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Stock Market & Financial Investment News

News Breaks
January 29, 2013
06:39 EDTRHHBY, TEVA, AMGN, BMY, MRK, GSK, SNY, JNJ, LLY, PFE, AZN, 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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October 9, 2014
08:50 EDTACTAllergan shares have further upside, says Wells Fargo
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08:32 EDTMRKMerck HCV solutions becoming more credible, says Bernstein
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08:10 EDTAZNAstraZeneca reports Phase IIb study of benralizumab met primary endpoint
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07:02 EDTGSKIsis Pharmaceuticals receives $18M milestone payment from GlaxoSmithKline
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October 8, 2014
11:31 EDTRHHBYFDA grants priority review for Genentech's Lucentis
Genentech, a member of the Roche Group (RHHBY), announced that the U.S. FDA has accepted to file the company's supplemental Biologics License Application and granted Priority Review of Lucentis for the treatment of diabetic retinopathy, an eye disease that impacts nearly 7.7M Americans. The FDA confirmed action date is February 6, 2015. The sBLA was submitted August 7 to address the unmet need for approved ocular medications for the treatment of diabetic retinopathy. If approved by the FDA, Lucentis could be the first eye medicine available for diabetic retinopathy patients. The submission is based on results of the RISE and RIDE Phase III trials in which meaningful improvements in the disease were observed in a clinically significant proportion of diabetic retinopathy patients treated with Lucentis at two years compared to patients treated with sham injections. Benefits of Lucentis treatment were maintained during year three of treatment. The safety in the RISE and RIDE Phase III trials was consistent with previous studies.
11:14 EDTMRKMerck presents new MK-5172/MK-8742 clinical study data
Merck announced that new data from clinical studies of the company’s investigational, oral, once-daily, fixed-dose combination chronic hepatitis C treatment grazoprevir/elbasvir, or MK-5172/MK-8742, are scheduled to be presented at the 65th American Association for the Study of Liver Diseases Annual Meeting, also known as The Liver Meeting. The meeting is scheduled to take place from November 7-11. New data will also be presented for MK-3682, formerly IDX21437, as part of its purchase of Idenix Pharmaceuticals.
11:08 EDTMRKLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analyst discusses IMPROVE-IT's regulatory and commercial implications for novel LDL-lowering therapies on an Analyst/Industry conference call to be held on October 9 at 2 pm.
10:55 EDTMRK, PFE, RHHBY, LLYLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analysts discuss prospects for drugs that raise HDL cholesterol, effects of CETP mechanism, expectations for REVEAL data and the potential place for CETP inhibitors in a crowded hypersholesterolemia landscape on an Analyst/Industry conference call to be held on October 9 at 11 am.
10:20 EDTAMGNAmgen biosimilar franchise underappreciated, says Piper Jaffray
After Amgen announced positive Phase 3 results for its biosimilar Humira in psoriasis, Piper Jaffray said it believes that Amgen's overall pipeline is underappreciated since the company's biosimilar franchise is generally not included in consensus estimates. The firm views Amgen as a top large cap picks and reiterate its Overweight rating on the stock.
09:16 EDTAMGNAmgen's ABP 501 for psoriasis shows positive Phase 3 results
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08:42 EDTACTSalix shares should be bought on weakness, says Sterne Agee
After Reuters yesterday afternoon reported that Actavis (ACT) plans to make a new merger approach to Allergan (AGN), Sterne Agee believes that Salix's standalone value is $162. The firm expects the shares to reach that level following approval of its Xifaxan IBS-D drug after the February 2015 PDUFA date.
08:09 EDTPFEPfizer presents LP2086 Phase 2 study data
Pfizer announced it will present the results of a Phase 2, randomized study to evaluate co-administration of the company’s investigational meningococcal group B vaccine, bivalent recombinant LP2086, or rLP2086, with a licensed quadrivalent human papillomavirus vaccine at IDWeek 2014. Data demonstrated immune responses to both vaccines were generated after concomitant administration of bivalent rLP2086 and HPV4. Prespecified noninferiority criteria were met for the bivalent rLP2086 antigens studied and three of the four antigens for HPV4. Primary immunogenicity endpoints, measured after the third dose, included geometric mean titers against HPV antigens in Groups 1 and 3 and human complement serum bactericidal assay GMTs against meningococcal group B disease test strains in Groups 1 and 2. Secondary immunogenicity endpoints included the rate of seroconversion to HPV antigens. Safety of bivalent rLP2086 was assessed after concomitant administration with HPV4 or saline. The prespecified noninferiority criteria were met for three of four HPV antigens and both meningococcal group B disease test strains. Seroconversion for all four HPV antigens was achieved by 99% or more of the subjects for the groups that received HPV4 concomitantly with bivalent rLP2086 or with saline. More local reactions occurred following administration of bivalent rLP2086 compared with saline but the incidence of these reactions did not increase with subsequent vaccine administration. The rates of local and systemic reactions were comparable when bivalent rLP2086 was given with HPV4 to bivalent rLP2086 given alone.
