House passes bill aimed at curbing oil reserve sales to companies with Chinese influence

 The House on Thursday passed a bill aimed at restricting sales from the country’s oil reserves to China.

The legislation bars sales of oil from the Strategic Petroleum Reserve (SPR) to entities under the control, ownership or influence of the Chinese Communist Party, unless that oil will not be exported to China. 

The bill passed in a bipartisan 331-97 vote. All 97 “no” votes came from Democrats, but 113 Democrats joined all Republicans who voted in passing the measure.

The bill, however, is unlikely to advance past the Democrat-controlled Senate, but still represents a significant window into Republican energy and foreign policy priorities for the new Congress. 

Tom Kloza, the global head of energy analysis at the Oil Price Information Service, has expressed skepticism about the approach in the legislation that passed on Thursday, recently telling The Hill that it sounded “pretty silly.”

While some of the oil that was sold from the strategic reserve ended up in other countries, including China, Kloza said the impact on the U.S. economy would have been the same regardless of where those barrels had ended up.

“It is a world market and it’s like water seeking its own level and when you sold oil on the incremental market whether it moved to domestic sources or whether it moved overseas it did temper the enthusiasm for high-priced oil,” he said last week. 

Some of the companies that were able to buy oil from the release are U.S. subsidiaries of foreign companies. 

Republicans argued that the Biden administration’s move to sell off oil from the nation’s reserves last year was political — and said that if it benefitted China, it was harmful to the nation’s security. 

“America’s SPR is meant for true energy supply disruptions, like those caused by hurricanes and natural disasters, not to help China,” said House Energy and Commerce Chair Cathy McMorris Rodgers, according to a copy of her floor remarks. 

“Draining our strategic reserves for political purposes and selling portions of it to China is a significant threat to our national security,” she added. 

Meanwhile, Rep. Frank Pallone (N.J.) the energy panel’s top Democrat, said he also opposes exporting U.S. oil to China, but said the GOP measure did not adequately address that issue. 

“If Republicans were serious about addressing this issue, they would have brought forward a bill that banned all oil exports to China,” said a copy of his remarks. 

“SPR barrels sold to Chinese firms represented only 2 percent of all the oil we sent to China last year. If we truly want to address China using American oil to build its reserves, let’s actually take a serious look at that, rather than skirt around the issue because Republicans are scared of Big Oil’s wrath,” he added. 

Republicans are expected to soon take up a second bill targeting the country’s oil reserves after the party criticized Biden’s use of the reserves amid a supply crunch this year that followed Russia’s invasion of Ukraine. 

The Biden administration has defended its use of the SPR. 

“The Biden administration, like administrations of both parties have historically done, rightly authorized emergency use of the SPR mission to address supply disruptions –providing relief to American families and refineries when needed the most. Treasury estimated that the Biden administration’s releases reduced prices at the pump by up to $0.40/gallon,” the Energy Department recently told The Hill in an emailed statement. 

Meanwhile, the House has also been critical of China more broadly. House Republicans, joined by a large contingent of Democrats, this week passed a resolution to create a committee focused on competition with China.

https://thehill.com/policy/energy-environment/3810363-house-passes-bill-aimed-at-restricting-oil-reserve-sales-to-companies-with-chinese-influence/

JPM23: Is GSK’s 15-day accelerated approval withdrawal new normal? Califf reply

 In a surprising move, GSK recently pulled multiple myeloma therapy Blenrep off the U.S. market just 15 days after the drug flunked a confirmatory trial. The product pull came at the request of the FDA, and the company's speedy action prompted industry watchers to wonder if there's a new benchmark for removing indications under the agency's accelerated approval program.

But as FDA Commissioner Robert Califf sees it, the Blenrep case doesn’t apply to all accelerated approvals.

During an interview on the sidelines of the J.P. Morgan Healthcare Conference, Califf lauded GSK’s move as “a great sign of corporate responsibility." Still, not all confirmatory trial failures should trigger immediate product withdrawals, the FDA chief argued.

“There may be results that are just clear-cut, the thing didn’t work, but there may be patients who are taking the treatment who have concerns,” Califf said.

