Research and Development

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Research shows Novartis’s Entresto reduces cardiovascular death and heart failure

April 4, 2016 Research and Development, Sales and Marketing Entresto, Novartis, Regeneron, Sanofi, cardiovascular, clinical trial, patent

Novartis has announced results from the PARADIGM-HF clinical trial that show that Entresto (sacubitril/valsartan) consistently demonstrated benefit among heart failure …

Amicus Therapeutics’ Fabry disease drug gets European regulatory support

April 4, 2016 Research and Development, Sales and Marketing Amicus Therapeutics, EMA, Fabry disease, genetic disorder, rare disease

Shares in biotechnology firm Amicus Therapeutics (Nasdaq: FOLD) rose to close up nearly 3% after the European regulators announced backing …
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Novo says Victoza bests MSD’s Januvia at lowering blood sugar

April 4, 2016 Research and Development Novo Nordisk, Victoza

Novo Nordisk says its diabetes drug Victoza, in combination with metformin, outperformed MSD’s Januvia plus metformin in reducing HbA1c – …
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Amgen’s high cholesterol drug at centre of patent court case yields positive clinical trial results

April 4, 2016 Research and Development, Sales and Marketing Amgen, Repatha, Sanofi, high cholesterol. ldl, ldl-c, phase III, statins

Amgen has announced positive results from the Phase III GAUSS-3 clinical trial evaluating Repatha (evolucumab) in patients with high cholesterol …

GSK’s gene therapy for rare condition in children gets EMA backing

April 4, 2016 Research and Development, Sales and Marketing ADA-SCID, European Medicines Agency, GlaxoSmithKline, Orphan Therapy, Rare Treatment, drug trial, gene therapy

UK drug major GlaxoSmithKline (LSE: GSK) has won marketing recommendation from European regulators for its first gene therapy to treat …
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Timeline of turmoil – Valeant Pharmaceuticals’ troubled March 2016

April 4, 2016 Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Share price, Valeant, fall, month from hell, timeline, turmoil

As far as months go, March 2016 couldn’t have gone much worse for Valeant Pharmaceuticals. The Canada-based company has been …
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Two CHMP nods for Janssen

April 4, 2016 Research and Development, Sales and Marketing Xeplion, darzalex, multiple myeloma

The European Commission’s scientific committee has recommended Janssen’s Darzalex (daratumumab) for multiple myeloma and Trevicta (paliperidone palmitate) for maintenance treatment …
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Pfizer’s cholesterol-lowering bococizumab shows promise in Phase III trials

April 1, 2016 Research and Development, Sales and Marketing Pfizer, bococizumab, lipid, phase 3, phase III, spire, spire-ai

Pfizer (NYSE: PFE) has announced positive top line results from the SPIRE-AI Phase III clinical trial evaluating bococizumab. This protein …
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FDA to review investigational hepatitis B vaccine

April 1, 2016 Medical Communications, Research and Development dynavax, hepatitis B, vaccines

Dynavax Technologies (NASDAQ: DVAX) says the FDA has accepted for review the company’s investigational adult hepatitis B vaccine, HEPLISAV-B. The FDA has set …
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Janssen to stop fulranumab development in osteoarthritis pain

April 1, 2016 Medical Communications, Research and Development, Sales and Marketing Amgen, Janssen

Janssen says it is discontinuing Phase III development for fulranumab in osteoarthritis pain. The J&J company says the decision is …
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FDA releases biosimilars labelling guidance

April 1, 2016 Manufacturing and Production, Medical Communications, Research and Development FDA, biosimilars

The US Food and Drug Administration (FDA) has issued draft guidance on the labelling of biosimilar drugs. The guidance states …

Sanofi and Regeneron announce positive Phase III trial results for chronic skin disease treatment

April 1, 2016 Medical Communications, Research and Development Dupilumab, Regeneron, Sanofi, atopic dermatitis, phase III, skin disease

Sanofi (NYSE: SNY) and Regeneron Pharmaceuticals (NASDAQ: REGN) have announced positive top line results for dupilumab in Phase III clinical …
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Lilly’s RA drug baricitinib meets Phase III goals

March 31, 2016 Research and Development Eli Lilly, Incyte, rheumatoid arthritis

Eli Lilly and Incyte have announced the publication of detailed Phase III trial results from a study of their biologic …
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Jazz Pharmaceuticals receives FDA approval for rare veno-occlusive disease treatment

March 31, 2016 Research and Development, Sales and Marketing FDA, jazz pharmaceuticals

Jazz Pharmaceuticals (NASDAQ: JAZZ) has announced that the US Food and Drug Administration (FDA) has granted marketing approval for Defitelio …
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Actinium gets Orphan Drug Designation for myeloid leukaemia drug

March 31, 2016 Research and Development Actinium Pharmaceuticals

New York-based biopharma Actinium Pharmaceuticals (NYSE MKT: ATNM) has received orphan drug designation from the US FDA for Iomab-B, a …
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