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CDER director on accelerated approval reforms and a court decision that will ‘send a chill’ across rare disease drug development

At the second of two hearings before the Senate Health, Education, Labor & Pensions Committee on the must-pass legislation (by the end of September)…

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At the second of two hearings before the Senate Health, Education, Labor & Pensions Committee on the must-pass legislation (by the end of September) regarding the funds from biopharma industry applications that will keep the FDA afloat over the next five years, CDER director Patrizia Cavazzoni raised particular concerns about a recent court decision while laying out several requests for congressional accelerated approval reforms.

Patrizia Cavazzoni

Responding to a question from Sen. Tammy Baldwin (D-WI), Cavazzoni said she wants to work with Congress to find a solution after a recent court decision against the FDA “will send a chill into the development of rare diseases and it will disproportionately affect children with rare diseases. It’s essential to continue to generate the study of drugs in children, so this decision will really go counter to that.”

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

https://endpts.com/catalyst-wins-reversal-in-orphan-exclusivity-court-battle-with-fda/[/realted]

The situation right now, Cavazzoni said, following the court’s decision “is a sponsor could study a disease in a very narrow segment of the population and then be able to block further approvals throughout the entire condition that that drug could address.”

Sen. Susan Collins (R-ME) also raised questions with Cavazzoni regarding CMS’ recent decision to not cover Biogen’s controversial Alzheimer’s drug, and its discussion of the safety of the drug.

Cavazzoni defended the approval, saying the data “are solid and the drug is appropriately made available to patients based on FDA’s decision. It’s important to distinguish FDA and CMS’ roles,” she said, adding that FDA is solely responsible for determining safety and effectiveness, and CMS has a different standard, reasonable and necessary, which translate into the setting in how the drug is covered.

“There are some areas when it comes to accelerated approval where we could use some help from Congress,” Cavazzoni said, noting that FDA doesn’t have the authority to require that confirmatory trials are started or be underway by the time the drug is approved, or at least have a detailed plan to conduct those trials.

“Another area we can use some help is in expediting the withdrawal of drugs when the confirmatory trials do not confirm the drug is associated with clinical benefit,” Cavazzoni said. “Right now the expedited withdrawal path is anything but expedited. It can take up to 2 years and require lots of resources and lots of administrative burden.”

Committee Chair Sen. Patty Murray of Washington acknowledged that the user fee programs in general have an important role, and they ensure that more drugs and devices cross the finish line and that the FDA gets the appropriate resources.

Richard Burr

“It should be unthinkable that after 2 years, when FDA’s work has been more important than ever, that we would fail to get this done or force the agency to send pink slips,” Murray said, while saying that they should look back at this pandemic — from FDA’s work to review and approve vaccines quickly to other issues like testing struggles and the hydroxychloroquine debacle.

The top Republican member of the committee, Richard Burr of North Carolina, raised concerns about the current lack of funds flowing into biotech in general, and said today’s hearing was about accountability, while mentioning the need for FDA “to speed not only the review of products but their development as well.”

He also raised several concerns, highlighting several benchmarks the agency failed to meet in the last user fee agreement.

“Now FDA wants double the money for mediocre performance improvements,” Burr said. “The more you use the user fee process to bully dollars out of industry, holding them hostage, the less accountable the FDA is.”

Peter Marks

CBER director Peter Marks also explained the current situation of Covid-19 vaccines for the youngest group of children (under 5), saying that as soon as the FDA receives an application, “we’ll move quickly. It’s one of our highest priorities.”

Again he said that an adcomm of outside experts will meet and review the data on the vaccines too, and in the next week, Marks said, the FDA will release a tentative timeline for those meeting(s) as the agency reviews these 2 applications from Pfizer and Moderna. He also stressed that the FDA can’t start or finish its reviews until the complete applications are submitted.

Companies often release statements ahead of the FDA on when such applications are fully submitted, he noted.

On the topic of vacancies, which is always a tenuous topic at the FDA as several senior vaccine and other leaders moved on recently, Cavazzoni said CDER is looking to fill roles for about 7-8% of its staff, which “isn’t a high rate for a large organization,” she said.

In response to questions over the recently unveiled McKinsey conflicts of interest with FDA regarding their opioid work, Cavazzoni stressed that CDER doesn’t have any contracts with McKinsey, and while McKinsey had worked with FDA, its work with FDA did not entail specific scientific reviews of products or processes.

