Highlights from the May 25-28 CHMP meeting

29 May 2020 - Eight new medicines recommended for approval. ...

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Protalix BioTherapeutics and Chiesi Global Rare Diseases announce submission of biologics license application to U.S. FDA for pegunigalsidase alfa for the treatment of Fabry disease

28 May 2020 - Protalix BioTherapeutics together with its development and commercialisation partner Chiesi Global Rare Diseases, today announced the submission ...

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Cardiff Oncology announces fast track designation granted by the FDA to onvansertib for second-line treatment of KRAS mutated colorectal cancer

28 May 2020 - Fast Track designation for onvansertib in KRAS mutated metastatic colorectal cancer underscores the urgent need for new ...

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Off-label drugs a risky business

28 May 2020 - Three years ago a 64cm blood clot caused by a drug used to treat acne, Diane ...

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Technegas – US FDA new drug application – next milestone in approval process successfully achieved

27 May 2020 - Cyclopharm is pleased to announce that the Company, through its wholly owned subsidiary Cyclomedica Australia, has been ...

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European medicines regulatory network fully mobilised in fight against COVID-19

28 May 2020 - The development and availability of medicines and vaccines for all patients in the European Union, including those ...

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Health Canada approves birth control arm implant Nexplanon

26 May 2020 - A popular birth control implant that has long been advocated for use in Canada has now ...

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Painkiller packs cut down to size as opioid crackdown intensifies

27 May 2020 - The drugs have become household names in Australia: oxycodone, codeine, morphine and tramadol. ...

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Tax payers paid to develop remdesivir but will have no say when Gilead sets the price

27 May 2020 - Critics say government deserves more credit for tens of millions in public money spent to develop coronavirus ...

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Australia avoids 'risky business' of coronavirus vaccine sweepstakes

27 May 2020 - Australia is avoiding huge financial risks by staying out of the global sweepstakes on coronavirus vaccines. ...

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FDA grants priority review of Nucala for patients with hypereosinophilic syndrome

27 May 2020 - An approval would give Nucala a third indication in an eosinophil driven disease. ...

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Trump tries to convince voters he’s lowered drug prices, based only on a modest tweak to Medicare

26 May 2020 - President Trump used a glitzy Rose Garden address, flanked by pharmaceutical company CEOs and patient advocates, ...

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COVID-19: UK authorises anti-viral drug remdesivir

26 May 2020 - A drug treatment called remdesivir that appears to shorten recovery time for people with coronavirus is ...

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Record flu vaccines in 2020 to protect Australians

27 May 2020 - An additional two million flu vaccines will available from this week bringing the total number available in ...

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Prospective dialogue between developers and regulators makes for better evidence generation

27 May 2020 - EMA, in collaboration with other parties, has recently published two scientific articles outlining the importance of ...

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Bristol Myers Squibb receives European Commission approval for Zeposia (ozanimod) for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease

27 May 2020 - Zeposia is the only approved sphingosine-1-phosphate receptor modulator for RRMS patients with active disease. ...

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