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Friday, July 2, 2021

White House to deploy response teams across U.S. to combat delta Covid variant

 The White House is deploying Covid-19 response teams across the United States focused on combatting the highly contagious delta variant, the Biden administration announced Thursday.

The teams, comprised of officials from the Centers for Disease Control and Prevention and other federal agencies, will work with communities at higher risk of experiencing outbreaks and will focus on increasing the rate of Covid-19 vaccinations, White House Covid czar Jeff Zients said during a White House news briefing on the pandemic.

The teams will also increase testing to expand detection of the virus, facilitate contact tracing and provide therapeutics to help treat those who become infected, he said, adding the government is ready to provide additional personnel.

There are 1,000 counties in the U.S. that have vaccination coverage of less than 30%, CDC Director Dr. Rochelle Walensky said at the briefing. These counties, primarily in the South and Midwest, are the most vulnerable to the variant, she said.

“To be clear, the federal government stands ready to meet the moment and work with our state partners to respond to the delta variant,” Zients said.

“As we continue to work with communities across the country to get more shots in arms, we will also be working with governors and state and local health authorities to identify and address the needs on the ground in places with emergency outbreaks,” he added.

The Biden administration’s comments come just ahead of the Fourth of July weekend, when many Americans are expected to gather for fireworks, barbeques and other large, in-person activities.

Delta, first identified in India but now in at least 96 countries, is expected to become the dominant variant of the disease in the U.S. The prevalence of the delta, estimated to be about 60% more transmissible than the alpha variant first found in the U.K., is doubling in the U.S. about every two weeks, according to the CDC.

Health officials say there were reports that the delta variant also causes more severe symptoms, but that more research is needed to confirm those conclusions. Still, there are signs the delta strain could provoke different symptoms than other variants.

This is a “highly contagious virus,” said Dr. Paul Offit, a pediatrician and vaccine advocate who has served on advisory panels for both the CDC and the Food and Drug Administration.

“We need to vaccinate now. I mean get everyone vaccinated now because these mutations are going to continue to occur,” he said. It’s only July but “as we head into the fall and early winter you’re going to see a surge and there are too many people in this country who are still unvaccinated.”

Delta accounts for around 26% of Covid cases in the U.S., the CDC has estimated. Dr. Anthony Fauci, the White House’s chief medical advisor, has called the variant the “greatest threat” to the nation’s attempt to eliminate Covid-19.

The WHO has said the variant is the fastest and fittest coronavirus strain yet, and it will “pick off” the most vulnerable people, especially in places with low Covid vaccination rates. It recently urged everyone, including vaccinated people, to continue to wear masks as the variant spreads.

In some regions of the country, nearly one in two sequences is the delta variant, Walensky said Thursday. As the variant spreads, officials expect to see an increase in transmission unless states can vaccinate more people, she added.

As of Thursday, more than 181 million Americans, or 54.6% of the U.S. population, have had at least one dose of a Covid vaccine, according to data compiled by the CDC. More than 155 million Americans are fully vaccinated, according to the CDC.

“The delta variant is predicted to be the second most prevalent variant in the United States, and I expect that in the coming weeks it will eclipse the alpha variant,” she said, urging those with symptoms to get tested for Covid.

https://www.cnbc.com/2021/07/01/delta-white-house-to-deploy-response-teams-across-us-to-combat-covid-variant.html

Oncology Pharma Updates on Next Phase of Growth and Expansion

 Oncology Pharma Inc. (OTC PINK:ONPH) Oncology Pharma, Inc. (the "Company") is developing a program to establish the use of its license utilizing NR2F6 agonists and antagonists coupled with the proprietary drug delivery systems in the treatment of various disorders including human pancreatic cancer and colon cancer. The work the Company is contracting to conduct is intended to do pre-clinical trials leading into seeking FDA approval for the combined efforts. Our team of industry experts and advisors have the expertise to lead the Company to efficiently conduct this next phase of development.

The developing program will allow Oncology Pharma to begin its own path towards producing proprietary intellectual property, for the pursuit and development of new therapies. The Company's established portfolio of licensing agreements is expected to allow the company the ability to develop its own innovations to stand out amongst its peers.

https://finance.yahoo.com/news/oncology-pharma-inc-entering-next-120000837.html

Zoetis donates animal COVID-19 vaccine candidate to about 70 U.S. zoos

 Animal health company Zoetis Inc said on Friday it had donated over 11,000 doses of its experimental COVID-19 vaccine to nearly 70 zoos across the United States.

The vaccine has been authorized for experimental use on a case-by-case basis by the United States Department of Agriculture (USDA) and the respective state veterinarians, the company said.

Zoetis, which has provided the vaccine to zoos across 27 U.S. states, supplied it to the San Diego Zoo earlier this year for use in the zoo's great apes following an outbreak that infected several members of a troop of gorillas.

Animals including Asiatic lions in India and a tiger at the Bronx Zoo in New York City have tested positive for COVID-19, but the U.S. Centers for Disease Control and Prevention has said https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/animals.html it does not yet know if all animals can get infected.

Zoetis said the Oakland Zoo in Northern California received their first shipment of vaccines on June 29 and tigers, black and grizzly bears, mountain lions and ferrets were the first to receive the first of two doses.

