Search This Blog

Thursday, June 1, 2023

US tries to force company to issue recall of air bag inflators

 The U.S. government is stepping up its quest to force ARC Automotive to recall 67 million potentially dangerous air bag inflators by ordering the company to answer questions under oath and threatening fines if it doesn’t respond.

NHTSA argues that the recall is justified because two people have been killed in the United States and Canada and at least seven others have been injured by ARC’s inflators. The explosions, which first occurred in 2009, have continued as recently as this year.

The special order from the National Highway Traffic Safety Administration asks multiple questions about whether ARC expects any of its inflators to blow apart in the future, and whether it has notified customers about the risk.

The agency wants ARC Automotive Inc., based in Knoxville, Tennessee, to recall the inflators, which could explode with such force as to blow apart a metal canister and expel shrapnel. But ARC is refusing, setting up a possible court fight.

ARC maintains that no safety defect exists, that NHTSA’s demand is based on a hypothesis rather than technical conclusions and that the agency has no authority to order a parts manufacturer to carry out recalls.

NHTSA has tentatively concluded that the inflators are defective. The next steps are a final conclusion, public hearing and potential lawsuit asking a judge to order a recall.

Since ARC inflators can be in both driver and passenger front air bags, people who travel in at least 33 million U.S. vehicles could be at risk.

https://thehill.com/homenews/4029826-us-tries-to-force-company-to-issue-recall-of-air-bag-inflators-after-deaths-injuries/

ATF: Marijuana users in Minnesota can’t own firearms despite new law

 Just one day after Minnesota legalized the recreational use of marijuana, an agency that regulates the use of firearms warned that any current user of marijuana is prohibited from possessing firearms or ammunition.  

The Bureau of Alcohol, Tobacco, Firearms and Explosives (AFT) field office in St. Paul, Minn., issued the clarification Tuesday shortly after Gov. Tim Walz (D) signed a bill legalizing recreational marijuana. The clarification states that under federal law, current users of marijuana are prohibited from possessing, receiving, transporting or shipping firearms or ammunition.  

“Until marijuana is legalized federally, firearms owners and possessors should be mindful that it remains federally illegal to mix marijuana with firearms and ammunition,” Jeff Reed, ATF’s acting special agent in charge of the St. Paul Field Division, said in a statement.

“As regulators of the firearms industry and enforcers of firearms laws, we felt it was important to remind Minnesotans of this distinction as the marijuana laws adjust here in the State of Minnesota.” 

According to an analysis by the RAND Corporation, nearly 40 percent of residents in Minnesota reported owning a gun between 2007 and 2016. According to the Centers for Disease Control and Prevention, about 18 percent of Americans reported using marijuana in 2019.  

The agency said that those looking to purchase firearms must attest whether they are a user of marijuana on their applications. The agency also noted that there is no exception for those who marijuana for medical purposes.  

On Tuesday, Minnesota became the 23rd state in the nation to fully legalize marijuana, allowing those 21 and older to carry up to 2 ounces of marijuana and possess 2 pounds of the substance at home beginning Aug. 1.  

“We’ve known for too long that prohibiting the use of cannabis hasn’t worked,” Walz said in a statement. “By legalizing adult-use cannabis, we’re expanding our economy, creating jobs, and regulating the industry to keep Minnesotans safe.” 

https://thehill.com/homenews/state-watch/4028705-atf-marijuana-users-in-minnesota-cant-own-firearms-despite-new-law/

Leaked documents show Iran planning new phase of attacks against US troops in Syria: WaPo

 Newly revealed leaked documents reveal Iran could be readying for new attacks against U.S. troops in Syria, according to a new Washington Post report.

The Post reports Iran is arming militants in Syria and building and training forces to use bombs specifically intended to target U.S. military vehicles — and to kill U.S. personnel. 

The escalatory move could risk U.S. lives in the region and prompt a more direct military confrontation with Tehran, according to the report. 

Another leaked document reportedly shows Russia, Syria and Iran are working on a broader effort to push the U.S. out of Syria. The U.S. has maintained a military presence in the country to guard against a resurgence of Islamic State militants.

he Post reports the documents show Russian, Iranian and Syrian officials met last year to agree on a “coordination center” — though the Post notes the documents don’t indicate Russia is directly involved in planning the purported bombing campaign.

