Manufacturing and Production

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descovy

FDA approves Gilead’s latest HIV treatment

April 5, 2016 Manufacturing and Production, Research and Development Gilead, HIV, descovy, taf, taf-based, therapy

Gilead (NASDAQ: GILD) has announced that the US Food and Drug Administration has approved their TAF-based HIV therapy, Descovy (emtricitabine, …
gilead-sciences

Gilead to buy Nimbus Therapeutics’ unit, trial drug for up to $1.2 billion

April 5, 2016 Manufacturing and Production, Research and Development, Sales and Marketing Gilead Sciences, M&A, MA, Nimbus Apollo, Nimbus Therapeutics, merger and acquisitions

Gilead Sciences (Nasdaq: GILD) has agreed to buy a unit of biotechnology firm Nimbus Therapeutics and its trial drug to …
legal

Janssen and Genmab sued for patent infringement in US

April 5, 2016 Manufacturing and Production, Research and Development, Sales and Marketing Genmab, Janssen, darzalex, morphosys, patent infringement

German biotech company, Morphosys, is suing Janssen and Genmab for alleged patent infringement in their oncology drug, Darzalex (daratumumab).
aldridge_roboty_thing

Outsourcing and Robots: how smart pharmas are optimising R&D operations

April 5, 2016 Manufacturing and Production

Faced with steadily rising research and development costs, as well as increasingly stringent regulatory requirements, pharmaceutical firms are re-evaluating their …
stats_data

Timeline of turmoil – Valeant Pharmaceuticals’ troubled March 2016

April 4, 2016 Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Share price, Valeant, fall, month from hell, timeline, turmoil

As far as months go, March 2016 couldn’t have gone much worse for Valeant Pharmaceuticals. The Canada-based company has been …

FTC files complaint against Endo for blocking generics of its pain drugs

April 1, 2016 Business Services, Manufacturing and Production, Medical Communications, Sales and Marketing Endo International, FTC, legal, regulation

The US Federal Trade Commission (FTC) has filed a complaint against Endo International (Nasdaq: ENDP) alleging the company used illegal …
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The US Food and Drug Administration (FDA) has issued draft guidance on the labelling of biosimilar drugs.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 …
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 …
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 …

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 …
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 …
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, …

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 …
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 …

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 …
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