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Vifor Fresenius Medical Care Renal Pharma and Relypsa announce Submission of Marketing Authorisation Application Requesting European Approval of Patiromer for treatment of hyperkalemia

R&Dpharmiweb2016-04-26 09:47 Read   446

Vifor Fresenius Medical Care Renal Pharma (VFMCRP), a common company of Galenica and Fresenius Medical Care, and Relypsa, Inc., a biopharmaceutical company, today announced that VFMCRP has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Patiromer*.

Upcoming events – Cara, Heron and Seres get ready for next phase

R&Depvantage2016-04-25 16:29 Read   116

Welcome to your weekly digest of approaching regulatory and clinical readouts. Cara Therapeutics and Heron Therapeutics are both progressing with postoperative pain candidates, with Cara due to resume enrolment in its paused phase III trial of intravenous CR845 next month, and Heron expecting more phase II data with HTX-011.

Trial backs Amgen's Nplate in paediatric ITP patients

R&Dpharmatimes2016-04-25 15:29 Read   98

Data from a late-stage trial testing Amgen’s Nplate in children with symptomatic immune thrombocytopenia (ITP) shows that the drug induced a durable platelet response, raising hopes for a new treatment option to help reduce bleeds in patients. 

Germany considering price limits for new drugs: report

R&Dfirst word2016-04-25 15:18 Read   309

Germany is considering curtailing the prices drugmakers can charge the country's national healthcare system for new medicines, The Wall Street Journal reported Friday.

A win for Sanofi on Jevtana after NICE reverses guidance

R&Dpharmafile2016-04-25 15:10 Read   99

Prostate cancer treatment Jevtana (cabazitaxel), marketed by Sanofi (NYSE: SNY) has been recommended by NICE in its final guidance.

Actelion Chief Says No Suitors Are Courting Drugmaker With Deals

R&Dbloomberg2016-04-22 13:09 Read   90

Actelion isn’t fending off any takeover approaches, Chief Executive Officer Jean-Paul Clozel said, days after a media report cited the drugmaker as a possible target for Sanofi or Johnson & Johnson.

Novartis splits U.S. honcho's job in two as current chief Christi Shaw steps down

R&Dfiercepharma2016-04-22 13:02 Read   127

Novartis will see a changing of the guard in the U.S. next week. Christi Shaw, who has headed up the Swiss drugmaker’s U.S. operations since April 2014, is stepping down for personal and family reasons, to be replaced by two current Novartis execs.

Novo Nordisk plans to invest more than 100 million euros in production plants in Chartres, France

R&Dnovonordisk2016-04-22 12:57 Read   90

Bagsværd, Denmark, 21 April 2016 ­- Novo Nordisk today announced that it plans to invest more than 100 million euros in production facilities at its site in Chartres, France.

Biogen Reports First Quarter 2016 Revenues of $2.7 Billion

R&Dbusinesswire2016-04-22 11:33 Read   224

Total revenues of $2.7 billion, a 7% increase versus the same period in the prior year. Growth was driven by a 15% increase in worldwide TECFIDERA® revenues as well as increased revenues from ELOCTATE® and ALPROLIX®.

Jardiance® (empagliflozin) to be studied for the treatment of people with chronic heart failure

R&Dinvestor.lilly2016-04-21 10:39 Read   155

Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced plans to conduct two outcome trials investigating the diabetes medicine Jardiance® (empagliflozin) for the treatment of people with chronic heart failure.

Brigham researchers demonstrate a systemic Trojan Horse approach for prostate cancer

R&Dfiercebiotech2016-04-21 09:54 Read   88

Gaining the ability to target a chemotherapy drug specifically to tumor cells, leaving healthy neighboring cells unscathed, is a long-standing goal in the field of cancer therapy.

Illumina Invests In New Venture Fund

R&Dbusinesswire2016-04-18 09:24 Read   87

Illumina, Inc. (NASDAQ: ILMN) today announced that it has committed to invest $100M in a new venture capital firm that is strategically aligned with Illumina’s vision to improve human health by unlocking the power of the genome.