In recent years, the FDA has faced criticism for a lack of oversight around its accelerated approval program. The pathway allows the agency more leniency to approve drugs in diseases where patients have few or no good options, but it does require companies to complete confirmatory trials after the speedy nods.

Critics have said the agency isn't enforcing confirmatory trial requirements and that it's not forcing companies to pull their drugs from the market when products do fail these studies.

For example, Merck's Keytruda, when used as a monotherapy in third-line PD-L1-positive stomach cancer, failed confirmatory trials in late 2017 and the spring of 2019. But the FDA only publicly scrutinized the indication in 2021, leading Merck to pull the indication the same year. In contrast, GSK’s quick withdrawal sparked the attention of cancer drug developers.

In the past, the FDA has cited trial design flaws or remaining unmet medical to keep accelerated approvals in place despite confirmatory study flops. But more recently, the agency has started calling for quick withdrawals in problematic indications. The regulator generally wants more power to pull flawed indications.

“If the confirmatory study has clearly failed, then I think the companies have to step up and take these drugs off the market as rapidly as possible,” FDA’s oncology chief Richard Pazdur said during the Friends of Cancer Research annual meeting in November.

At the time, Pazdur lamented how many resources went into the FDA's battle with Roche over a breast cancer indication more than a decade ago. He called the experience a "nightmare."

“I believe very strongly we need more teeth," Califf said during the November meeting, “because once the approval occurs, it’s very difficult to hold back the marketeers.” One idea the agency has floated is a requirement that confirmatory studies are ongoing before the accelerated approval is granted

But despite this increased scrutiny, the FDA has consistently retained some wiggle room in its regulations.

The bar for obtaining an accelerated approval still depends on the indication and existing treatment options, Califf said this week at JPM. As for the timely initiation of confirmatory studies, Pazdur has told Fierce that several factors could affect the agency's final decision on accelerated nods, such as the breakthrough nature of the drug and how far along the research has progressed.

https://www.fiercepharma.com/pharma/jpm23-gsks-15-day-accelerated-approval-withdrawal-new-normal-hear-fda-commissioner-califfs

Vertex Leans into Gene Editing Space with Extended Arbor Pact

 Wednesday, Vertex Pharmaceuticals extended its existing strategic partnership with Arbor Biotechnologies to gain rights to the latter’s novel precision editing technology for up to three diseases.

Under the extended agreement, Arbor will be eligible for research, development, regulatory and commercial milestones. The Massachusetts-based biotech will also be entitled to tiered royalties on potential net sales of any product that may arise from this alliance.

The two companies first collaborated on gene-editing medicines in 2018, when Vertex made a $30 million upfront payment in a cystic fibrosis deal. In 2021, Vertex pledged up to $1.2 billion in milestone payments to expand this partnership to include ex vivo next-generation cell therapies for diabetes and blood diseases.

At the core of Wednesday’s extended partnership is Arbor’s precision editing technology, which uses the reverse transcriptase enzyme to accurately deliver therapeutic edits while limiting off-target side effects.

In a statement, Devyn Smith, Ph.D., CEO of Arbor, said that the company’s editors are specifically made to “provide more precise editing while being smaller in size to allow for further streamlined delivery and manufacturing.” This makes Arbor’s molecules attractive tools “in treating a broad range of diseases.”

Vertex in the Cell and Gene Therapy Space

Also headquartered in Massachusetts, Vertex has been expanding its presence in the cell and gene therapy space as of late.

In July 2022, the company inked a definitive acquisition agreement with ViaCyte, Inc. a private biotech focused on using stem cell-derived therapies to find a functional cure for type 1 diabetes (T1D). The transaction was valued at $320 million in cash.

ViaCyte’s buyout is projected to boost Vertex’s VX-880, an investigational allogeneic stem cell-derived, fully differentiated, insulin-producing islet cell therapy for T1D.

In a statement at the time, Reshma Kewalramani, M.D., CEO and president of Vertex, said “the acquisition of ViaCyte will accelerate our goal of transforming, if not curing T1D by expanding our capabilities and bringing additional tools, technologies and assets to our current stem cell-based programs.”

