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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

Top Ten most popular articles on Pharmafile.com this week

August 30, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing pharma, top 10

Happy Friday! It’s time for another rundown of the top 10 most popular articles with Pharmafile.com readers this week.10. NICE …

Roche’s Tecentriq combo becomes first EU-approved immunotherapy for triple-negative breast cancer

August 30, 2019
Medical Communications, Sales and Marketing EMA, Europe, Roche, breast cancer, pharma, tecentriq

Roche has announced the approval of Tecentriq (atezolizumab), in combination with Celgene’s chemotherapy drug Abraxane (nab paclitaxel), by the European …

Genmab & Novartis’ ofatumumab tops Sanofi’s Aubagio in relapsing multiple sclerosis

August 30, 2019
Medical Communications, Research and Development Genmab, Novartis, multiple sclerosis, ofatumumab, pharma

Genmab and Novartis have revealed positive new data from two Phase 3 studies of its monthly subcutaneous formulation of ofatumumab …

AbbVie shuts down Rova-T development in first-line advanced small-cell lung cancer following another trial failure

August 30, 2019
Medical Communications, Research and Development AbbVie, pharma, rova-t, small-cell lung cancer

AbbVie has announced its intention to terminate development of Rova-T (rovalpituzumab tesirine) in the first-line maintenance of advanced small-cell lung …

Using advanced digital capabilities to unlock hard-to-see HCPs access

August 29, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing digital pharma, pharma, veeva

Pharmaceutical companies face a ‘digital imperative’ to engage with healthcare professionals through their channel preferences and ensure they are getting …

Celgene signs $1.5bn partnership with Immatics to fight cancer with engineered T-cell therapies

August 29, 2019
Research and Development Cancer, Celgene, immatics, immunotherapy, pharma

Celgene and biopharma firm Immatics Biotechnologies have announced that they have entered a partnership valued at a potential $1.5 billion …

FDA warns three Hepatitis C drugs may worsen liver function in some rare cases

August 29, 2019
Medical Communications, Research and Development AbbVie, FDA, Gilead, HCV, MSD, hepatitis C, public health

The FDA has warned that three Hepatitis C (HCV) drugs made by AbbVie, Gilead and MSD are worsening liver function …

AstraZeneca lupus drug makes comeback to meet main goal at Phase 3

August 29, 2019
Research and Development AstraZeneca, Lupus, anifrolumab, pharma

AstraZeneca has lifted the curtain on new Phase 3 data for anifrolumab, noting that the drug met its primary endpoint …

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