to The New York Times. Amgen (AMGN) and Roche's (RHHBY) Genentech are proposing legislation that would restrict pharmacists' ability to substitute generic drugs for brand name products, the newspaper explained. Reference Link
News For RHHBY;AZN;PFE;LLY;JNJ;SNY;GSK;MRK;BMY;AMGN;TEVA;ACT From The Last 14 Days
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January 15, 2015
16:04 EDTAMGNAmgen announces new data from Phase 2 PEAK, Phase 3 PRIME studies
Amgen announced new data from the Phase 2 PEAK and Phase 3 PRIME studies that support the first-line use of Vectibix in combination with Folfox, an oxaliplatin-based chemotherapy regimen, in patients with wild-type RAS metastatic colorectal cancer. In an exploratory analysis from the PEAK study, treatment with Vectibix compared to Avastin resulted in a "significantly higher proportion" of patients with earlier tumor shrinkage at week eight, 64% vs. 45%, respectively, and among responding patients, a longer duration of response, 11.4 vs. 8.5 months, respectively, and greater depth of response . Overall response rates appeared to be similar between Vectibix and Avastin. This is consistent with observed overall survival and progression-free survival (PFS) rates, and with data previously reported, Amgen said. It added, "While the primary analysis from PEAK showed similar ORR between the Vectibix- and bevacizumab-based regimens, this exploratory analysis demonstrates that Vectibix produces early, sustained anti-tumor activity, which may in part explain the OS and PFS benefits seen with Vectibix versus bevacizumab in this trial."
14:31 EDTGSKMylan launches generic Epivir-HBV tablets
Mylan (MYL) announced the U.S. launch of its Lamivudine Tablets, 100 mg, which is the generic version of GlaxoSmithKline's (GSK) Epivir-HBV. Mylan received final approval from the U.S. FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. Lamivudine Tablets, 100 mg, had U.S. sales of approximately $18.1M for the 12 months ending September 30, 2014, according to IMS Health. Currently, Mylan has 284 ANDAs pending FDA approval representing $109.1B in annual brand sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $29.3B in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.
12:10 EDTJNJJohnson & Johnson volatility elevated into Q4 and outlook
Johnson & Johnson January weekly call option implied volatility is at 22, February is at 16, April is at 15; compared to its 26-week average of 15 according to Track Data, suggesting large movement into the expected release of Q4 results on January 20.
11:20 EDTLLY, MRK, JNJ, PFEGoldman cuts J&J to sell citing competitive pressures
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10:00 EDTLLYOn The Fly: Analyst Upgrade Summary
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10:00 EDTJNJOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: American Campus (ACC) downgraded to Sell from Neutral at Goldman... Apple (AAPL) downgraded to Neutral from Buy at Mizuho... Archer Daniels (ADM) downgraded to Neutral from Buy at Goldman... Barrick Gold (ABX) downgraded to Underweight from Equal Weight at Barclays... CNOOC (CEO) downgraded to Underperform from Hold at Jefferies... CSC (CSC) downgraded to Underweight from Neutral at JPMorgan... Computer Programs (CPSI) downgraded to Market Perform from Outperform at William Blair... D.R. Horton (DHI) downgraded to Neutral from Buy at UBS... DDR Corp. (DDR) downgraded to Neutral from Overweight at JPMorgan... Dominion Diamond (DDC) downgraded to Equal Weight from Overweight at Barclays... EVERTEC (EVTC) downgraded to Neutral from Overweight at JPMorgan... Education Realty (EDR) downgraded to Sell from Neutral at Goldman... Franco-Nevada (FNV) downgraded to Underweight from Equal Weight at Barclays... General Cable (BGC) downgraded to Neutral from Buy at Longbow... Green Dot (GDOT) downgraded to Neutral from Overweight at JPMorgan... Greif (GEF) downgraded to Neutral from Buy at BofA/Merrill... Grupo Simec (SIM) downgraded to Neutral from Buy at Goldman... Hecla Mining (HL) downgraded to Hold from Buy at BB&T... Host Hotels (HST) downgraded to Hold from Buy at MLV & Co.... Ingredion (INGR) downgraded to Sell from Neutral at Goldman... Insulet (PODD) downgraded to Market Perform from Outperform at Raymond James... Johnson & Johnson (JNJ) downgraded to Sell from Neutral at Goldman... Magna (MGA) downgraded to Hold from Buy at TD Securities... Molson Coors (TAP) downgraded to Neutral from Buy at Goldman... Nuverra Environmental (NES) downgraded at Roth Capital... Omnicom (OMC) downgraded to Hold from Buy at Evercore ISI... PetroChina (PTR) downgraded to Underperform from Hold at Jefferies... Philip Morris (PM) downgraded to Sell from Neutral at Goldman... Precision Castparts (PCP) downgraded to Hold from Buy at KeyBanc... Rio Tinto (RIO) downgraded to Neutral from Outperform at Macquarie... STAG Industrial (STAG) downgraded to Neutral from Overweight at JPMorgan... Silicon Laboratories (SLAB) downgraded to Equal Weight from Overweight at Barclays... Sinopec (SNP) downgraded to Underperform from Hold at Jefferies... Sky (SKYAY) downgraded to Neutral from Outperform at Exane BNP Paribas... Teledyne (TDY) downgraded to Underweight from Hold at KeyBanc... Woodward (WWD) downgraded to Underweight from Hold at KeyBanc... Xilinx (XLNX) downgraded to Equal Weight from Overweight at Barclays.
