Aug 7, 2020 | News, Regulatory
Pfizer announced today (8/7) that it has signed a multiyear agreement for Gilead’s remdesivir, a treatment for COVID-19. With Gilead aiming to produce enough remdesivir to treat more than 2 million patients by the end of the year, and agreeing to send... 
Aug 6, 2020 | News, Regulatory
The FDA issued yesterday (8/5) Emergency Use Authorization for Vela Diagnostics for the manual version of their COVID-19 PCR test. The manual version of the test enables flexible sample processing, facilitating widespread use of the test throughout the United States.... 
Jul 31, 2020 | News, Regulatory
The FDA approved today of (7/31) RedHill Biopharma’s, a specialty pharmaceutical company headquartered in Israel, investigational new drug (IND) application for phase 3 of RHB-204 in adults with pulmonary nontuberculous myobacteria (NTM) disease.... 
Jul 29, 2020 | News, Regulatory
The US House of Representatives approved of a $3.2 billion budget for the FDA for the 2021 fiscal year, a $40.8 million increase from the 2020 fiscal year. The additional funding is meant to support new initiatives for greater collaboration across departments within... 
Jul 23, 2020 | Health, Interpretation, Medical Translation
Japan has one of the world’s largest and most successful medical markets, with leading pharmaceutical companies including Eisai, Takeda, and Daiichi Sankyo, and medical device manufacturers like Terumo, NIPRO, and Hitachi Medico. As a founding member of the... 
Jul 22, 2020 | News, Regulatory
The US government will pay American pharmaceutical leader Pfizer and German biotech BioNTech $1.95 billion USD to buy enough COVID-19 vaccines for approximately 50 million people. Pfizer and BioNTech will not receive payment until their... 
Jul 17, 2020 | News, Regulatory
The European Commission (EC) has granted approval for Novartis’ Enzair Breezhaler, a drug therapy for uncontrolled asthma. The drug is utilized as a maintenance treatment for adults with asthma. “Novartis is working to reimagine medicine for people with uncontrolled...
