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RSS FeedPosted by Michael Wonder on 27 Jan 2022
COVID-19: EMA recommends conditional marketing authorisation for Paxlovid
27 January 2022 - The EMA’s CHMP has recommended granting a conditional marketing authorisation for the oral antiviral medicine Paxlovid ...
Posted by Michael Wonder on 19 Jan 2022
FDA grants breakthrough device designation to Diadem's AlzoSure predict prognostic blood test for the early prediction of Alzheimer's disease
18 January 2022 - First prognostic blood test that can predict likely progression to Alzheimer's disease up to six years in ...
Posted by Michael Wonder on 19 Jan 2022
NeuroMetrix receives FDA breakthrough device designation for treatment of chronic chemotherapy induced peripheral neuropathy with its wearable neurostimulation technology
18 January 2022 - NeuroMetrix today announced that its Quell technology has received breakthrough designation from the U.S. FDA for reducing ...
Posted by Michael Wonder on 18 Jan 2022
Discussion paper and online questionnaire for information session on a potential pan-Canadian formulary
18 January 2022 - On 18 January 2022, the advisory panel and CADTH will host an information session on the panel’s ...
Posted by Michael Wonder on 18 Jan 2022
Antares Pharma receives FDA fast track designation for ATRS-1902 for adrenal crisis rescue
18 January 2022 - Antares Pharma today announced that the U.S. FDA has granted fast track designation for ATRS-1902 for adrenal ...
Posted by Michael Wonder on 18 Jan 2022
TGA ‘knowingly putting pharmacists in serious danger’
18 January 2022 - The pharmacists’ union has accused the medical regulator of putting workers and customers at risk of ...
Posted by Michael Wonder on 18 Jan 2022
TGA in review (2021)
19 January 2022 - Using a liberal definition of what constitutes a 'new medicine', we have determined the TGA approved ...
Posted by Michael Wonder on 18 Jan 2022
Celularity receives fast track designation from U.S. FDA for its NK cell therapy CYNK-101 in development for the first-line treatment of advanced HER2/neu positive gastric and gastro-oesophageal junction cancers
18 January 2022 - CYNK-101 is an investigational genetically modified natural killer cell therapy designed to synergise with antibody therapeutics for ...
Posted by Michael Wonder on 18 Jan 2022
COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy
18 January 2022 - Vaccination remains a major pillar of the response to COVID-19, particularly as variants of the virus continue ...
Posted by Michael Wonder on 18 Jan 2022
bluebird provides update on FDA review timelines for betibeglogene autotemcel for beta thalasszemia and elivaldogene autotemcel for cerebral adrenoleukodystrophy
18 January 2022 - FDA PDUFA goal dates for both therapies extended by three months. ...
Posted by Michael Wonder on 18 Jan 2022
Gilead withdraws use of Zydelig to treat two types of cancer
14 January 2022 - Gilead Sciences on Friday notified the U.S. health regulator of its decision to voluntarily withdraw the ...
Posted by Michael Wonder on 18 Jan 2022
Canada approves Pfizer COVID drug
18 January 2022 - Canada’s health regulator has approved a pill by Pfizer that treats the effects of COVID-19. ...
Posted by Michael Wonder on 17 Jan 2022
Hyposensitisation with AR101 in peanut allergy: proof of lesser benefit
17 January 2022 - In the patient-relevant outcomes, there are only disadvantages for 4- to 17-year-olds compared to a pure peanut-avoiding ...
Posted by Michael Wonder on 17 Jan 2022
Swissmedic grants temporary authorisation to Xevudy for COVID-19 patients
14 January 2022 - Corona medication Xevudy from GSK (sotrovimab) granted temporary authorisation in Switzerland ...
Posted by Michael Wonder on 17 Jan 2022
Serb receives EU approval for Voraxaze (glucarpidase) as rescue therapy for high dose methotrexate toxicity
14 January 2022 - Serb and BTG Specialty Pharmaceuticals today announced that the European Commission has granted marketing authorisation for ...
Posted by Michael Wonder on 17 Jan 2022
Keytruda reimbursement boosts MSD’s R&D of follow-up drug
17 January 2022 - The government’s recognition of MSD’s Keytruda (pembrolizumab) for reimbursement as the first-line therapy for lung cancer ...