Jean-Pierre ripped after claiming Biden parolee program decreased illegal immigration by 90%

 White House press secretary Karine Jean-Pierre was slammed by critics after boasting Monday about the Biden administration’s humanitarian “parolee” program for asylum seekers from Cuba, Nicaragua, Haiti and Venezuela — as the US preps for a fresh surge of migrants at the southern border.

“You’ve seen the parolee program be so successful,” Jean-Pierre said during her press briefing. “It has, it has, it has, when it comes to illegal migration, you’ve seen it come down by more than 90%, and that’s because of this act — the actions that this president has taken.”

The program, instituted in October for Venezuelans and extended to residents of the other three countries in January, has allowed 30,000 asylum seekers who followed the legal application process to be admitted to the US each month.

Migrants from those countries who showed up at the border without applying for the process were swiftly expelled.

The program had contributed to an overall drop in enforcement encounters at the border, from a record high of 252,012 people in December to 156,787 in January. By March, however, that number had bounced back to 191,899, according to the Department of Homeland Security, which had not yet released numbers for April.

Department of Homeland Security statistics show a steep drop in Border Patrol encounters with residents of Cuba, Nicaragua, Haiti and Venezuela under a new parolee program for residents of those nations.

White House press secretary Karine Jean-Pierre lauded the Biden administration’s “parolee” program for asylum seekers.

REUTERS

White House press secretary Karine Jean-Pierre said the program resulted in a 90% decrease in illegal border crossings.

James Keivom

Enforcement encounters involving citizens of the four countries targeted by the program had dropped from 91,346 to 14,509 in March — a decline of 84% rather than the “more than 90%” Jean-Pierre claimed.

“Looking forward to reactions from the people who set their hair on fire over Sean Spicer’s crowd size numbers,” joked one Twitter user, Steve Robinson.

“I mean this is just the worse [sic] of her lying for this administration,” said another user. “She may believe it, doubt it, but this is a flat-out lie.”

“A provable lie,” sniffed GOP operative Matt Mackowiak. “Execrable.”

Tens of thousands of migrants hoping to seek asylum in the US are waiting in Juarez, Mexico, for Title 42 to expire on May 11.

The Trump-era emergency health order — which was extended by President Biden last year — has been used to expel some 2.5 million migrants during the COVID-19 pandemic.

More than 73,000 asylum seekers have crossed the southern border in the last 10 days as panic set in ahead of the order’s lapse, the US Border Patrol said Monday. Officials added that 17,000 “gotaways” avoided detection and entered the US illegally.

Migrants gather outside Sacred Heart Church on Monday, in El Paso, Texas. Some 90,000 migrants crossed the southern border in the last 10 days — 17,000 of them illegally, according to the US Border Patrol.

James Keivom

Overall, the number of undocumented immigrants in the US was at an estimated 11.5 million as of February 2022, according to the Center for Immigration Studies, an independent research organization.

That figure was up from 10.2 million when Biden took office in January 2021, but down from 11.8 million in January 2016, when Barack Obama was president.

During the first three years of the Trump administration, there were between 11.4 million and 11.5 million illegal immigrants in the country, the group estimated. Figures were not available for 2020 or this year.

https://nypost.com/2023/05/02/illegal-migration-from-cuba-nicaragua-haiti-and-venezuela-plummets-white-house-says/

Lilly, Sanofi to cap monthly insulin prices for uninsured in New York

 Eli Lilly (LLY) and Sanofi (SNY) have agreed to cap the price of their insulin products at $35 per month for uninsured citizens in New York.

https://seekingalpha.com/news/3963574-lilly-sanofi-cap-monthly-insulin-prices-uninsured-in-new-york

Goodbye privacy: AI’s next terrifying advancement is reading your mind

 This is actually happening: AI is starting to read minds.

Researchers at the University of Texas Austin have successfully created an artificial intelligence system that “can translate a person’s brain activity” into plain, readable language.

The high-tech device, known as a semantic decoder, can do so by utilizing similar technology implemented by ChatGPT and Google’s Bard — no surgery or special implant is required.

“For a noninvasive method, this is a real leap forward compared to what’s been done before, which is typically single words or short sentences,” professor and research lead Alex Huth said.

“We’re getting the model to decode continuous language for extended periods of time with complicated ideas.”

“For a noninvasive method, this is a real leap forward compared to what’s been done before, which is typically single words or short sentences,” professor and research lead Alex Huth said.

