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RSS FeedPosted by Michael Wonder on 30 Nov 2020
Zymeworks receives FDA breakthrough therapy designation for HER2-targeted bispecific antibody zanidatamab in patients with biliary tract cancer
30 November 2020 - Zymeworks today announced that the U.S. FDA has granted breakthrough therapy designation for zanidatamab in patients with ...
Posted by Michael Wonder on 30 Nov 2020
Moderna submits vaccine for FDA regulatory approval
30 November 2020 - Recent vaccine developments have been met with optimism among scientists and stock markets, but experts also urge ...
Posted by Michael Wonder on 30 Nov 2020
Dupixent (dupilumab) approved by European Commission as first and only biologic medicine for children aged 6 to 11 years with severe atopic dermatitis
30 November 2020 - Pivotal trial showed more than four times as many children achieved itch reduction and more than three ...
Posted 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 ...