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BUSINESS WIRE: Ipsen announces a first set of results on positive phase III clinical study of Dysport in the …

Posted: Published on December 16th, 2014

MITTEILUNG UEBERMITTELT VON BUSINESS WIRE. FUER DEN INHALT IST ALLEIN DAS BERICHTENDE UNTERNEHMEN VERANTWORTLICH. PARIS --(BUSINESS WIRE)-- 12.04.2014 -- Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced that a first set of results on phase III clinical study of Dysport in the treatment of adults suffering from Upper Limb Spasticity was presented on Saturday, April 12th, at the 8th World Congress for NeuroRehabilitation in Istanbul (Turkey). Claude Bertrand, Executive Vice-President Research & Development and Chief Scientific Officer of Ipsen, commented: We are pleased that the first robust set of results from the phase III clinical study was presented by the Principal Investigator of the study (Pr JM Gracies) at this major congress. We look forward to sharing with the scientific community some additional data at coming international congresses. Four weeks after Dysport injection, the Phase III clinical study results demonstrated that: Additionally, patients treated with Dysport showed a higher proportion of responders from baseline in improved passive function versus placebo (exhibiting 1 grade decrease as measured by the disability assessment scale). At week 4, patients treated with Dysport 1000 units showed a statistically significant response rate of 62%. Patients treated with Dysport 500 units showed a clinically relevant response … Continue reading

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BUSINESS WIRE: Data from Biogen Idecs Portfolio of Multiple Sclerosis Therapies and Pipeline Featured at Medical …

Posted: Published on December 16th, 2014

MITTEILUNG UEBERMITTELT VON BUSINESS WIRE. FUER DEN INHALT IST ALLEIN DAS BERICHTENDE UNTERNEHMEN VERANTWORTLICH. -Scientific Presentations Showcase InnovativeMS Medicines and Experimental Therapies- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- 30.05.2014 -- Biogen Idec (NASDAQ: BIIB) today announced that more than 60 company-sponsored presentations highlighting key data from its industry-leading portfolio of marketed and investigational multiple sclerosis (MS) therapies are being featured during two neurology conferences, further demonstrating its commitment to meeting the individual needs of MS patients and improving outcomes with research that addresses important efficacy and safety questions. Data are being presented during the annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC) and the Sixth Cooperative Meeting with Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS; May 28 May 31 in Dallas, Texas); and the Joint Congress of the European Federation of Neurological Societies (EFNS) and European Neurological Society (ENS; May 31 June 3 in Istanbul, Turkey). Our research and development efforts over the past 30 years have positioned Biogen Idec at the forefront of MS innovation, and the scope of data we are presenting at CMSC/ACTRIMS and EFNS/ENS underscores our commitment to improving the lives of people living with MS, said Katherine Dawson, M.D., vice president, global … Continue reading

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BUSINESS WIRE: CHMP Adopts Positive Opinion for PLEGRIDY (Peginterferon Beta-1a) as a Treatment for Multiple …

Posted: Published on December 16th, 2014

MITTEILUNG UEBERMITTELT VON BUSINESS WIRE. FUER DEN INHALT IST ALLEIN DAS BERICHTENDE UNTERNEHMEN VERANTWORTLICH. European Commission Decision on Marketing Authorization Anticipated in 2H of 2014 PLEGRIDY May Offer People with MS a Combination of Efficacy, Favorable Safety Profile and Low Frequency Dosing Schedule CAMBRIDGE, Mass. --(BUSINESS WIRE)-- 23.05.2014 -- Biogen Idec (NASDAQ: BIIB) today received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing authorization of PLEGRIDY (peginterferon beta-1a), a pegylated interferon administered subcutaneously for adults with relapsing-remitting multiple sclerosis (RRMS). The CHMPs positive opinion is now referred to the European Commission (EC), which grants marketing authorization for medicines in the EU. The CHMPs positive opinion for PLEGRIDY marks an important milestone in bringing a meaningful treatment advance to people with MS in the EU, said Douglas E. Williams, Ph.D., Biogen Idecs executive vice president of Research and Development. We believe PLEGRIDY will offer physicians and those living with MS a unique treatment option that combines efficacy, a favorable safety profile consistent with the established interferon class, and a once-every-two-week dosing schedule. The CHMP opinion is primarily based on Phase 3 data from ADVANCE, one of the … Continue reading

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BUSINESS WIRE: New Data Reinforce Efficacy of TECFIDERA (Dimethyl Fumarate) in MS Patients with High Disease Activity

