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Nice rejects BMS’ immunotherapy Opdivo for previously treated kidney cancer on pricing

July 5, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Bristol-Myers Squibb, NICE, QALY, immunotherapy, opdivo, regulation

UK regulators have rejected Bristol-Myers Squibb’s (NYSE: BMY) immunotherapy Opdivo for previously treated kidney cancer on pricing and substantial uncertainty …

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UCB scores Japanese approval for seizure therapy, Vimpat

July 5, 2016
Manufacturing and Production, Research and Development Daiichi Sankyo, Japan, UCB, japanese

UCB Biopharma (EURONEXT: UCB) and Daiichi Sankyo have announced that Vimpat (lacosamide) has been approved as an adjunctive therapy in …

News

Sanofi, Regeneron say cholesterol drug Praluent approved in Japan

July 5, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Japan, Regeneron, Sanofi, cardiovascular, cholestrol, praleunt

Sanofi (Euronext: SAN) and Regeneron Pharmaceuticals (Nasdaq: REGN) said the lawmakers in Japan have granted marketing and manufacturing authorization for …

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Eisai launches cancer drug Lenvatinib in Mexico

July 4, 2016
Research and Development, Sales and Marketing Cancer, Eisai, Mexico, lenvatinib, product launch

Japanese drug firm Eisai Co (TYO: 4523) said it has launched its anticancer agent Lenvima (lenvatinib mesylate) in Mexico. Lenvima …

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allergan

Allergan says its double chin correction therapy Belkyra gets positive opinion from Swedish regulators

July 4, 2016
Research and Development, Sales and Marketing Allergan, Belkyra, Botox, EU, Sweden, double chin, drug trial

Botox maker Allergan (NYSE: AGN) said it has received a positive opinion from the Swedish Medical Products Agency for its …

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Amgen says its blood cancer drug gets European backing for extended indication

July 4, 2016
Research and Development, Sales and Marketing Amgen, European Commission, Kyprolis, blood cancer, drug trial

Amgen (Nasdaq: AMGN) said the European Commission (EC) has approved a variation to the marketing authorization for its Kyprolis (carfilzomib) to include use …

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Merck says its Erbitux in combination with Folfox improves outcomes in colorectal cancer

July 4, 2016
Research and Development, Sales and Marketing Cancer, China, ESMO, Merck, colorectal cancer, drug trial, research, study

Merck said late-stage trials for its Erbitux (cetuximab) in combination with Folfox significantly improved progression free survival in metastatic colorectal …

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Weekly Movers: Regulus, Nymox, Akers…

July 4, 2016
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Shares, drug trial, markets, stocks

Shares in Regulus Therapeutics (Nasdaq: RGLS) dropped after the company said it has received verbal notification from the US Food …

Feature
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AstraZeneca licenses skin-condition drug to Leo Pharma for $115 million upfront

July 1, 2016
Medical Communications, Research and Development, Sales and Marketing AstraZeneca, Deals, Licencing, Loe Pharna, Valeant, drug development

UK drug firm AstraZeneca (LSE: AZN) said it has licenced its drug for skin diseases to Leo Pharma for an …

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US doctors received $6.5 billion from drug, device firms in 2015

July 1, 2016
Medical Communications, Research and Development, Sales and Marketing US, affordable care act, pharma, regulation

Doctors and hospitals received nearly $6.5 billion in research and speaking fees as well as other goods or services from …

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UK healthcare professionals received £340.3 million in benefits from pharma industry in 2015 discloses ABPI

July 1, 2016
Business Services, Medical Communications, Sales and Marketing ABPI, Pharmacutical, corruption, disclosure, regulation

“We don’t want our neighbours to know what we earn,” said Mike Thompson, the chief executive of industry body Association …

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AbbVie’s Imbruvica secures fourth breakthrough therapy designation from US FDA

July 1, 2016
Medical Communications, Research and Development, Sales and Marketing AbbVie, US FDA, drug trial, imbruvica

US pharma firm AbbVie (NYSE: ABBV) said the US Food and Drug Administration has granted Imbruvica a fourth breakthrough therapy …

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Shire says Phase II trial for rare eye condition in premature infants fails

July 1, 2016
Medical Communications, Research and Development Shire, US FDA, drug trial, rare eye condition in infants

Shire plc (LSE: SHP) said its drug compound to treat a rare eye condition in infants failed mid-stage trials. The …

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Bayer says its Stivarga improved overall survival in liver cancer in late-stage trials

June 30, 2016
Research and Development, Sales and Marketing Bayer, Stivarga, drug trial, liver cancer

German pharma and crop sciences giant Bayer (ETR: BAYN) said late-stage trials for its drug to treat liver cancer showed a …

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Galena’s breast cancer immunotherapy fails in late-stage trials; shares plunge

June 30, 2016
Research and Development, Sales and Marketing Galena Biopharma, Stock, breast cancer, drug trial

Shares in Galena Biopharma (Nasdaq: GALE) dropped over 80% after the company said an independent Data Monitoring Committee recommended that …

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Tesaro’s niraparib hits primary goal in late-stage trials for ovarian cancer trial; shares jump

June 30, 2016
Research and Development, Sales and Marketing Tesaro, drug trial, niraparib, ovarian cancer

Shares in Tesaro (Nasdaq: TSRO) jumped to more than double after the company reported late-stage trials for its drug to …

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Eli Lilly says FDA panel backs approval of Jardiance for cardiovascular indication

June 30, 2016
Research and Development, Sales and Marketing Eli Lilly, cardiovascular, diabetes, jardiance

US drugmaker Eli Lilly (NYSE: LLY) said a US regulatory panel has backed its Jardiance (empagliflozin) for reducing cardiovascular death …

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Shire says trial drug for ADHD shows positive results

June 30, 2016
Research and Development, Sales and Marketing ADHD, Shire, US FDA, drug trial, regulation

UK drugmaker Shire plc (LSE: SHP) said its trial drug to treat Attention-Deficit/Hyperactivity Disorder (ADHD) showed positive topline results.  Philip …

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Regulus’ shares drop as FDA puts trials for hepatitis C drug on hold

June 29, 2016
Research and Development, Sales and Marketing Regulus Therapeutics, US FDA, drug trial, hepatitis C virus, regulation

Shares in Regulus Therapeutics (Nasdaq: RGLS) plunged as much as 60% after the company said the US Food and Drug …

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Mayne Pharma to buy a portfolio of Teva’s generic drugs for $652 million

June 29, 2016
Research and Development, Sales and Marketing Allergan, Deals, Mayne Pharma, Teva, generics, merger and acquisition

Australia’s Mayne Pharma Group Ltd (ASX: MYX) said it will acquire US generic products from Israel-based drugmaker Teva Pharmaceuticals (NYSE: …

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