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Wednesday, January 10, 2024

Gilead to Face HIV Drug Development Delay Negligence Claim

 Gilead Sciences Inc. can’t avoid the claims of thousands of plaintiffs who allege they were harmed by early HIV medications because the company delayed the development of safer ones.

The plaintiffs’ negligence theory is viable even though they don’t contend that the drug they used was flawed, the California Court of Appeal said Tuesday.

“No California case appears to have expressly considered” the relationship between “defect” and “negligence,” wrote Associate Justice Jeremy M. Goldman for California’s First District Court of Appeal in the published opinion.

Texas GOP Moves To Support Gold

Via SchiffGold.com,

This March, Republican primary voters in Texas won’t just be choosing which candidates to represent their party in November – they will also be voting on a series of ballot propositions that while not legally binding offer a way for voters to guide their leaders.

Here’s why what is happening in Texas matters and what it says about the future of gold. 

Among the ballot propositions is one for the Texas government to have the Texas State Comptroller’s office start a program to “administer access to gold and silver through the Texas Bullion Depository for use as legal tender.” Texas already has a state-run depository for precious metals that began operations in 2018.

It’s probably not a surprise that after years of harsh inflation Texas voters would be sympathetic to the use of precious metals as legal tender. Texas isn’t alone in taking steps towards gold as legal tender. As reported earlier by SchiffGold’s Michael Maharrey, lawmakers in Florida and Oklahoma have introduced bills into their respective state legislatures that would follow Texas by creating their own state-run depositories. 

What’s happening in Texas matters and has an impact on the future of gold. 

Politically, Texas is not just the second most populous state it’s also the most populous red state. Unlike Vegas, things that start in Texas tend not to stay there. Texas, like Florida, introduces policies that tend to spread nationwide. Texas was the first state to introduce state-run depositories and it looks like other states may be following in the near future. Plus, the pro-gold movement in Texas isn’t being pushed by a particular politician who will eventually retire or voted out of office, it’s being driven by grassroots political demand of Texas Republican voters. And since the Republican Party controls the Texas government, successful ballot propositions from Republican voters often become law.

Will this ballot proposition succeed in the GOP primary? If history is any guide, then yes. In 2022, Texas GOP primary voters voted on ten ballot propositions, and all ten of them passed. And while politicians may not always listen to voters and the government can sometimes move slowly, some of these propositions have already been turned into Texas law on areas ranging from transgender issues to teaching of critical race theory in public schoolsThis proposition would send a strong signal to Republican politicians in Texas- and across the country. Ambitious politicians seeking to appeal to Republicans, independents, and all voters who are concerned about inflation and seeking a stable store of value will know that there are votes to be won by backing pro-gold policies.

This ballot proposition is also important because it shows the underlying stable grassroots demand for the use of gold as an investment, but also as currency. When the government or Wall Street or Silicon Valley billionaires push a new financial product there’s often special interests or unsavory connections lurking in the background. For example, the SEC’s Gary Gensler who seems poised to back crypto ETF’s has close ties to the family of Caroline Ellison, the crypto CEO and SBF ex-girlfriend who pled guilty of fraud. And of course the securities and investment industry spends hugely on influencing the federal government

But gold has retained its central place and enduring value without legions of high-paid lobbyists or paid-off policy makers. But still demand from consumers, investors, and governments around the world means gold is still too important to ignore. That’s why pro-gold initiatives like eliminating the capital gains tax on the sale of gold and silver keep cropping up in states around the nation. As long as America is a republic, it seems likely that voters will always favor the stability of gold over endless years of inflation that eat away at the dollar. 

https://www.zerohedge.com/markets/texas-gop-moves-support-gold

Biden admin rescinds much of Trump ‘conscience’ rule for health workers

 The Biden administration will largely undo a Trump-era rule that boosted the rights of medical workers to refuse to perform abortions or other services that conflicted with their religious or moral beliefs.

The final rule released Tuesday partially rescinds the Trump administration’s 2019 policy that would have stripped federal funding from health facilities that required workers to provide any service they objected to, such as abortions, contraception, gender-affirming care and sterilization.

The health care conscience protection statutes represent Congress’s attempt to strike a balance between maintaining access to health care and honoring religious beliefs and moral convictions, the Department of Health and Human Services said in the rule.

“Some doctors, nurses, and hospitals, for example, object for religious or moral reasons to providing or referring for abortions or assisted suicide, among other procedures. Respecting such objections honors liberty and human dignity,” the department said.

But at the same time, Health and Human Services said “patients also have rights and health needs, sometimes urgent ones. The Department will continue to respect the balance Congress struck, work to ensure individuals understand their conscience rights, and enforce the law.”

The move comes as many Republican-led states have enacted abortion bans in the wake of the Supreme Court’s decision to overturn Roe v. Wade. An increasing number of states have also put limits or bans on gender-affirming care for minors.

There are federal laws in place that allow health care providers to refuse care in certain circumstances based on their religious beliefs. The Trump administration’s rule would have dramatically expanded how those laws were interpreted and implemented.

Critics said they would have emboldened health care professionals to discriminate against women, minorities and underserved communities, LGBTQ people, and people with disabilities.

“Protecting conscience rights and ensuring access to health care are critically important, no matter who you are, where you live, who you love, or your faith and conscience. Our office has statutory mandates to protect people across the country and takes this responsibility very seriously,” said Melanie Fontes Rainer, director of the Department of Health and Human Services Office for Civil Rights.

“We are proud of today’s rule, which advances conscience protections, access to health care, and puts our health care system on notice that we will enforce the law. As a law enforcement agency, we are committed to this work,” Fontes Rainer added.

