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RSS FeedPosted by Michael Wonder on 30 Nov 2020
Pharmacies add freezers, train staff to handle COVID-19 vaccination drive
29 November 2020 - Many supermarkets have offered customers flu shots for years, but COVID-19 vaccine distribution will require more coordination ...
Posted by Michael Wonder on 30 Nov 2020
Deploying big data to determine how well vaccines work
29 November 2020 - As the initial rollout starts, it’s time to start planning a registry to monitor health outcomes. ...
Posted by Michael Wonder on 30 Nov 2020
FDA approves device for treatment of osteoid osteoma in the extremities
27 November 2020 - The FDA approved the Sonalleve MR-HIFU system (Profound Medical) for the treatment of osteoid osteoma in ...
Posted by Michael Wonder on 29 Nov 2020
America will be the first country to roll out a COVID-19 vaccine
28 November 2020 - Here is how the federal government and states plan to do it. ...
Posted by Michael Wonder on 28 Nov 2020
Alnylam announces innovative value-based agreement framework for Oxlumo (lumasiran) to accelerate access for patients with primary hyperoxaluria type 1 and deliver ultra-rare orphan disease pricing solutions to U.S. payers
24 November 2020 - Expedited access to Oxlumo aims to support children and adults living with PH1 who face inevitable disease ...
Posted by Michael Wonder on 28 Nov 2020
Vertex announces European Commission approval for Symkevi (tezacaftor/ivacaftor) with Kalydeco (ivacaftor) for eligible children with cystic fibrosis ages 6-11 years
27 November 2020 - The combination therapy is a new treatment option for CF patients who are homozygous for F508del. ...
Posted by Michael Wonder on 28 Nov 2020
Polaryx Therapeutics receives both rare paediatric disease and orphan drug designations for the treatment of GM2 gangliosidosis with PLX-300
25 November 2020 - Polaryx Therapeutics announced today that it has received from the U.S. FDA both rare paediatric disease and ...
Posted by Michael Wonder on 28 Nov 2020
FDA approves first treatment for weight management for people with certain rare genetic conditions
27 November 2020 - The U.S. FDA has approved Imcivree (setmelanotide) for chronic weight management (weight loss and weight maintenance for ...
Posted by Michael Wonder on 28 Nov 2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases announce extension of PDUFA date for pegunigalsidase alfa for the proposed treatment of Fabry disease
27 November 2020 - Protalix BioTherapeutics today announced that the U.S. FDA has extended the Prescription Drug User Fee Act (PDUFA) ...
Posted by Michael Wonder on 27 Nov 2020
Global regulators urge continuation of COVID-19 vaccine trials for longer-term safety and efficacy follow-up
27 November 2020 - EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities that urges all stakeholders, ...
Posted by Michael Wonder on 26 Nov 2020
TGA announces approval of new medicine from ASX listed company
26 November 2020 - Afamelanotide acetate (Scenesse) was approved on 22 October 2020. ...
Posted by Michael Wonder on 26 Nov 2020
After admitting mistake, AstraZeneca faces difficult questions about its vaccine
25 November 2020 - Some trial participants only got a partial dose of AstraZeneca’s vaccine. Experts said the company’s spotty disclosures ...
Posted by Michael Wonder on 26 Nov 2020
European Medicines Agency validates application for tepotinib for the treatment of advanced NSCLC with METex14 skipping alterations
26 November 2020 - Merck today announced that the EMA has validated for review, the application for tepotinib for the ...
Posted by Michael Wonder on 26 Nov 2020
Moderna signs deal with EU for 160 million COVID-19 vaccine doses
26 November 2020 - The European Commission has signed a supply deal with Moderna which will see it secure an ...
Posted by Michael Wonder on 26 Nov 2020
FDA defers approval of daxibotulinumtoxinA for injection in glabellar lines due to COVID-19 related travel restrictions impacting manufacturing site inspection
25 November 2020 - Revance Therapeutics today announced that the United States FDA has deferred a decision on the biologics license ...