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News Breaks
March 24, 2014
06:19 EDTRHHBY, AZN, BMY, MRKBristol-Myers, Roche, working on possible blockbusters for melanoma, WSJ says
Bristol-Myers (BMY), Roche (RHHBY) and Merck (MRK) are all working to launch potential blockbuster drugs in the next 18 months that would treat advanced melanoma, the Wall Street Journal reports. The companies' drugs could be launched later this year or in late 2015 if approved. AstraZeneca (AZN) also has an earlier-stage candidate that it's developing. Reference Link
News For BMY;RHHBY;MRK;AZN From The Last 14 Days
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March 20, 2015
11:33 EDTRHHBYFly Review: Analysts correctly predict jump in Biogen shares
The shares of Biogen (BIIB) are rallying after the company reported results for a Phase 1b study of its Alzheimer's drug, BIIB-037. On March 18, as reported on that day by The Fly, RBC Capital predicted that the stock would rise after the results were published. A number of other firms were also upbeat on the stock ahead of the data release. WHAT'S NEW: Earlier this morning Biogen announced that the three milligram, six milligram, and ten milligram dose versions of its Alzheimer's treatment, aducanumab, had reduced the amount of amyloid plaque in the brains of Alzheimer's patients taking the drug by statistically significant amounts compared with those taking placebos. Beta amyloid is a protein that produces plaque in the brain. Scientists suspect that plaques in the brain are a cause of Alzheimer's. The cognitive decline of patients taking BIIB-037 was also significantly less than that of patients who were taking placebos, the company reported. PRE-EVENT CALLS: RBC Capital analyst Michael Yee predicted earlier this week in a note to investors that Biogen would report strong data for BIIB-037 and the stock should "work higher" after the data is unveiled. Alzheimer's patients taking the high dose of Biogen's BIIB-037 drug should exhibit a stabilization of cognition levels, Yee stated. Conversely, the cognition levels of patients taking the placebo should drop slightly, the analyst predicted. On March 13, in a note summarized by The Fly on that day, JPMorgan recommended buying Biogen shares ahead of the data release. Investors still incorporated a low probability of success for the drug, and the stock could rise further, the firm wrote. On March 19, in a note also published by The Fly, Credit Suisse wrote that Biogen's multiple could rise if the data on BIIB-037 was positive. It raised its price target on the name to $500 from $400. ANALYST REACTION: This morning, Barclays raised Biogen's price target to $500 from $435 following the company's report of "impressive" full results from the Alzheimer's study. Piper Jaffray analyst Joshua Schimmer also raised his price target for Biogen shares to $500 this morning, calling today’s BIIB-037 results "robust and impressive." Schimmer believes the trial showed a "consistent and dramatic" dose effect on both radiographic and clinical disease features and thinks the side effects "pale in comparison" to the drug’s efficacy. OTHERS TO WATCH: Eli Lilly (LLY) and Roche (RHHBY) are also currently developing similar Alzheimer's treatments. PRICE ACTION: In late morning trading, Biogen rose 7% to $464. The stock is up about 9% since Wednesday. Eli Lilly shares are up 1.6% to $75.40 this morning, while Roche rose 2.2% to $35. Reference Link
09:01 EDTRHHBYEli Lilly up 2% to $75.75 in pre-market trading
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07:55 EDTAZN, BMYAstraZeneca seen as potential target again if oncology drugs lag, Bloomberg says
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07:41 EDTMRKAmerican Academy of Dermatology to hold annual meeting
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March 19, 2015
16:14 EDTRHHBYProthena report positive results from Phase 1 study of PRX002
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08:37 EDTAZNNektar and Daiichi Sankyo to commercialize Movantik in the U.S.
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07:02 EDTRHHBYSigma-Aldrich signs exclusive distribution agreement with Roche
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March 18, 2015
12:48 EDTRHHBYFly Watch: Biogen predicted to report strong Alzheimer's data this Friday
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07:46 EDTRHHBYLilly Roche would have upbeat read through from strong BIIB data, says Bernstein
Bernstein notes that the data for Biogen's (BIIB) Alzheimer's treatment, due to be released on Friday, is widely expected to be positive. The firm thinks that positive data would boost the outlook for similar Alzheimer's drugs being developed by Eli Lilly (LLY) and Roche (RHHBY), since consensus estimates for those drugs are low. The firm keeps Outperform ratings on Eli Lilly and Roche.
March 17, 2015
14:10 EDTAZNIGI Laboratories recent sell-off a buying opportunity, says Craig-Hallum
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08:13 EDTRHHBYCelldex announces clinical trial collaboration with Roche
Celldex Therapeutics (CLDX) announced that it has entered into a clinical trial collaboration with Roche (RHHBY) to evaluate the safety, tolerability and preliminary efficacy of varlilumab, Celldex's CD27 targeting investigational antibody, and MPDL3280A, Roche's investigational cancer immunotherapy in a Phase 1/2 study in renal cell carcinoma. Varlilumab and MPDL3280A are part of a new class of investigational medicines known as cancer immunotherapies that are designed to harness the body's own immune system to fight cancer through separate yet complementary mechanisms of action that may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells. Preclinical data suggest the combination of these two mechanisms are synergistic and may enhance anti-tumor immune response compared to either agent alone. In Celldex's Phase 1 study of varlilumab in multiple solid tumors, promising signs of clinical activity in patients with refractory renal cell carcinoma were observed, including a durable partial response that has continued to decrease in tumor volume over time and prolonged stable disease. Under the terms of this agreement, Roche will provide study drug and Celldex will be responsible for conducting and funding the study, which is expected to begin in 2015.