Aside from ViaCyte, Vertex is also working with CRISPR Therapeutics on exagamglogene autotemcel (exa-cel), an investigational one-time gene therapy for sickle cell disease and transfusion-dependent beta-thalassemia.

Exa-cel is an ex vivo CRISPR/Cas9-based therapy that uses a patient’s own hematopoietic stem cells that have been gene-edited to produce high levels of fetal hemoglobin. Last September, the FDA granted exa-cel rolling review and the companies expect to complete submission early this year.

https://www.biospace.com/article/vertex-leans-into-gene-editing-space-with-extended-arbor-pact/

Oramed Pharma Shares Sink After Diabetes Candidate Fails In Phase 3

 

• Oramed Pharmaceuticals Inc (NASDAQ: ORMP) announced top-line results from its Phase 3 trial (ORA-D-013-1) comparing the efficacy of ORMD-0801 to placebo in patients with Type 2 Diabetes (T2D) at 26 weeks.

• ORA-D-013-1 enrolled 710 patients with T2D and inadequate glycemic control on two or three oral glucose-lowering agents.

• The ORA-D-013-1 trial did not meet its primary endpoint, which compared the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by the mean change from baseline in A1C at 26 weeks.

• The trial also did not meet its secondary endpoint, which assessed the mean change from baseline in fasting plasma glucose at 26 weeks.

• There were no serious drug-related adverse events. Therefore, Oramed expects to discontinue its oral insulin clinical activities for T2D.

• CEO Nadav Kidron commented, "Today's outcome is very disappointing, given the positive results from prior trials. Once full data from the studies are available, we expect to share relevant learnings and future plans."

• In November, Oramed announced additional data from its Phase 2 trial (ORA-D-N02) of oral insulin candidate (ORMD-0801) to reduce liver fat content in Type 2 Diabetes patients with non-alcoholic steatohepatitis (NASH).

• The whole Liver showed a placebo-adjusted mean decrease in liver fat content of 0.96 with a placebo-adjusted median decrease of 6.0 for ORMD-0801.

https://finance.yahoo.com/news/oramed-pharma-shares-sink-diabetes-111906372.html

Deadline Passes For Pfizer To Submit Post-Vaccination Heart Inflammation Study To US Regulators

 by Zachary Stieber  via The Epoch Times (emphasis ours),

The deadline has passed for Pfizer to submit the results of a study exploring the frequency of heart inflammation following receipt of the company’s COVID-19 vaccine.

Pfizer was required by the U.S. and Food and Drug Administration (FDA) to conduct multiple studies on its vaccine after the FDA approved the shot in August 2021 because regulators determined that without the studies, there would not be sufficient data to assess the “known serious risks of myocarditis and pericarditis,” or heart inflammation and a related condition.

Regulators were also concerned about the potential risk of subclinical myocarditis, or heart inflammation without typical symptoms.

The FDA told Pfizer to carry out six studies, with various deadlines for completion and reporting final results to the agency. The first final deadline arrived on Dec. 31, 2022.

Pfizer was required to submit a report on the study, which was to assess the incidence of subclinical myocarditis following administration of a third dose of Pfizer’s vaccine, or a booster shot, in people aged 16 to 30.

It’s unclear whether Pfizer met the deadline. The company and the FDA did not respond to requests for comment, and neither have issued any information about the study or its results since the deadline passed.

According to the FDA, Pfizer had until June 30, 2022, to complete the study and then another six months to prepare and submit the final results.

In a Dec. 8, 2022, memorandum explaining why the FDA authorized Pfizer’s bivalent booster without any clinical data, FDA officials noted that Pfizer was “conducting additional safety-related post-authorization/post-marketing studies for the PfizerBioNTech COVID-19 Vaccine, including post-marketing requirements to assess known serious serious risks of myocarditis and pericarditis and an unexpected serious risk of subclinical myocarditis..”

‘Shouldn’t Have to Ask’

The results of the study should be shared promptly, according to Jessica Adams, a former regulatory officer at the FDA.

