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RSS FeedPosted by Michael Wonder on 03 Feb 2021
Geistlich Pharma granted FDA breakthrough device designation for Chondro-Gide articular cartilage cover
2 February 2021 - Geistlich Pharma announced that the Chondro-Gide articular cartilage cover has been granted a breakthrough device designation from ...
Posted by Michael Wonder on 03 Feb 2021
Cost recovery implementation statement (2020-2021)
3 February 2021 - This Cost Recovery Implementation Statement provides information on how the Therapeutic Goods Administration, within the Department of ...
Posted 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
VBI Vaccines announces U.S. FDA acceptance of BLA filing for VBI’s 3 antigen prophylactic hepatitis B vaccine
2 February 2021 - FDA sets a target action date of 30 November 2021. ...
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
Janssen announces CAR-T therapy ciltacabtagene autoleucel (cilta-cel) accepted for accelerated assessment in Europe for the treatment of patients with heavily pretreated multiple myeloma
1 February 2021 - Janssen announced today that the CHMP of the EMA will perform an accelerated assessment of the ...
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
Investigation reveals no specific risk of COVID-19 vaccinations in elderly patients
2 January 2021 - On 14 January 2021 the TGA received reports of about 30 deaths in over 40,000 elderly ...
Posted by Michael Wonder on 02 Feb 2021
Chiesi Group receives the European Marketing authorization for the extrafine triple-combination therapy for the treatment of moderate to severe asthma
1 February 2021 - It is the first extrafine fixed triple combination therapy in a single inhaler to be approved for ...
Posted by Michael Wonder on 02 Feb 2021
COVID‑19 vaccines – are we there yet?
1 February 2021 - The novel coronavirus SARS-CoV-2, the cause of the COVID-19 pandemic, is a highly infectious human respiratory ...
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 ...