08:05 EDTTEVATeva initiates NDA submission to FDA for CEP-33237
Teva Pharmaceutical announced the initiation of a rolling New Drug Application submission to the U.S. Food and Drug Administration for hydrocodone bitartrate extended-release tablets designed with Teva’s proprietary technology providing potential abuse-deterrent properties CEP-33237 as allowed for fast track designated products. Teva expects to complete the NDA submission by the end of 2014. Teva also announced positive results from a nasal Human Abuse Liability study which supports the NDA. The nasal HAL study found that in nondependent, recreational opioid users, abuse potential for crushed intranasal CEP-33237 was significantly lower than intranasal immediate-release hydrocodone. Teva has now completed positive HAL studies in the two most common routes of hydrocodone abuse, oral and intranasal. CEP-33237 demonstrated a safety profile in the Phase III study that is consistent with the known safety profile of hydrocodone and other opioid analgesic therapies. Adverse events reported in 5% or more of hydrocodone-treated patients during either the titration or double-blind treatment periods included nausea, constipation, vomiting, headache, somnolence and dizziness.
08:03 EDTBMYBristol-Myers resolves outstanding U.S. litigation on efavirenz
Bristol-Myers Squibb Company says it has "successfully resolved all outstanding U.S. patent litigation relating to efavirenz, an active ingredient contained in our Sustiva -- efavirenz -- and Atripla products. Accordingly, we believe that loss of exclusivity in the U.S. for efavirenz should not occur until December 2017. Bristol-Myers Squibb remains committed to delivering our medicines and to developing new and innovative treatments to help patients prevail over serious disease. Atripla is currently the #1 prescribed U.S. regimen in its category, with over 8 million prescriptions written since its launch in 2006. Earlier this year the company submitted a new drug application to the U.S. Food and Drug Administration for a fixed-dose combination of atazanavir sulfate and cobicistat, an investigational pharmacokinetic enhancer. In addition, studies are ongoing for new treatments including an HIV-1 attachment inhibitor, an HIV-1 maturation inhibitor and an anti-PD-L1. The establishment of intellectual property rights allows Bristol-Myers Squibb to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We will continue to defend our intellectual property rights against infringement as we remain focused on providing a deep and broad portfolio of innovative medicines to patients around the world."
07:19 EDTAMGN, PFE, RHHBYCBI to hold a conference
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07:18 EDTPFE, MRK, SNY, BMYInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.
07:11 EDTAMGNEuropean Academy of Dermatology and Venereology to hold a conference
23rd EADV Congress is being held in Amsterdam, The Netherlands on October 8-12.
06:47 EDTACT, TEVALawmakers may push for new regulations on generic drug makers, NY Times says
After the prices of some generic drugs soared more than 1,000% over the last year, two influential members of Congress are probing the sector and threatening to look to impose new regulations on it, according to The New York Times. Generic drug makers include Teva (TEVA), Mylan (MYL), Actavis (ACT), and Lannett (LCI).Reference Link
06:23 EDTACTActavis more inclined to pursue Allergan over Salix, says Citigroup
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06:11 EDTLLY, GSKNovartis says expects three executive committee members to leave
Novartis (NVS) confirmed that following completion of the transactions with GlaxoSmithKline (GSK) and Eli Lilly and Company (LLY) in the coming months, that the three business leaders of the Novartis divisions at the center of the transaction will leave the Executive Committee of Novartis. The expected changes to the ECN are subject to the closing of the transactions announced on April 22 - Novartis expects the transaction with GSK to be completed in the first half of 2015, and the transaction with Eli Lilly for its Animal Health Business to close in the first quarter of 2015. George Gunn, currently Division Head, Novartis Animal Health, will reach his contractual retirement age in July 2015 and will retire from Novartis. Upon closing of the Animal Health transaction with Lilly he will leave the ECN. Brian McNamara, currently Division Head, Novartis OTC, will transition to GSK as Head of Americas and Europe for the consumer health businesses, reporting to the President of GSK Consumer Healthcare, effective at closing of the transaction. Andrin Oswald, currently Division Head, Novartis Vaccines, will be leaving Novartis to pursue other opportunities following closing of the transaction with GSK.
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