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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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Alexion’s Soliris scoops up expanded EU approval in neuromyelitis optica spectrum disorder

August 28, 2019
Research and Development, Sales and Marketing Alexion, FDA, US, pharma, soliris

Alexion has announced the expanded EU approval of Soliris (eculizumab) as a treatment for neuromyelitis optica spectrum disorder (NMOSD) in …

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FDA greenlights Nebriva’s Xenleta for community-acquired bacterial pneumonia

August 20, 2019
Manufacturing and Production, Sales and Marketing FDA, Nabriva, US, Xenleta, pharma, pneumonia

The FDA has awarded approval in the US to Nebriva Therapeutics’ Xenleta (lefamulin) for the treatment of adult patients with …

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British and American healthcare professionals predict further delays to Brexit as Europeans expect no-deal

August 19, 2019
Sales and Marketing EU, UK, US, brexit, brexit delay, healthcare, no-deal, pharma

The majority of healthcare professionals in Europe, Britain and America think Brexit will happen. However they do not believe that …

FDA approve new drug for treatment-resistant TB

August 15, 2019
Research and Development FDA, TB, US, pharma, pretomanid, tuberculosis

The US FDA has approved BPaL, the TB Alliance’s treatment for drug-resistant tuberculosis (TB). The US regulator gave the go-ahead …

Brammer Bio to set up new plant in Norton, Massachusetts

August 12, 2019
Sales and Marketing Brammer Bio, Massachusetts, US, norton, pharma

Cambridge, Massachusetts-based Brammer Bio is planning to set up a new manufacturing facility in Norton, Massachusetts. The Thermo Fisher subsidiary …

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Daiichi Sankyo’s Turalio becomes first FDA-approved therapy for rare tumour

August 5, 2019
Sales and Marketing Cancer, Daiichi Sankyo, FDA, Turalio, US, pharma, rare cancer

Daiichi Sankyo has seen its CSF1R inhibitor Turalio (pexidartinib) approved by the FDA in the treatment of symptomatic tenosynovial giant …

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US presidential candidate Bernie Sanders pledges to allow Americans to import drugs from Canada

August 2, 2019
Medical Communications Bernie Sanders, Canada, Trump, US, democrats, prescription drugs

Democratic presidential candidate Bernie Sanders has said he will, on his first day in office, allow for the importation of …

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MSD to bring over 400 new jobs to North Carolina with two site expansions

July 31, 2019
Manufacturing and Production, Research and Development MSD, US, pharma

MSD has announced a $650 million expansion of its existing facilities in North Carolina – a move which is bring …

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Top Ten most popular articles on Pharmafile.com this week

July 26, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Biohaven, FDA, Lyrica, NICE, Pfizer, UK, US, pharma, top ten

At the end of a week that could certainly be called “eventful” here in the UK – one that saw …

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Lilly’s Baqsimi nasal powder gains FDA approval after proving non-inferior to injection

July 25, 2019
Sales and Marketing Baqsimi, Eli Lilly, FDA, US, diabetes, pharma

Eli Lilly has been awarded approval from the FDA for its Baqsimi nasal powder in the treatment of severe hypoglycaemia, …

Ohio prosecutors file charges against opioid distributor Miami-Luken

July 22, 2019
Sales and Marketing US, USA, West Virginia, criminal case, opioid crisis, opioids

Federal prosecutors in Cincinnati have filed criminal charges against opioid distributor Miami-Luken, and four others, over the role they played …

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FDA approves MSD’s combo therapy Recarbrio for urinary tract and intra-abdominal infections

July 18, 2019
Sales and Marketing FDA, MSD, Recarbrio, US, pharma, urinary tract

MSD has announced the approval from the FDA of its combination therapy Recarbrio (imipenem, cilastatin and relebactam) in the treatment …

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AstraZeneca’s Farxiga fails to get FDA approval for patients with Type 1 diabetes

July 15, 2019
Sales and Marketing AstraZeneca, EMA, FDA, US, diabetes, farxiga

The FDA had said it will not approve AstraZeneca’s diabetes drug Farxiga for use as a supplement to insulin in …

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Novartis aims to solve EpiPen shortage with generic launch of Symjepi to US pharmacies

July 10, 2019
Manufacturing and Production, Research and Development, Sales and Marketing Mylan, Novartis, Sandoz, US, epipen, pharma

Novartis has announced the immediate availability of its generic epinephrine auto-injector in pharmacies throughout the US, as it moves to …

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