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RSS FeedPosted by Michael Wonder on 12 May 2020
COVID-19 update: FDA takes new actions to accelerate development of novel prevention, treatment options for COVID-19
11 May 2020 - Today, the U.S. FDA took important actions to help accelerate the development of prevention and treatment options ...
Posted by Michael Wonder on 12 May 2020
FDA's drug approval system is more open than Australia's
11 May 2020 - Australia’s secretive drug approval system gives what some believe is an unfair advantage to rival drug companies. ...
Posted by Michael Wonder on 11 May 2020
CRISPR Therapeutics and Vertex Pharmaceuticals announce FDA regenerative medicine advanced therapy designation granted to CTX001 for the treatment of severe hemoglobinopathies
11 May 2020 - CTX001 has received orphan drug designation from the U.S. FDA for transfusion-dependent beta thalassemia and from the ...
Posted by Michael Wonder on 11 May 2020
EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation
11 May 2020 - EMA’s human medicines committee (CHMP) has recommended expanding the compassionate use of the investigational medicine remdesivir ...
Posted by Michael Wonder on 11 May 2020
Enhertu granted breakthrough therapy designation in the U.S. for HER2 positive metastatic gastric cancer
11 May 2020 - Designation based on data from pivotal phase 2 DESTINY-Gastric01 trial. ...
Posted by Michael Wonder on 10 May 2020
COVID-19 raises questions about the value of personalised medicine
8 May 2020 - A group of medical dissenters argues that tailoring treatment to the genetic profiles of individuals, a longstanding ...
Posted by Michael Wonder on 10 May 2020
CytoDyn clarifies status of biologics license application
8 May 2020 - CytoDyn today further clarified the status of the Company’s submission of its biologics license application to the ...
Posted by Michael Wonder on 09 May 2020
European Commission approves subcutaneous formulation of Entyvio (vedolizumab) for use as maintenance therapy in adults with moderately to severely active ulcerative colitis or Crohn’s disease
8 May 2020 - Approval makes Entyvio the only maintenance therapy approved across Europe with both intravenous and subcutaneous formulation options ...
Posted by Michael Wonder on 09 May 2020
Lynparza (olaparib) approved by FDA as first-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer
8 May 2020 - Improved the median time to disease progression (37.2 months) vs. bevacizumab alone (17.7 months) following response ...
Posted by Michael Wonder on 08 May 2020
FDA grants fast track designation for omecamtiv mecarbil in heart failure
8 May 2020 - Fast track designation highlights the urgent need for new heart failure treatment options. ...
Posted by Michael Wonder on 08 May 2020
FDA approves first therapy for patients with lung and thyroid cancers with a certain genetic mutation or fusion
8 May 2020 - Today, the U.S. FDA approved Retevmo (selpercatinib) capsules to treat three types of tumours – non-small cell ...
Posted by Michael Wonder on 08 May 2020
EU actions to support availability of medicines during COVID-19 pandemic – update #5
8 May 2020 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual ...
Posted by Michael Wonder on 08 May 2020
Health care leaders question how remdesivir is being distributed
8 May 2020 - Hospitals and doctors seek more transparency on what criteria the Trump administration is using to ship the ...
Posted by Michael Wonder on 08 May 2020
Influenza vaccines released for 2020 season
8 May 2020 - Six influenza vaccines are available in Australia in 2020. All of these vaccines are quadrivalent, which ...
Posted by Michael Wonder on 08 May 2020
The pandemic is a chance to revamp India’s pharmaceutical industry
9 May 2020 - Companies could switch from primarily making generics to producing higher-margin licensed drugs. ...