The Trump administration’s 2019 rule was blocked by three federal courts and never took effect after several states, cities and advocacy groups — including New York, California, San Francisco, the American Civil Liberties Union and Planned Parenthood — sued.

The rule would have allowed doctors, nurses, medical students, pharmacists and other health workers to refuse to provide any procedure to which they objected, including abortions, contraception, gender-affirming care, and HIV and STD services.

Alexis McGill Johnson, president and CEO of Planned Parenthood Federation of America, applauded the final policy in a statement.

“It’s critical that everyone has all the relevant information they need to make informed decisions about their health and families and access to the health care services they need. Today’s action from the Biden-Harris administration is an important step in that direction,” McGill Johnson said.

https://thehill.com/policy/healthcare/4397912-biden-administration-rescinds-much-of-trump-conscience-rule-for-health-workers/

STADA and Alvotech secure approval for Uzpruvo, Europe’s first ustekinumab biosimilar to Stelara

 

  • Marketing authorization issued in European Economic Area for Uzpruvo®, the first biosimilar to Stelara®, a biologic therapy within gastroenterology, dermatology, and rheumatology

  • Authorization paves way for biosimilar competition in the approximately €2.5 billion (US$2.7 billion) EU ustekinumab market as soon as possible after expiry of intellectual-property rights in July 2024

  • Approval for the Uzpruvo biosimilar is based on comprehensive package comprising analytical, non-clinical and clinical similarity data, including the AVT04-GL-301 confirmatory comparative efficacy and safety clinical trial in patients with moderate to severe chronic plaque-type psoriasis

Masimo Boosts FY23 Adj. EPS Outlook

 Technology company Masimo Corp. (MASI) announced Wednesday select preliminary financial results for the fourth quarter and full-year ended December 30, 2023 and provided estimates for its full-year 2024 guidance.

For the fourth quarter, the company now expects consolidated revenue between $541 million and $551 million, compared to the prior outlook of between $526 million and $576 million.

On average, eight analysts polled by Thomson Reuters expect the company to report revenues of $536.91 million for the quarter.

For fiscal 2023, the company now sees earnings in a range of $1.34 to $1.54 per share and adjusted earnings in a range of $3.39 to $3.59 per share on consolidated revenue between $2.041 billion and $2.051 billion.

Previously, the company expected earnings in a range of $1.34 to $1.54 per share and adjusted earnings in a range of $2.85 to $3.05 per share on consolidated revenue between $2.025 billion and $2.075 billion.

Analysts expected earnings of $2.91 per share on revenues of $2.04 billion for the year.

Looking ahead to fiscal 2024, the company now projects earnings in a range of $1.91 to $2.08 per share and adjusted earnings in a range of $3.44 to $3.60 per share on consolidated revenue between $2.045 billion and $2.165 billion, with Healthcare revenue between $1.345 billion and $1.385 billion as well as Non-healthcare revenue between $700 million and $780 million.

The Street is looking for earnings of $3.08 per share on revenues of $2.09 billion for the year.

https://www.rttnews.com/3415940/masimo-boosts-fy23-adj-eps-outlook.aspx

Xeris in Worldwide License Agreement for Xeriject® Formulation of Teprotumumab

 Xeris Biopharma, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced that it has entered into an exclusive worldwide license agreement for Amgen to develop, manufacture, and commercialize a subcutaneous formulation of teprotumumab using Xeris’ XeriJect® technology in Thyroid Eye Disease (TED) - a serious, progressive and potentially vision-threatening rare autoimmune disease. Teprotumumab-trbw is known as TEPEZZA® in the United States.

https://www.biospace.com/article/releases/xeris-biopharma-enters-into-an-exclusive-worldwide-license-agreement-for-xeriject-formulation-of-teprotumumab/

Bayer plans US expansion despite blood thinner drug setback

 Germany's Bayer will continue its expansion into the U.S. despite its November announcement that its promising blood thinner candidate failed to demonstrate superiority over a competing medicine, the drugmaker's pharmaceuticals head Stefan Oelrich said on Monday.

Bayer's experimental anticoagulant asundexian could still be a blockbuster if its second trial for stroke prevention reads out positively, Oelrich told Reuters at the JPMorgan health conference in San Francisco.

He said there is also strong opportunity in the U.S. for the company's cardiovascular and menopause symptom relief treatments, including its experimental elinzanetant, which Bayer said on Sunday eased hot flashes and improved sleep in late-stage trials.

"When you look at any of the opportunities that we're talking about (in those areas), typically the reward for innovation in the U.S. is superior to the one in Europe," he said.

Bayer announced in late November that asundexian was shown to be inferior to Bristol-Myers Squibb and Pfizer's established Eliquis in preventing strokes in high-risk patients part-way into a late-stage trial called OCEANIC-AF.

The company earlier that month said it started a trial called OCEANIC-AFINA to test the experimental blood thinner in patients with a trial fibrillation who are ineligible for oral anticoagulant treatment because of increased risk of bleeding.

Oelrich said Bayer still plans to sell the drugs it is developing itself in the country, rather than partner with U.S. companies like it has in the past.

Bayer executive Sebastian Guth told Reuters last March that the drugmaker intended to move away from relying on partners in the U.S. and planned to spend $1 billion on drug research and development in the country in 2023.

Oelrich declined to say whether Bayer would revise its 5 billion euro forecast for asundexian after its trial setback.

https://finance.yahoo.com/news/bayer-plans-us-expansion-despite-011519438.html