Nolan Zunk/University of Texas at Austin

The breakthrough uses an fMRI scanner in tandem with the decoder to transcribe a person’s thoughts after a cumbersome process.

A test subject is instructed to listen to hours of podcasts while inside of the scanner before having their own “thoughts decoded” by either telling a story in their heads or imagining a story, according to the university. They are also shown silent video clips.

This is what “allows the machine to generate corresponding text from brain activity alone.”

Admittedly, the AI can’t yet develop a word-for-word translation, but “instead, researchers designed it to capture the gist of what is being said or thought, albeit imperfectly.”

Transcriptions from a person’s mind to actual words were accurate nearly half the time.

University of Texas at Austin
Still, nearly half the time the text is near or spot on to a person’s thoughts.

“For example, in experiments, a participant listening to a speaker say, ‘I don’t have my driver’s license yet’ had their thoughts translated as, ‘She has not even started to learn to drive yet,’ ” the release added.

Although the researchers intend on the technology being used for mentally conscious individuals who can’t speak — like stroke victims — they are well aware of what can happen if this AI put into the wrong hands.

“We take very seriously the concerns that it could be used for bad purposes and have worked to avoid that,” fellow lead researcher Jerry Tang said. “We want to make sure people only use these types of technologies when they want to and that it helps them.”

Researchers Alex Huth and Jerry Tang made breakthroughs on artificial intelligence scanning brains.

Nolan Zunk / University of Texas at Austin
At the moment, nefarious uses of the decoder are extremely limited as “a person needs to spend up to 15 hours lying in an MRI scanner, being perfectly still, and paying good attention to stories that they’re listening to before this really works well on them,” Huth said.

The research team also shared ways that test subjects were able to “easily and completely thwart” the decoding — thinking of animals was a major block.

“I think right now, while the technology is in such an early state, it’s important to be proactive by enacting policies that protect people and their privacy,” said Tang. “Regulating what these devices can be used for is also very important.”

https://nypost.com/2023/05/02/ais-next-terrifying-advancement-is-reading-your-mind/

Pliant’s latest lung disease data fail to convince

 Pliant has been drip feeding data from the Integris-IPF trial, a phase 2a testing bexotegrast in idiopathic pulmonary fibrosis, since mid-2022, and until now had managed to keep the doubters at bay. But following 24-week data investors appear no longer willing to give the company benefit of the doubt. An apparent further waning in efficacy, from a previous 12 week cut of the data, on forced vital capacity, a measure of lung function, combined with discrepancies from previous presentations raised eyebrows. As did safety, with dyspnea and IPF occurring at 23% and 18% in the active arm, versus zero for control. The sellside came out in defence: SVB Securities said the group’s statistical approach explained discrepancies from prior releases, adding that the totality of the data support a best-in-class profile. Hopes that signs of disease stabilisation would emerge were clearly misplaced, and all eyes now turn to a phase 2b study, Beacon-IPF, that is due to start mid-year. That will not read out until 2025, however, and while Pliant has the cash to get there, many investors clearly believe there are better places to put their money in the meantime. Having more than tripled since June, the stock sank 21% yesterday.

Source: Pliant company presentation.

https://www.evaluate.com/vantage/articles/news/trial-results-snippets/pliants-latest-lung-disease-data-fail-convince

Astellas doesn’t buy Apellis

 Geographic atrophy is a large and untapped market, so it is no wonder that players in this disease are attracting takeout interest. However, those hoping for an acquisition of the sector’s leader, Apellis, were disappointed on Sunday when Astellas swooped for its cheaper rival Iveric Bio, offering $5.9bn.

This is an understandable move from the Japanese group, given that the companies’ competing projects look fairly similar on a cross-trial basis. Astellas also managed to bag Iveric for a relatively small 22% premium over Friday’s closing share price, raising doubts about the fee that Apellis might be able to command.

However, this figure does not tell the whole story. Both Iveric and Apellis’s stock prices have been climbing since early April, when Bloomberg reported that the latter was drawing interest from large pharma. Indeed, Astellas pointed out that the $40 per share it was paying for Iveric was a 64% premium over that group’s closing share price on 31 March.

Perhaps more surprising than the target is the buyer. Astellas is hardly an ophthalmology giant, with its sole clinical project being ASP7317, a stem cell therapy for geographic atrophy. And the group's last big acquisition, of the gene therapy player Audentes, has been a disaster.