March 16, 2015
15:33 EDTMRKMerck says study shows VYTORIN reduced CV events more than simvastatin alone
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07:30 EDTAZNAmerican College of Cardiology to hold an expo
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March 13, 2015
16:04 EDTMRKMerck provides update on investigational medicine sugammadex injection
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11:19 EDTAZNBioMarin rallies amid positive call on DMD drug timeline, takeover rumor
The shares of drug maker BioMarin (BMRN) are climbing after research firm Jefferies quoted a regulatory expert as saying that the company's drisapersen drug has a good chance of being approved on an accelerated basis by the FDA. Drisapersen is a treatment for Duchenne Muscular Dystrophy, or DMD. WHAT'S NEW: "There is a strong possibility" that the FDA will grant accelerated approval to drisapersen because there is currently no approved drug for the treatment of DMD, Jefferies analyst Eun Yang quoted the expert as saying. The expert is also optimistic about the outlook for accelerated approval because she had a good experience working with BioMarin while she was with the FDA and because BioMarin has a favorable track record with the FDA, according to Yang. There is a 60% chance that drisapersen will be approved by the end of this year and the stock can rise to $155, versus its current level of about $121.50, if that does occur, the analyst stated. Yang's price target on the stock increased to $135 from $125 and the analyst kept a Buy rating on the shares. WHAT'S NOTABLE: Pharmaceutical giant AstraZeneca (AZN) has been rumored to be interested in buying BioMarin for $175 per share in cash, British newspaper Daily Mail reported. , Piper Jaffray analyst Joshua Schimmer wrote in a note to investors this morning that BioMarin, along with Vertex (VRTX) and Incyte (INCY), have a "clear path" to joining the group of companies with market caps of over $10B projected to deliver greater than 20% EPS CAGR, which the analyst identified as a set of criteria that has previously pointed to companies that make good potential takeover targets. PRICE ACTION: In mid-morning trading, BioMarin climbed nearly 4% to $120.
08:07 EDTAZNAstraZeneca rumored to have BioMarin 'on shopping list,' Daily Mail says
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March 12, 2015
17:08 EDTAZNActavis: Court grants injunction pending appeal relating to Pulmicort RESPULES
Actavis (ACT) confirmed that the United States Court of Appeals for the Federal Circuit has granted AstraZeneca's (AZN) request for an injunction pending appeal preventing Actavis from further distribution of its generic version of Pulmicort RESPULES. Under the ruling, Actavis' sales of generic Pulmicort have been enjoined pending the resolution of AstraZeneca's appeal before the Court. The Court has set an expedited briefing schedule for the appeal, with expedited briefing to be concluded within 33 days. The injunction does not address product shipped prior to its issuance. Actavis' sales of generic Pulmicort had previously been enjoined under a temporary injunction granted by the Appeals Court on February 16. The Appeals Court ruling followed the Feb. 13 launch of Actavis' product after the United States District Court for the District of New Jersey (i) found United States Patent No. 7,524,834 invalid, and (ii) denied AstraZeneca's request for a permanent injunction. Pulmicort RESPULES is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years. For the 12 months ended June 30, 2014, total U.S. brand and generic sales of Pulmicort RESPULES were approximately $1.1B.
15:02 EDTBMYBristol-Myers announces FDA acceptance of NDA for daclatasvir
Bristol-Myers Squibb Company announced that the resubmitted new drug application, or NDA, for daclatasvir, an investigational NS5A replication complex inhibitor, has been accepted for review by the FDA for use in combination with sofosbuvir for the treatment of chronic hepatitis C, or HCV, genotype 3. The original NDA has been amended to include data from the Phase III ALLY-3 trial, which showed high cure rates for the combination, with sustained virologic response 12 weeks after treatment in 90% of treatment-naïve and 86% of treatment-experienced genotype 3 HCV patients. SVR12 rates were higher in non-cirrhotic genotype 3 patients, regardless of treatment history. The FDA will now review the submission within a six-month timeframe.
12:49 EDTBMYWHO recommends tenofovir or entecavir for hepatitis B treatment
The World Health Organization issued its first-ever guidance for the treatment of chronic hepatitis B. Its recommended medicines consist of Gilead's (GILD) tenofovir or Bristol-Myers' (BMY) entecavir. Teva (TEVA) has FDA approval for generic entecavir.
11:14 EDTMRKPiper Jaffray biopharm analyst analyst/industry conference call at 12 pm
***TIME CHANGED TO 12pm from 11am on March 12***Biopharmaceuticals Analyst Schimmer, along with Dr. Bianca Weinstock-Guttman, discuss the current and future treatment paradigm and practice dynamics in MS on an Analyst/Industry conference call to be held on March 12.
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