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Manufacturing and Production

Showing 15 posts of 5866 posts found.

fda

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The US Food and Drug Administration (FDA) has issued draft guidance on the labelling of biosimilar drugs.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

Janssen-Cilag’s HIV treatment gets NHS backing

March 31, 2016 Manufacturing and Production, Research and Development, Sales and Marketing HIV, Janssen, NHS, drug trial

Janssen-Cilag Ltd (Janssen) has said NHS England (NHSE) will fund its combination treatment for HIV.  The company said following the …
News
aedes_aegypti_mosquito

Roche to initiate testing for Zika virus under FDA investigational new drug application approval

March 31, 2016 Manufacturing and Production, Research and Development Roche, Zika

Roche (SWX: RO) has announced that the US Food and Drug Administration (FDA) has provided approval to initiate the collection …
News

US lawmakers demand price cut for Astellas, Medivation’s prostate cancer drug Xtandi

March 30, 2016 Business Services, Manufacturing and Production, Research and Development, Sales and Marketing Astellas, Japan, Medivation, US FDA, Xtandi, drug price

US lawmakers have asked the National Institutes of Health and the Department of Health and Human Services to ‘use its …
News
sunpharma

Sun Pharma forays into Japan with $293 million product buy from Novartis

March 30, 2016 Manufacturing and Production, Research and Development, Sales and Marketing Japan, M&A, MA, Novartis, Sun Pharma, generics

Shares of Sun Pharma (BOM: 524715), the largest Indian drug maker rose over 2% Wednesday as the company announced the …
News
ea_pharma

Eisai announces agreement to set up new gastrointestinal speciality company

March 30, 2016 Manufacturing and Production, Research and Development, Sales and Marketing Ajinomoto, Eisai, absorption, acquisition, ea pharma, gastrointestinal, merger, speciality

Eisai (TYO: 4523) and Ajinomoto Co. (TYO: 2802) have announced an agreement to establish a new gastrointestinal speciality pharmaceutical company, …
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 …
News
gsk_corp_hq_brentford_2

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 …
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
novo_flag

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 …
News
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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
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 …
News
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 …
News
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, …
News
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