Sunday, 20 Jun 2021

FDA Panel Review Not Necessary For Iterum’s Antibiotic, All Eyes On July 25

Shohei Ohtani scratched from start, not because of an injury but transportation issues

Baseball fans know how important Shohei Ohtani is to the game right now, pitching and hitting at a level that hasn't been seen since Babe Ruth. 

So when he was scratched from his scheduled start on the mound Thursday night against the Oakland A's, alarm bells started going off.

It shouldn't come as a surprise, considering how much concern there was when Ohtani's velocity dipped several mph below normal in his last start.

Was he injured? Is the stress of hitting every day and pitching every sixth finally starting to take its toll?

Turns out, there was a far less disastrous explanation.

Here’s a 30-second snippet of Joe Maddon explaining the Shohei Ohtani/BART situation.

Angels manager Joe Maddon told reporters at his pregame press conference that one of the Angels' team buses was delayed in traffic making the trip from the team hotel in San Francisco across the Bay to Oakland. 

The players and coaches on the bus then had to find an alternate method of transportation, but there was an issue with BART trains as well. 

Herald morning quiz: May 28

Test your brains with the Herald’s morning quiz. Be sure to check back on at 3pm for the afternoon quiz.

To challenge yourself with more quizzes, CLICK HERE.

Nuggets vs. Trail Blazers live blog: Real-time updates from Game 3 of the NBA playoffs first-round series – The Denver Post

Live updates, tweets, photos, analysis and more from the Nuggets playoff game against the Portland Trail Blazers at Moda Center in Portland, Ore., on May 27, 2021.

Mobile users, if you can’t see the live blog, tap here.

Tim Tebow gets into the end zone at Jacksonville Jaguars OTAs as he tries to show he belongs

Instead of taking snaps as a quarterback, Tim Tebow crashed into handheld blocking dummies and made cuts to get open for passes during tight end drills.

Each time it came his turn during a drill or was on the field for seven-on-seven work during the Jacksonville Jaguars' organized team activity workout on Thursday, cameras focused exclusively on Tebow.

And the media members on hand for the Jaguars' first open offseason practice that included all 90 players took notice.

Despite playing quarterback his entire career, including when he won the 2007 Heisman Trophy and helped Urban Meyer win two national championships at Florida, he's trying to catch on quickly as a tight end. 

Going into his first full week since signing a one-year veteran minimum contract valued at $920,000, Tebow hasn't been on an NFL roster since 2015, when he failed to make the Philadelphia Eagles' final 53-man for the regular season. 

Weird? More like awkward with Tebow at tight end

F.D.A. authorizes another antibody treatment for high-risk Covid patients.

By Rebecca Robbins

The Food and Drug Administration on Wednesday authorized a monoclonal antibody drug developed by GlaxoSmithKline and Vir as the third treatment of its kind cleared to help keep high-risk Covid patients out of the hospital.

Opinion | Our Collective, Violent PTSD

By Charles M. Blow

Opinion Columnist

There was another mass shooting on Wednesday, this time leaving nine people dead, just one of the latest mass shootings of the 230-plus so far this year, according to a tally maintained by The New York Times.

The T List: Five Things We Recommend This Week

A new season of “Special,” Carole Wantz’s debut exhibition — and more.

Welcome to the T List, a newsletter from the editors of T Magazine. Each week, we share things we’re eating, wearing, listening to or coveting now. Sign up here to find us in your inbox every Wednesday. And you can always reach us at [email protected].

FDA Panel Review Not Necessary For Iterum’s Antibiotic, All Eyes On July 25

Iterum Therapeutics plc (ITRM) has been notified by the FDA that an Advisory Committee meeting to review the company’s new drug application for Sulopenem etzadroxil/probenecid is no longer necessary.

Sulopenem etzadroxil/probenecid, referred to as Oral Sulopenem, is an antibiotic therapy proposed for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen.

The Advisory Committee meeting to review Oral Sulopenem was scheduled for June 2, 2021.

Now that Sulopenem etzadroxil/probenecid is not going to be reviewed by an FDA panel, it is one step closer to the FDA decision, which is expected on July 25, 2021.

Iterum has collaboration with EVERSANA, a provider of commercial services to the life science industry, to support Oral Sulopenem launch.

If approved, Oral Sulopenem is expected to achieve peak sales of $300 million, according to analysts. The company believes that Oral Sulopenem has the potential to achieve blockbuster status.

Cash position:

As of March 31, 2021, Iterum’s cash on hand totaled $100.5 million.

ITRM has traded in a range of $0.45 to $4.65 in the last 1 year. The stock closed Thursday’s trading at $1.23, up 3.36%. In after-hours, the stock was up over 24% at $1.53.

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