“We shouldn’t have to ask or demand this information. We should expect that it’d be promptly shared by default,” Adams wrote on Twitter.

Dr. Janet Woodcock, the agency’s principal deputy director, told Adams in an email that the FDA is “not allowed to comment on potential actions on regulated products.”

It’s not clear how reporting results on a study relates to potential regulatory actions.

In light of the growing amount of evidence related to post-vaccination adverse events, some others are questioning the FDA’s delay in sharing information on the study.

“Why are FDA officials dragging their feet on making Pfizer’s prospective study data on subclinical myocarditis available to the public when evidence has been published in the medical literature that Pfizer’s pre-EUA clinical trials revealed ‘a 36 percent higher risk of serious adverse events in vaccinated participants in comparison to placebo recipients,'” Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times via email.

She was citing a reanalysis of the original trial data that found vaccinated participants had a higher risk of serious adverse events.

“With 79 percent of Americans having received at least one COVID shot and so many vaccinated young adults, especially physically fit athletes suffering heart attacks and sudden deaths, public health officials should insist that the company with the biggest market share of the COVID vaccine business in the U.S. be completely transparent about what it knows about the biological mechanisms of heart inflammation induced by the mRNA COVID vaccine Pfizer maintains is both safe and effective,” Fisher added.

Warning

The FDA added a warning about myocarditis following Pfizer and Moderna vaccination to patient and health care provider fact sheets in June 2021. Both vaccines utilize messenger RNA (mRNA) technology. Prospective vaccine recipients were told the risk of myocarditis was increased after vaccination, particularly after the second dose of the two-dose primary series.

If certain symptoms appeared after vaccination, such as chest pain or shortness of breath, people were told to immediately seek medical care.

U.S. authorities, and some officials elsewhere, have since acknowledged that the vaccines cause heart inflammation.

“The current evidence supports a causal association between mRNA COVID-19 vaccination and myocarditis and pericarditis,” Dr. Tom Shimabukuro, a top CDC official, said during a meeting in 2022.

Some cases of the post-vaccination inflammation have ended in death.

Some 5,163 reports of post-vaccination myocarditis, pericarditis, or myopericarditis have been filed with the Vaccine Adverse Event Reporting System (VAERS), a passive early warning system that alerts officials to possible side effects from vaccines. The reports don’t prove a connection with a vaccine but are an undercount of the true number of cases, research has found and authorities have acknowledged.

More than 800,000 other adverse events following receipt of the Pfizer vaccine have been lodged with the system.

Moderna Studies

The FDA also required Moderna to conduct post-approval studies after approving the company’s shot in early 2022.

Moderna was told to carry out six studies, the same number as Pfizer, focusing on assessing the incidence of myocarditis and pericarditis, the long-term impact of myocarditis, and the occurrence of subclinical myocarditis.

Two studies were due to be completed by Dec. 31, 2022, but the deadlines for submission of the results to the FDA aren’t until June 30, 2023.

Other deadlines for the Moderna and Pfizer studies stretch months or even years into the future, including one in 2025 and one in 2028.

https://www.zerohedge.com/covid-19/deadline-passes-pfizer-submit-results-post-vaccination-heart-inflammation-study-us

Looking old for your age may lead to health problems: study

 People who look older than they actually are could be more prone to developing age-related conditions such as cataracts and osteoporosis, according to a new study published Tuesday in the British Journal of Dermatology.

“In other words, if you look younger than you are, then the health of your organ systems, body and mind are likely to reflect this,” lead author Tamar Nijsten, a dermatologist at Erasmus University Medical Center Rotterdam, told the Daily Mail.

The Netherlands study involved gathering photographs and medical histories of 2,679 European people between the ages of 51 and 87. An independent panel assessed the photos.

Researchers found the people who looked five years younger than their actual age performed better on cognitive tests and were 24% less likely to get osteoporosis and 15% less likely to develop chronic obstructive pulmonary disease.

A new study shows those who appear to look older may face greater health risks.

Getty Images
People who looked younger were also at less risk for cataracts and age-related hearing loss, the study determined.

