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Thursday, May 6, 2021

Nymox Eyes Date for Fexapotide Filing

 Nymox Pharmaceutical Corporation (NASDAQ: NYMX) (the “Company”) is pleased to announce that it will be filing for marketing approval of Fexapotide Triflutate for benign prostate hyperplasia (BPH) before the end of the summer, on or before 15 September 2021.

CEO Dr. Paul Averback said, "The Company will file on or before September 15. We hope but cannot be certain that the date may be before September. Company management will communicate updates where appropriate."

https://finance.yahoo.com/news/nymox-announces-date-fexapotide-filing-173000788.html

CTI BioPharma started at Buy by Stifel

 Target $5.50

https://finviz.com/quote.ashx?t=CTIC

House GOP bill to keep Biden from waiving IP protections for COVID vax

 Republican Rep. Byron Donalds is expected to roll out legislation that would prohibit the Biden administration from "giving away" American intellectual property after the White House announced its support for a waiver of IP protections for COVID-19 vaccines.

The bill, titled the "Preventing Foreign Attempts to Erode Healthcare Innovation Act," is intended to "prevent the Biden Administration from senselessly giving away America's intellectual property to countries like China," Donalds, R-Fla., told Fox News.

"It deeply concerns me to hear of the Biden administration's plan to forgo IP protections on COVID-19 vaccines. This plan is a direct infringement upon American ingenuity and innovation and hands over our nation's intellectual prowess for the world's taking," Donalds told Fox News. "This administration has made it a point to put America last, and this is just another glaring example of this sad reality." 

Donalds’ legislation has the support of the House Republican Study Committee and its chair, Rep. Jim Banks.

"Biden is once again proving that the Chinese Communist Party (CCP) and not the American people have a seat at his table. In a brazen move, Biden has agreed to waive the IP rights of American innovators and workers," Banks told Fox News. "By refusing to support American inventions and hard work, he is ensuring that China, where this pandemic began, reaps the benefits of American ingenuity." 

He added: "Rep. Donalds’ bill is a win for American workers, families and innovators." 

The bill comes after U.S. Trade Representative Katherine Tai on Wednesday announced the Biden administration’s support for the Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization waiver, which would waive IP protections for COVID-19-related patents, such as vaccines. 

"This is a global health crisis and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures," Tai said in a statement Wednesday. "The administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines." 

Tai said the administration would be "actively" participating in "text-based negotiations at the World Trade Organization needed to make the happen." 

"Those negotiations will take time given the consensus-based nature of the institution and the complexity of the issues involved," Tai said, adding that the Biden administration’s aim is to "get as many safe and effective vaccines to as many people as fast as possible." 

"As our vaccine supply for the American people is secured, the administration will continue to ramp up its efforts—working with the private sector and all possible partners—to expand vaccine manufacturing and distribution," Tai said, adding that the administration will also work to "increase the raw materials needed to produce those vaccines." 

White House principal deputy press secretary Karine Jean-Pierre on Thursday said the White House discussed the issue with experts before presenting options to President Biden. 

"The president supported the waiver, he thought of it as a humanitarian issue…to help save lives," Jean-Pierre told reporters aboard Air Force One Thursday. "You're all standing here with masks, living in an unprecedented time with the pandemic—we have to do everything we can."

https://www.foxbusiness.com/politics/house-gop-bill-prohibit-biden-administratio-waiving-ip-protections-covid-vaccines

Can COVID-19 vaccines affect my period?

 Can COVID-19 vaccines affect my period?

It’s not known, but researchers are starting to study the issue.

Vaccines are designed to activate your immune system, and some experts have wondered if that could temporarily disrupt menstrual cycles.

So far, reports of irregular bleeding have been anecdotal. And it’s hard to draw any links to the vaccines since changes could be the result of other factors including stress, diet and exercise habits. There’s also a lack of data tracking changes to menstrual cycles after vaccines in general.

If scientists do eventually find a link between the vaccine and short-term changes in bleeding, experts say that would be no reason to avoid getting vaccinated. “The benefits of taking the vaccine certainly way outweigh putting up with one heavy period, if indeed they’re related,” said Dr. Mary Jane Minkin, a gynecologist and a professor at the Yale University School of Medicine.

Researchers recently launched a survey to begin gathering data. The findings won’t determine whether there’s a relationship between COVID-19 vaccines and menstrual changes, but could help form the basis for further research, said Katharine Lee, one of the researchers, who is based at Washington University in St. Louis.

