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Janssen’s Stelara becomes first European-approved biologic IL-12/IL-23 inhibitor for ulcerative colitis

September 5, 2019
Sales and Marketing Europe, Janssen, Stelara, pharma, ulcerative colitis

Janssen has announced that its therapy Stelara (ustekinumab) hass secured a label expansion from the European Commission, approving the drug …

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BMS’ Opdivo falls short at Phase 3 in glioblastoma multiforme

September 5, 2019
Research and Development BMS, glioblastoma multiforme, opdivo, pharma

Bristol-Myers Squibb has revealed that its blockbuster immunotherapy Opdivo (nivolumab) fell short of its primary Phase 3 endpoint in the …

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Cancer drugs have surged since the 80s to account for 1 in 4 FDA approvals, report reveals

September 5, 2019
Research and Development, Sales and Marketing Cancer, FDA, US, pharma

The number of cancer drug approvals in the US has surged over the last decade to account for over one …

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Ireland will not suffer immediate medicine shortages in event of no-deal Brexit, says health authority

September 5, 2019
Medical Communications, Sales and Marketing England, Ireland, UK, brexit, pharma

Though MPs are moving forward with their plan to block UK Prime Minister Boris Johnson’s supposed no-deal Brexit from the …

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Key legal considerations in accelerating pharma using artificial intelligence

September 4, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AI, artificial intelligence, pharma

Charlotte Walker-Osborn, Partner and International Technology Sector Head and Nabil Asaad, Senior Associate, Intellectual Property Law Group – both from …

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FREE WEBINAR: Leveraging technology for optimal engagement

September 4, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Pharmafocus, Webinar, Within3, pharma

Join Pharmafocus and Within3 for a special webinar event on Thursday, 19 September, for a session exploring the changing trends …

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Keytruda scores EU approval in combination with Inlyta for first-line advanced renal cell carcinoma

September 4, 2019
Research and Development, Sales and Marketing EU, Europe, MSD, keytruda, pharma, renal cell carcinoma

The European Commission has awarded yet another authorisation in the region to MSD’s Keytruda, this time in combination with the …

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Ardelyx’s tenapanor combo meets all key goals at Phase 3 in hyperphosphatemia patients on dialysis

September 4, 2019
Research and Development Ardelyx, pharma, tenapanor

Ardelyx has revealed that its small molecule, non-binder, phosphate absorption inhibitor tenapanor met all primary and key secondary endpoints at …

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NICE recommends Novartis’ gene therapy Luxturna for inherited retinal dystrophy

September 4, 2019
Research and Development, Sales and Marketing Luxturna, NHS, NICE, UK, gene therapy, pharma

NICE has chosen to recommend the use of Novartis’ one-time gene therapy Luxturna (voretigene neparvovec) for use on the NHS …

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AZ’s Tagrisso secures China approval in first-line advanced lung cancer

September 4, 2019
Research and Development, Sales and Marketing AstraZeneca, China, Tagrisso, lung cancer, pharma

AstraZeneca’s Tagrisso (osimertinib) has secured approval in China from the country’s National Medical Products Administration (NMPA) in the first-line treatment …

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Sandoz acquires global commercialisation rights to Polpharma’s multiple sclerosis biosimilar

September 3, 2019
Manufacturing and Production, Sales and Marketing Polpharma, Sandoz, biosimilar, multiple sclerosis, pharma

Sandoz has revealed that it has sealed a deal with Polpharma Biologics to commercialise the latter’s proposed biosimilar version of …

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NICE issues new quality standard for cerebal palsy treatment

September 3, 2019
Manufacturing and Production, Research and Development

NICE has moved to publish a draft quality standard on the treatment of cerebral palsy (CP) in adults, it has …

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Novartis’ ofatumumab outclasses Sanofi’s Aubagio at Phase 3 in relapsing multiple sclerosis

September 3, 2019
Manufacturing and Production, Research and Development Arzerra, Genmab, Novartis, multiple sclerosis, pharma

New data from two Phase 3 studies have indicated that Novartis’ ofatumumab outperformed Sanofi Genzyme’s Aubagio (teriflunomide) in the treatment …

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AstraZeneca shows off Farxiga heart failure efficacy at ESC 2019

September 3, 2019
Manufacturing and Production, Research and Development

AstraZeneca has revealed new Phase 3 data illustrating that Farxiga (dapagliflozin), in combination with standard of care, met its primary …

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University of Limerick’s Pharmaceutical Manufacturing Technology Centre to expand operations with €5m funding injection

September 3, 2019
Manufacturing and Production Ireland, UK, pharma

The Pharmaceutical Manufacturing Technology Centre (PMTC) at the University of Limerick’s Bernal Institute in Ireland has secured €5 million ($5.5 …

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Mylan gets provisional FDA greenlight for generic version of Lilly’s blockbuster cancer drug Alimta

September 2, 2019
Sales and Marketing Alimta, Cancer, Eli Lilly, FDA, Mylan, pharma

Mylan has scored a preliminary approval in the US from the FDA for its generic version of Eli Lilly’s blockbuster …

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No-deal Brexit will “make the disintegration of the health service an ever more real prospect”, BMA warns

September 2, 2019
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing BMA, NHS, UK, brexit, pharma

As the UK hurtles towards a catastrophic and autocratic exit from the European Union, the British Medical Association (BMA) has …

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AstraZeneca presents strong Phase 3 Brilinta data for reducing CV risk

September 2, 2019
Research and Development, Sales and Marketing AstraZeneca, Brilinta, pharma

AstraZeneca has unveiled new positive Phase 3 data on the efficacy of Brilinta (ticagrelor) in combination with aspirin, showing that …

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Novartis’ Entresto narrowly misses Phase 3 goal in heart failure patients

September 2, 2019
Research and Development, Sales and Marketing Entresto, Novartis, heart failure, pharma

New Phase 3 data for Novartis’ Entresto (sacubitril/valsartan) have been released, showing that the therapy narrowly missed its primary endpoint …

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Roche’s Xofluza reduces risk of catching flu by 86% in Phase 3 trial

September 2, 2019
Research and Development, Sales and Marketing Roche, Xofluza, flu, influenza, pharma

Roche has brought forward new Phase 3 data on Xofluza (baloxavir marboxil), proving the therapy’s efficacy in the preventative treatment …

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