A Department of Defense contractor was killed and five U.S. service members were wounded in northeast Syria in March when a suspected Iranian-origin drone struck a facility on a Coalition base near Hasakah. 

The U.S. in turn ordered strikes on facilities used by groups affiliated with Iran’s Revolutionary Guard. President Biden said the U.S. would respond “forcefully” to protect its personnel in the region, though he stressed the U.S. “does not seek conflict with Iran.”

https://thehill.com/policy/international/4029985-leaked-documents-show-iran-planning-new-phase-of-attacks-against-us-troops-in-syria-report/

Greene says McCarthy will release Jan. 6 tapes to three more outlets

 Rep. Marjorie Taylor Greene (R-Ga.) announced Wednesday that three additional media outlets will receive access to footage from the Jan. 6 attacks on the Capitol.  

“Huge news: As I promised the J6 tapes will be released,” Greene tweeted.

Greene said in her post that three outlets will receive “unfettered access to the J6 tapes,” noting that reporting on it will start Thursday. House Speaker Kevin McCarthy (R-Calif.), according to Greene, will give the tapes to Just the News founder John Solomon and Julie Kelly, a senior writer at American Greatness — but she did not mention what the third outlet would be.

Discussions over whether the Jan. 6 tapes should be released to media outlets ramped up earlier this year after McCarthy granted former Fox News host Tucker Carlson access to more than 44,000 hours of footage from the attacks on the Capitol. The move prompted criticism from Democrats and media pundits who warned that the footage could threaten security procedures at the Capitol.  

When airing the footage on his program, Carlson described the attacks as “mostly peaceful chaos.”  

That prompted Greene to reiterate her calls to publicly release all the Jan. 6 footage, saying earlier this month that she was “wondering” when the tapes would be released.

“We need to release the J6 tapes to a public on line source so that everyone knows what did and didn’t happen, we need to restore fair justice, and America can move on,” she tweeted at the time

News organizations filed a lawsuit last month to gain access to the tapes, alleging that federal agencies have not given them the requested footage. The news organizations also wrote that they had asked McCarthy to grant them access to the footage.

“Plaintiffs have continued to press the Speaker’s Office for access to the videos as quickly as possible and on equal terms with other media requestors, only to be told that the Speaker’s Office will not even provide a timeline for when such access might begin,” the complaint states. 

The outlets included in the lawsuit are Advance Publications, The Associated Press, CNN, CBS, The E.W. Scripps Company, Gannett, The New York Times, Politico and ProPublica. 

The Hill has reached out to McCarthy’s office for comment.  

https://thehill.com/blogs/blog-briefing-room/4028956-greene-says-mccarthy-will-release-jan-6-tapes-to-three-more-outlets/

'COVID clawback in debt limit deal spurs public health fears'

 Some public health advocacy groups are sounding the alarm over a provision in the debt ceiling deal to claw back about $27 billion in unspent pandemic relief money, arguing it could have consequences for future public health initiatives. 

Unspent COVID-19 dollars have long been a target of Republicans, and taking back some of that money gives Speaker Kevin McCarthy (R-Calif.) a political win.

The federal COVID-19 public health emergency ended earlier this month, and President Biden had indicated he was open to a deal that included coronavirus funding rescissions. That clawback was included in the final measure to raise the debt limit, which cleared the House in a bipartisan 314-117 vote Wednesday and now heads to the Senate, where leaders hope it will pass quickly ahead of a Monday deadline given by the Treasury Department.

According to the White House, some of the unspent money will now be used to help shore up nondefense spending. 

“The appropriators will use some of that money to spread around how they see fit,” said Shalanda Young, director of the White House Office of Management and Budget. “We didn’t get into the individual line items in this bill.”

According to the Congressional Budget Office, a majority of the reductions would come from the Public Health and Social Service Emergency Fund, as well as from certain infrastructure and disaster relief programs.

Over the course of the pandemic, Congress appropriated nearly $5 trillion to various programs and agencies — including the Department of Health and Human Services (HHS), the Small Business Administration, the Department of Veterans Affairs and the Transportation Department.

Across HHS, Congress would take back more than $13 billion from the Centers for Disease Control and Prevention, the Food and Drug Administration and other agencies for programs including vaccine efficacy and supply chain monitoring.

The funds were unspent for a variety of reasons. According to a summary circulated by the White House and obtained by The Hill, some of the programs had concluded, and there was no longer demand for others.  

