Search This Blog

Wednesday, September 27, 2023

Viatris and Ocuphire Pharma Announce FDA OK of RYZUMVl™ (Phentolamine Ophthalmic Solution)

 Viatris Inc. (NASDAQ: VTRS), a global healthcare company, and Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved RYZUMVI (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents.  RYZUMVl is expected to be commercially available in the U.S. in the first half of 2024.

https://finance.yahoo.com/news/viatris-ocuphire-pharma-announce-fda-120000051.html

ionis licences to Roche for Alzheimer's, Huntington's

 

  • Roche gains exclusive worldwide rights to develop, manufacture and commercialize the investigational medicines discovered by Ionis

  • Ionis to receive a $60 million upfront payment

Ginkgo RNA Discovery Collaboration with Pfizer

 Ginkgo Bioworks (NYSE: DNA) today announced a collaboration with Pfizer (NYSE: PFE) focused on the discovery of RNA-based drug candidates. In the collaboration, Pfizer will leverage Ginkgo's proprietary RNA technology to advance the discovery and development of novel RNA molecules across priority research areas. Ginkgo will receive an upfront payment and is eligible to receive research fees and development and commercial milestone payments, up to an aggregate total of $331 million across three programs. Ginkgo is entitled to potential further downstream value in the form of royalties on sales.

https://finance.yahoo.com/news/ginkgo-bioworks-announces-multi-target-110100311.html

Allakos started at Outperform by JMP

 Target $11

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

Apellis CMS code for geographic atrophy treatment

 Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has assigned a permanent and product-specific J-code (J2781) for SYFOVRE® (pegcetacoplan injection), the first-ever treatment for geographic atrophy (GA) secondary to age-related macular degeneration. The J-code for SYFOVRE will become effective on October 1, 2023.

https://finance.yahoo.com/news/apellis-receives-permanent-j-code-113000005.html

Biden officials kept immigration jails despite internal cost concerns

 Biden administration officials last year recommended closing or downsizing nine immigration detention centers because of high costs and staffing shortages, a move that could have saved $235 million, a draft U.S. Immigration and Customs Enforcement (ICE) memo reviewed by Reuters shows. But ICE ultimately only ended contracts with two of the detention centers flagged in the memo.

Six of the nine detention centers identified in the August 2022 memo were operated by private companies. Among the for-profit detention centers was the Torrance County Detention Facility in New Mexico, where a government watchdog earlier had called for the relocation of all detainees due to "critical staffing shortages that have led to safety risks and unsanitary living conditions."

A finalized version of the memo dated Sept. 1, 2022, and reviewed by Reuters, omitted the recommendation to close Torrance. The finalized memo was shared with Homeland Security Secretary Alejandro Mayorkas' office, one current and one former U.S. official said, requesting anonymity to discuss the internal process.

U.S. President Joe Biden promised during the 2020 campaign to reform immigration detention and cut out for-profit companies. But with record numbers of migrants attempting to illegally cross the U.S.-Mexico border in 2022, some officials argued Torrance - about an hour southeast of Albuquerque - was needed due to its proximity to the border, the current and former officials said.

The failed Biden administration detention reform effort shows the challenges Biden will face to deliver on his earlier campaign promises as he seeks another term in 2024.

"There's always perpetual fear about losing beds, that we'll look bad and get jammed," the current U.S. official told Reuters.

Following a Reuters request for comment, an ICE official said Torrance was a key detention center and that ICE keeps the population lower than capacity to avoid overburdening the staff.

ICE did not comment on the authenticity of the documents reviewed by Reuters or the decision-making process.

"The agency continuously reviews and enhances civil detention operations to ensure non-citizens are treated humanely, protected from harm, provided appropriate medical and mental health care, and receive the rights and protections to which they are entitled," ICE spokesperson Jenny Burke said.

The draft memo stated that CoreCivic, the company that operates Torrance, could not maintain staffing and that the daily cost to house a detainee was more than double the average.

Brian Todd, a CoreCivic spokesperson, called allegations against Torrance "false and misleading" and said the facility provides "a safe, humane and appropriate environment" for detainees.

ICE ended contracts with two little-used facilities named in both memos: the Berks County Residential Center in Pennsylvania and Yuba County Jail in California. Both were run by the counties.

At Berks, which held families until 2021, each detainee cost about $1,200 per day, according to the draft memo, far beyond the $142 average in fiscal year 2022. At Yuba, the daily cost per detainee was $8,000, the memo said.

