Why Is Pulmonary Hypertension-Focused Liquidia Stock Soaring

 Liquidia Corp 

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 stock jumped after a win in a patent dispute with United Therapeutics Corporation 

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 revolving around U.S. Patent 10,716,793 (the ’793 patent).

"We have considered United Therapeutics (UTC's) remaining arguments and find them unpersuasive," the three judge panel wrote in its decision. "For the reasons provided above, we affirm the Board's unpatentability determination."

United Therapeutics owns the ’793 patent, which is directed to treating pulmonary hypertension (PAH) and PAH-associated with interstitial lung disease by inhaling treprostinil, which United Therapeutics markets as Tyvaso.

In November 2021, the FDA issued a tentative approval of Yutrepia (treprostinil) inhalation powder, but it cannot yet be marketed, pending resolution of Hatch-Waxman litigation commenced by United Therapeutics in June 2020. 

In its Q3 earnings release, Liquidia said that the FDA accepted the amendment to the New Drug Application (NDA) for Yutrepia to add the indication of pulmonary hypertension associated with interstitial lung disease (PH-ILD) to the label and has set a Prescription Drug User Fee Act (PDUFA) goal date of January 24, 2024. 

Final approval of the PH-ILD indication cannot occur until the new clinical investigation exclusivity granted to Tyvaso expires on March 31, 2024. 

https://www.benzinga.com/general/biotech/23/12/36328394/why-is-pulmonary-hypertension-focused-liquidia-stock-soaring-today

36 Million Customers Affected In Massive Comcast Data Breach

 Your holiday present from Comcast has arrived, in the form of a massive data breach that has compromised the personal information of nearly 36 million customers. Comcast released a statement on Monday this week stating that a "recent data security incident" occurred involving Citrix software.

"On October 10, 2023, Citrix announced a vulnerability in software used by Xfinity and thousands of other companies worldwide," Comcast wrote.

"Citrix issued additional mitigation guidance on October 23, 2023. Xfinity promptly patched and mitigated the Citrix vulnerability within its systems. However, during a routine cybersecurity exercise on October 25, Xfinity discovered suspicious activity and subsequently determined that between October 16 and October 19, 2023, there was unauthorized access to its internal systems that was concluded to be a result of this vulnerability."

"Xfinity notified federal law enforcement and initiated an investigation into the nature and scope of the incident. On November 16, Xfinity determined that information was likely acquired," the release said.

"After additional review of the affected systems and data, Xfinity concluded on December 6, 2023, that the customer information in scope included usernames and hashed passwords; for some customers, other information may also have been included, such as names, contact information, last four digits of social security numbers, dates of birth and/or secret questions and answers."

So, everything?

Conveniently not included in the release but disclosed in follow up reporting by PhillyBurbs.com was the fact that over 35.8 million customers were affected by the breach, according to a report with Maine's Attorney General. 

Comcast has said it is requiring all of its customers to reset their passwords and that it is encouraging its users to use 2FA in the future. 

"Xfinity advises customers not to re-use passwords across multiple accounts, the company is recommending that customers change passwords for other accounts for which they use the same username and password or security question," the release said.

Just in case you didn't have anything to do heading into the holidays...

https://www.zerohedge.com/markets/36-million-customers-affected-massive-comcast-data-breach

Biden Admin Linked To Trump Ballot Ban In Colorado

 While many are focusing on the Ivy League Democrats on Colorado's Supreme Court who voted to kick Donald Trump off the 2024 primary ballot, there underlying case itself has a direct link to the Biden administration.

The Colorado case against Trump was brought by Citizens for Responsibility and Ethics in Washington (CREW), headed by President and CEO Noah Bookbinder...

...who sits on the Biden administration's Department of Homeland Security (DHS) Advisory Council  (HSAC), as the Daily Caller's James Lynch reports.

"Our Constitution clearly states that those who violate their oath by attacking our democracy are barred from serving in government. It has been an honor to represent the petitioners, and we look forward to ensuring that this vitally important ruling stands," Bookbinder gloated in a press release.

It gets better...

Bookbinder is a former trial attorney for the Department of Justice’s (DOJ) public integrity section and former chief counsel for criminal justice for the Senate Judiciary Committee. He repeatedly donated to former President Barack Obama’s re-election campaign during his tenure with the Senate, Federal Elections Commission (FEC) records show.

The DHS appointed Bookbinder and 32 other new members to HSAC in March 2022 ahead of the council’s first meeting under Secretary Mayorkas. -Daily Caller

DHS Secretary Mayorkas said in a March 2022 press release related to HSAC: "Together, we will ensure that the Department is best positioned to meet the challenges we confront today, foresee and be ready for the challenges of tomorrow, capitalize on the power of technological innovation, and serve our country by living up to our highest ideals. Our Department is privileged to benefit from the experience, vision, and creativity of these incredibly accomplished individuals."

U.S. Homeland Security Secretary Alejandro Mayorkas

According to Lynch, HSAC has met numerous times - where they've produced various reports for Mayorkas ranging from "disinformation" to supply chains.

Bookbinder was in attendance during a September 2023 in-person meeting of HSAC, according to meeting minutes.

