Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomark, Cassiopea, Galecto, Glaxosmithkline, Laurent, Rocket, Sirtex, Taysha Gene Therapies.
A number of controversies have swirled around the U.S. FDA’s handling of the COVID-19 pandemic, including the question of the emergency use authorization (EUA) program for testing. The FDA’s Tim Stenzel said on an Aug. 26 testing town hall that he would not answer questions about the rescission order for FDA regulation of lab-developed tests (LDTs), but also said, “we are simply overwhelmed” with EUA filings for testing.
HONG KONG – Telangana, India-based Dr. Reddy’s Laboratories Ltd. has launched Avigan (favipiravir), Fujifilm Holdings Corp.’s potential COVID-19 treatment, in India.
After a steady upward trend since the beginning of the year, the BioWorld Infectious Diseases index has hit a speed bump for the first time and dropped almost 8% so far in August. Companies in the group focusing on treatments for COVID-19 took the brunt of the valuation decline as investors became notably anxious about other drug developers making it to market sooner with their COVID-19 therapies.
While the COVID-19 pandemic has brought disruptions to R&D, market activities in the biopharmaceutical sector have remained active during the first half of this year in China. Venture capital investments, IPOs and partnering activity showed upward trends, except for M&A activity, which has declined for two years.
The truth that every action has a reaction is being proven again in the public square of the U.S. as the shrill, endless clamor of politicians hoping to score against their opponents via health care issues or accomplishments threatens to undermine confidence in the FDA, the products it approves and even the guidance offered by the Centers for Disease Control and Protection (CDC). In the past, politicians from both parties blamed “greedy” biopharma companies and self-appointed social influencers for patients refusing to fill prescriptions, get tested or be immunized. Now they have themselves to blame.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Centers for Medicare & Medicaid Services, HHS.
RSS
