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RSS FeedPosted by Michael Wonder on 03 Feb 2021
Chinook receives rare paediatric disease designation from U.S. FDA for CHK-336 for treatment of primary hyperoxaluria
2 February 2021 - CHK-336 on track for Phase 1 clinical trial initiation in the second half of 2021. ...
Posted by Michael Wonder on 03 Feb 2021
Cerecor announces fast track designation for CERC-803 for the treatment of leukocyte adhesion deficiency type II
2 February 2021 - Cerecor today announced that the U.S. FDA has granted fast track designation to CERC-803 for the treatment ...
Posted by Michael Wonder on 02 Feb 2021
If 2021 is to be the year of U.S. drug price controls, how should biopharma companies respond?
2 February 2021 - As the Biden administration assumes leadership in Washington and former President Donald Trump’s most favoured nation ...
Posted by Michael Wonder on 02 Feb 2021
Biden freeze hits two Trump drug price rules
1 February 2021 - A freeze by the new Biden administration on Trump era regulations will hit at least two rules ...
Posted by Michael Wonder on 02 Feb 2021
Cystic fibrosis sufferer Bella Powell hits out at drug company for stalling PHARMAC funding
2 February 2021 - A cystic fibrosis patient is calling out American drug company Vertex, for not achieving PHARMAC funding. ...
Posted by Michael Wonder on 02 Feb 2021
Novo Nordisk receives positive opinion from the European regulatory authorities for once-weekly Sogroya (somapacitan) for the treatment of adult growth hormone deficiency
29 January 2021 - Novo Nordisk announced today that the CHMP, under the EMA, adopted a positive opinion for the use ...
Posted by Michael Wonder on 02 Feb 2021
Bayer receives approval in the UK for Xarelto (rivaroxaban) to treat children with venous thromboembolism and to prevent recurrence
1 February 2021 - Paediatric use of rivaroxaban is based on data from the phase III paediatric thromboembolism programme, EINSTEIN-Junior. ...
Posted by Michael Wonder on 02 Feb 2021
Precision medicine helping to change the prognosis of a rare subtype of bowel cancer
2 February 2021 - Australians with a specific type of bowel cancer are no longer subject to a ‘one-size fits ...
Posted by Michael Wonder on 02 Feb 2021
Mirum Pharmaceuticals announces completion of rolling NDA submission for maralixibat in Alagille syndrome
1 February 2021 - Maralixibat U.S. launch expected in second half of 2021, if approved. ...
Posted by Michael Wonder on 02 Feb 2021
Bristol Myers Squibb application for Zeposia (ozanimod) for the treatment of ulcerative colitis accepted for filing with priority review by U.S. FDA
1 February 2021 - U.S. Food and Drug Administration assigned an action date of 30 May 2021. ...
Posted by Michael Wonder on 02 Feb 2021
Celltrion Healthcare receives Health Canada marketing authorization for world's first subcutaneous formulation of infliximab, Remsima SC, for the treatment of people with rheumatoid arthritis
1 February 2021 - This novel formulation provides an alternative administration option for Canadian physicians and their patients. ...
Posted by Michael Wonder on 01 Feb 2021
Vyne Therapeutics announces FDA approval of Amzeeq (minocycline) label ppdate
1 February 2021 - Vyne Therapeutics today announced approval by the U.S. FDA to include new information in the product ...
Posted by Michael Wonder on 01 Feb 2021
Merck receives positive EU CHMP opinion for expanded approval of Keytruda (pembrolizumab) in certain patients with relapsed or refractory classical Hodgkin lymphoma
1 February 2021 - Opinion granted based on significant progression-free survival benefit demonstrated with Keytruda monotherapy compared to brentuximab vedotin in ...
Posted by Michael Wonder on 01 Feb 2021
Patient advocate slams cancer agency report over 'wall of silence' on PHARMAC funding
2 February 2021 - The Cancer Control Agency has released its first report into cancer in New Zealand, but one patient ...
Posted by Michael Wonder on 01 Feb 2021
Adamas announces FDA approval for second indication for Gocovri as an adjunctive treatment to levodopa/carbidopa in Parkinson’s disease patients experiencing OFF episodes
1 February 2021 - Gocovri is now the first and only medication approved to treat OFF and dyskinesia motor complications. ...