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Tuesday, September 7, 2021

Biden under pressure to ratchet up world vaccine aid

 Lawmakers are pushing for billions in federal funding to boost global COVID-19 vaccine manufacturing in Democrats' coming $3.5 trillion package, arguing that the Biden administration needs to do more to fight the pandemic worldwide and prevent dangerous new variants from forming.

A group of 116 Democratic lawmakers, including more than half of the House Democratic Caucus, wrote to congressional leaders and President Biden last month, calling on them to back $34 billion to increase global manufacturing of COVID-19 vaccines and to help distribute the vaccines around the world.

The push comes as health experts increasingly call on the administration to do more to vaccinate the world, as many countries have still only vaccinated a small percentage of their population, providing fertile ground for new variants to develop that could threaten everyone, including Americans.

But backers of the push in Congress say they have yet to receive firm commitments on the issue from either congressional leadership or the White House. 

“No one’s made any commitments to me about it,” said Rep. Tom Malinowski (D-N.J.), one of the leaders of the letter, saying he had spoken to Speaker Nancy Pelosi (D-Calif.) and “everybody I’ve spoken to understands the need.”

Henry Connelly, a Pelosi spokesman, said: “We continue to pursue ways to increase funding for global vaccine distribution and manufacture, building on the nearly $8 billion in funds for GAVI, the Global Vaccine Alliance, and the Global Fund secured by the Speaker in earlier covid relief bills.”

Rep. Raja Krishnamoorthi (D-Ill.), another leader of the push, said backers had not yet received a “formal response” from the White House. 

“I think we have more work to do,” Krishnamoorthi said. “We have to persuade people that this is a top priority.”

White House COVID-19 response coordinator Jeff Zients did announce on Thursday a roughly $3 billion investment in the vaccine manufacturing supply chain in the United States, which he said would also help boost supply for the world.

“We can and we will do even more,” Zients said. 

The Biden administration already plans to donate 500 million COVID-19 vaccine doses across this year and next, with more than 130 million doses already delivered.

But lawmakers and experts say much more is needed, including building up manufacturing capacity to produce more doses in lower-income countries. 

Malinowski says the administration has to “step up” its efforts. 

“They announced the donation of 500 million doses,” he said. “While that sounds like a very large number, in fact it’s missing a zero.”

Global health leaders have consistently raised the alarm about inequitable access to vaccine supply between richer and poorer countries. 

The World Health Organization has set a goal of vaccinating the most vulnerable 10 percent of every country’s population by the end of September. But it said Thursday that 42 of Africa’s 54 countries are set to miss that goal given the current pace of vaccinations. Only nine African countries have vaccinated 10 percent of their populations so far. 

More than 200 health experts and civil society groups in August wrote to Biden calling for a “wartime footing” to ramp up COVID-19 vaccine manufacturing for the world. 

The letter urged the president to come up with a plan to reach capacity for 8 billion doses of vaccine per year within six months and called for a plan to be announced within one month.

The letter's signatories included Thomas Frieden, the former Obama-era director of the Centers for Disease Control and Prevention, and Paul Farmer, co-founder of the group Partners in Health. 

“Supply is being controlled by a very small number of countries,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center. “It’s not being distributed in an equitable way.”

“Part of why we need to invest more in manufacturing is to create a globally distributed model of manufacturing,” he said, granting more access to low- and middle-income countries.

Lawmakers leading the push say the full $34 billion in new funding might not be needed if there are already funds available that have been allocated but said they do not have a clear accounting of how much is currently available. 

report from PrEP4All, an HIV advocacy group also working on the COVID-19 response, found that the Biden administration had spent just $12 million out of $16 billion provided in the American Rescue Plan earlier this year for manufacturing and procurement of vaccines, drugs and equipment. 

A group of experts also called on world leaders this week to convene a global summit during this month’s United Nations General Assembly and commit to actions including making 7 billion vaccine doses available by the end of the year. 

“We're seeing a lot of piecemeal efforts,” said Udayakumar, one of the experts making that call. “None of this is going to get solved unless it’s taken on in some comprehensive way.”

Krishnamoorthi said funding is needed in Congress’s coming package to “end” the pandemic rather to simply “manage” it.

If funding is not included, he said, it “dooms us to managing and muddling our way through this pandemic until we get to the next Greek letter variant.”

https://thehill.com/policy/healthcare/570657-biden-under-pressure-to-ratchet-up-vaccine-aid

COVID-19 cases, deaths, hospitalizations skyrocket from last year's Labor Day

 COVID-19 cases, deaths and hospitalizations skyrocketed this Labor Day in comparison to Labor Day 2020.

The Washington Post COVID-19 tracker found that hospitalizations on Labor Day in 2021 reached 99,270 individuals, up from 38,192 people in 2020.

That is a 160 percent increase in hospitalization over the past year, despite the U.S. having more than half of the country vaccinated.

Johns Hopkins University data showed there was a 316 percent increase in COVID-19 cases between the two Labor Days, USA Today reported.

COVID-19 deaths were also twice as high on the federal holiday compared to last year.

The rise in cases is led by the delta variant that has been devastating state hospital systems and causing some states to reimplement mask mandates and other restrictions.

The rise in cases also caused the U.S. to surge to more than 40 million total COVID-19 cases throughout the pandemic, with more than 680,000 deaths. 

Although fully vaccinated people have also been catching the variant strain, it is much less likely for a fully vaccinated individual to go to the hospital or die from the virus. 

https://thehill.com/policy/healthcare/571041-covid-19-cases-deaths-hospitalizations-skyrocket-from-last-years-labor-day

'Biden to outline strategy for controlling delta variant'

 Biden on Thursday will outline additional steps his administration is taking to get the coronavirus pandemic under control as cases and hospitalizations increase in some areas of the country.

