Fauci: Feds could free up Covid curbs--or could lock you down again

 Federal Covid-19 guidelines "will be much more liberal" by the Fourth of July if US cases drop as more Americans are vaccinated, Dr. Anthony Fauci said Sunday.

"If by the time we get to the Fourth of July, with the rollout of the vaccine, we get the level of infection so low -- I'm not going to be able to tell you exactly what the specific guidelines of the (US Centers for Disease Control and Prevention) are, but I can tell you for sure (guidelines) will be much more liberal than they are right now about what you can do," the director of the National Institute of Allergy and Infectious Diseases told CNN's Jake Tapper on "State of the Union."

Asked whether people will return to a degree of normal without masks and distancing by the summer holiday, Fauci, President Joe Biden's chief medical adviser, replied: "Yes ... there will be a greater degree of confidence" in that.

The comments from Fauci come nearly a week after the CDC released new guidance saying people fully vaccinated against Covid-19 can safely visit with other vaccinated people and small groups of unvaccinated people in some circumstances.

The agency is still urging unvaccinated Americans to socially distance from people who don't live in their home, wear masks and avoid crowds, measures that have been critical to slowing the spread of the deadly virus over the last year.

Fauci also warned that the US could see a situation similar to that in Italy, where a surge in cases due to new variants and other issues caused the government to announce a new lockdown starting Monday.

close dialog

Sign up for CNN's

CNN's Chris Cillizza cuts through the political spin and tells you what you need to know.

By subscribing, you agree to our

privacy policy.

"They had a diminution of cases. They plateaued and they pulled back on public health measures," he said. "They've opened restaurants. They've opened some of the bars. The younger people particularly stopped wearing masks. All of a sudden you have a surge that went right back up."

He continued: "That's where we are right now. We can avoid that, Jake. We can avoid that if we continue to vaccinate people, get more and more protection without all of a sudden pulling back on public health measures."

And pressed by Tapper on research that suggests no significant difference in coronavirus spreading in schools where students were six feet apart versus three feet apart, Fauci said the findings do indicate to him that three feet of distancing is good enough and that the CDC is aware of the new data.

"I can tell you and promise you, I talk to the CDC, to (Director Rochelle Walensky) every single day," he said. "She is acutely aware of the accumulation of data and the fact that her team will be acting on the data the way they always do."

Appearing later on the program, Maryland Gov. Larry Hogan, a Republican, weighed in on the slow pace of his state's vaccine rollout, telling Tapper that Maryland can meet Biden's plan to order states to allow all adults to receive vaccines by May 1 only if they receive more doses from the federal government.

"We can do it today. All we need is the vaccines from the federal government," he said. "We can't purchase vaccines. We can't manufacture vaccines. So if the President and his team is able to deliver, we don't have to wait until May 1, we can get there faster."

In announcing his plan last week, Biden laid out new steps the administration believes makes the May 1 timeline realistic, including expanding the types of professionals who are able to administer vaccine shots. Dentists, veterinarians and paramedics will all be included in the new approved list.

https://www.cnn.com/2021/03/14/politics/anthony-fauci-fourth-of-july-covid-guidelines-cnntv/index.html

'Virtually Every Indicator' Shows Pandemic Sets Back Child Development: UNICEF

 There's no question that the virus pandemic has impacted the younger generation that could deeply scar them, mentally and physically, for years. More than one year since the pandemic began, UNICEF warns, "progress has gone backward across virtually every key measure of childhood."

"The number of children who are hungry, isolated, abused, anxious, living in poverty and forced into marriage has increased. At the same time, their access to education, socialization and essential services including health, nutrition, and protection has decreased", Henrietta Fore, UNICEF Executive Director, said in a statement. 

"The signs that children will bear the scars of the pandemic for years to come are unmistakable," Fore continued. 

UNICEF's latest data is a stark reminder that shuttering the economy and schools for an extended period is a flawed policy decision. In a rare moment on Wednesday, Anthony Fauci told CNN there is no scientific reason why people who have had the COVID-19 vaccine are still having their freedoms restricted. Further, there has been widespread evidence showing that children's immune response to the virus is better than adults'. But still, many schools are closed around the world... 

Fore requested governments place children "at the heart of recovery efforts," particularly by "prioritizing schools in reopening plans."

Here are UNICEF's results that show "virtually every indicator" of progress for children has reversed under lockdowns: 

• In developing countries, child poverty is expected to increase by around 15 percent. An additional 140 million children in these countries are also already projected to be in households living below the poverty line.
  