08:36 EDTGSKOncoMed enrolls first biomarker-selected patient in Notch1 antibody Phase trial
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07:59 EDTPFE, MRK, AMGNAmerican Society of Clinical Oncology to hold a symposium
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07:07 EDTLLYEli Lilly upgraded at Goldman
As previously reported, Goldman upgraded Eli Lilly to Neutral from Sell. The firm upgraded shares based on new product launches and pipeline assets, and cost reductions. Price target is $70.
07:06 EDTJNJJohnson & Johnson downgraded at Goldman
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06:44 EDTJNJJohnson & Johnson downgraded to Sell from Neutral at Goldman
06:44 EDTLLYEli Lilly upgraded to Neutral from Sell at Goldman
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January 14, 2015
18:18 EDTACTOn The Fly: After Hours Movers
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16:59 EDTACTGalena, Orexo AB receive "Paragraph IV" patent certification notice from Actavis
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10:30 EDTRHHBYHuman Longevity signs genome sequencing pact with Roche unit
Human Longevity announced a multi-year agreement with Genentech, a member of the Roche Group, to conduct whole genome sequencing of tens of thousands of de-identified samples from Genentech. HLI, using proprietary tools and unique expertise, will sequence genomes to 30x coverage and analyze the data. Financial details of the agreement were not disclosed.
09:51 EDTJNJJohnson & Johnson unit says study shows consistent Xarelto safety
Johnson & Johnson unit Janssen announced that a new post-marketing study evaluating the safety of once-daily Xarelto shows, in patients with non-valvular atrial fibrillation, rates and patterns of major bleeding in routine clinical practice are generally consistent with those observed in Phase 3 clinical trials used to approve the medicine for this indication. The fifteen-month results, published today in Clinical Cardiology, represent initial findings from an ongoing, five-year, observational study of patients using Xarelto daily over the course of their lives.
08:34 EDTMRKMerck and Practice Fusion's health vaccine initiative shows positive results
Merck and Practice Fusion announced the results of a recent collaboration designed to improve public health outcomes through a Population Health Management program for adult vaccines. Launched in April, the program contributed to a statistically significant relative increase in recorded vaccinations among eligible patients on Practice Fusion's EHR platform. During the four-month test period, Practice Fusion observed a 73% relative increase in recorded vaccinations in test versus control patients.
07:37 EDTAZNJPMorgan to hold a conference
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07:03 EDTAZNAstraZeneca says Pegasus-TIMI 54 study met primary efficacy endpoint
AstraZeneca announced that the PEGASUS-TIMI 54 study, a large scale outcomes trial involving over 21,000 patients, successfully met its primary efficacy endpoint. The study assessed BRILINTA tablets at either 60mg twice daily or 90mg twice daily plus low-dose aspirin for the secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study start. The primary efficacy endpoint was a composite of cardiovascular death, myocardial infarction or stroke. Preliminary analysis did not reveal any unexpected safety issues. Full evaluation of the data is ongoing. The PEGASUS-TIMI 54 study investigated two different doses of ticagrelor on a background of low dose aspirin versus placebo plus low dose aspirin, in patients aged 50 and older with a history of heart attack and one additional CV risk factor. The study was designed to better understand the management of patients more than 12 months after their heart attack, who remain at high risk for major thrombotic events. Complete results from the PEGASUS-TIMI 54 study will be submitted to a scientific meeting in 2015 and pending further analysis, AstraZeneca plans to file this data with regulatory health authorities. The PEGASUS-TIMI 54 study is part of AstraZeneca’s PARTHENON program. The PLATO study, involving over 18,000 ACS patients, was the first study in the program and is the basis on which ticagrelor has been approved in over 100 countries and included in 12 major ACS treatment guidelines globally. Further ongoing PARTHENON studies are investigating ticagrelor for the prevention of cardiovascular events in patients with peripheral arterial disease, ischaemic stroke or transient ischaemic attack, and in patients with diabetes and coronary atherosclerosis. BRILINTA is not approved for secondary prevention of atherothrombotic events in patients with a history of heart attack beyond one year or for the prevention of cardiovascular events in patients with PAD, stroke, diabetes or atherosclerosis.
07:03 EDTAZNAstraZeneca says Pegasus-TIMI 54 study met primary efficacy endpoint
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