approval

Avigan still awaits Japanese approval as coronavirus cure

TOKYO — The approval of Avigan, a candidate drug for treating coronavirus infections, has been postponed by Japan’s Ministry of Health, Labor and Welfare until June or later.

The delay has dashed the hopes of many, including Prime Minister Shinzo Abe, who previously said that he “will aim for approval by the end of May.” It comes as the anti-flu drug’s effectiveness as a coronavirus treatment has yet to be proven.

In the meantime, Avigan will continue clinical trials and research.

Health minister Katsunobu Kato said at a news conference on Tuesday that the ministry had “assumed” Avigan would be

Read More

Avigan set for approval this month in Japan as coronavirus drug

TOKYO — Japan looks to approve flu drug Avigan as a coronavirus treatment within the month, Prime Minister Shinzo Abe told reporters Monday, speeding up the process by months.

The drug originally was on track for approval in July or later, but Abe has directed the health ministry to accelerate its review of the drug.

Japan currently has no approved treatments for COVID-19, and the health ministry is giving priority to applications related to the virus. Avigan, developed by a subsidiary of Fujifilm Holdings, blocks viruses from reproducing within the body.

Meanwhile, a Japanese arm of U.S.-based Gilead Sciences filed

Read More

Japan asks US for stable remdesivir supply as Tokyo rushes approval

TOKYO — Japan aims to approve remdesivir as a treatment for the coronavirus in as little as a week, the health minister said Saturday, as Tokyo asked the U.S. to ensure it receives adequate supplies of the drug.

The moves follow emergency U.S. approval of remdesivir, developed by Gilead Sciences, on Friday. Japan’s expedited authorization procedures allow reporting of domestic clinical trials to be postponed to a later date, meaning the antiviral drug could be approved by mid-May.

“Gilead Sciences will file for approval [in Japan] within days,” Health Minister Katsunobu Kato said at a news conference. “I issued a

Read More

Pfizer to expand coronavirus vaccine trials with eye on fall approval

MAPLEWOOD, U.S. (Reuters) — Pfizer on Tuesday said it expects its experimental coronavirus vaccine to move into expanded clinical trials by October that could allow for emergency use or accelerated approval, as it ramps up efforts to combat the pandemic.

The company left its full-year adjusted profit forecast of $2.82 to $2.92 per share unchanged, saying it expects the pandemic to have little impact on its overall results.

Pfizer said most of its drugs are not administered at the physician’s office, which would help it emerge from the pandemic with a “negligible” impact on its results. Millions of Americans have

Read More