• Schools for more than 168 million schoolchildren globally have been closed for almost a year. Two-thirds of countries with full or partial closures are in Latin America and the Caribbean.
  
• At least 1 in 3 schoolchildren has been unable to access remote learning while their schools were closed.
  
• Around 10 million additional child marriages may occur before the end of the decade, threatening years of progress in reducing the practice.
  
• At least 1 in 7 children and young people has lived under stay-at-home policies for most of the last year, leading to feelings of anxiety, depression, and isolation.
  
• As of November 2020, an additional 6 to 7 million children under age 5 may have suffered from wasting or acute malnutrition in 2020, resulting in almost 54 million wasted children, a 14 percent rise that could translate into more than 10,000 additional child deaths per month – mostly in sub-Saharan Africa and South Asia. With a 40 percent decline in nutrition services for children and women, many other nutrition outcomes can worsen.

Politicians and unelected officials experimented with lockdowns, social distancing, and school delays without considering the long-term consequences. So far, according to the research above, the impact on younger generations has been horrific. We've mentioned before - this has produced a slow-motion mental health explosion.

https://www.zerohedge.com/political/virtually-every-indicator-shows-pandemic-sets-back-childhood-development-unicef

Biotech week ahead, Mar. 15

 Biotech stocks snapped back from their weekly losses and ended higher for the week ended March 12, with the broader market recovery partly aiding the reversal.

Entera Bio Ltd. ENTX 70.79% was the biggest gainer of the week after it disclosed Phase 2 biomarker data that showed positive efficacy for EB613, its investigational drug being evaluated in postmenopausal women with osteoporosis.

The week also witnessed a slew of updates from companies developing COVID-19 treatments and vaccines.

AVEO Pharmaceuticals, Inc. (AVEO) received the regulatory nod for its new drug application for Tivozanib, for difficult-to-treat kidney cancer that has spread from where it was originally formed. This culminates an eight-year-long wait from the initial filing date.

IPO news flow returned, with Prometheus Biosciences, Inc. Common Stock NASDAQRXDX, a biopharma focusing on therapies for inflammatory bowel disease, and Longboard Pharmaceuticals, Inc. Common Stock NASDAQLBPH, a neurological diseases company, debuting on Wall Street.

The two companies together raised a combined $270 million in gross proceeds from the initial public offerings.

Here are the key catalysts for the unfolding week:

Conferences

The 15th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders: March 9-14
33rd Annual Virtual ROTH Conference: March 15-17
Muscular Dystrophy Association, or MDS, Virtual Clinical & Scientific Conference: March 15-18
Morgan Stanley Virtual Innovation in Pharma Week: March 15-19
Morgan Stanley Healthcare Corporate Access Days: March 16
Oppenheimer 31st Annual Healthcare Conference (Virtual): March 16-18
The Society of Gynecologic Oncology, or SGO, 2021 Annual Meeting: March 19-25
The Endocrine Society's ENDO 2021: March 20-23

PDUFA Dates

FibroGen Inc FGEN 0.14% and AstraZeneca plc's AZN 0.51% roxadustat PDUFA date of March 20 (Saturday) is likely to be extended, as the FDA has decided to hold an advisory committee meeting before deciding on the new drug application. FibroGen, the sponsor of the application, is seeking approval for the drug to treat anemia in chronic kidney disease patients.

Clinical Trial Readouts/Presentations

MDA Conference Presentations

Sarepta Therapeutics, Inc. SRPT 0.8%: Phase 1 data for SRP-9001 in Duchenne muscular dystrophy, and new long-term functional data from a Phase 1/2 study of gene therapy candidate SRP-9003 that is being developed for limb-girdle muscular dystrophy type 2E

Solid Biosciences Inc. SLDB 1.71%: one-year efficacy and safety data from a Phase 1/2 ascending dose study of single intravenous infusion of SGT-001 microdystrophin gene therapy for Duchenne muscular dystrophy (Thursday, 4 p.m.)