He also worked on a report produced by the DHS's 'Openness and Transparency Subcommittee' - providing recommendations for how DHS can become more transparent without compromising its law enforcement mission (sure!).

https://www.zerohedge.com/political/course-biden-admin-linked-trump-ballot-ban-colorado

BioMarin settles with Elliott, adds 3 independent directors

  BioMarin reached a settlement with activist investor Elliott Investment Management where the biotechnology company will add three independent directors to its board and form a committee to review operations.

The new Strategic and Operating Review Committee will evaluate the company's business, strategy and operations, financial and capital allocation priorities, and long-term planning and priorities, the company said in a statement.

In November, Reuters reported that Elliott owns a stake in BioMarin and had been holding discussions with the company, valued at $18 billion, about possible changes.

Since Elliott's involvement became public on Nov. 7 and since the company announced a new CEO earlier in November, the stock price has climbed 22% and closed trading at $92.66 on Tuesday.

The agreement marks the second settlement Elliott, which oversees $60 billion in assets, reached this week.

Earlier on Tuesday, wireless tower owner Crown Castle averted a proxy fight with Elliott when it added two new directors, including one Elliott executive, only weeks after announcing that its CEO will leave next month.

At BioMarin, the company and hedge fund agreed on three industry and finance experts who have no direct ties to Elliott.

Dr. Athena Countouriotis, co-founder and CEO of Avenzo Therapeutics; Mark Enyedy, CEO of ImmunoGen; and Barbara Bodem, who worked in finance at several pharmaceutical companies, join the board on Dec. 27.

AbbVie is acquiring ImmunoGen.

The BioMarin board will temporarily expand to 15 directors before returning to 11 directors after next year's shareholder meeting, the company said.

The settlement comes less than two months after San Rafael, California-based BioMarin hired former Genentech CEO Alexander Hardy to replace Jean-Jacques Bienaime, who is retiring.

Before Elliott's involvement became public BioMarin's share price was off roughly 24% for the year as it grappled with slow progress in the launch of its hemophilia drug Roctavian. The poor share price performance had led some analysts to speculate about whether the company could become a takeover target. 

https://finance.yahoo.com/news/biomarin-settles-elliott-adds-3-220829877.html

FDA declines to approve Merck's chronic cough drug

 The U.S. Food and Drug Administration (FDA) has declined to approve Merck's drug for chronic cough, the company said on Wednesday, marking the second rejection in less than two years. The health regulator concluded that the company's application for the drug, gefapixant, did not meet substantial evidence of effectiveness for treating refractory chronic cough and unexplained chronic cough. In November, the agency's advisory committee panel voted 12 to 1 against the late-stage data submitted for the drug, on concerns over how well it works. The FDA's decision was not related to the drug's safety, Merck said, adding that it is reviewing the agency's feedback to determine next steps. There is no approved treatment for refractory or unexplained chronic cough or coughing bouts that don't go away despite treatment of underlying conditions or have no identifiable cause.

https://finance.yahoo.com/news/1-us-fda-declines-approve-214745135.html

FDA approves first test to identify opioid use addiction risk

 The U.S. Food and Drug Administration (FDA) said on Tuesday it has approved the first test to assess if there is a risk of opioid use addiction in certain individuals.

The test, AvertD, is developed by privately held SOLVD Health. The FDA granted the approval to AutoGenomics, a unit that SOLVD acquired in 2019.

AvertD is intended to be used before the first use of oral opioid painkillers in those who are being considered for a 4 to 30 days prescription for the treatment of acute pain, such as in patients scheduled to undergo a planned surgical procedure.

It is a prescription-use only genetic laboratory test for patients 18 years and older for those who have not previously used oral opioid painkillers.

The test involves swabbing the cheek of a patient to collect a DNA sample that is then used to determine if there is a combination of genetic variants that may be associated with an elevated risk of developing opioid use disorder.

The addictive potential of the painkillers has fueled an opioid epidemic that has caused more than half a million overdose deaths in the United States over a period spanning more than two decades.

AvertD is not intended to be used in patients being treated for chronic pain, the FDA said.

An advisory panel to the health regulator in October last year had convened to discuss an earlier version of the test.

https://finance.yahoo.com/news/us-fda-approves-first-test-232116700.html

FDA OKs Calliditas' kidney disease drug

 The U.S. Food and Drug Administration granted full approval to Swedish drugmaker Calliditas Therapeutics' drug to treat rare kidney disease IgA Nephropathy (IgAN), the company said on Wednesday.

The decision makes the drug, branded as Tarpeyo, the first drug to be granted a full approval in the United States for IgAN, ahead of Travere Therapeutics' rival, Filspari, which won accelerated approval earlier this year.

The health regulator, in 2021, granted accelerated approval to Tarpeyo, for adults with primary IgAN to reduce increased protein levels in the urine, a condition called proteinuria.

IgAN, also known as Berger's disease, occurs when a type of antibody deposit builds up in the kidneys, causing inflammation that damages its tiny filtering units.

The disease affects about 130,000–150,000 people in the United States, according to the company. 

https://finance.yahoo.com/news/1-us-fda-approves-sweden-213012228.html