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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 08 Jul 2020
Lynparza approved in the EU for BRCA mutated metastatic pancreatic cancer
8 July 2020 - Only PARP inhibitor approved in this disease. ...
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 07 Jul 2020
Novartis receives EC approval for Enerzair Breezhaler, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU
7 July 2020 - Optional digital companion with sensor and app that provide inhalation confirmation, medication reminders and access to objective ...
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
Launch of public consultation on joint network strategy to 2025
6 July 2020 - EMA and the Heads of Medicines Agencies have developed a joint strategy for the next five ...
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
EMA validates and grants accelerated assessment for trastuzumab deruxtecan for the treatment of HER2 positive metastatic breast cancer
6 July 2020 - Daiichi Sankyo today announced that the EMA has validated the marketing authorisation application for trastuzumab deruxtecan, ...
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 ...