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China Suggests It Could Maintain ‘Zero COVID’ Policy For 5 Years

China Suggests It Could Maintain ‘Zero COVID’ Policy For 5 Years

Authored by Paul Joseph Watson via Summit News,

China has suggested it will…

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China Suggests It Could Maintain 'Zero COVID' Policy For 5 Years

Authored by Paul Joseph Watson via Summit News,

China has suggested it will maintain its controversial ‘zero COVID’ policy for at least 5 years, eschewing natural immunity and guaranteeing repeated rounds of new lockdowns.

“In the next five years, Beijing will unremittingly grasp the normalization of epidemic prevention and control,” said a story published by Beijing Daily.

The article quoted Cai Qi, the Communist Party of China’s secretary in Beijing and a former mayor of the city, who said that ‘zero COVID’ approach would remain in place for 5 years.

After the story prompted alarm, reference to “five years” was removed from the piece and the hashtag related to it was censored by social media giant Weibo.

“Monday’s announcement and the subsequent amendment sparked anger and confusion among Beijing residents online,” reports the Guardian.

“Most commenters appeared unsurprised at the prospect of the system continuing for another half-decade, but few were supportive of the idea.”

Although western experts severely doubt official numbers coming out of China, Beijing claimed success in limiting COVID deaths by enforcing the policy throughout 2021.

However, this meant that China never achieved anything like herd immunity, and at one stage the Omicron variant caused more more coronavirus cases in Shanghai in four weeks than in the previous two years of the entire pandemic.

Back in May, World Health Organization Director General Tedros Adhanom Ghebreyesus suggested that China would be better off if it abandoned the policy, but Beijing refused to budge.

As we previously highlighted, the only way of enforcing a ‘zero COVID’ policy is via brutal authoritarianism.

In Shanghai, children were separated from their parents in quarantine facilities and others were left without urgent treatment like kidney dialysis.

Panic buying of food also became a common occurrence as the anger threatened to spill over into widespread civil unrest.

Former UK government COVID-19 advisor Neil Ferguson previously admitted that he thought “we couldn’t get away with” imposing Communist Chinese-style lockdowns in Europe because they were too draconian, and yet it happened anyway.

“It’s a communist one party state, we said. We couldn’t get away with it in Europe, we thought,” said Ferguson.

“And then Italy did it. And we realised we could,” he added.

*  *  *

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Tyler Durden Tue, 06/28/2022 - 18:05

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No sign of major crude oil price decline any time soon

Bullish pressure on crude oil markets doesn’t seem to be easing Crude oil prices fell last week, notching their second weekly decline in the face of…

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Bullish pressure on crude oil markets doesn’t seem to be easing

Crude oil prices fell last week, notching their second weekly decline in the face of concern that rising interest rates could push the global economy into recession.

Yet the future of crude oil still seems bullish to many. Spare capacity, or lack of it, is just one of the reasons.

The global surplus of crude production capacity in May was less than half the 2021 average, the U.S. Energy Information Administration (EIA) reported on Friday.

The EIA estimated that as of May, producers in nations not members of the Organization of Petroleum Exporting Countries (OPEC) had about 280,000 barrels per day (bpd) of surplus capacity, down sharply from 1.4 million bpd in 2021. It said 60 per cent of the May 2021 figure was from Russia, which is increasingly under sanctions related to its invasion of Ukraine.

The OPEC+ alliance of oil producers is running out of capacity to pump crude, and that includes its most significant member, Saudi Arabia, Nigerian Minister of State for Petroleum Resources Timipre Sylva told Bloomberg last week.

“Some people believe the prices to be a little bit on the high side and expect us to pump a little bit more, but at this moment there is really little additional capacity,” Sylva said in a briefing with reporters on Friday. “Even Saudi Arabia, Russia, of course, Russia, is out of the market now more or less.” Nigeria was also unable to fulfil its output obligations, added Sylva.

Recent COVID-19-related lockdowns in parts of China – the world’s largest crude importer – also played a significant role in the global oil dynamics. The lack of Chinese oil consumption due to the lockdowns helped keep the markets in a check – somewhat.

Oil prices haven’t peaked yet because Chinese demand has yet to return to normal, a United Arab Emirates official told a conference in Jordan early this month. “If we continue consuming, with the pace of consumption we have, we are nowhere near the peak because China is not back yet,” UAE Energy Minister Suhail Al-Mazrouei said. “China will come with more consumption.”

