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FDA defies advisory panel recommendation, rejecting Mesoblast’s Ryoncil in paediatric steroid-refractory acute graft versus host disease

October 5, 2020 Sales and Marketing FDA, Mesoblast, Ryoncil

The FDA has issued a surprising rejection of Mesoblast’s Ryoncil (remestemcel-L) as a treatment for paediatric steroid-refractory acute graft versus …
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Remdesivir has a “favourable” benefit/risk profile in COVID-19 but more data needed, DSRU review argues

October 5, 2020 Research and Development, Sales and Marketing COVID-19, Drug Safety Research Unit, pharma, remdesivir

Southampton’s Drug Safety Research Unit (DSRU) has released a systematic benefit/risk analysis of Gilead’s antiviral drug remdesivir in the treatment …
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Covis Group to acquire AMAG Pharmaceuticals in $647m deal

October 5, 2020 Sales and Marketing AMAG Pharmaceuticals, Covis group, acquisition, pharma

Luxembourg-based Covis Group is set to acquire Massachusetts-based AMAG Pharmaceuticals in a new deal worth approximately $647 million on an …
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Across Health to hold first iD.cast webcast ‘Digital Acceleration in Biopharma’ on 15 October

October 2, 2020 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Webinar, event

Across Health is hosting its first iD.cast webcast, titled Digital Acceleration in Biopharma on 15 October. This ninety-minute webinar online …
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NICE gives go-ahead for Sandoz’s Rizmoic to treat opioid-induced constipation

September 30, 2020 Research and Development, Sales and Marketing NHS, NICE, Rizmoic, Sandoz, UK

The National Institute for Health and Care Excellence (NICE) has recommended Sandoz’s Rizmoic (naldemedine) for the treatment of opioid-induced constipation …
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Company veteran Belén Garijo named as Merck KGaA’s first-ever female CEO

September 30, 2020 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Merck KGaA

German pharma firm Merck KGaA has taken the decision to appoint its first female Chief Executive Officer in its 352-year …
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Pharmafile.com’s weekly COVID-19 news round-up

September 30, 2020 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing pharma, top ten

The coronavirus news this week focuses on the development of treatments to alleviate symptoms of the virus, as Australian biotech …
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The October 2020 issue of Pharmafocus is available to read free online now!

September 29, 2020 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing 2020, October 2020, Pharmafocus, digital edition, pharma

The latest monthly edition of Pharmafocus is available to read for free online now! As the US sails past the …
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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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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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