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Bayer lymphoma treatment speeds to FDA approval

September 18, 2017
Sales and Marketing Aliqopa, Bayer, biotech, drugs, pharma, pharmaceutical

The FDA gave Bayer priority review for its treatment Aliqopa (copanlisib) in May of this year, and it quickly came …

News

Santhera ‘surprised’ by European rejection of DMD drug

September 18, 2017
Sales and Marketing Duchenne Muscular Dystrophy, biotech, drugs, pharma, pharmaceutical, santhera

Santhera Pharmaceutical has announced the EMA’s CHMP rejected its treatment for Duchenne muscular dystrophy (DMD) but revealed that it planned …

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Top Ten most popular articles on Pharmafile.com this week

September 15, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Cosentyx, Eli Lilly, Martin Skreli, Teva, pharma, top ten

This week has been a particularly eventful one for the industry: among our top stories, Martin Shkreli finally heads to …

News

Pfizer receives prostate cancer drug boost with trial results

September 15, 2017
Medical Communications, Research and Development Astellas, Pfizer, Xtandi, biotech, drugs, pharma, pharmaceutical

Pfizer, and its partner Astellas Pharma, received a major boost to its plans for prostate cancer treatment, Xtandi, by announcing …

News

FDA approves first-ever biosimilar for cancer treatment

September 15, 2017
Medical Communications, Sales and Marketing Amgen, Cancer, FDA, Mvasi, avastin, biosimilar

The FDA has announced the news that it has awarded approval to the first-ever biosimilar for the treatment of cancer …

News
gsk_hq_logo

GSK receives positive opinion for triple-therapy inhaler

September 15, 2017
Medical Communications, Sales and Marketing GSK, biotech, drugs, pharma, pharmaceutical

GSK, alongside its partner Innoviva, has announced that it has received a positive opinion from the EMA’s CHMP for its …

News
sandoz

Sandoz psoriasis biosimilar tops reference product Humira in latest Phase 3 data

September 15, 2017
Medical Communications, Research and Development AbbVie, Humira, Novartis, Sandoz, adalimumab, biosimilar, biosimilars, pharma, pharmaceutical

Sandoz, the biologics and generics division of Novartis, has unveiled new Phase 3 data confirming the efficacy and safety profile …

News

Recipharm and Kancera collaborate to manufacture clinical trial supply

September 14, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Recipharm

Recipharm, a leading contract development and manufacturing organisation (CDMO) and Kancera, a development company focused on cancer therapy, have signed …

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Press release
astrazeneca_logo_building

AstraZeneca’s Forxiga displays potential in type 1 diabetes

September 14, 2017
Research and Development AstraZeneca, Forxiga, biotech, drugs, farxiga, pharma, pharmaceutical

Forxiga is AstraZeneca’s treatment for those living with type 2 diabetes but the results from a new trial have found …

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data

GDPR and Human Data Samples: Being ‘somewhat prepared’ is not enough

September 14, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing GDPR, biotech, data, drugs, pharma, pharmaceutical

Thomas Hirse, Partner, and Paetrick Sakowski, Associate, CMS, discuss what pharmaceutical companies need to be aware of ahead of the …

Feature
gsk_boronia_australia

FDA panel gives GSK’s Shingrix unanimous approval

September 14, 2017
Sales and Marketing GSK, Shingrix, biotech, drugs, pharma, pharmaceutical, shingles

The FDA’s advisory panel has given a strong signal that GSK’s Shingrix should not have too much difficulty getting full …

News

Novo’s Xultophy beats basal insulin in cutting cardiovascular risk

September 14, 2017
Research and Development Novo Nordisk, Xultophy, diabetes, pharma, pharmaceutical, type 2 diabetes

Novo Nordisk has unveiled new data on its diabetes treatment Xultophy (insulin degludec/liraglutide) which supports its efficacy in reducing risk …

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martin_shkreli_2016

‘Pharma bro’ Shkreli heads to jail

September 14, 2017
Medical Communications Martin Shkreli, Shkreli, biotech, drugs, pharma, pharmaceutical

Martin Shkreli’s habit of being unable to stay out of the headlines continues, although this time with the repercussion that …

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shutterstock_159488225

Amicus pulls plug on rare skin disease drug after Phase 3 failure

September 14, 2017
Research and Development Amicus, epidermolysis bullosa, pharma, pharmaceutical, trial failure

New Jersey-based biotech firm Amicus Therapeutics has been forced to terminate its development of its candidate for treating rare skin …

News
antibiotic_sensitvity_and_resistance

UK collaboration presents promising data in the fight against antibiotic resistance

September 13, 2017
Research and Development Auspherix, antibiotic resistance, domainex, pharma

The collaborative efforts of Domainex and Auspherix have made new progress in the development of a solution to the growing …

News
sanofi_regeneron

Sanofi/Regeneron new asthma data bolstered by potential indications

September 13, 2017
Research and Development Dupixent, Regeneron, Sanofi, biotech, drugs, pharma, pharmaceutical

Sanofi and Regeneron’s Dupixent is predicted to grow to be one of the largest selling drugs in the industry but …

News

Novartis’ Cosentyx proves long-term efficacy in psoriasis skin clearance

September 13, 2017
Research and Development Cosentyx, Novartis, pharma, pharmaceutical, psoriasis

At the European Academy of Dermatology and Venereology Congress in Geneva, Switzerland, Novartis unveiled new Phase 3 data for Cosentyx …

News
23andme

23andMe raises $250m in financing, research points towards its future

September 13, 2017
Research and Development, Sales and Marketing 23andME, biotech, drugs, pharma, pharmaceutical

23andMe made two announcements on the same day that point towards the future of its business: it revealed it had …

News

Recipharm and CTC launch integrated first in human service

September 13, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Recipharm, biotech, drugs, pharma, pharmaceutical

Contract development and manufacturing organisation (CDMO) Recipharm and contract research organisation (CRO) Clinical Trial Consultants (CTC) have partnered to launch …

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Press release
virus-1812092_960_720

Newly adopted flu vaccine could save 1,700 lives

September 12, 2017
Research and Development, Sales and Marketing biotech, drugs, flu, fluad, pharma, pharmaceutical, seqirus

The Fluad flu vaccine, produced by Seqirus, was approved by the MHRA for use beginning in 2018 and further data …

News
The Gateway to Local Adoption Series

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