Posted: Published on December 16th, 2014

MITTEILUNG UEBERMITTELT VON BUSINESS WIRE. FUER DEN INHALT IST ALLEIN DAS BERICHTENDE UNTERNEHMEN VERANTWORTLICH. Additional Real-World Data Show Tolerability Profile Consistent with Pivotal Studies CAMBRIDGE, Mass. --(BUSINESS WIRE)-- 30.04.2014 -- New data reinforce the efficacy of TECFIDERA in a wide range of patients with relapsing-remitting multiple sclerosis (RRMS), as well as support its favorable safety and tolerability profile in the real-world setting. These data were presented by Biogen Idec (NASDAQ: BIIB) at the 66th American Academy of Neurology (AAN) annual meeting in Philadelphia. A new post-hoc analysis from the Phase 3 studies, DEFINE and CONFIRM, reinforce that TECFIDERA can be effective in RRMS patients with high disease activity. In addition, new data from the Phase 4 MANAGE study show that gastrointestinal (GI) events experienced by patients in the clinical practice setting were mostly mild to moderate and generally manageable, and significantly decreased in prevalence within the first two months of TECFIDERA treatment. These new data further reinforce the benefits TECFIDERAs strong efficacy may bring to a wide range of people with relapsing forms of multiple sclerosis (MS), said Alfred Sandrock, M.D., Ph.D., group senior vice president and chief medical officer at Biogen Idec. In addition, as we gain even more … Continue reading

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Killed mother sought help for son

Posted: Published on December 16th, 2014

Joan Hendry A teenager who allegedly stabbed his mother to death in White Gum Valley on Monday night may have had a psychotic episode after earlier seeking hospital treatment. The major crime squad is investigating the death of Joan Hendry, 52, who died after an apparent frenzied incident at her Stevens Street house just after 11.30pm. Ms Hendry's 19-year-old son Gabe Lang is in hospital with critical injuries from what are believed to be self-inflicted knife wounds. "We saw him come out and fall into a car bonnet with what looked like a stab wound on his neck," one neighbour said. Several neighbours said they heard screams coming from the house before the sound of sirens. Ms Hendry's partner Bruce Abbott and her daughter Rosie Lang were also injured in the incident that left a community bewildered and heartbroken. "It is such a tragedy and will be a big loss," Frank Sander, Ms Hendry's friend of more than 20 years, said. "People are looking for answers. "We called her Joanie the one and only - she was a very exquisite woman." More here: Killed mother sought help for son … Continue reading

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BUSINESS WIRE: New TYSABRI Analysis at AAN Annual Meeting Shows Improved Walking Speed in Significant Number of MS …

Posted: Published on December 16th, 2014

MITTEILUNG UEBERMITTELT VON BUSINESS WIRE. FUER DEN INHALT IST ALLEIN DAS BERICHTENDE UNTERNEHMEN VERANTWORTLICH. Additional Data Show Escalation to TYSABRI Following Relapse Improves Clinical Outcomes Compared to Remaining On or Switching Between First-Line Interferon Beta and Glatiramer Acetate CAMBRIDGE, Mass. --(BUSINESS WIRE)-- 01.05.2014 -- Biogen Idec(NASDAQ: BIIB) today announced that a post hoc analysis of data from the AFFIRM study shows TYSABRI (natalizumab) significantly increased the proportion of relapsing-remitting multiple sclerosis (RRMS) patients with confirmed improvement in walking speed (CIWS) relative to placebo at two years. Additional data from observational registry studies show that switching to TYSABRI after experiencing a multiple sclerosis (MS) relapse while taking interferon beta (IFN) or glatiramer acetate (GA) reduced the risk of future relapses and treatment discontinuation. These data were presented at the 66th American Academy of Neurology (AAN) annual meeting in Philadelphia, Pa. (April 26-May 3, 2014). We know that MS has a significant impact on ambulation a key concern for many people living with this disease which is why we analyzed data from AFFIRM to evaluate the potential impact of TYSABRI on walking speed, said Alfred Sandrock, M.D., Ph.D., group senior vice president and chief medical officer at Biogen Idec. TYSABRI was associated … Continue reading

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Personalized therapy for cancer: Additional applications for FL118

Posted: Published on December 16th, 2014

A team led by Fengzhi Li, PhD, and Xinjiang Wang, PhD, of Roswell Park Cancer Institute (RPCI) has reported new findings regarding therapeutic targets of the novel anticancer agent FL118. Previous studies from these researchers have showed that FL118 induces cancer cell death, or apoptosis, by inhibiting expression of multiple cell-survival proteins (survivin, Mcl-1, XIAP or cIAP2). Study results published in the peer-reviewed American Association for Cancer Research journal Cancer Research showed that FL118 can also activate the p53 tumor-suppressor pathway in cancer cells, encouraging cell senescence, or aging. In both processes, FL118 demonstrates potent antitumor efficacy, suggesting additional applications as a personalized, targeted therapy for certain cancer tumors. In a study of preclinical models of colorectal cancer, the researchers identified an underlying mechanism for the activation of p53 by FL118. The agent activates the p53 tumor-suppressor protein largely independent of ataxia telangiectasia mutated (ATM)-dependent DNA damage-mediated p53 activation. ATM-dependent activation of p53 is usually induced by many -- if not all -- types of DNA-damage drugs, including camptothecin compounds such as irinotecan and topotecan, leading the authors to conclude that FL118's mechanisms of action are distinct among camptothecin analogues. "While FL118 is an analogue of irinotecan and topotecan, two … Continue reading