Al-Mazrouei warned that without more investment across the globe, OPEC and its allies can’t guarantee sufficient supplies of oil as demand fully recovers from the pandemic.

But the check on the Chinese crude consumption seems to be easing.

On Saturday, Beijing, a city of 21 million-plus people, announced that primary and secondary schools would resume in-person classes. And as life seemed to return to normal, the Universal Beijing Resort, which was closed for nearly two months, reopened on Saturday.

Chinese economic hub Shanghai, with a population of 28 million-plus people, also declared victory over COVID after reporting zero new local cases for the first time in two months.

The two major cities were among several places in China that implemented curbs to stop the spread of the omicron wave from March to May.

But the easing of sanctions should mean oil’s price trajectory will resume its upward march.

In the meantime, in the U.S., the Biden administration is eying tougher anti-smog requirements. According to Bloomberg, that could negatively impact drilling across parts of the Permian Basin, which straddles Texas and New Mexico and is the world’s biggest oil field.

While the world is looking for clues about what the loss of supply from Russia will mean, reports are pouring in that the ongoing political turmoil in Libya could plague its oil output throughout the year.

The return of blockades on oilfields and export terminals amid renewed political tension is depriving the market of some of Libya’s oil at a time of tight global supply, said Tsvetana Paraskova in a piece for Oilrpice.com.

And in the ongoing political push to strangle Russian energy output, the G7 was reportedly discussing a price cap on oil imports from Russia. Western countries are increasingly frustrated that their efforts to squeeze out Russian energy supplies from the markets have had the counterproductive effect of driving up the global crude price, which is leading to Russia earning more money for its war chest.

To tackle the issue, and increase pressure on Russia, U.S. Treasury Secretary Janet Yellen is proposing a price cap on Russian crude oil sales. The idea is to lift the sanction on insurance for Russian crude cargo for countries that accept buying Russian oil at an agreed maximum price. Her proposal is aimed at squeezing Russian crude out of the market as much as possible.

So the bullish pressure on crude oil markets doesn’t seem to be easing.

By Rashid Husain Syed

Toronto-based Rashid Husain Syed is a respected energy and political analyst. The Middle East is his area of focus. As well as writing for major local and global newspapers, Rashid is also a regular speaker at major international conferences. He has provided his perspective on global energy issues to the Department of Energy in Washington and the International Energy Agency in Paris.

Courtesy of Troy Media

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WTI Extends Gains After Unexpected Crude Draw

WTI Extends Gains After Unexpected Crude Draw

Oil prices are higher today following relatively positive news from China (easing some of its…

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WTI Extends Gains After Unexpected Crude Draw

Oil prices are higher today following relatively positive news from China (easing some of its COVID quarantine restrictions), Macron-inspired doubts over the ability of Saudi Arabia and the United Arab Emirates to significantly boost output, and unrest in Ecuador and Libya helped lift prices.

“We’re in the crunch period, it’s hard to see any meaningful price relief for crude,” said John Kilduff.

There’s a lot of strength with China relaxing its Covid restrictions and starting its independent refiners, “we’re going to have another chunk of demand for crude oil,” as China relaxes its Covid-19 restrictions.

With no EIA data released last week due to a "systems issue" (they have issued a statement confirming that the data - and the newest data - will both be released tomorrow), the only guidance we have for now on the past week's inventory changes is from API...

API (last week)

  • Crude +5.607mm

  • Cushing -390k

  • Gasoline +1.216mm - first build since March

  • Distillates -1.656mm

API (this week)

  • Crude -3.799mm

  • Cushing -650k

  • Gasoline +2.852mm

  • Distillates +2.613mm

Crude stocks unexpectedly fell last week, almost erasing the major build from the week before (according to API). Gasoline stocks rose for the second straight week

Source: Bloomberg

WTI was hovering around $111.75 and pushed up to $112 after the unexpected crude draw...

Finally, we note that the tight supply situation in oil (especially European) is revealing itself in the WTI-Brent spread, grew to $6.19, the widest in almost three months.

“European demand will remain robust, especially as natural gas supplies run out, while the North American demand for crude is weakening,” said Ed Moya, senior market analyst at Oanda.

This is not good news for President Biden as prices are rising...

And his ratings are hitting record lows.

Tyler Durden Tue, 06/28/2022 - 16:37

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