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News Breaks
November 14, 2012
05:55 EDTSPPI, SPPI, WAT, WAT, HSIC, HSIC, ISIS, ISIS, THOR, THOR, GWAY, GWAY, HRC, HRC, HWAY, HWAY, MYGN, MYGN, BMRN, BMRN, DRRX, DRRX, MCK, MCKCredit Suisse to host a conference
2012 Healthcare Conference is being held in Phoenix on November 14-15.
News For MCK;DRRX;BMRN;MYGN;HWAY;HRC;GWAY;THOR;ISIS;HSIC;WAT;SPPI From The Last 14 Days
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July 6, 2015
16:28 EDTTHORThoratec announces first HeartMate 3 implant in European study
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07:05 EDTISISAkcea Therapeutica receives orphan drug designatoin from FDA for Volanesorsen
Akcea Therapeutics, a wholly-owned subsidiary of Isis Pharmaceuticals, announced that the FDA has granted Orphan Drug Designation to volanesorsen for the treatment of patients with Familial Chylomicronemia Syndrome. FCS is a rare genetic disease characterized by extremely high triglyceride levels and risk of pancreatitis. In a Phase 2 study published in the NEJM in December 2014, patients with FCS treated with volanesorsen achieved substantial reductions in apoC-III, triglycerides, chylomicrons and apoC-III-associated very low density lipoprotein-cholesterol particles.1 Akcea is currently conducting an international multi-center, randomized, double-blind, placebo-controlled Phase 3 study in patients with FCS.
July 2, 2015
13:59 EDTBMRNNHS to wait on NICE to make call on PTC Therapeutics, BioMarin drugs
NHS England has set out its planned investment decisions for certain specialized services as part of its annual commissioning round. NHS England has agreed with the recommendations from CPAG that final funding decisions on the following two treatments should be made after NICE has concluded its Highly Specialized Technology Appraisal process: BioMarin Pharmaceutical's (BMRN) Vimizim for Morquio A Syndrome and PTC Therapeutics' (PTCT) Translarna for Duchenne muscular dystrophy. The decisions on those two drugs came among 39 proposed new investments that the group said were "carefully considered against the principles NHS England follows when making investment decisions." Reference Link
June 29, 2015
12:53 EDTBMRNSarepta NDA submission for eteplirsen done ahead of schedule, says Piper Jaffray
Piper Jaffray noted that Sarepta (SRPT) completed its rolling NDA submission for eteplirsen ahead of schedule and the firm believes that concurrent advisory committee meetings for its DMD drug and BioMarin's (BMRN) drisapersen could take place this fall. The firm has a Neutral rating and $20 price target on Sarepta and Overweight rating and $147 target on BioMarin.
11:18 EDTHWAYJames Flynn reports 6.91% passive stake in Healthways
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08:36 EDTBMRNBioMarin announces FDA acceptance of drisapersen NDA
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07:36 EDTSPPISpectrum coverage assumed with a Buy at H.C. Wainwright
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June 25, 2015
16:03 EDTBMRNBioMarin announces EMA validates MAA for drisapersen for treatment of DMD
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09:23 EDTWATMedtronic announces resignation of Christopher O'Connell
Medtronic (MDT) announced in a regulatory filing that Christopher J. O’Connell is resigning as the company’s EVP and President, Restorative Therapies Group. The company also announced the appointment of Geoff Martha as the company’s EVP and President, Restorative Therapies Group, effective immediately. The Fly notes that Waters (WAT) this morning named O'Connell as its new president, CEO and member of its Board of Directors, effective in September.
09:15 EDTWATWaters names Christopher O'Connell as CEO, effective in September
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June 24, 2015
08:10 EDTDRRXDURECT likely to announce partnership soon, says Cantor
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08:05 EDTMCK McKesson reaffirms FY16 EPS $12.20-$12.70, consensus $12.59
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07:02 EDTSPPISpectrum announces publication of Beleodaq data in Journal of Clinical Oncology
Spectrum Pharmaceuticals announced the publication of results from the pivotal BELIEF -- CLN-19 -- Study, which was selected as a Rapid Communication in the Journal of Clinical Oncology, the journal of the American Society of Clinical Oncology. The study, led by Dr. Owen O’Connor from the Center for Lymphoid Malignancies, Department of Medicine, Columbia University Medical Center, New York, NY, showed that monotherapy with Beleodaq produced complete and durable responses with manageable toxicity in patients with R/R PTCL across the major subtypes, irrespective of the number or type of prior therapies. Beleodaq, previously known as belinostat, is a histone deacetylase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. This indication is approved under accelerated approval based on tumor Response Rate and Duration of Response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. The primary endpoint of the BELIEF study was ORR as assessed centrally by an Independent Review Committee using the International Working Group criteria. The ORR in the 120 evaluable patients was 25.8%, including 13 Complete Responses and 18 Partial Responses. Secondary endpoints included a median DoR of 13.6 months by IWG criteria and 8.4 months to disease progression or death, with the longest ongoing patient at ≥36 months. The most common Grade 3/4 adverse events were anemia, thrombocytopenia, dyspnea, and neutropenia. No clinically relevant ECG changes were identified, and cardiovascular monitoring of ECGs is not required at baseline or during treatment. In this pivotal study, monotherapy with Beleodaq produced complete and durable responses with manageable toxicity in patients with R/R PTCL across the major disease subtypes, irrespective of the number or type of prior therapies and with a low incidence of Grade 3/4 thrombocytopenia.

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