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Showing 15 posts of 68 posts found.

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Sobi, Biogen’s haemophilia B therapy gets European approval

May 13, 2016
Medical Communications, Research and Development, Sales and Marketing Biogen, haemophilia B, orphan designation, regulation, sobi

Sobi (STO: SOBI) and Biogen (Nasdaq: BIIB) on Friday said the European Commission has approved their drug to treat haemophilia B. The …

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AstraZeneca says its trial drug for thyroid cancer granted US FDA orphan drug designation

May 12, 2016
Research and Development, Sales and Marketing AstraZeneca, Orphan Drug Designation, US FDA, drug trial, regulation

AstraZeneca (LSE: AZN) on Thursday said the US Food and Drug Administration (FDA) has granted Orphan Drug Designation its trial …

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Nice recommends two blood tests to rule out pre-eclampsia in pregnant women

May 11, 2016
Medical Communications, Sales and Marketing NICE, Roche, regulation

The National Institute for Health and Care Excellence (Nice) has backed two blood tests to help rule-out a complication in …

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Nice backs GSK’s lupus drug Benlysta

May 11, 2016
Research and Development, Sales and Marketing GSK, NHS, NICE, regulation

The National Institute for Health and Care Excellence (Nice) has backed GlaxoSmithKline’s (LSE: GSK) Benlysta (belimumab) to treat lupus.  The …

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Scottish Medicines Consortium does not back Vertex’ cystic fibrosis drugs Orkambi, Kalydeco

May 10, 2016
Manufacturing and Production, Research and Development Kalydeco, Orkambi, SMC, Vertex Pharma, cystic fibrosis, regulation

The Scottish Medicines Consortium did not back two cystic fibrosis therapies from Vertex Pharmaceutical (Nasdaq: VRTX).  SMC did not recommend …

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China evaluating investigations into pharma firms to take on drug pricing issue

May 9, 2016
Business Services, Research and Development, Sales and Marketing China, France, G7, regulation

Lawmakers globally have acknowledged the concerns over unbridled drug costs as regulators stress the need for a more open debate …

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Eisai says European Commission backs Halaven to treat of advanced Liposarcoma in Europe

May 5, 2016
Research and Development, Sales and Marketing EC, Eisai, US FDA, oncology, regulation, soft tissue sarcoma

The European Commission has backed marketing for the Japanese drug major Eisai’s (TYO: 4523) Halaven (eribulin) to treat advanced soft …

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Eli Lilly’s cancer drug candidate scores FDA priority review

May 5, 2016
Eli Lilly, US FDA, oncology, regulation

US drugmaker Eli Lilly (NYSE: LLY) said the US Food and Drug Administration (FDA) has granted priority review for its …

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Nice extends price-negotiation talks for PTC’ muscle wasting drug

May 4, 2016
Research and Development, Sales and Marketing Duchenne Muscular Dystrophy, NICE, PTC Therapeutics, Translarna, market access, regulation

UK regulators have extended the cost negotiation talks with PTC Therapeutics (Nasdaq: PTCT) by a week for the drug to …

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Novartis’ two cancer drugs get NICE backing as combination treatment for skin cancer

April 29, 2016
Medical Communications NICE, Novartis, combination therapy, regulation, skin cancer

The National Institute for Health and Care Excellence (NICE) on Friday backed a combination therapy for skin cancer comprising two …

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NICE backs BMS’ paclitaxel in ovarian cancer; drops Eli Lilly’s Gemzar, J&J’s Yondelis

April 27, 2016
Research and Development, Sales and Marketing BMS, Eli Lilly, J&J, JJ, NICE, ovarian cancer, regulation

The National Institute for Health and Care Excellence (NICE) has backed Bristol-Myers Squibb’s paclitaxel as a treatment for ovarian cancer. …

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Eli Lilly gets European marketing authorisation for psoriasis drug

April 26, 2016
EC, EU, Eli Lilly, drug trial, psoriasis, regulation

US pharma firm Eli Lilly and Co (NYSE: LLY) on Tuesday said the European Commission backed marketing authorisation for its …

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NICE recommends PTC Therapeutics’ Translarna to treat Duchenne muscular dystrophy

April 18, 2016
Sales and Marketing DMD, Duchenne Muscular Dystrophy, NICE, PTC Therapeutics, Translarna, regulation

Shares in drug maker PTC Therapeutics (Nasdaq: PTCT) jumped after the National Institute for Health and Care Excellence (NICE) backed …

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FDA staff raises doubts on efficacy, safety of Clovis’ trial drug for lung cancer, shares plunge

April 11, 2016
AstraZeneca, Clovis Oncology, US FDA, drug trial, lung cancer, regulation, rociletinib

Shares in Clovis Oncology Inc (Nasdaq: CLVS) plunged to close down nearly 18% after the US regulators expressed doubts if …

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FTC launches tool to help mobile health app developers determine applicable regulations

April 8, 2016
Medical Communications, Sales and Marketing FDA, FTC, apps, health, health apps, regulation

The US Federal Trade Commission has created a new web-based tool for developers of health-related mobile apps to help them …

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