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RSS FeedPosted by Michael Wonder on 21 May 2020
Mithra and Searchlight Pharma announce filing of new drug submission for Estelle in Canada
20 May 2020 - Searchlight Pharma's new drug submission for a novel combined oral contraceptive accepted for review by Health Canada. ...
Posted by Michael Wonder on 21 May 2020
AstraZeneca secures orders for virus vaccine under testing
21 May 2020 - Drug maker AstraZeneca has secured the first agreements Thursday for 400 million doses of a COVID-19 vaccine ...
Posted by Michael Wonder on 21 May 2020
Health Canada grants market authorisation to Rozlytrek (entrectinib) for ROS1-positive, locally advanced or metastatic non-small cell lung cancer patients, not previously treated with crizotinib
20 May 2020 - Data show responses in 73% of patients who were treated with Rozlytrek. ...
Posted by Michael Wonder on 20 May 2020
A new entry in the race for a coronavirus vaccine: hope
20 May 2020 - Scientists are increasingly optimistic that a vaccine can be produced in record time. But getting it manufactured ...
Posted by Michael Wonder on 20 May 2020
Evoke receives FDA conditional acceptance of Gimoti brand name following NDA resubmission
20 May 2020 - Evoke Pharma today announced that the U.S. FDA has conditionally accepted the proprietary brand name, “Gimoti,” for ...
Posted by Michael Wonder on 20 May 2020
Karyopharm submits supplemental new drug application to FDA for Xpovio (selinexor) as a treatment for patients with multiple myeloma after at least one prior line of therapy
20 May 2020 - Karyopharm Therapeutics today announced it has submitted a supplemental new drug application to the U.S. FDA seeking ...
Posted by Michael Wonder on 20 May 2020
Global regulators commit to cooperate on observational research in the context of COVID-19
20 May 2020 - Regulators from around the world have agreed three priority areas for cooperation on observational research during ...
Posted by Michael Wonder on 20 May 2020
Lynparza approved in the US for HRR gene-mutated metastatic castration-resistant prostate cancer
20 May 2020 - Only PARP inhibitor to improve overall survival versus enzalutamide or abiraterone in a biomarker-based subset of prostate ...
Posted by Michael Wonder on 20 May 2020
Europe falls behind U.S. in funding coronavirus vaccine and securing access
19 May 2020 - U.S. was faster in shouldering drug companies’ costs to develop and manufacture vaccine candidates, putting the bloc ...
Posted by Michael Wonder on 19 May 2020
Nine ways COVID-19 may forever upend the U.S. health care industry
19 May 2020 - In the U.S. alone, COVID-19 has claimed nearly 100,000 lives and 30 million jobs. ...
Posted by Michael Wonder on 19 May 2020
CEO tapped by Trump to make generic drugs during pandemic has a dicey track record
19 May 2020 - As the chief executive of Phlow, the new company awarded $354 million by the federal government ...
Posted by Michael Wonder on 19 May 2020
Eiger BioPharmaceuticals announces FDA acceptance of NDA for filing with priority review of Zokinvy (lonafarnib) for treatment of progeria and progeroid laminopathies
19 May 2020 - Eiger BioPharmaceuticals today announced that the U.S. FDA accepted the new drug application for accelerated review of ...
Posted by Michael Wonder on 19 May 2020
Teva Canada secures salbutamol inhalers from its global supply chain to mitigate shortage in Canadian market
19 May 2020 - Teva Canada to be first company to import emergency supply of salbutamol inhalers - providing access to ...
Posted by Michael Wonder on 19 May 2020
Gilead ups its donation of the COVID-19 drug remdesivir for U.S. hospitals
18 May 2020 - Gilead Sciences, the drug company behind the experimental COVID-19 therapy remdesivir, has upped the number of ...
Posted by Michael Wonder on 19 May 2020
(COVID-19) update: FDA collaborations promote rigorous analyses of real world data to inform pandemic response
19 May 2020 - Today, the FDA is announcing another step in our effort to harness diverse streams of data to ...