In addition to zoos, Zoetis' vaccine will be used in over 100 mammalian species in more than a dozen conservatories, sanctuaries, academic institutions and government organizations, the company said.

https://news.yahoo.com/zoetis-donates-animal-covid-19-133918268.html

Arrowhead Pauses ARO-ENaC Phase 1/2 Clinical Study

 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today notified regulatory agencies, institutional review boards, and investigators that effective immediately it is voluntarily pausing AROENaC1001, a Phase 1/2 clinical study of ARO-ENaC, the company’s investigational RNA interference (RNAi) therapeutic being developed as a treatment for patients with cystic fibrosis (CF), after receiving a preliminary update from an ongoing chronic toxicology study in rats that contained unexpected signals of local lung inflammation. The company has instructed investigators to pause new screening, enrollment, and any further dosing of investigational ARO-ENaC pending additional data from the ongoing chronic rat toxicology study and an additional ongoing chronic primate toxicology study.

Javier San Martin, M.D., chief medical officer at Arrowhead, said: "The safety of patients that participate in clinical trials of our investigational medicines is paramount to us at Arrowhead. While we have not seen any concerning safety or tolerability signals in subjects enrolled in the AROENaC1001 study, out of an abundance of caution we have decided to pause new screening, enrollment, and any further dosing of investigational ARO-ENaC in the study while we await additional information from ongoing nonclinical toxicology studies. After we receive the full data from these studies, we will assess whether there is an acceptable path forward for further clinical investigation. While we determine our next steps with ARO-ENaC, we look forward to continued progress with the other 8 clinical drug candidates in our pipeline as well as our rapidly expanding preclinical initiatives, including additional lung-targeted programs."

https://finance.yahoo.com/news/arrowhead-pauses-aro-enac-phase-113000317.html

EQT, Goldman near deal to buy contract-research firm Parexel for nearly $9B

 EQT AB and Goldman Sachs Group Inc's investment arm are in advanced talks to buy contract research company Parexel International Corp for nearly $9 billion including debt, the Wall Street Journal reported on Thursday.

The sale to EQT and Goldman could be completed this week, the report said https://www.wsj.com/articles/eqt-and-goldman-near-deal-to-buy-parexel-11625185563?mod=latest_headlines, citing people familiar with the matter.

https://finance.yahoo.com/news/eqt-goldman-near-deal-buy-005128713.html

Iterum Says FDA Found Deficiencies in Drug Application

 Iterum Therapeutics Plc said Thursday that U.S. regulators have found deficiencies in its review of a drug that the company is developing.

The U.S. Food and Drug Administration's findings relate to sulopenem etzadroxil/probenecid, a candidate drug to treat urinary tract infections. The deficiencies found "preclude the continuation of the discussion of labeling and post marketing requirements/commitments at this time," Iterum said. The company added that the FDA didn't provide further details about the deficiencies.

Iterum said it plans to work with the FDA to resolve the deficiencies.

https://www.marketscreener.com/quote/stock/ITERUM-THERAPEUTICS-PLC-43499891/news/Iterum-Says-FDA-Found-Deficiencies-in-Drug-Application-35775196/

FDA Accepts Filing of HUTCHMED NDA for Surufatinib to Treat Advanced Neuroendocrine Tumors

 U.S. FDA Accepts Filing of HUTCHMED's NDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors

- U.S. FDA has assigned a target action date of April 30, 2022 -

- If approved, surufatinib would be HUTCHMED's first novel oncology drug marketed outside of China -

HUTCHMED (China) Limited ('HUTCHMED') (Nasdaq/AIM: HCM; HKEX: 13) today announces that the U.S. Food and Drug Administration ('FDA') has accepted its filing of the New Drug Application ('NDA') for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors ('NETs'). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is April 30, 2022.

Surufatinib received fast track designation in April 2020 for the treatment of pancreatic and extra-pancreatic NET. Orphan Drug Designation for pancreatic NET was also granted in November 2019.

Dr. Marek Kania, Managing Director and Chief Medical Officer of HUTCHMED International Corporation, said: 'This NDA filing acceptance of surufatinib in the U.S. is a significant achievement for HUTCHMED as we expand our global operations and work to bring our innovative oncology drugs to cancer patients worldwide. The FDA's acceptance of the NDA highlights the clinical value of this submission package and the importance of bringing more treatment options to US NET patients.'

The NDA is supported by data from two positive Phase III studies of surufatinib in patients with pancreatic and extra-pancreatic NET in China (SANET-p1 and SANET-ep2 both previously reported in The Lancet Oncology), and a surufatinib study conducted in the U.S.3 The data package will also be used to file a Marketing Authorization Application ('MAA') to the European Medicines Agency ('EMA') imminently, based on scientific advice from the EMA's Committee for Medicinal Products for Human Use.

HUTCHMED has initiated an Expanded Access Protocol (EAP) in the U.S. to ensure patients with NET with limited therapeutic options have access to this treatment. Regulatory clearance of this protocol has been granted by the FDA and this program is open for site activation (clinicaltrials.gov identifier: NCT04814732).

https://www.marketscreener.com/quote/stock/HUTCHMED-CHINA-LIMITED-59660104/news/HUTCHMED-China-nbsp-U-S-FDA-Accepts-Filing-of-HUTCHMED-s-NDA-for-Surufatinib-for-the-Treatment-of-35775529/