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Merck says US FDA to review its Keytruda for head & neck cancer

April 14, 2016
Research and Development, Sales and Marketing Cancer Immunotherapy, Merck & Co, US FDA, keytruda

The US Food and Drug Administration has accepted Merck & Co’s (NYSE: MRK) supplemental biologics license application (sBLA) for its immunotherapy cancer …

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Zika causes microcephaly and other birth defects, says CDC

April 14, 2016
Medical Communications, Research and Development CDC, Zika, Zika virus, birth defects, microcephaly

The US Centers for Disease Control and Prevention has concluded that the Zika virus is a cause of microcephaly and …

News
merck-sharp--dohme-corp

Merck says its Zepatier showed better efficacy and safety compared with competition in Phase III trials

April 14, 2016
Research and Development, Sales and Marketing Gilead, HCV, Merck & Co, Zepatier

US pharma giant Merck (NYSE: MRK) on Thursday said late-stage trials for its Zepatier (elbasvir and grazoprevir) to treat chronic …

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abbvie_0

AbbVie announces positive Phase III results in hepatitis C drug

April 14, 2016
Manufacturing and Production, Research and Development AbbVie, hepatitis, phase III

AbbVie (NYSE: ABBV) has announced positive results from their Phase III evaluating the combination of Viekirax and Exviera, with or …

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NICE issues new guidance on the safer use of controlled drugs

April 13, 2016
Medical Communications NICE, controlled drugs, guidance

The National Institute for Health and Care Excellence (NICE) has issued guidance bringing together legislation and existing advice on the …

News
sanofi_hq__boetie_hall

Sanofi reinforces collaboration with Stevenage Bioscience Catalyst with partnering office

April 13, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Sanofi, Stevenage Bioscience Catalyst, academia, industry, partnership, pharma, stevenage

Sanofi has reinforced its collaboration with Stevenage Bioscience Catalyst with the opening of a new partnering office. This office will …

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opdivo_1

Bristol-Myers Squibb cancer immunotherapy Opdivo approved in EU

April 13, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Bristol-Myers Squibb, Cancer, EU, NICE, approval, immunotherapy, opdivo

Bristol-Myers Squibb has announced that its potentially life-extending cancer immunotherapy, Opdivo (nivolumab), has been approved by the European Commission to …

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fda_logo-web

US FDA committee recommends against fast-track approval of Clovis’ cancer drug, asks for more data

April 13, 2016
Medical Communications, Research and Development

Shares in Clovis Oncology Inc (Nasdaq: CLVS) closed down 5.4% Tuesday after the US Food and Drug Administration advisory committee recommended …

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zika_purdue

Structure of Zika virus revealed in new study

April 13, 2016
Research and Development NIH, Purdue, Zika, glycoprotein, structure

Researchers have examined the structure of the Zika virus in a new study and found that is broadly similar to …

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msd

FDA accepts biologics license application for MSD’s allergy immunotherapy drug

April 13, 2016
Research and Development, Sales and Marketing MSD, Merck, allergy, dust mite, house, immunotherapy, mk-8237

MSD (NYSE: MRK) has announced that the US Food and Drug Administration has accepted for review the biologics license application …

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birdlr

Boehringer Ingelheim’s Giotrif significantly lowers lung cancer progression in Phase II trials

April 13, 2016
Research and Development AstraZeneca, Boehringer Ingelheim, Iressa, giotrif, lung cancer

German drugmaker Boehringer Ingelheim on Wednesday said a mid-stage study has shown its cancer drug Giotrif (afatinib) reduced the risk …

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stocks2

Valeant bondholders issue notice to default

April 13, 2016
Research and Development, Sales and Marketing Valeant, bondholders, default, fears, possibility

Valeant (NYSE: VRX) has issued a statement detailing plans from some of its bondholders to call a default because of …

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cancer

Focus: Ovarian cancer and the case of elusive cure

April 12, 2016
Research and Development J&J, JJ, Pfizer, drug trials, ovarian cancer

Each year, more than 21,000 women in the US are diagnosed with ovarian cancer, according to research and more than …

Feature
chemo-web

EUSA Pharma acquires global rights to oncology support drug

April 12, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Eusa Pharma, acroral, acroral tab, global rights, oncology

EUSA Pharma has announced the acquisition of global rights to oncology support care product, Arcoral Tab, from Arcoral Pharma.

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regeneron

Regeneron agrees six-year $75 million upfront licencing deal with Intellia for gene technology

April 12, 2016
Manufacturing and Production, Research and Development, Sales and Marketing IPO, Intellia Therapeutics, Licencing, Regeneron Pharmaceuticals, crispr, deal, gene editing, genetics

Regeneron Pharmaceuticals Inc (Nasdaq: REGN) on Tuesday said it has signed a six-year licencing deal with biotech firm Intellia Therapeutics …

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KaloBios announces new affordable pricing model, refuses to engage in “price gouging”

April 12, 2016
Manufacturing and Production, Sales and Marketing CEO, Drug pricing, KaloBios, Martin Shkreli, Shkreli, affordable, price gouging, price model, responsible

Price gouging has become synonymous with drug costs in the US, with the infamous Martin Shkreli and troubled Valeant becoming …

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astrazeneca_sign_sky

Clinical studies point to consistent efficacy in AstraZeneca’s treatment for drug-resistance bacteria

April 12, 2016
Manufacturing and Production, Research and Development AstraZeneca, avibactam, ceftazidime, gram resistant

AstraZeneca has presented results from a series of trials which show the consistent efficacy of investigational antibiotic, ceftazidime-avibactam (CAZ-AVI) in …

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roche

Roche’s Venclexta gets accelerated approval from US FDA for chronic lymphocytic leukemia

April 12, 2016
Manufacturing and Production, Research and Development, Sales and Marketing AbbVie, Roche, US FDA, Venclexta, chronic lymphocytic leukemia

Swiss drug firm Roche (SIX: ROG) on Tuesday said the US Food and Drug Administration (FDA) has granted accelerated approval …

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Insys Therapeutics sees revenue from Subsys at $61-$62 million; shares plunge 21%

April 11, 2016
Business Services, Manufacturing and Production, Sales and Marketing Insys Therapeutics, Stock Price, Subsys, opioids, pain drug

Insys Therapeutics Inc (Nasdaq: INSY) stock plunged nearly 21% Monday after the company said sales for its pain drug will …

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iqwigsmall

IQWiG says Gilead’s anti-HIV drug genvoya offers slightly lower benefits than competition

April 11, 2016
Medical Communications, Research and Development Bristol-Myers Squibb, Gilead, HIV, anti-HIV

German Institute for Quality and Efficiency in Health Care (IQWiG) said USdrug maker Gilead’s (Nasdaq: GILD) anti-HIV drug Genvoya provides marginally …

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