The panel of 27 people were asked to guess the age of the person in the image.

Each subject was assigned a perceived age score, which the study authors calculated by taking the difference between the person’s actual age and estimated age.

If the panel thought someone looked four years younger than their photo, they would receive a perceived age score of four — meaning the higher you score, the younger you look.

The medical specialists also examined the subjects’ health and lifestyle habits, finding those who looked younger had better results in key areas.

Researchers believe there’s a link between health conditions, the facial aging process and changes in tissue and bone density.

“The study clearly demonstrates that something is going on, likely on a biological level and beyond the usual lifestyle factors such as UV exposure or smoking,” Nijsten told the Daily Mail.

https://nypost.com/2023/01/11/looking-old-for-your-age-may-lead-to-health-problems-study/

Hochul: Not enough ‘statewide interest’ in migrant issue to bring up in State of the State

 Gov. Kathy Hochul said Wednesday that she did not talk about the huge inflow of migrants into the five boroughs while unveiling her 2023 legislative priorities Tuesday because the problem is not important enough to New Yorkers.

“In my State of the State, there’s hundreds of other proposals for talking about. I was focusing on my key signature areas that have broad, statewide interest — housing, mental health challenges, the childcare and the minimum wage,” she told reporters about her speech covering topics from rising crime to community gardens.

While Hochul claimed lack of interest, New York City Mayor Eric Adams has warned that the ongoing arrival of tens of thousands of people bussed from other states like Texas could bankrupt the Big Apple considering the cost of housing them.

“This is an expensive endeavor that we are in and we have to find ways of carrying out this task without bankrupting the city,” he said.

Hochul has joined Adams’ call for the feds to pick up the tab while arguing the migrants could give the state a big boost if they were allowed to legally work.

Mayor Eric Adams has warned that the Big Apple cannot afford to absorb an inflow of migrants without help from state and federal leaders.

Gregory P. Mango

“As we said yesterday, there was much to celebrate in Governor Hochul’s address, and we look forward to continuing to collaborate with the governor on a number of issues, including the topic of asylum seekers, in the upcoming budget,” Adams spokesman Fabien Levy said about Hochul’s comments Wednesday.

Hochul did find time Tuesday to reminisce about her parents starting their “married life in a trailer park” before bragging about her time as governor, including a deal her administration help land to create a new microchip hub in the Syracuse area.

“We’ve had many conversations with the Mayor on what the needs of the city are. We’ll be talking about things as the process plays out, but also we have put substantial — millions of dollars — for providing legal services to the people newly arrived because that’s how they get on the path to having opportunity, the pathway to be able to get the status, to be able to get a job,” Hochul added Wednesday.

Yet, the newly-elected Hochul steered the conversation away from the touchy issue Tuesday while enjoying the soapbox provided by her 47-minute speech to Albany lawmakers ahead of state budget negotiations.

The word “migration” only entered the one-way conversation while she outlined how she would battle the “out-migration” of New Yorkers to other states.

“This issue has gone from non-existent to near-existential, and the mayor should not be the only Democratic elected official pressuring the Biden administration for relief,” City Councilman Joe Borelli (R-Staten Island) told The Post.

Hochul made no mentions of “migrants” in her State of the State speech.

Hans Pennink/AP

“This should have been a blurb at the least,” he added.

A 277-page briefing book provided to reporters made a few mentions about how Hochul might propose that tens of thousands of new residents, many of whom only speak Spanish, might get the social services and support they need to make their way to a new life in New York.

Republican state Sen. George Borrello (R-Jamestown) suggested that Hochul might have her reasons for keeping migrants out of the limelight during her State of the State address while making her arguments about other controversial issues like possible changes to bail reform.

“I think it’s a negative for her no matter how she approaches it. Eric Adams is calling it a crisis that is having a huge negative impact on NYC. But she knows the progressives support the idea of a sanctuary city,” he said.

https://nypost.com/2023/01/11/kathy-hochul-says-migrant-not-big-enough-issue-to-bring-up-in-state-of-the-state-speech/