Still, advocates said they are concerned lawmakers have not learned lessons from the pandemic. 

“I think the issue is that it just speaks to this notion of nothing happened between 2020 and 2023,” said Ellie Dehoney, senior vice president of policy and advocacy at Research!America.

HHS saw a tremendous infusion of cash during the pandemic. According to the Government Accountability Office, six pandemic relief laws appropriated about $349 billion to HHS’s Public Health and Social Services Emergency Fund between March 2020 and March 2021. 

For context, the White House’s 2024 budget request would provide about $278 million for the emergency fund, which would be about $160 million more than what was enacted in the fiscal 2023 spending bill.

The White House summary indicated there was about $20 billion remaining in the fund and said it was able to keep $10 billion to develop the next generation of vaccines, test procurement and research into long COVID.

Georges Benjamin, executive director of the American Public Health Association, said he understands the agreement was probably the best-case scenario with Republicans in control of the House. 

Still, his primary concern was that public health is being sacrificed to make fiscal ends meet.

“They didn’t do this to the military budget. The military didn’t just crash the economy … but an infectious disease did. And we’re still inadequately investing in infectious disease right now,” Benjamin said.

But other experts said the immediate impact will not be significant because the White House was able to protect key investments.

Jen Kates, a senior vice president and global health expert at KFF, said it’s not totally clear what the funds would have been used for. 

As recently as last year, the Biden administration was asking Congress for more money. Republicans rebuffed the requests and insisted the White House hadn’t given an adequate accounting of where the previously appropriated funds had been spent. 

“I think that the federal government has not always shown the details of what [money] is left and why. And I think that doesn’t make your case very well,” Kates said. 

“Congress has basically said COVID is over … they want this money to come back. They have not had any appetite to provide more funding. In their view, COVID is done, and so the fact that this money was sitting there without a clear sense of why did not help [the administration’s] case,” Kates said. 

The larger concern for many is the legislation’s cap on nondefense discretionary spending will be kept roughly flat for 2024 and then given a 1 percent increase in 2025.

The cap could significantly curb spending for health agencies including the Centers for Disease Control and Prevention and the National Institutes of Health, which have been facing GOP attacks. 


https://thehill.com/policy/healthcare/4029227-covid-clawback-in-debt-limit-deal-spurs-public-health-fears/

US FDA approval and panel tracker: May 2023

 Last month the FDA granted approval for the first and second ever respiratory syncytial virus vaccines, from GSK and Pfizer respectively. Both companies have committed to conducting postmarketing studies to assess signals of Guillain-Barré syndrome and other immune-mediated demyelinating conditions. Another big event for the jabs is looming, with the CDC's advisory committee on immunization practices due to meet on 21 June to discuss how the vaccines should be used. Both companies anticipate launch before the upcoming RSV season. Separately Pfizer also gained a positive adcom for Abrysvo’s use in very young children, via maternal vaccination. Sarepta had its ups and downs in May: after a favourable adcom for its DMD gene therapy contender SRP-9001, the FDA decided to postpone the final decision until 22 June. An accelerated approval is now expected to be restricted to patients aged 4-5 years old. And Intercept's Nash dream came crashing down again as an adcom voted against obeticholic acid, causing shares to sink to a record low. The final nail in the coffin, another CRL, is expected later this month.

This snippet has been updated to include Pfizer's postmarketing plans for its RSV vaccine in older adults.