Stifel analysts highlighted Novartis and Roche as more likely suitors; both have a presence in eye disease, and have previously tried and failed in geographic atrophy. Both are also still active here: Novartis via its 2021 purchase of Gyroscope, and Roche through deals with Ionis and Lineage Cell Therapeutics. Roche recently discontinued another project, RG6312.

This apparent lack of interest from the big eye players could raise doubts about how they see the potential size of the geographic atrophy market, Stifel suggested. However, investors shrugged off such worries with Apellis’s stock closing flat yesterday.

It might just be that the group, with a market cap of nearly $10bn, is overpriced.

Approaching approval

Apellis’s main advantage is that its drug, Syfovre, is already approved. An early indication of how launch is going will come on Thursday when the group reports first-quarter results; consensus is for under $2m in sales, according to Evercore ISI.

Meanwhile Iveric’s avacincaptad pegol (Zimura) is in front of regulators, with a Pdufa date of 19 August. Although Iveric only enrolled patients with extrafoveal lesions in its pivotal trials, Evercore expects broad approval. Apellis included both foveal and extrafoveal subjects. Both compounds appear to have a stronger effect in extrafoveal lesions.

Both drugs are complement inhibitors, but Syfovre targets C3 while Zimura hits C5. While both have been shown to decrease geographic atrophy lesion growth, neither has produced a benefit in best-corrected visual acuity on a prespecified basis.

Iveric and Apellis presented data at the recent ARVO meeting, detailing post-hoc analyses suggesting improvements in vision. Here, Apellis focused on patients with extrafoveal lesions.  

Even Evercore’s Umer Raffat, an Apellis bull, has concluded that the drugs are probably “more similar than different from a biological activity perspective”.

In this context Astellas’s move makes sense. The question now is whether any big players are willing to shell out a premium to get their hands on Syfovre and compete with the Japanese group.

https://www.evaluate.com/vantage/articles/news/deals/astellas-doesnt-buy-apellis

US FDA approval and panel tracker: April 2023

 Biogen and Ionis’s Qalsody is already backed by a positive panel, and received a US greenlight last month in ALS patients with Sod1 mutations. The accelerated decision was based on a neurofilament biomarker, and the ongoing Atlas trial in pre-symptomatic carriers will serve as the confirmatory study. Stifel analysts highlighted the broader readthrough to the neurology division's openness to biomarkers, noting Sarepta’s closely watched panel this month for the Duchenne muscular dystrophy gene therapy SRP-9001. Elsewhere manufacturing issues scuppered Ascendis’s TransCon PTH, intended to treat hypoparathyroidism, and Lilly’s mirikizumab in ulcerative colitis. In addition, a panel to discuss Lynparza’s use in first-line prostate cancer voted to restrict the label to Brca-positive patients, based on data from the Propel study. Attention now turns to the EU, where the EMA gave Lynparza a broad prostate cancer label at the end of last year.

Notable first-time US approval decisions in April 2023
Project	Company	Indication(s)	2028e SBI ($m)	Outcome
TransCon PTH	Ascendis	Adults with hypoparathyroidism	1,214	Deficiencies identified in NDA, then CRL (manufacturing issues)
Mirikizumab (Omvoh)	Lilly	Ulcerative colitis	630	CRL (manufacturing issues)
LetibotulinumtoxinA/ Botulax/ Letybo	Hugel	Glabellar lines	276	CRL (second, inspection issues)
Quizartinib (Vanflyta) + standard cytarabine and anthracycline induction	Daiichi Sankyo	Newly diagnosed FLT3-ITD­ +ve AML	120	Extended to 24 July owing to REMS
Omisirge (omidubicel)	Gamida Cell	Cell therapy for patients with blood cancers to reduce risk of infection following stem cell transplantation	82	Approved (extended Pdufa had been expected 1 May)
Qalsody (tofersen)	Biogen/Ionis	ALS associated with a mutation in Sod1 gene	10	Approved (accelerated)
Vowst (SER-109)	Seres	Clostridioides difficile infection	5	Approved
Abilify Asimtufii (Aripiprazole 2-month)	Otsuka/ Lundbeck	Treatment of schizophrenia and maintenance treatment of bipolar I disorder	-	Approved
SBI: sales by indication. Sources: Evaluate Pharma & company releases.

