Blog
RSS FeedPosted by Michael Wonder on 22 Jul 2021
COVID-19 vaccine weekly safety report (22 July 2021)
22 July 2021 - Over the last week, four additional cases of blood clots with low blood platelets have been assessed ...
Posted by Michael Wonder on 21 Jul 2021
We’re seeing what happens when the FDA loses credibility
21 July 2021 - It’s not just politicians who are worried about the decision to approve a new Alzheimer’s drug. ...
Posted by Michael Wonder on 21 Jul 2021
Fit for purpose real world data assessments in oncology: a call for cross stakeholder collaboration
21 July 2021 - Real world evidence remains a promising frontier in evidence generation to support improved health related patient outcomes. ...
Posted by Michael Wonder on 21 Jul 2021
Recently approved Alzheimer drug raises questions that might never be answered
21 July 2021 - The FDA’s approval June 7 of the drug aducanumab was notable for a number of reasons. ...
Posted by Michael Wonder on 21 Jul 2021
Pfizer provides update on U.S. FDA review of abrocitinib and Xeljanz filings
21 July 2021 - Pfizer announced today that the U.S. FDA has notified the company that it will not meet the ...
Posted by Michael Wonder on 21 Jul 2021
How an unproven Alzheimer’s drug got approved
19 July 2021 - Though some of its own senior officials said there was little evidence of benefit for patients, the ...
Posted by Michael Wonder on 21 Jul 2021
Myovant Sciences announces European Commission approval for Ryeqo for the treatment of women with uterine fibroids
20 July 2021 - Ryeqo is the first and only once-daily long-term treatment for uterine fibroids in Europe. ...
Posted by Michael Wonder on 21 Jul 2021
EMA publishes agenda for 19-22 July CHMP meeting
19 July 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 21 Jul 2021
Venetoclax (Venclexta) granted US FDA breakthrough therapy designation in higher risk myelodysplastic syndrome
21 July 2021 - This is the sixth breakthrough therapy designation granted for venetoclax as AbbVie continues to show ongoing commitment ...
Posted by Michael Wonder on 21 Jul 2021
U.S. FDA expands indication for Prograf for prevention of organ rejection in adult and paediatric lung transplant recipients
21 July 2021 - Prograf becomes first immunosuppressive drug approved in the U.S. for people receiving a lung transplant. ...
Posted by Michael Wonder on 21 Jul 2021
New treatment authorised and available for Canadians with HER2 positive breast cancer
20 July 2021 - Phesgo, a fixed dose combination of pertuzumab and trastuzumab for subcutaneous injection combines two treatments into ...
Posted by Michael Wonder on 20 Jul 2021
Albireo announces FDA approval of Bylvay (odevixibat), the first drug treatment for patients with progressive familial intrahepatic cholestasis
20 July 2021 - Commercial launch of Bylvay immediate; available for prescription in the coming days. ...
Posted by Michael Wonder on 20 Jul 2021
NeuroMetrix receives FDA breakthrough device designation for treatment of fibromyalgia with its wearable neurostimulation technology
20 July 2021 - NeuroMetrix today announced that its Quell device has received breakthrough designation from the U.S. FDA for treating ...
Posted by Michael Wonder on 20 Jul 2021
FDA approves Octapharma’s Octagam 10% for adult dermatomyositis
20 July 2021 - FDA approval based on positive results of international, multi-center ProDERM study. ...
Posted by Michael Wonder on 20 Jul 2021
EMA starts rolling review of COVID-19 vaccine Vidprevtyn
20 July 2021 - EMA’s CHMP has started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur. ...