Notable first-time US approval decisions in May 2023
ProjectCompanyIndication(s)2028e SBI ($m)Outcome
SRP-9001 (delandistrogene moxeparvovec)SareptaAmbulatory patients with Duchenne muscular dystrophy with a confirmed mutation in the DMD gene2,036Delayed from 29 May until 22 June, positive adcom
Veozah (fezolinetant)AstellasModerate-to-severe vasomotor symptoms associated with menopause1,904Approved
ArexvyGSKPrevention of lower respiratory tract disease caused by RSV in adults ≥60 years1,729Approved
AbrysvoPfizerPrevention of lower respiratory tract disease caused by RSV in adults ≥60 years1,306*Approved
Epkinly (epcoritamab, DuoBody-CD3xCD20)Genmab/AbbvieRelapsed/refractory large B-cell lymphoma after ≥2 lines of systemic therapy1,187Approved (accelerated)
BimzelxUCBPlaque psoriasis718FDA issued a Form 438 relating to manufacturing deficiencies
Vyjuvek (B-Vec, beremagene geperpavec)KrystalDystrophic epidermolysis bullosa636Approved
Inpefa (sotagliflozin)LexiconHeart failure (HFrEF & HFpEF pts with/out diabetes)333Approved
Alhemo (concizumab)Novo NordiskHaemophilia A and B with inhibitors198CRL (additional information requested)
Xacduro (sulbactam-durlobactam, Sul-Dur)Innoviva (Entasis)Hospital‐acquired and ventilator‐associated bacterial pneumonia caused by Acinetobacter baumannii‐calcoaceticus complex in adults82Approved
MydcombiEyenoviaDrug-device combination for in-office pupil dilation (mydriasis)54Approved
Elfabrio (pegunigalsidase alfa, PRX-102)Chiesi/ProtalixFabry disease-Approved
Trastuzumab duocarmazine (SYD985)ByondisHer2-positive unresectable breast cancer-CRL (additional information requested)
BrixadiCamurusOpioid use disorder-Approved
Anktiva (N-803)ImmunitybioBCG-unresponsive non-muscle-invasive bladder cancer-CRL (manufacturing deficiencies and CMC problems)
Miebo (NOV03)Bausch & LombDry eye disease-Approved
Posluma (flotufolastat F 18/ 18F-rhPSMA-7.3)Blue Earth Diagnostics/ BraccoPSMA-targeted PET imaging agent for prostate cancer-Approved
*Older adults and maternal setting not split out. SBI: sales by indication. Sources: Evaluate Pharma & company releases.

 

Advisory committee meetings in May 2023
ProjectCompanyIndication2028e SBI ($m)Outcome
SRP-9001 (delandistrogene moxeparvovec)SareptaAmbulatory patients with Duchenne muscular dystrophy with a confirmed mutation in the DMD gene2,0368-6 in favour
AbrysvoPfizerPrevention of (severe) lower respiratory tract disease caused by RSV in infants from birth through 6 months by active immunisation of pregnant individuals1,306*In favour, 14-0 on effectiveness and 10-4 on safety
Ocaliva (obeticholic acid)InterceptPre-cirrhotic liver fibrosis due to Nash66312-2 against (benefits do not outweigh the risks)
15-1 vote to defer until outcomes data are available
Epinephrine nasal spray (Neffy)ARS PharmaceuticalsEmergency treatment of allergic reactions (type I) including anaphylaxis in adults and children ≥30 kg-16-6 in favour (adults), 17-5 in favour (children)
OpillPerrigoDaily oral contraceptive (progestin-only)-17-0 in favour of making Opill available for OTC use
*Older adults and maternal setting not split out. SBI: sales by indication. Sources: FDA adcom calendar, Evaluate Pharma & company releases.

 

Supplementary and other notable approval decisions in May 2023
ProductCompanyIndication (clinical trial)Outcome
KalydecoVertexCystic fibrosis in children from 1 month to <4 months of ageApproved
PaxlovidPfizerPatients who are at high risk of progression to severe disease from Covid-19 (additional analyses of Epic-HR and Epic-SR trials)Approved
RexultiOtsuka/
Lundbeck
Agitation associated with Alzheimer’s dementiaApproved
AyvakitBlueprintIndolent systemic mastocytosis (Pioneer)Approved
Opvee (OPNT003 nasal nalmefene)Indivior (Opiant)Opioid overdose (NCT04759768NCT05219669NCT04828005)Approved
RinvoqAbbvieAdult patients with moderately to severely active Crohn's disease (U-ExceedU-ExcelU-Endure)Approved
FarxigaAstrazenecaHeart failure with preserved ejection fraction (Deliver)Approved
Yuflyma (high concentration Humira biosimilar)CelltrionRA, juvenile idiopathic arthritis, PsA, ankylosing spondylitis, Crohn’s disease, UC, plaque psoriasis and hidradenitis suppurativaApproved
RA: rheumatoid arthritis; PsA: psoriatic arthritis; UC: ulcerative colitis. Source: Evaluate Pharma & company releases.

https://www.evaluate.com/vantage/articles/insights/nme-approvals-snippets/us-fda-approval-and-panel-tracker-may-2023

INmune started at Outperform by Baird

 Target $16

https://finviz.com/quote.ashx?t=INMB&p=d