White House: no one pressuring FDA to approve coronavirus vaccine

Gersh Signs Alexandra LaRoche

Director Alexandra LaRoche has signed with The Gersh Agency for representation.

With more than 20 years in the business, she has worked on such shows as Legends of Tomorrow, MacGyver, Magnum PI and the upcoming movie based on the VC Andrews book, Pearl in the Mist.

Prior to the pandemic, she had spent a lot of her time on the CW series The Flash, directing several episodes of the hit series. While the schedule is still coming together on her future projects, she is already booked for an episode of another hit CW series, Supergirl, which stars Melissa Benoist and Chyler Leigh.

She also recently joined the Warner Bros. family with an overall deal that will primarily focus on Berlanti shows like Supergirl and The Flash.

Stock Alert: Duluth Hits New 52-week High After Earnings Surprise

Shares of Duluth Holdings Inc. (DLTH) are rising almost 6 percent or $0.61 in Thursday’s morning trade at $11.08, after touching a new 52-week high of $11.57 as the company reported better-than-expected quarterly results.

Duluth Holdings, a seller of casual wear, workwear, and accessories, said Thursday that its second-quarter net income surged to $5.9 million or $0.18 per share from $1.9 million or $0.06 per share in the prior-year quarter. Net sales grew 12.6 percent to $137.4 million from $122.0 million in the year-ago period.

Analysts polled by Thomson Reuters had a consensus earnings estimate of $0.02 per share for the quarter on revenues of $118.55 million. Analysts’ estimates typically exclude special items.

Duluth Holdings has traded in a range of $2.82 to $11.57 in the past 52 weeks.

Georgians reviving ancient honey-harvesting tradition

Culture of harvesting honey from wild bees without use of modern box hives is returning to country’s west.

In western Georgia, an ancient culture of harvesting honey from wild bees is enjoying a revival.

But it is being done without the use of modern box hives.

And, as Al Jazeera’s Robin Forestier-Walker reports, it is no longer a job exclusively held by men.

National Institute Of Health Announces $129.3 Mln In Support Of COVID-19 Testing Technologies

The National Institutes of Health has awarded a total of $129.3 million in funding to support scaling-up coronavirus testing and manufacturing new testing technologies.

The U.S. health agency said it is awarding contracts to nine companies for technologies that include portable point-of-care tests for immediate results and high-throughput laboratories that can return results within 24 hours.

“Diagnostic testing is a critical component of the nation’s strategy to meet the challenge of the COVID-19 pandemic,” said NIH Director Francis S. Collins, M.D., Ph.D. “Just started at the end of April, the RADx initiative has moved swiftly to speed innovation and later-stage development in the biomedical technology sector. The results thus far have been outstanding.”

The nine companies that received a cut in the $129 million funding included, MatMaCorp, Maxim Biomedical Inc, MicroGEM International, Aegis Sciences, Broad Institute, Ceres Nanoscience Inc, Illumina, PathGroup, and Sonic Healthcare USA.

NIH said MatMaCorp, Maxim Biomedical Inc and MicroGEM International will offer point-of-care tests that produce immediate results. While, the remaining six will offer lab-based tests.

In July, NIH made a similar contribution of $248.7 million to seven companies.

Akebia: Vadadustat Trial Achieves Efficacy Endpoints; Fails To Meet Primary Safety MACE Endpoint

Akebia Therapeutics, Inc. (AKBA) reported top-line results from its PRO2TECT Global phase 3 program of Vadadustat for treatment of Anemia due to chronic kidney disease in adult patients not on dialysis. Vadadustat achieved the primary and key secondary efficacy endpoint in each of the two PRO2TECT studies, demonstrating non-inferiority to darbepoetin alfa. However, Vadadustat did not meet the primary safety endpoint of the PRO2TECT program, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of major adverse cardiovascular events.

The company plans to submit to the FDA a New Drug Application for vadadustat for the treatment of anemia due to chronic kidney disease in adult dialysis-dependent and non-dialysis dependent patients as early as possible in 2021. Akebia and its collaborator, Otsuka Pharmaceutical, are working in close collaboration to prepare a Marketing Authorization Application for submission to the European Medicines Agency.

Shares of Akebia Therapeutics were down 70% in pre-market trade on Thursday.

Eskom Suspends Plant Managers as South Africa Suffers Power Cuts

Eskom Holdings SOC Ltd., South Africa’s state-owned power company, has suspended the managers of three of its biggest generating plants as the country suffers crippling electricity outages, people familiar with the situation said.

Eskom suspended the managers of the Kendal, Duvha and Tutuka plants, three people said, asking not to be identified as an announcement hasn’t been made. Eskom spokesman Sikonathi Mantshantsha said he couldnt comment immediately.

White House says it does not expect a government shutdown at months' end

WASHINGTON (Reuters) – The White House on Thursday said it expects Congress to approve the legislation needed to avoid a government shutdown at the end of the month, when current spending bills expire.

“We do believe that we’ll be able to get funding to avoid a shutdown,” White House Press Secretary Kayleigh McEnany told reporters.

White House: no one pressuring FDA to approve coronavirus vaccine

WASHINGTON (Reuters) – White House Spokeswoman Kayleigh McEnany said on Thursday there is no political pressure on the U.S. drugs regulator to quickly approve a vaccine for the deadly coronavirus disease, after drugmakers and the Centers for Disease Control suggested one could be ready just ahead of the November presidential election.

“No one is pressuring the FDA to do anything,” McEnany said, referring to the Food and Drug Administration.