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acadia

FDA says positives outweigh risks on Acadia’s Parkinson’s psychosis drug

March 30, 2016
Research and Development, Sales and Marketing FDA, Parkinson's, Parkinsons, acadia, nuplazid, pimavanserin, psychosis

Acadia Pharmaceuticals (NASDAQ: ACAD) has announced a positive result from the US Food and Drug Administration (FDA) concerning Nuplazid (pimavanserin) …

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biosimilars_squiggly_thing

Biosimilars could save healthcare systems $100bn by 2020

March 30, 2016
Research and Development, Sales and Marketing biosimilars

The growth of the market for biosimilar drugs has the potential to save EU and US healthcare systems up to …

News

Lupin drops on FDA observations; company reassures of no disruption at facility

March 29, 2016
Business Services, Manufacturing and Production, Sales and Marketing Lupin, US FDA, regulation

Shares of India’s Lupin dropped over 14% Tuesday following news the US Food and Drug Administration (FDA) has made observations …

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GSK’s Nucala gets regulatory approval in Japan to treat bronchial asthma

March 29, 2016
Manufacturing and Production, Research and Development GlaxoSmithKline, Japan, Nucala, US FDA, bronchial asthma

GlaxoSmithKline (LSE: GSK) on Tuesday said the Japanese regulators have approved its drug to treat bronchial asthma.  The Japanese Ministry …

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valeant

Valeant’s outgoing CEO subpoenaed by US congressional committee

March 29, 2016
Medical Communications, Research and Development Drug pricing, Michael Pearson, US, Valeant, committee, pearson, pharma, price hikes, senate aging committee, subpoena, subpoenaed

The US Senate Aging Committee has announced the issuing of a subpoena to the outgoing CEO of Valeant Pharmaceuticals, Michael …

News

TREND: Rare disease, cancer drugs will drive pharma M&A’s, growth

March 29, 2016
Manufacturing and Production, Research and Development, Sales and Marketing M&A, MA, Orphan Drugs, cancer drugs

Moody’s Investor Service lowered its growth outlook for the global pharma sector but maintained the mergers and acquisitions in the …

Feature
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Novo Nordisk breaks ground on new $2 billion production facility in North Carolina

March 29, 2016
Manufacturing and Production, Research and Development $2 billion, Clayton, Novo, Novo Nordisk, building, diabetes, nordisk, north carolina, production facility

Novo Nordisk has begun work on a new $2 billion production facility in Clayton, North Carolina, which will produce active …

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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 …

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yong_jun_liu

Sanofi names MedImmune chief head of research

March 29, 2016

Sanofi has announced the appointment of Yong-Jun Liu as head of research at the French company.Liu, an immunology specialist with …

Appointment

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. …

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brintellix

FDA issues CRL for Takeda/Lundbeck’s Brintellix

March 29, 2016
Manufacturing and Production, Research and Development Lundbeck, Takeda, brintellix

Takeda and Lundbeck have received a complete response letter from the US Food and Drug Administration (FDA) for the supplemental …

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174571_1

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 …

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takeda_research_centre

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, …

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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 …

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msd

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 …

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ptc_therapeutics_logo

PTC Therapeutics to cut jobs after FDA rejects Duchenne drug

March 24, 2016
Manufacturing and Production Duchenne Muscular Dystrophy, PTC Therapeutics

PTC Therapeutics has announced plans to reduce its operating expenses that will see it cut almost a fifth of its …

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Phase III trial initiated for enzalutamide in treatment of prostate cancer

March 24, 2016
Research and Development Astellas, Medivation, arches, clinical trial, enzalutamide, phase 3, phase III, prostate cancer

Astellas Pharma (TSE: 4503) and Medivation (NASDAQ:MDVN) have announced the initiation of the ARCHES Phase III clinical trial to evaluate …

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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 …

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msd

MSD teams up with Harvard to develop new leukaemia treatments

March 24, 2016
Medical Communications, Research and Development AML, Harvard, MSD, leukaemia

MSD has entered a new collaboration with Harvard University aimed at developing innovative new small-molecule therapeutics for leukaemia and other …

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) …

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