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RSS FeedPosted by Michael Wonder on 08 Jul 2020
Concert Pharmaceuticals receives FDA breakthrough therapy designation for CTP-543 for the treatment of alopecia areata
8 July 2020 - Designation based on Phase 2 data demonstrating significant hair regrowth in patients with alopecia areata. ...
Posted by Michael Wonder on 08 Jul 2020
Biogen completes submission of biologics license application to FDA for aducanumab as a treatment for Alzheimer’s disease
8 July 2020 - If approved, aducanumab would be the first treatment with the potential to meaningfully change the course of ...
Posted by Michael Wonder on 08 Jul 2020
Merck and Eisai receive complete response letter for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) combination as first-line treatment for unresectable hepatocellular carcinoma
8 July 2020 - Merck and Eisai today announced that the U.S. FDA has issued a complete response letter regarding Merck’s ...
Posted by Michael Wonder on 07 Jul 2020
U.S. commits $2 billion for COVID-19 vaccine, drug supplies
7 July 2020 - Novavax, Regeneron are awarded government funding. ...
Posted by Michael Wonder on 07 Jul 2020
Senhwa Biosciences's silmitasertib receives rare paediatric disease designation from U.S. FDA for treatment of recurrent sonic hedgehog medulloblastoma
7 July 2020 - Senhwa Biosciences today announced that the U.S. FDA granted rare paediatric disease designation for its drug silmitasertib, ...
Posted by Michael Wonder on 07 Jul 2020
FDA approves oral combination of decitabine and cedazuridine for myelodysplastic syndromes
7 July 2020 - Today, the Food and Drug Administration approved an oral combination of decitabine and cedazuridine (Inqovi, Astex ...
Posted by Michael Wonder on 06 Jul 2020
The development of COVID-19 vaccines: safeguards needed
6 July 2020 - A safe and effective vaccine against coronavirus disease 2019 (COVID-19) is the best way to control and ...
Posted by Michael Wonder on 06 Jul 2020
Developing a SARS-CoV-2 vaccine at warp speed
6 July 2020 - The coronavirus disease 2019 (COVID-19) pandemic has unleashed major and substantial changes in the provision of health ...
Posted by Michael Wonder on 06 Jul 2020
Pharma industry seizes on pandemic as a shot at redemption
6 July 2020 - It is almost five years since Hillary Clinton sent her $15 billion tweet. ...
Posted by Michael Wonder on 06 Jul 2020
EspeRare receives FDA breakthrough therapy designation for investigational prenatal treatment ER-004 in X-linked hypohidrotic ectodermal dysplasia
6 July 2020 - EspeRare today announced that the U.S. FDA has granted breakthrough therapy designation to investigational ER-004 protein ...
Posted by Michael Wonder on 06 Jul 2020
Will we be hostages to drug makers’ Covid vaccine pricing?
6 July 2020 - The United States is the only developed nation unable to balance cost, efficacy and social good in ...
Posted by Michael Wonder on 05 Jul 2020
FDA Commissioner says he can't predict when vaccine will be ready after Trump's timeline claims
5 July 2020 - Food and Drug Administration Commissioner Stephen Hahn said Sunday that he would not make a prediction ...
Posted by Michael Wonder on 03 Jul 2020
FDA approves new HIV treatment for patients with limited treatment options
2 Jul 2020 - Today, the U.S. FDA approved Rukobia (fostemsavir), a new type of anti-retroviral medication for adults living with ...
Posted by Michael Wonder on 03 Jul 2020
MetVital announces FDA fast track designation of anhydrous enol-oxaloacetate for the treatment of patients with newly diagnosed glioblastoma multiforme
1 July 2020 - MetVital today announces that the U.S. FDA has notified MetVital that its lead drug candidate, "Anhydrous ...
Posted by Michael Wonder on 02 Jul 2020
Regression discontinuity design
2 July 2020 - The method is used to study the outcomes related to an abrupt change when it is not ...