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January 24, 2014
05:48 EDTLLY, NVS, RHHBY, JNJ, AZN, SNY, PFE, GSKDrug firms again focus on R&D for antibiotics, WSJ reports
Over the past 15 years, drug companies left antibiotic development due to high R&D costs, poor returns and growing regulations. Now, they're finding that it's again important to search for new antibiotics as so-called superbugs increase, reports the Wall Street Journal.Reference Link
News For RHHBY;GSK;AZN;NVS;PFE;JNJ;LLY;SNY From The Last 14 Days
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March 17, 2015
05:30 EDTNVSNovartis receives EU approval for Jakavi in polycythemia vera
Novartis announced that the European Commission has approved Jakavi for the treatment of adult patients with polycythemia vera, or PV, who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients. Jakavi is the only JAK 1/2 inhibitor available to treat PV and is also currently approved in more than 80 countries to treat myelofibrosis.
March 16, 2015
15:04 EDTJNJPharmacyclics says committee recommends unblinding after primary endpoint met
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08:23 EDTSNYPCSK9 data continues to impress, says Leerink
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07:32 EDTGSKEmergent BioSolutions signs agreements with GSK, Oxford University, NIAID
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07:30 EDTAZNAmerican College of Cardiology to hold an expo
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07:27 EDTLLYBiodel BIOD-961 Phase 1 clinical trial meets primary efficacy endpoint
Biodel (BIOD) announced positive preliminary results from Study 6-101, a Phase 1 clinical trial comparing Biodel's lyophilized glucagon formulation BIOD-961, designed for use in a proprietary Glucagon Emergency Management, or GEM, auto-reconstitution device, to Eli Lilly's (LLY) Glucagon Emergency Rescue Kit and Novo Nordisk's GlucaGen HypoKit, which are marketed for the treatment of severe hypoglycemia. Study 6-101 was a randomized, single-center, double blind, six-period cross over study in 15 healthy volunteers who received each glucagon administered subcutaneously, or SC, and intramuscularly, or IM, in a randomized treatment sequence. The objectives of the study were to compare the pharmacokinetic, or PK, profiles, the pharmacodynamic, or PD, glucose, responses, and the PK/PD relationships of IM and SC dosing, as well as to assess safety profiles of the three test glucagons. Study 6-101 was a Phase 1 randomized, single-center, double blind, six-period cross over study designed to evaluate the PK and PD profiles of BIOD-961 compared to marketed glucagon formulations manufactured by Eli Lilly and Novo Nordisk. BIOD-961 is a lyophilized glucagon formulation designed for use in the GEM auto-reconstitution device. On six separate dosing days, each subject received 1 mg of one of the test glucagons delivered either SC or IM. Fifteen normal, healthy subjects were randomized into the study and ten completed all dosings. The objectives of the study were to compare the PK profiles, the PD responses, and the PK/PD relationships of IM and SC dosing, as well as to assess safety profiles of the three test glucagons. These data will facilitate selection of an appropriate marketed glucagon to use as a comparator in the planned pivotal study, in which the primary efficacy endpoint for approval is to demonstrate PK and PD bioequivalence of BIOD-961 to one of the marketed comparators.
07:16 EDTSNYRegeneron Sanofi dupilumab drug can generate $6B+ in revenue, says Bernstein
Bernstein believes that dupilumab, a drug made by Regeneron and Sanofi, has shown strong efficacy in patients with severe atopic dermatitis. The firm notes that the drug is currently in pivotal trials involving patients with severe levels of other common diseases. The firm thinks the drug can generate $1.5B of revenue by 2018 and $3.8B by 2020. Bernstein keeps a $500 price target and Outperform rating on Regeneron.
06:40 EDTSNY, PFEPCSK9 studies show potential improvement in heart health, WSJ says
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March 15, 2015
13:04 EDTSNYSanofi, Regeneron announce publication of results of ODYSSEY long term trial
Sanofi (SNY) and Regeneron Pharmaceuticals (REGN) today announced that 18-month results of a Phase 3 trial of Praluent, alirocumab, an investigational therapy, involving 2,341 high risk patients with hypercholesterolemia were published online in The New England Journal of Medicine. In the ODYSSEY LONG TERM trial, Praluent 150 mg every two weeks reduced low-density lipoprotein cholesterol by an additional 62% at week 24 when compared to placebo, the primary efficacy endpoint of the study, with consistent LDL-C lowering maintained over 78 weeks."These results demonstrated the durable efficacy for Praluent when added to maximally-tolerated statin therapy and further reinforce its generally consistent safety profile," said Jennifer Robinson, M.D., M.P.H., Director of the Prevention Intervention Center, Professor, Departments of Epidemiology & Medicine, College of Public Health at the University of Iowa. "Additionally, the post hoc analysis of major cardiovascular events represents an important finding for Praluent -- we look forward to results from the ongoing ODYSSEY OUTCOMES trial, which is prospectively evaluating the potential of Praluent to reduce cardiovascular events."
March 13, 2015
14:34 EDTJNJU.S. appeals court revives lawsuit over J&J's Benecol assertions
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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.
10:37 EDTSNYSanofi says NHS England de-lists cabazitaxel, aflibercept
Sanofi announcd that NHS England has confirmed that it is de-listing both cabazitaxel and aflibercept from the Cancer Drugs Fund, so that neither of these medicines will be available to new patients in England on the NHS. It added, "However regarding cabazitaxel NHS England have agreed to engage in talks to explore immediate ways of maintaining access to patients until it is reviewed by NICE." Tarja Stenvall, General Manager for Sanofi in the UK, commented, "We are hugely disappointed that cabazitaxel and aflibercept have been cut from the CDF and that new patients in England will no longer have access to these crucial cancer treatments. However NHS England remains in dialogue with Sanofi to explore immediate ways of maintaining access to patients for cabazitaxel until the outcome of any NICE review. Our concern is for patients who should continue to have access to cabazitaxel until a longer term solution is reached and who may feel confused and uncertain until this happens."
08:07 EDTAZNAstraZeneca rumored to have BioMarin 'on shopping list,' Daily Mail says
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07:23 EDTJNJJohnson & Johnson has a conference call hosted by JPMorgan
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05:40 EDTNVSNovartis to present Cosentyx data at AAD 2015
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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.
16:39 EDTPFEPfizer says primary endpoint not achieved in Phase 4 study of Lyrica
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13:01 EDTLLYEli Lilly management to meet with SunTrust
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11:21 EDTGSKGlaxoSmithKline to sell half of Aspen Pharmacare stake
GlaxoSmithKline announces that it intends to sell approximately half of its 12.4% stake in Aspen Pharmacare. The disposal will be through a placing of ordinary shares in Aspen to institutional investors. The offering is expected to comprise 28.2M Aspen ordinary shares. After the proposed transaction, GSK would remain a 6.2% shareholder in Aspen and has undertaken not to dispose of any shares in Aspen for a period of 180 days following completion, subject to certain limited exceptions. GSK has entered into a placing agreement with Citigroup Global Markets Limited and UBS Limited to act as the Joint Bookrunners in relation to the Offering. Proceeds from the transaction will be used for general corporate purposes, GSK said. The net profit on disposal will not be included in core operating profit and core EPS in 2015 and it is expected that GSK will no longer account for Aspen as an associate going forward.
11:14 EDTNVSPiper 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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