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Press Conference for Researcher Accused of Fraud Becomes TV Phenomenon in Japan

Posted: Published on December 16th, 2014

TOKYO Live broadcasts of scientist Haruko Obokata's press conference, in which she defended her groundbreaking stem cell research against allegations of data fabrication, were a ratings hit on multiple TV networks and online platforms on Wednesday. The event in a hotel in Osaka attracted 300 members of the domestic and international media, and was broadcast live on most of Japan's major networks. Nihon Terebi (NTV) topped the ratings with 12.3 percent, with public broadcaster NHK in second with 9.4 percent and Tokyo Broadcasting Systems (TBS) in third with 6.8 percent, according to Video Research Inc. GALLERY: Bollywood's Blatant Copies of Hollywood Movie Posters The press conference was scheduled to run for 30 minutes, but ended up lasting more than two hours, as Obokata, age 30, sometimes struggled to answer questions from hostile members of the media. TV networks extended news programs and shifted schedules to continue coverage. TV Tokyo, famous for ignoring major news events and sticking with its regular schedule, went ahead with an episode of Law & Order, followed by straight-to-video Canadian action movie Recoil. The Wednesday lunchtime event attracted more than 1.26 million to a live Ustream broadcast and 550,000 viewers to a live stream on Nico … Continue reading

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Alnylam Provides Pipeline Update, Growth Strategy – Analyst Blog

Posted: Published on December 16th, 2014

Alnylam Pharmaceuticals, Inc. ( ALNY ) announced its pipeline growth strategy for the development and commercialization of RNAi therapeutics across three strategic therapeutic areas (STArs) - genetic medicines, cardio-metabolic disease and hepatic infectious disease. Alnylam's genetic medicine STAr consists of a broad pipeline of RNAi therapeutics including patisiran (phase III - APOLLO) and revusiran (phase III - ENDEAVOUR), being developed for the treatment of transthyretin-mediated amyloidosis. Additionally, the company reported positive initial data from a phase I study on ALN-AT3 last week. The company is advancing ALN-AT3 for the treatment of hemophilia and rare bleeding disorders. Further, the company plans to initiate a phase I/II study on ALN-CC5 for paroxysmal nocturnal hemoglobinuria. Meanwhile, Alnylam intends to commercialize its genetic medicine products in the U.S. and EU, while Genzyme, a Sanofi ( SNY ) company, will develop and commercialize in the rest of the world. In its cardio-metabolic disease STAr, Alnylam recently initiated a phase I study on ALN-PCSsc (RNAi therapeutic targeting PCSK9 for the treatment of hypercholesterolemia) with initial data expected in mid-2015. Alnylam has an agreement with The Medicines Company ( MDCO ) for ALN-PCSsc. Alnylam is also advancing other candidates including ALN-AC3 (hypertriglyceridemia), ALN-ANG (hypertriglyceridemia and mixed hyperlipidemia) … Continue reading

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Penrose offers genetic counseling via telemedicine

Posted: Published on December 16th, 2014

By Bryan Grossman Thanks to modern technology, genetic counselors in Colorado Springs now can meet with patients in Durango by two-way live audio/video conferencing. Patients in Durango who seek genetic counseling can schedule appointments with Penrose Cancer Center genetic counselors and meet with them virtually. Penrose is in partnership with Mercy Regional Medical Center. Appointments physically take place at Mercy Family Medicines Three Springs and Horse Gulch locations in Durango, where a medical assistant sits down with the patient in the clinic room, initiates the video counseling session and introduces the patient. In Colorado Springs, a Penrose Cancer Center genetic counselor logs on simultaneously and meets with the patient as if it were an in-person appointment. Prior to the start of this program, patients at MRMC didnt have access to local genetic counseling services, saidElena Strait, certified genetic counselor. This telemedicine program allows us to meet a need in a way that makes sense for MRMC patients. They are thrilled to receive this service without leaving home, and Durango medical providers appreciate having us as a resource for their patients. Genetic counseling services include recording a detailed family history and using family history information to estimate the risk of developing … Continue reading

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