 

Advisory committee meetings in April 2023
Project	Company	Indication	2028e SBI ($m)	Outcome
Lynparza + Zytiga + prednisone/prednisolone	Astrazeneca/Merck & Co	1st-line castration-resistant prostate cancer (Propel)	1,339*	11-1 vote to restrict label to Brca+ve patients (Pdufa had been expected in March)
Rexulti	Otsuka/ Lundbeck	Agitation associated with Alzheimer’s dementia	783	9-1 in favour (Pdufa 10 May)
Sulbactam-durlobactam for injection (Sul-Dur)	Innoviva (Entasis)	Hospital‐acquired and ventilator‐associated bacterial pneumonia caused by Acinetobacter baumannii‐calcoaceticus complex in adults	82	12-0 in favour (Pdufa 29 May)
*Already on the market in different treatment line. Sources: Evaluate Pharma, FDA adcom calendar & company releases.

 

Supplementary and other notable approval decisions in April 2023
Product	Company	Indication (clinical trial)	Outcome
Polivy + Rituxan + R-CHP	Roche	Previously untreated DLBCL (Polarix)	Approved
Padcev + Keytruda	Seagen/Astellas (Pfizer)	1L urothelial cancer cisplatin ineligible patients (Ph1b/2 EV-103/Keynote-869 dose escalation/cohort A & cohort K)	Approved (accelerated)
Trikafta	Vertex	Cystic fibrosis in children aged 2-5	Approved
Prevnar20	Pfizer	Pneumococcal vaccine in infants & children 6 weeks to 17 years old (ph3 NCT04382326, NCT04546425, NCT04379713, Ph2)	Approved
Qulipta	Abbvie	Preventative treatment of chronic migraine (Progress)	Approved
Sogroya	Novo Nordisk	Growth hormone deficiency in children up to 11 years old (Real4)	Approved
Hyqvia	Takeda	Primary immunodeficiency in children aged 2-16	Approved
Tepezza	Horizon	Thyroid eye disease regardless of thyroid eye disease activity or duration (ph4 NCT04583735)	Approved
Rizafilm Versafilm (Rizaport)	Intelgenx/Gensco	Acute migraine	Approved
mdc-IRM (Uzedy) (risperidone extended-release)	Teva/Medincell	Maintenance treatment of schizophrenia	Approved
Lumryz (FT218)	Avadel	Treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy	Final approval
Gohibic (vilobelimab)	Inflarx	Treatment of critically ill adult Covid-19 patients (Panamo)	EUA granted
AVT02	Alvotech/Teva	Humira biosimilar interchangeability	CRL (second, for manufacturing issues)
Imbruvica	Abbvie/J&J	Previously untreated mantle cell lymphoma (Shine) and relapsed or refractory marginal zone lymphoma (Selene)	Withdrawn, confirmatory data insufficient to support conversion to full approval (Shine did not show OS; Selene did not meet PFS)
Makena (and generics)	Covis (private)	Reducing risk of preterm birth in women who have a history of singleton spontaneous preterm birth	Withdrawn (final decision)
Monovalent mRNA Covid-19 vaccines	Moderna and Pfizer/Biontech	Immunisation to prevent Covid-19	EUA removed
Sources: Evaluate Pharma & company releases. https://www.evaluate.com/vantage/articles/insights/nme-approvals-snippets/us-fda-approval-and-panel-tracker-april-2023

Can-Fite IDs Mechanism to Inhibit Pancreatic Cancer

 

• The anti-cancer effect in pancreatic carcinoma is mediated via a key signal transduction pathway

• According to the American Society of Clinical Oncology (ASCO) in 2020 an estimated 496,000 people were diagnosed with pancreatic cancer globally

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced that it discovered the mechanism of action (MOA) involved with the significant anti-cancer effect of Namodenoson in pancreatic carcinoma. Namodenoson de-regulates the Wnt signal transduction pathway, a key modulator of pancreatic carcinoma cell growth.

The discovery was made when analyzing results from pre-clinical studies conducted on advanced pancreatic carcinoma patient cells exposed to Namodenoson, which had a significant anti-cancer effect. This is the same MOA at work for Namodenoson in liver cancer.

Namodenoson is currently under a pivotal Phase III study for the treatment of advanced liver cancer and has completely cleared cancer in an advanced liver cancer patient who remains cancer-free 6 years after starting treatment.

https://finance.yahoo.com/news/inhibition-pancreatic-cancer-namodenoson-molecular-110000959.html