Dr. Jen Gunter, an obstetrician and gynecologist in the San Francisco Bay Area, said a link is possible, since the uterine lining, which is shed during menstruation, contains immune cells that help protect the uterus.

There’s no evidence that any vaccines, including COVID-19 vaccines, affect fertility, according to the U.S. Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists.

https://apnews.com/article/coronavirus-pandemic-lifestyle-health-be83f95d68315be48e95af4dd2577688

More support easing vaccine patent rules, but hurdles remain

 France joined the United States on Thursday in supporting an easing of patent protections on COVID-19 vaccines that could help poorer countries get more doses and speed the end of the pandemic. While the backing from two countries with major drugmakers is important, many obstacles remain.

The United States’ support for waiving the protections marked a dramatic shift in its own position, and many thought it could lead to a breakthrough, drawing cheers from activists and complaints from Big Pharma. Still, even just one country voting against a waiver would be enough to block efforts at the World Trade Organization.

With the administration’s announcement on Wednesday, the U.S. became the first country in the developed world with big vaccine manufacturing to publicly support the waiver idea floated by India and South Africa in October. And the vocal support that followed from French President Emmanuel Macron suggested that countries were reassessing their positions.

“I completely favor this opening up of the intellectual property,” Macron said Thursday on a visit to a vaccine center.

Like many pharmaceutical companies, Macron also insisted that a waiver of intellectual property rights will not solve the problem of access to vaccines. Those protections give companies that developed vaccines special rights about how the know-how is used — and by whom.

Even if those protections are eased, manufacturers in places like Africa are not now equipped to make COVID-19 vaccines — so donations of shots should be prioritized instead, Macron said.

Many other leaders chimed in — though not all expressed immediate support. Italian Foreign Minister Luigi Di Maio wrote on Facebook that the U.S. announcement was “a very important signal” and that the world needs “free access” to patents for the vaccines. But Italian Premier Mario Draghi was more circumspect.

Australian Prime Minister Scott Morrison called the U.S. position “great news” but did not directly respond to a question about whether his country would support a waiver. South Korean officials say they ware also paying close attention to the Biden administration’s call but also sidestepped questions on whether Seoul endorses the idea.

Russian President Vladimir Putin said his country would support it.

In closed-door talks at the WTO in recent months, Australia, Britain, Canada, the European Union, Japan, Norway, Singapore and the United States opposed the waiver idea, according to a Geneva-based trade official on condition of anonymity because he was not authorized to discuss the matter publicly.

Brazil was the only developing country to oppose it, while China and Russia — two other major COVID-19 vaccine makers — didn’t express a position either way but were open to more discussions, the official said.

Some 80 countries, mostly developing nations, have supported the Indian and South African proposal, the official said.

While Macron was forceful, others in Europe were not. The EU Commission president, Ursula von der Leyen, said the 27-nation bloc was ready to talk about the waiver idea, but remained noncommittal for now and emphasized that the bloc has been exporting vaccines widely — while the U.S. has not.

That echoed the position of the global pharmaceutical industry, which insists a faster solution would be for rich countries that have vaccine stockpiles to start sharing them with poorer ones. Several European leaders also underscored that.

“All countries around the world where vaccines are produced must be prepared to export it to others too,” said German Health Minister Jens Spahn. “The EU stands ready in word and deed.... We are happy if the U.S. is, too, now.”

EU leaders said the bloc will start discussing whether they should join the U.S. move, possibly at a summit that starts Friday.

The industry has resisted the waiver, insisting that production of coronavirus vaccines is complicated and can’t be ramped up by easing intellectual property protections. Instead, it says that reducing bottlenecks in supply chains and a scarcity of ingredients that go into vaccines are the more pressing issues for now.

“A waiver is the simple but the wrong answer to what is a complex problem,” said the International Federation of Pharmaceutical Manufacturers and Associations. “Waiving patents of COVID-19 vaccines will not increase production nor provide practical solutions needed to battle this global health crisis.”

The industry also says an IP waiver will do more harm than good in the long run. Easing patent protections would eat into their profits, reducing the incentives that push innovators to make the kind of tremendous leaps they did with the COVID-19 vaccines, which have been churned out at a blistering, unprecedented pace.

Critics and supporters have disagreed on whether there are any manufacturers standing by that could make the vaccines if they were given the blueprints. Those opposed have noted that the COVID-19 vaccines can be incredibly difficult to make.

