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US FDA issues observations for Natco Pharma’s Indian plants

March 29, 2016 Manufacturing and Production, Research and Development, Sales and Marketing

Shares in India-based Natco Pharma (BOM: 524816) dropped on the Bombay Stock Exchange following news the US Food and Drug …
News

Portola Pharma stock drops on dismal Phase III trial results for blood-clot drug

March 29, 2016 Manufacturing and Production, Research and Development, Sales and Marketing Portola Pharmaceuticals, blood clot drug, drug trial, phase III

Shares in Portola Pharmaceuticals (Nasdaq: PTLA) dropped after the company reported disappointing late-stage trial results for its blood clotting drug. …
News
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US govt demands records of Novartis’ educational events in kickbacks suit

March 29, 2016 Business Services, Manufacturing and Production, Sales and Marketing Novartis, US government, legal, regulation

Swiss pharma major Novartis (VTX: NOVN) has said the US lawsuit has exploded with the regulators demanding information for about …
News
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Japanese approval for AZ lung cancer drug

March 29, 2016 Manufacturing and Production, Sales and Marketing AstraZeneca, Tagrisso, lung cancer

AstraZeneca’s Tagrisso (osimertinib) has been approved in Japan for the treatment of a specific form of clung cancer. Japanese regulator, …
News
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Mylan launches generic of Valeant’s Ultram in the US

March 29, 2016 Manufacturing and Production, Sales and Marketing FDA, Mylan, Valeant, abbreviate new drug application, generic, pain, tramadol, ultram

Mylan (NASDAQ, TASE: MYL) has announced the launch of its generic version of Valeant’s Ultram tablets in the US. The …
News
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Gilead must pay MSD $200m in hep C drug patent case

March 29, 2016 Manufacturing and Production, Sales and Marketing Gilead Sciences, MSD, Solvadi, harvoni

A Californian federal jury has ordered Gilead Sciences to pay MSD and Ionis $200 million for infringing on patents relating …
News
sunpharma

Sun Pharma agree deal to distribute AstraZeneca type-2 diabetes drug in India

March 24, 2016 Sales and Marketing AstraZeneca, India, Sun Pharma, diabetes, oxra, type 2, type-2

Sun Pharma has agreed a deal with AstraZeneca to promote and distribute their type-2 diabetes drug, dapagliflozin, in India. Marketed …
News

EMA to review Pfizer’s Xeljanz for patients with rheumatoid arthritis

March 24, 2016 Research and Development, Sales and Marketing EMA, Pfizer, Xeljanz, approval, authorisation, marketing, review, rheumatoid arthritis

Pfizer (NYSE: PFE) has announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application (MAA) …
News
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Novartis settles bribery charges in China for $25m

March 24, 2016 Medical Communications, Sales and Marketing Novartis

Novartis will pay $25 million to the US Government’s Securities and Exchange Commission to settle charges that it bribed healthcare …
News
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Teva announces FDA approval for asthma injection, Cinqair

March 24, 2016 Research and Development, Sales and Marketing FDA, Teva, approval, asthma, cinqair

The US Food and Drug Administration has approved Cinqair (reslizumab), an injection for patients with severe asthma developed by Teva …
News
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Bristol-Myers Squibb to acquire Padlock Therapeutics for up to $600m

March 23, 2016 Research and Development, Sales and Marketing Bristol-Myers Squibb, Padlock Therapeutics, rheumatoid arthritis

Bristol-Myers Squibb is to acquire Massachusetts-based auto-immune disease specialist Padlock Therapeutics in a deal worth up to $600 million. The …
News
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Thirty-seven arrested in China vaccine scandal

March 23, 2016 Sales and Marketing China, vaccines

Police in China have arrested 37 people in eastern China in relation to illegal vaccine sales conducted by a ring …
News

NDA Group and PharmApprove announce merger

March 23, 2016 Sales and Marketing NDA Group

NDA Group, a leading strategic regulatory and HTA consultancy in Europe, and PharmApprove, a leading strategic regulatory and scientific communications …
News
Press release
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FDA approves Lilly’s plaque psoriasis drug Taltz

March 23, 2016 Research and Development, Sales and Marketing Eli Lilly, Enbrel, Taltz, plaque psoriasis

The US Food and Drug Administration (FDA) has approved Eli Lilly’s Taltz (ixekizumab) for the treatment of moderate-to-severe plaque psoriasis in …
News
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NICE draft guidance says ‘no’ to cystic fibrosis drug Orkambi

March 23, 2016 Research and Development, Sales and Marketing NICE, Orkambi, Vertex, cystic fibrosis

NICE has issued draft guidance not recommending Vertex’s Orkambi (lumacaftor/ivacaftor) for use on the National Health Service (NHS) in England …
News
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