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FDA greenlights Genentech’s Xofluza for acute, uncomplicated influenza

October 18, 2019
Medical Communications FDA, Genetech, Roche, US, Xofluza, flu, pharma

Roche subsidiary Genentech has announced that its polymerase acidic endonuclease inhibitor Xofluza (baloxavir marboxil) has been awarded FDA approval in …

FDA approves first and only transdermal patch for schizophrenia

October 16, 2019
Research and Development, Sales and Marketing FDA, Noven Pharma, Secuado, US, pharma, schizophrenia

Hisamitsu Pharmaceutical subsidiary Noven Pharmaceuticals has revealed the FDA approval of Secuado (asenapine) in adult schizophrenia patients, making it the …

Lilly’s Reyvow becomes first FDA-approved 5-HT1F receptor agonist for acute migraine

October 15, 2019
Manufacturing and Production, Sales and Marketing Eli Lilly, FDA, Reyvow, US, migraine, pharma

Eli Lilly has announced that the FDA has given the green light to Reyvow (lasmiditan) in the acute treatment of …

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FDA approves Janssen’s Xarelto for blood clot prevention

October 15, 2019
Manufacturing and Production, Sales and Marketing FDA, Janssen, US, Xarelto, pharma, thromboembolism

Janssen’s Xarelto (rivaroxaban) has secured FDA approval for the prevention of venous thromboembolism (VTE), or blood clots, in hospitalised acutely …

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Biotechnology Innovation Organization Chief to step down after US 2020 elections

October 11, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Biotechnology Innovation Organization, US, biotech, pharma

The Biotechnology Innovation Organization (BIO), the largest trade body representing the world’s biotechnology industry, has revealed that its President and …

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Boehringer’s Ofev scores first-of-its-kind FDA approval in rare lung disease

September 10, 2019
Manufacturing and Production, Sales and Marketing Boehringer Ingelheim, FDA, US, lungs, ofev, pharma, rare disease

Boehringer Ingelheim’s Ofev (nintedanib) capsules have now secured marketing authorisation in the US, it has emerged, for the treatment of …

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Trump’s FDA: Is the US regulator being steered by the President?

September 9, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Trump, US, drug safety, pharma

FDA activity has fallen under Donald Trump, with the number of warning letters issued by the regulator dropping by a …

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View of pharma industry sinks to new low in US, poll reveals

September 6, 2019
Medical Communications US, pharma

The public have always been reticent with their trust in the pharmaceutical industry, but that trust has hit an all-time …

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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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