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RSS FeedPosted by Michael Wonder on 31 May 2020
Highlights from the May 25-28 CHMP meeting
29 May 2020 - Eight new medicines recommended for approval. ...
Posted by Michael Wonder on 28 May 2020
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 ...
Posted by Michael Wonder on 28 May 2020
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 ...
Posted by Michael Wonder on 28 May 2020
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 ...
Posted by Michael Wonder on 28 May 2020
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 ...
Posted by Michael Wonder on 28 May 2020
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 ...
Posted by Michael Wonder on 28 May 2020
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 ...
Posted by Michael Wonder on 28 May 2020
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. ...
Posted by Michael Wonder on 28 May 2020
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 ...
Posted by Michael Wonder on 28 May 2020
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. ...
Posted by Michael Wonder on 27 May 2020
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. ...
Posted by Michael Wonder on 27 May 2020
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, ...
Posted by Michael Wonder on 27 May 2020
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 ...
Posted by Michael Wonder on 27 May 2020
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 ...
Posted by Michael Wonder on 27 May 2020
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 ...
Posted by Michael Wonder on 27 May 2020
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. ...