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February 2, 2014
20:16 EDTSNY, AZN, BMYFDA's approval of AstraZeneca's Brilinta questioned, WSJ says
The FDA's approval of AstraZeneca's (AZN) anticlotting drug Brilinta is being called into question as a medical professor at Johns Hopkins Hospital who specializes in such drugs, maintains the study numbers may have been manipulated, says the Wall Street Journal. AstraZeneca has marketed Brilinta as a potential "mass-market blockbuster" that is more effective than Plavix which is co-marketed by Sanofi (SNY) and Bristol-Myers Squibb (BMY), added the Wall Street Journal. Reference Link
News For AZN;SNY;BMY From The Last 14 Days
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November 18, 2014
14:59 EDTAZNRanbaxy sues FDA for rescinding approval of Nexium, Valcyte copies, Reuters says
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12:16 EDTSNYSanofi to host seminar on New Medicines
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07:29 EDTAZNPfizer less likely to pursue AstraZeneca after PD-L1 deal, says JPMorgan
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07:18 EDTAZNWoodford confident in Astra, sees 50% chance of new Pfizer bid, Reuters reports
Investment manager Neil Woodford of Woodford Investment Management said he now has an even stronger belief in AstraZeneca (AZN), citing the company's strong product pipeline, and put the chances of a new takeover bid from Pfizer (PFE) at 50/50, reported Reuters, citing a statement from Woodford. Reference Link
06:39 EDTAZNAstraZeneca: 'Hard to comment' on whether Pfizer will come back, Reuters reports
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November 17, 2014
11:06 EDTBMYLeerink biotech analysts hold an analyst/industry conference call
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09:37 EDTAZNAstraZeneca to host investor day
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08:13 EDTBMYPortola, Bristol-Myers, Pfizer announce results from Phase 3 ANNEXA-A studies
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08:10 EDTBMYBristol-Myers presents results from Phase IIIb AVERT trial at ACR
Bristol-Myers Squibb Company announced results of several new sub-analyses of the Phase IIIb AVERT trial that investigated the use of Orencia plus methotrexate in biologic and MTX-naïve citrullinated protein-positive early moderate to severe rheumatoid arthritis patients. These data were presented this week at the American College of Rheumatology 2014 annual meeting. Orencia is currently indicated in adults for moderate to severe RA. Orencia should not be administered with tumor necrosis factor antagonists and should not be used with other biologic RA drugs. One of the analyses looked at anti-CCP antibodies, which are a marker of RA and may contribute to disease progression. The analysis assessed the development of anti-CCP antibodies in patients with early rapidly progressing RA by measuring isotypes and the number of epitopes recognized after treatment with Orencia plus MTX, Orencia alone, or MTX alone. Results demonstrated Orencia plus MTX numerically reduced the concentrations of all CCP isotypes and the average number of epitopes recognized over one year of treatment more than Orencia alone or MTX alone. Over 12 months of treatment, 6.7 percent, 12.1 percent, and 7.8 percent of patients on Orencia plus MTX, Orencia alone, and MTX alone, respectively, experienced a serious adverse event and 1.7 percent, 4.3 percent and 2.6 percent led to discontinuation. Serious infections were observed in 0.8 percent of patients in the combination arm and 3.4 percent in the Orencia monotherapy arm. None of the patients in the MTX alone arm experienced a serious infection. Malignancies were reported in 0.8 percent, 1.7 percent, and 0 percent of patients in the Orencia + MTX, Orencia, and MTX arms, respectively. Additionally at ACR, investigators presented 12-month efficacy data from AVERT, including new results assessing the effect of Orencia on more clinically stringent remission criteria than DAS-defined remission, as well as new MRI data. Significantly more patients on Orencia plus MTX achieved the stringent clinical endpoint of Boolean-defined remission at 12 months.
07:16 EDTSNY, AZNMilken Institute--Faster Cures to hold a conference
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07:08 EDTAZNMedImmune presents positive Phase IIb data for mavrilimumab in RA
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07:07 EDTAZNMedImmune presents new data in systemic lupus
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06:43 EDTAZNAstraZeneca, Pfizer deal seen less likely after Merck transaction, Reuters says
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November 16, 2014
14:44 EDTSNYRegulus, Sanofi present new data enhancing the preclinical profile of RG-012
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13:36 EDTAZNAstraZeneca presents data from studies of lesinurad combined with allopurinol
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13:07 EDTBMYBristol-Myers announces results from CheckMate -066 study
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12:56 EDTSNYGenzyme’s Lemtrada approved by the FDA
Genzyme, a Sanofi company, announced that the U.S. Food and Drug Administration has approved Lemtrada, alemtuzumab, for the treatment of patients with relapsing forms of multiple sclerosis. Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS. “Today’s approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada,” said Genzyme President and CEO, David Meeker. “Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in the two studies which were the basis for approval. A comprehensive risk evaluation and mitigation strategy will be instituted in order to help detect and manage the serious risks identified with treatment.” The FDA approval of Lemtrada is based on two pivotal randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif in patients with relapsing remitting MS who were either new to treatment or who had relapsed while on prior therapy . In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a. The clinical development program for Lemtrada involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up. “The unmet need in MS remains high,” said Edward Fox, M.D., Ph.D., Director of the Multiple Sclerosis Clinic of Central Texas. “It is a great day for people living with relapsing forms of MS in the United States, who will now have access to this new meaningful treatment”.
November 14, 2014
14:53 EDTBMY, SNY, AZNCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
07:14 EDTAZN, BMYAmerican College of Rheumatology is holding a meeting
2014 ACR/ARHP Annual Meeting is being held in Boston on November 14-19.
06:05 EDTBMYBristol-Myers to construct biologics manufacturing facility in Ireland
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