Biden will deliver remarks laying out what a White House official described as a six-pronged strategy to slow the spread of the highly infectious delta variant and boost vaccination rates.

"As the President has said since day 1, his administration will pull every lever to get the pandemic under control," the official said in a statement.

Biden indicated last week following an underwhelming jobs report that his administration is looking for ways to make it safer for kids to return to school and for workers to return to the office.

Cases dipped dramatically and the nation appeared to be turning a corner in the early weeks of summer, but as the delta variant has become the dominant strain, cases have exploded across the country and the president has since struggled to get the pandemic back under control.

Biden and other White House officials have repeatedly described the situation as a "pandemic of the unvaccinated," pointing to statistics that breakthrough cases in vaccinated individuals remain rare and hospitalizations are extremely rare for those who have gotten the shot.

The Washington Post COVID-19 tracker found that hospitalizations on Labor Day in 2021 reached 99,270 individuals, a sharp increase from 38,192 people in 2020. The U.S. this week surpassed 40 million confirmed cases of the virus since the pandemic began.

https://thehill.com/homenews/administration/571085-biden-to-outline-strategy-for-controlling-delta-variant

Why Adaptimmune Therapeutics Is Bolting Higher

 Shares of the clinical-stage biotech Adaptimmune Therapeutics (NASDAQ:ADAP) popped by as much as 25% in premarket trading Tuesday morning. The cancer specialist's stock is on the move this morning in response to a licensing and collaboration agreement with Roche's (OTC:RHHBY) subsidiary Genentech. 

Per the terms of the deal, Adaptimmune will receive $150 million up front to develop and subsequently commercialize so-called "off-the-shelf" (allogeneic) cell therapies targeting multiple oncology indications. The biotech might also receive another $150 million based on various developmental, regulatory, and commercial milestones over the next five years. Lastly, Adaptimmune is in line to earn tiered royalties on the net sales of any approved products stemming from the collaboration.

The two companies noted in this morning's press release that the total aggregate value of the deal may potentially exceed $3 billion. That's a sizable chunk of change for a biotech that had a market cap of around $600 million less than a month ago. 

Perhaps most importantly, though, Roche's decision to back Adaptimmune's novel cell therapy platform is a major vote of confidence. Roche, after all, is one of the biggest players in the field of oncology. 


Is Adaptimmune's stock still a buy after this early morning move? The answer is most definitely a yes. Even after this double-digit move higher, Adaptimmune's market cap is still under $1 billion. While the biotech's cell therapy platform has yet to be fully validated via a regulatory approval, Adaptimmune sports a series of high-value clinical and regulatory catalysts over the next year -- many of which could push its shares even higher in the near term. In short, there's a lot to like about this small-cap cancer stock. 

https://www.fool.com/investing/2021/09/07/why-adaptimmune-therapeutics-stock-is-bolting-high/

Ziopharm Oncology to Participate in September Investor Conferences

  Ziopharm Oncology, Inc. (“Ziopharm” or the “Company”) (Nasdaq: ZIOP), today announced that Kevin S. Boyle, Sr., Chief Executive Officer of Ziopharm, is scheduled to participate in five upcoming virtual investor conferences:

2021 Wells Fargo Virtual Healthcare Conference

Date:

September 9, 2021

Presentation Time:

10:00 am EDT

Morgan Stanley 19th Annual Global Healthcare Conference

Date:

September 10, 2021

No presentation – management available for one-on-one meetings

H.C. Wainwright 23rd Annual Global Investment Conference

Date:

September 13, 2021

Time:

7:00 am EDT (access to on demand webcast begins)

Lake Street 5th Annual Best Ideas Growth Conference

Date:

September 15, 2021

No presentation – management available for one-on-one meetings

2021 Cantor Virtual Global Healthcare Conference

Date:

September 28, 2021

Presentation Time:

3:20 pm EDT

https://finance.yahoo.com/news/ziopharm-oncology-participate-september-investor-200500001.html

Forward Pharma appeal dismissed

 

  • The stock price of Forward Pharma A/S (NASDAQ: FWP) fell by almost 20% during the premarket.

  • Investors are responding negatively to the Technical Board of Appeal (TBA) of the European Patent Office (EPO), dismissing Forward’s appeal to revoke the EP2801355 patent (355 patent) following the oral hearing.

  • The TBA had made its decision after considering Forward’s appeal against the decision of the Opposition Division and third-party submissions from several opponents.

  • TBA will issue detailed reasons for the decision in written form in due course, and following receipt and review of the details, Forward will announce plans for the Company.

  • Such a plan may involve a petition for review at the Enlarged Board of Appeal of the EPO to overturn the unfavorable outcome.

  • But the chances of a petition for review being successful is low.

RenovoRx Cleared on Delivery System for Targeted Treatment of Solid Tumors

 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, today announced it has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary RenovoCath Delivery System. The RenovoCath Delivery System is the device component of the Company's initial product, RenovoGem™. This drug/device combination used in RenovoRx's Trans-Arterial Micro-Perfusion (RenovoTAMP) therapy platform is a dual-balloon infusion catheter delivering chemotherapy directly to tumors via arteries. This new design provides more targeted delivery of therapy which the Company believes can translate into more effective treatment with fewer side effects. RenovoRx received its initial 510(k) for the RenovoCath delivery system in 2014.

RenovoTAMP is the Company's novel therapy platform designed to deliver well-established chemotherapeutic agents for localized treatment of solid cancer tumors. It is under clinical investigation for increasing survival and improving quality of life. This platform technology may enable physicians to isolate the anatomy and micro-perfuse targeted tissue with small molecule chemotherapy.

https://finance.yahoo.com/news/renovorx-receives-510-k-clearance-100000432.html