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Canadian approval for Reblozyl for transfusion-dependent anaemia in beta-thalassemia patients

September 29, 2020
Manufacturing and Production, Sales and Marketing BMS, Canada, Reblozyl

Bristol Myers Squibb and Acceleron have managed to secure regulatory approval in Canada for Reblozyl (luspatercept) for the treatment of …

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Pfizer’s Xeljanz approved by the FDA for the treatment of children with arthritis

September 29, 2020
Manufacturing and Production

The FDA has approved Pfizer’s Xeljanz (tofacitinib) for the treatment of children and adolescents with active polyarticular course juvenile idiopathic …

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Trump announces 150 million Abbott COVID-19 tests will be deployed across the US

September 29, 2020
Manufacturing and Production

President Donald Trump announced on Monday that the government will distribute 150 million coronavirus tests from Abbott Laboratories across the …

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FDA pauses the planning stages of Inovio’s late-stage COVID-19 vaccine trials

September 29, 2020
Manufacturing and Production COVID-19 vaccine, FDA, coronavirus vaccines

The FDA has put Inovio’s planning stages for the final trials of its coronavirus vaccine on hold as the regulator …

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Jyseleca secures European approval in rheumatoid arthritis

September 28, 2020
Research and Development, Sales and Marketing Europe, Jyseleca, arthritis, pharma

The European Commission has awarded approval to Gilead and Galpagos for their oral JAK inhibitor Jyseleca (filgotinib) as a treatment …

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Novel prophylactic nasal spray reduced COVID-19 replication by 96% in animal studies

September 28, 2020
Research and Development, Sales and Marketing COVID-19, Ena Respiratory, Nasal Spray

Australian biotech Ena Respiratory has revealed new data demonstrating that its novel nasal spray almost halted replication of the SARS-CoV-2 …

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FDA approves GlaxoSmithKline’s Nucala to treat hypereosinophilic syndrome

September 28, 2020
Sales and Marketing

The FDA has announced its approval of GlaxoSmithKline’s Nucala (mepolizumab) as a treatment for hypereosinophilic syndrome (HES).  This is specifically …

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UK promises £500m to global vaccine sharing scheme

September 28, 2020
Sales and Marketing

UK Prime Minister Boris Johnson has announced in a speech to the UN General Assembly that the UK is set …

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FDA issues a warning against Benadryl TikTok challenge

September 28, 2020
Medical Communications, Sales and Marketing Benadryl, FDA, TikTok

The FDA has released a warning following cases of teens filming themselves overdosing on the antihistamine Benadryl and uploading the …

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Japan approves Gilead and Eisai’s Jyseleca for rheumatoid arthritis

September 25, 2020
Medical Communications, Sales and Marketing Eisai, Gilead, Japan, Jyseleca

Gilead and Eisai have secured approval for their oral JAK1 preferential inhibitor Jyseleca (filgotinib) from the Japanese Ministry of Health, …

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GSK confirms deal to supply 300 million COVID-19 vaccine doses to the EU

September 25, 2020
Manufacturing and Production, Medical Communications COVID-19, EU, GSK, Vaccine

GlaxoSmithKline has confirmed a new COVID-19 vaccine supply deal to deliver 300 million doses of its candidate to the European …

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Trump approves plan to make the import of Canadian drugs easier

September 25, 2020
Medical Communications

President Trump has outlined his “America First Health Plan” on Thursday, which will allow the easy importation of prescription drugs …

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British consumers have increasingly turned to community pharmacies during COVID-19

September 25, 2020
Medical Communications

British consumers have increasingly turned to community pharmacies during the coronavirus pandemic, according to a new study. Research conducted by …

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Top Ten most popular articles on Pharmafile.com this week

September 25, 2020
Medical Communications

The top 10 news stories this week focus on coronavirus vaccine trials, as around one in seven patients who have …

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Novartis’ Zolgensma hits regulatory hurdle after FDA asks to review another study

September 24, 2020
Research and Development FDA

The FDA has requested an additional study in older children being treated with Novartis’ Zolgensma in the review process for …

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COVID-19 track and trace app launched in England and Wales after months of delays

September 24, 2020
Medical Communications, Sales and Marketing UK, VOCID-19, app, test and trace

The UK Government’s track and trace app for COVID-19 has finally launched in England and Wales, after months of delays …

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FDA grants Emergency Use Authorization for first antibody point-of-care COVID-19 test

September 24, 2020
Research and Development

The FDA has issued an Emergency Use Authorization (EUA) for the first antibody (serology) point-of-care test for coronavirus.  This is …

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‘Smart drugs’ may contain unapproved pharmaceuticals, according to a new study

September 24, 2020
Sales and Marketing FDA, regulation, smart drugs

Some supplements billed as ‘smart drugs’ may contain unapproved drugs in potentially dangerous combinations and doses, according to a new …

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Gilead agrees to pay $97 million to settle Medicare kickbacks case

September 24, 2020
Business Services Gilead, Medicare, drugs, kickbacks

Gilead has agreed to pay $97 million to resolve claims from the US Government that it used an independent charity …

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Science community calls for transparency on AstraZeneca’s halted US COVID-19 vaccine trial

September 23, 2020
Research and Development AstraZeneca, COVID-19, Vaccine

The halting of AstraZeneca’s COVID-19 vaccine trial around the world was cause for much initial concern over the eventual safety …

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