Intellectual property expert Shyam Balganesh, a professor at Columbia Law School, said a waiver would remove “a lot of the bureaucracy” around WTO rules, but it would only go so far because of other bottlenecks in the manufacturing and distribution of vaccines.

But activists and public health advocates cheered the U.S. move, which marks a nearly complete reversal in U.S. policy under the Trump administration that was critical of both the WTO and the World Health Organization.

“A waiver of patents for #COVID19 vaccines & medicines could change the game for Africa, unlocking millions more vaccine doses & saving countless lives. We commend the leadership shown by South Africa, India & the United States, & urge others to back them,” WHO Africa chief Matshidiso Moeti tweeted.

Just over 20 million vaccine doses have been administered across the African continent, which counts some 1.3 billion people.

Gavi, the vaccine alliance that is co-leading the U.N.-backed effort to get shots to countries where they are needed, also welcomed the U.S. decision and an American commitment to also boost production of the raw materials that go into vaccines and are in short supply.

There is precedent. In 2003, WTO members agreed to waive patent rights and allow poorer countries to import generic treatments for HIV/AIDS, malaria and tuberculosis.

Many hope for a historic replay to fight COVID-19.

The Africa CDC director, John Nkengasong, told reporters: “We believe that when the history of this pandemic is written, history will remember the move by the U.S. government as doing the right thing at the right time.” 

https://apnews.com/article/africa-coronavirus-pandemic-global-trade-business-science-e60a859a0164f51aa20feb4b9b24b6a9

Patents not 'limiting factor' for vaccine production: BioNTech

 German firm BioNTech said Thursday that patent protection for Covid-19 vaccines is not holding back production or supply of the jabs that it developed with Pfizer.

"Patents are not the limiting factor for the production or supply of our vaccine. They would not increase the global production and supply of vaccine doses in the short and middle term," it told AFP in a statement, in a tacit rejection of a call from the United States to waive patent protections for Covid vaccines.

https://www.theaustralian.com.au/news/latest-news/patents-not-limiting-factor-for-vaccine-production-biontech/news-story/62596513f425f993502f8d737fbdd72f


Private Practices' Share of U.S. Medicine Continues to Shrink

 Fewer than half of U.S. physicians worked in private practice during 2020, continuing a trend that has accelerated in recent years, according to a survey by the American Medical Association (AMA).

Data collected from 3,500 U.S. physicians showed that 49.1% worked in physician-owned practices, a relative 9% decrease from the previous survey in 2018, when 54% of respondents said they worked primarily in private practice. The decline is the largest 2-year change since AMA started the biennial survey in 2012.

The shift away from private-practice settings has been in evidence for several years, but the magnitude of decline from 2018 to 2020 suggested the shift toward larger, nonphysician-owned practices has increased. The newest survey showed that 17.2% of physicians worked in practices with 50 or more physicians, as compared with 14.7% in 2018.

"There are several contributing factors to the ongoing shifts in practice size and ownership that include mergers and acquisitions, practice closures, physician job changes, and the different practice settings chosen by younger physicians compared to those of retiring physicians," said AMA President Susan R. Bailey, MD, in a statement.

"To what extent the COVID-19 pandemic was a contributing factor in the larger-than-usual changes between 2018 and 2020 is not clear. Physician practices were hit hard by the economic impact of the early pandemic as patient volume and revenues shrank while medical supply expenses spiked. The impact of these economic forces on physician practice arrangements is ongoing and may not be fully realized for some time," she added.

Despite the historically large shift away from private practice, the survey continued to reflect diversity in practice types, sizes, and ownership arrangements for medical practices. As a result, no single practice style or characteristic should be considered a "typical physician practice," according to the AMA.

Other key categorized findings from the survey included:

  • Employed physicians: 50.2% of all patient care physicians in 2020, as compared with 47.4% in 2018 and 41.8% in 2012
  • Self-employed physicians: 44% of all patient care physicans in 2020 versus 45.9% in 2018 and 53.2% in 2012
  • Ownership: About 40% of patient care physicians worked directly for hospitals or in practices at least partly owned by hospitals
  • Practice size: 53.7% work in practices of 10 or fewer physicians, as compared with 61.4% in 2012
  • Private-practice business structure: limited liability company (27.8%), S corporation (24.7%), C corporation (15%), partnership (~10%), and sole proprietorship (~10%)

The survey is part of the AMA Policy Research Perspective series examining long-term trends in medical practice arrangements and payment methods. It is available on the AMA website.

https://www.medpagetoday.com/practicemanagement/practicemanagement/92451