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News Breaks
May 9, 2014
14:03 EDTSNY, JNJ, AGNAllergan rebuffed by white knights J&J, Sanofi, Bloomberg reports
News For AGN;JNJ;SNY From The Last 14 Days
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September 2, 2015
07:09 EDTAGNAllergan announces topline results from RECAPTURE 1 and 2
Allergan announced positive topline results from RECAPTURE 1 and 2, the pivotal Phase III studies evaluating the antibiotic AVYCAZ as a treatment for adult hospitalized patients with complicated urinary tract infections, including pyelonephritis. AVYCAZ consists of a cephalosporin, ceftazidime, an established treatment for serious bacterial infections, and the first and only non-beta lactam beta-lactamase inhibitor, avibactam. The addition of avibactam protects ceftazidime from being broken down by certain beta-lactamases that are produced by these resistant bacteria. The global RECAPTURE 1 and 2 Phase III studies evaluated the safety and efficacy of AVYCAZ administered intravenously as a two-hour infusion, compared to doripenem, administered intravenously as a 30-minute infusion, in hospitalized adult patients with cUTI, including pyelonephritis. Data from the studies were analysed as a single-pooled dataset with the agreement of the US FDA and the EMA. AVYCAZ was also effective in treating cUTI patients infected with ceftazidime-resistant bacteria. Allergan plans to submit this data as a supplemental New Drug Application (sNDA) to the Food and Drug Administration by the end of 2015.
September 1, 2015
16:17 EDTSNYArdelyx regains NaP2b program from Sanofi
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09:01 EDTSNYRegeneron and Sanofi announces Praluent Phase 3 data
Regeneron (REGN) and Sanofi (SNY) announced that, in a new pooled analysis of heterozygous familial hypercholesterolemia patients included in the ODYSSEY clinical trial program, Praluent significantly reduced bad cholesterol, known as low-density lipoprotein cholesterol. This analysis included 1,257 HeFH patients, the largest group of HeFH patients ever studied in a Phase 3 program. At week 24, when the primary efficacy endpoint was assessed, patients treated with Praluent had an average 56 percent greater reduction in LDL-C compared to placebo in both arms. Reductions were observed as early as week 4 and were maintained for the duration of therapy, until week 78.
August 31, 2015
09:07 EDTSNYSanofi, Google Life Sciences to collaborate to improve diabetes health outcomes
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08:04 EDTAGNAllergan completes Nuarex acquisition
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07:39 EDTAGNCiti calls Allergan a 'stock to own,' keeps $360 target
Citi analyst Liav Abraham calls Allergan a "stock to own" given its "attractive" organic growth profile, pipeline potential and ability to do more acquisitions. He reiterates a Buy rating on the stock with a $360 price target.
06:35 EDTSNYAlnylam price target raised to $184 from $180 at Piper Jaffray
Piper Jaffray analyst Edward Tenthoff raised his price target for Alnylam Pharmaceuticals (ALNY) to $184 saying the company over the weekend reported positive Phase I data on ALN-PCS showing LDL-cholesterol lowering comparable to Amgen (AMGN) and Sanofi/Regeneron's (REGN) anti-PCSK9 antibodies, but with only quarterly or potentially every 6-month injections. Tenthoff recommends using the recent pullback in shares of Alnylam as a buying opportunity and keeps an Overweight rating on the name.
August 30, 2015
15:50 EDTSNYAlnylam, The Medicines Co. say ALN-PCSsc reduces LDL cholesterol as much as 83%
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August 28, 2015
09:50 EDTAGNAllergan plans for generic version of Endo's Fortesta blocked, Bloomberg reports
A judge upheld Endo's (ENDP) patents on Fortesta expiring in 2018 and blocked Allergan's (AGN) bid to launch a generic version of the testosterone gel, according to Bloomberg.
08:01 EDTSNYAmgen pricing for Repatha competitive with Praluent, says Piper Jaffray
After the FDA announced last night that it has approved Amgen's (AMGN) Repatha injection, Piper Jaffray analyst Joshua Schimmer said that the drug's indications seem "generally in line" with those for Praluent from Regeneron (REGN) and Sanofi (SNY). Amgen disclosed an annual WAC of $14,100 for Repatha, which the analyst notes is about $500 per year below Praluent, but Schimmer said that the actual recognized price for each will ultimately be determined by discounting. Schimmer also noted that Amgen said it is working with payers and other purchasers on "innovative pricing programs," though he is uncertain if that means the company is working on a kind of "pay per performance" scheme. The analyst, who believes the market will prove large enough for both treatments, keeps a $200 price target and Overweight rating on Amgen shares.
August 27, 2015
19:49 EDTJNJJohnson & Johnson to open shared services headquarters in Florida
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19:14 EDTSNYExpress Scripts to cover both Repatha, Praluent for now, Bloomberg says
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August 25, 2015
13:01 EDTJNJJ&J unit to sell Splenda brand to Heartland Food, terms not disclosed
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09:03 EDTJNJAcorda has major overhang removed by IPR denials, says Leerink
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08:14 EDTAGNAllergan multiple is low, says Leerink
Leerink predicts that Allergan's 2016 EPS will come in at $17-$18. The firm thinks the company has "durable revenue streams," and a "deep pipeline with several potential blockbuster candidates." Leerink adds that the company "has significant capacity for M&A." It keeps a $388 price target and Outperform rating on the shares.
06:18 EDTJNJSears names Lynn Pendergrass as Hardlines president
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August 24, 2015
08:37 EDTAGNAllergan recalls certain lots of REFRESH, FML, Blephamide treatments
Allergan announced that it is conducting a voluntary recall down to consumer level of specific lots of its REFRESH Lacri-Lube 3.5g and 7g for dry eye, REFRESH P.M. 3.5g for dry eye, FML 0.1%, and Blephamide 10%/0.2% sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5g. Allergan chose to initiate this recall based on a small number of customer complaints which reported a small black particle at the time of use. Allergan has informed the U.S. Food and Drug Administration of this voluntary recall. Allergan is contacting retailers and wholesalers who have been shipped affected product lots to initiate the recall and is informing them of the steps needed to return affected product.
August 21, 2015
09:01 EDTJNJLeerink medical devices analyst holds an analyst/industry conference call
Medical Device Analyst Newitter, along with MEDACorp Specialists Dorance Dillon and Terence Farrell, discuss the Centers for Medicare & Medicaid Services' recently proposed "Comprehensive Care For Joint Replacement Payment Model" and how this model might influence ortho pricing and hospital-vendor relationships on an Analyst/Industry conference call to be held on August 24 at 1 pm.
August 20, 2015
11:33 EDTSNY, JNJLeerink major pharmaceuticals analyst holds an analyst/industry conference call
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08:16 EDTAGNAllergan's Botox resubmission for lower limb spasticiy accepted by FDA
Allergan 's resubmission of its Supplemental Biologics License Application for Botox for the treatment of adults with lower limb spasticity in adults has been accepted by the FDA. A six-month review period has been assigned for the sBLA. The Prescription Drug User Fee Act date is expected to be in 1Q16. The resubmission provides additional data from a double-blind, placebo controlled study involving 468 patients with lower limb spasticity. The FDA also approved an increase to the maximum Botox cumulative dose within three months from 360 to 400 units in adults treated for one or more indications.
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