On Tuesday night, the American Civil Liberties Union (ACLU) of New Mexico said it filed a wrongful death lawsuit in state court on behalf of the estate of Kesley Vial, a 23-year-old Brazilian man who hanged himself in Torrance on Aug. 17, 2022.

The lawsuit cites ICE contracting reports that said Torrance staffing shortages impacted safety, security and care. The suit cites government watchdog inspections that also found the facility failed to meet minimum medical staffing levels.

"That's a recipe for disaster," said Rebecca Sheff, a senior staff attorney with the ACLU of New Mexico.

EXORBITANT COSTS

The August 2022 draft ICE memo called for renegotiating contracts at Adelanto ICE Processing Center in California and the Farmville Detention Center in Virginia, two for-profit detention centers where ICE paid outsize sums to house a handful of detainees.

At the time, court orders intended to halt the spread of COVID-19 kept ICE from sending more detainees to both facilities, but ICE continued to pay for a minimum of nearly 1,500 beds at Adelanto and 500 at Farmville.

Each detainee cost about $2,000 per day at Adelanto, operated by the private prison company GEO Group, according to the memo. At Farmville, run by another private firm, Immigration Centers of America (ICA), it was $8,000 a day.

ICE reduced the minimum beds it paid for at Adelanto, according to ICE data posted in May 2023, but Farmville's minimum remains unchanged.

An ICE official said Adelanto is "a very well-run facility" that could be useful in the future although the court order continues to block new detainees from entering.

A separate U.S. official said Farmville is needed because of limited East Coast detention space. The facility held 70 people as of this week, ICE data shows.

GEO Group spokesperson Christopher Ferreira said the company could not comment on memos it had not reviewed but touted Adelanto as "a modern, state-of-the art facility built to suit ICE's needs."

ICA did not respond to requests for comment.

The Biden administration has held more migrants in ICE detention in recent months following the mid-May implementation of stricter asylum rules.

https://news.yahoo.com/exclusive-biden-officials-kept-immigration-040540957.html

Musk's X disabled feature for reporting electoral misinformation - researcher

Elon Musk's X, formerly called Twitter, disabled a feature that let users report misinformation about elections, a research organisation said on Wednesday, throwing fresh concern about false claims spreading just before major U.S. and Australian votes.

After introducing a feature in 2022 for users to report a post they considered misleading about politics, X in the past week removed the "politics" category from its drop-down menu in every jurisdiction but the European Union, said the researcher Reset.Tech Australia.

Users could still report posts to X globally for a host of other complaints such as promoting violence or hate speech, the researcher added.

X was not immediately available for comment.

Removing a way for people to report suspected political misinformation may limit intervention at a time when social media platforms are under pressure to curtail falsehoods about electoral integrity, which have grown rapidly in recent years.

It comes less than three weeks before Australia holds a referendum, its first in a quarter century, on whether to change the constitution to establish an Indigenous advisory body to parliament and 14 months before a U.S. presidential election.

"It would be helpful to understand why X have seemingly gone backwards on their commitments to mitigating the kind of serious misinformation that has translated into real political instability in the US, especially on the eve of the 'bumper year' of elections globally," said Alice Dawkins, executive director of Reset.Tech Australia.

In a letter to X's managing director for Australia, Angus Keene, Reset.Tech Australia said the change may leave content that violates X's own policy banning electoral misinformation online without an appropriate review process.

"It is extremely concerning that Australians would lose the ability to report serious misinformation weeks away from a major referendum," said the letter which was published online.

Since billionaire Musk took Twitter, as it was then known, private in late 2022, the company, which cut most of its workforce, has been accused of allowing the proliferation of antisemitism, hate speech and misinformation.

As previously reported by Reuters, Reset.Tech Australia found X failed to remove or label a single post containing misinformation about the Australian referendum over a three-week period, including after it was reported using the now-disabled feature.

Musk has said X's "Community Notes" feature, which allows users to comment on posts to flag false or misleading content, is a better way of fact checking. But those notes are only made public when they are rated as helpful by a range of contributors with varying points of view, according to X's website.

Australia's internet safety regulator wrote to X in June demanding an explanation for an explosion in hate speech on the platform, noting it had reinstated some 62,000 high profile accounts of individuals who espouse Nazi rhetoric.

The Australian Electoral Commission (AEC), which will oversee the Oct. 14 referendum, has said the spread of electoral misinformation is the worst it has seen.

The commission said it was still able to report posts containing political misinformation directly to X, even after the feature was disabled. For other users, the AEC was "available for people to ask questions or seek information".

https://news.yahoo.com/musks-x-disabled-feature-reporting-015423675.html