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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*.

AstraZeneca sets out to build 5-petabyte, 2M-genome database

Frontierfiercebiotech2016-04-26 09:27 Read   123

AstraZeneca ($AZN) is redefining what big looks like in genome research. While a range of initiatives have been branded population-scale sequencing programs, none wear the label quite as comfortably as AstraZeneca’s scheme.

Patient advocates descend on FDA panel as Sarepta squares off against regulators

Commentsfiercebiotech2016-04-26 09:20 Read   84

Hundreds of Duchenne muscular dystrophy activists descended on an FDA panel review of Sarepta's eteplirsen Monday morning, looking to exert the maximum amount of pressure possible to spur an endorsement from the experts.

Toxicity, second cancers cause researchers to question radiation’s role in Hodgkin lymphoma

Frontierhealio2016-04-25 16:52 Read   108

Radiation therapy has been an integral part of treatment for patients with early-stage Hodgkin lymphoma since the 1960s.

Propensity matching and the GIGO principle

Frontierhealio2016-04-25 16:48 Read   140

It has become much harder to be a rational person with a modicum of biostatistical knowledge who can refrain from becoming irritated in the current “academic” oncology environment.

Symposium findings provide ‘wake-up call’ about postoperative complications, registry discrepancies

Meetinghealio2016-04-25 16:41 Read   92

The Society of Surgical Oncology’s 69th Annual Cancer Symposium, held March 2-5 in Boston, featured the theme “Tomorrow’s Treatments for Today’s Patients.”

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.

WHO stays positive as dose of reality hits malaria vaccine hopes

Commentsfirst word2016-04-25 15:15 Read   86

The World Health organization (WHO) has ordered up to five pilot programmes to take place in sub-Saharan Africa to test GlaxoSmithKline's malaria vaccine Mosquirix, also known as RTS, S, and only if those prove successful will a wider go-ahead be given, reported the Financial Times.

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 ups outlook for 2016, reports Q1 net income up 12%

EVENTSpharmafile2016-04-25 15:05 Read   112

Swiss biotech company Actelion (VTX: ATLN) raised its outlook for 2016 and reported a 12% rise in first quarter net income.