SGO Meeting Presentations

Aravive, Inc. ARAV 1.98%: updated data from the Phase 1b trial evaluating AVB-500 in platinum resistant ovarian cancer (Friday, 3:35 p.m.); additionally, new information is to be presented on the Phase 1/2 investigator-sponsored trial of AVB-500 in combination with durvalumab in patients with platinum resistant, recurrent epithelial ovarian cancer

Leap Therapeutics, Inc. LPTX 4.82%: Additional data from the Phase 2 study of DKN-01 and Paclitaxel chemotherapy medication in endometrial cancer

ENDO Meeting Presentations

BridgeBio Pharma, Inc. BBIO 0.39%: Early results from a Phase 2b study of encaleret on mineral physiology in autosomal dominant hypocalcemia type 1, a rare form of hypoparathyroidism

Rhythm Pharmaceuticals, Inc. RYTM 2.39%: data from the Phase 2 study of setmelanotide in obesity patients and Phase 3 study data for the same investigational therapy in treating obesity due to Bardet-Biedl syndrome or Alstrom syndrome

Spruce Biosciences, Inc. SPRB 14.67%: data from the Phase 1 and 2 program of tildacerfont for the treatment of classic congenital adrenal hyperplasia

Strongbridge Biopharma plc. SBBP 2.3%: Interim safety and efficacy results, including new data analyses, from the Phase 3 LOGICS study that is evaluating COR-003 in endogenous Cushing's syndrome

Standalone Releases

Eli Lilly and Company LLY 1.44% will present an update on the TRAILBLAZER clinical trial program as well as an update on the Phase 2 TRAILBLAZER-ALZ 2 trial at a webcast on Monday at 10:30 a.m. The Phase 2 trial is evaluating Lilly's investigational drug donanemab for Alzheimer's disease.

Secondary analyses of data from the Phase 2 study presented over the weekend at the 15th Conference on Alzheimer's & Parkinson Diseases showed donanemab consistently slowed cognitive and functional decline. Prespecified exploratory analyses showed donanemab slowed the accumulation of tau across key brain regions in patients affected by Alzheimer's disease.

In Alzheimer's patients, tau protein molecules found in neurons of the brain bind with each other to form tangles inside the neurons, disrupting synaptic communication between neurons.

Rubius Therapeutics, Inc. RUBY 3.4% is scheduled to issue a pre-market press release and conduct a webcast on Monday to discuss the initial clinical data findings from the ongoing Phase 1/2 trial of RTX-240 in patients with advanced solid tumors.

Earnings

Monday

Agenus Inc. AGEN 1.19% (before the market open)
Enzo Biochem, Inc. ENZ 2.23% (before the market open)
Corbus Pharmaceuticals Holdings, Inc. CRBP 0.43% (before the market open)
AcelRx Pharmaceuticals, Inc. ACRX 2.78% (after the close)
Amphastar Pharmaceuticals, Inc. AMPH 1.68% (after the close)
Catalyst Pharmaceuticals, Inc. CPRX 3.18% (after the close)

Tuesday

Calithera Biosciences, Inc. CALA 0.34% (after the close)
Cue Biopharma, Inc. CUE 0.63% (after the close)
Curis, Inc. CRIS 2.73% (after the close)
Kindred Biosciences, Inc. KIN 0.82% (after the close)
Exagen Inc. XGN 0.15% (after the close)
OncoCyte Corporation OCX 1.05% (after the close)
Eton Pharmaceuticals, Inc. ETON 1.56% (after the close)
Organogenesis Holdings Inc. ORGO 4.79% (after the close)
Infinity Pharmaceuticals, Inc. INFI 2.63% (after the close)
Ra Medical Systems, Inc. RMED 0.33% (after the close)

Wednesday

ThermoGenesis Holdings, Inc. THMO 4.36% (after the close)

Thursday

Legend Biotech Corporation LEGN 1.16% (before the market open)
PDS Biotechnology Corporation PDSB 7.21% (before the market open)
Metacrine, Inc. MTCR 1.56% (before the market open)
Entera Bio Ltd. ENTX 70.79% (before the market open)
UroGen Pharma Ltd. URGN 0.96% (before the market open)
Galmed Pharmaceuticals Ltd. GLMD 0.29% (before the market open)
Acutus Medical, Inc. AFIB 2.41% (after the close)
Alpine Immune Sciences, Inc. ALPN 2.15% (after the close)
Viveve Medical, Inc. VIVE 0.84% (after the close)
Salarius Pharmaceuticals, Inc. SLRX 3.82% (after the close)

IPOs

Bethesda, Maryland-based Gain Therapeutics, Inc. is proposing to offer 3.64 million shares of its common stock in an initial public offering, with the issue expected to be priced between $10 and $12.

The clinical-stage biopharma that is focused on developing therapeutics for lysosomal storage disorders has applied for listing its shares on the Nasdaq under the ticker symbol "GANX."

https://www.benzinga.com/general/biotech/21/03/20155210/week-ahead-in-biotech-march-14-20-update-on-fibrogen-astrazenecas-anemia-drug-earnings-and-presen