Bird flu: How US states are testing cattle and humans for the virus

 States in the U.S. are playing a key role in the nation's response to a growing outbreak of avian flu among dairy cattle that has also infected a small number of humans.

The states are chiefly responsible for testing cows and people for the virus, but they take different approaches. Scientists tracking bird flu are increasingly concerned that current surveillance efforts are not sufficient.

Federal officials have warned that further spread of the virus among cows could heighten the risk of more human infections, though the risk to the general public remains low.

As of July 9, bird flu had infected 139 dairy cow herds across 12 states since March, according to the U.S. Department of Agriculture. Four dairy workers have also been infected, the most recent in Colorado on July 3.

Here is how the 12 U.S. states with bird flu cases in dairy herds are handling human and cattle testing:

HUMAN TESTING

As of early July, 99 people had been tested for bird flu in four states this year, according to state health officials: Michigan (56 people), Texas (20), Idaho (8), Colorado (8) and New Mexico (7).

Officials in North Carolina, Ohio, South Dakota and Minnesota told Reuters they had not tested any people since the dairy outbreaks began.

The states varied in their testing criteria, considering factors like whether a patient was exposed to sick animals or displayed symptoms.

Health departments in Wyoming and Kansas did not respond to requests for their human testing figures. Iowa's health department said it is monitoring all people exposed to the virus for symptoms but did not provide a figure for any human tests.

The Centers for Disease Control and Prevention has said at least 53 people have been tested for bird flu. The figures are different because the CDC is only reporting tests done on people exposed to sick dairy cattle, whereas states are also in some cases testing people exposed to other sick animals like cats, said CDC spokesperson Jason McDonald.

The CDC advises clinicians to notify local and state health departments if they wish to test someone for bird flu. The doctor should then notify CDC immediately if the tests are positive or inconclusive.

CATTLE TESTING

States with bird flu in dairy herds are testing cattle at the behest of farmers who suspect infections, for research, or for other reasons, agriculture department officials said.

Iowa is additionally requiring testing for dairy herds within a 20-kilometer (12.4-mile) radius of any poultry farms with bird flu infections, which is currently about 25 to 35 herds, said Don McDowell, communications director for the Iowa Department of Agriculture and Land Stewardship.

Minnesota is testing farms with contact to infected herds, said Brian Hoefs, the state's chief veterinarian and executive director of the Minnesota Board of Animal Health, tracing suppliers, equipment and staffing that had access to an infected farm.

The USDA in May began requiring states to test lactating dairy cows before they were shipped across state lines, the only national testing requirement the agency has issued. About 6,600 cows have been tested under that order, according to USDA data.

A spokesperson for the USDA said the agency is committed to working with states on their efforts to contain and eliminate bird flu, including possible further testing requirements.

https://www.yahoo.com/news/factbox-us-states-testing-cattle-101447148.html

FTC Ban That Would Make Switching Jobs Easier Hits Roadblock

 Opposition to the Federal Trade Commission’s final rule that bans nearly all new noncompete clauses has resulted in a roadblock that could lead to the ban—which makes it easier to switch jobs—never going into effect. However, the uncertainty surrounding its fate shouldn’t affect biopharma job searches, according to Carina Clingman, founder and CEO of Recruitomics Consulting, which specializes in talent acquisition and talent strategy for startup biotechs.  

“In this climate, if you need a job, you’re on the job market,” she told BioSpace. 

In fact, Clingman noted she’s heard little about the ban from job candidates in comparison to how much she heard about the Massachusetts Noncompete Agreement Act, which passed in 2018, significantly restricting the use of noncompetes.  

“I think that’s just a mark of how stressed everybody is about everything else in biotech, because I’m hearing a ton of other things and other complaints—other worries, other fears—and that’s just not one of them, which is really surprising to me,” she said. 

Those fears include concern about the job market. 

“It’s kind of a fraught time,” Clingman said. “I think people are starting to settle down a little bit because we are seeing more jobs opening up, and we are seeing a little bit more funding. The climate’s slightly better this year than it was last year. But people are just very anxious.” 

Why the Final Rule May Not Go Into Effect

While there was immediate opposition to the FTC’s final rule after its issue, there’s increased uncertainty it will go into effect because of a July 3 decision from Judge Ada Brown of the U.S. District Court for the Northern District of Texas. Brown partially blocked the rule by postponing when the commission can enforce it for a group of plaintiffs suing the FTC. While the ban is set to take effect nationwide on Sept. 4, that date won’t apply to Ryan LLC, a tax services firm in Dallas that filed the lawsuit, and several groups that joined the suit, including the U.S. Chamber of Commerce.  

Furthermore, Brown wrote in her decision that the court intends to rule on the merits of the lawsuit on or before Aug. 30. She noted the plaintiffs are likely to succeed on those merits.   

In its lawsuit, Ryan asserted that the FTC’s actions were unlawful in part because it acted without statutory authority. Brown agreed, stating in her ruling that “the FTC lacks substantive rulemaking authority with respect to unfair methods of competition.” She also noted there’s a substantial likelihood that the FTC’s final rule is unreasonably overbroad and imposes a one-size-fits-all approach. 

How the FTC’s Final Rule Would Work

The FTC’s final rule covers businesses in various industries, although the commission’s compliance guide notes that some employers, such as banks and federal credit unions, are outside its jurisdiction and aren’t subject to the rule. The rule also doesn’t apply to noncompetes between a buyer and seller of a business. 

If the ban goes into effect Sept. 4, on that date, companies can no longer enter into new noncompetes with employees and can only enforce existing noncompetes for senior executives. Senior executives are defined as those earning more than $151,164 annually who are in a policymaking position, such as a president or CEO. Businesses will need to notify all other workers that their noncompetes are unenforceable. 

The FTC has provided model language for those notices. 

What Biopharma Professionals Should Do Now

Given the FTC’s final rule could get struck down, and as a general practice, biopharma professionals should pay attention to what they agree to when they join a company, according to Clingman. This can make it easier to pursue other opportunities later. 

“You should always understand fully your employment agreement,” Clingman said. “That just allows you to have peace of mind if you do want to make a change that you’re not going to run into any issues.” 

Clingman also shared that it’s OK to bring your employment contract to a prospective employer’s recruiter so they can have the company’s legal team review it. That way, she said, legal can determine if there’ll be any hiring issues, although there usually aren’t any. 

“In most cases, the argument can be made that one individual, especially below a C-suite level, doesn’t know enough to be able to really steal secrets or materially impact the business,” Clingman said, adding that this approach supports the spirit of noncompete laws. “Protect business, but allow people the freedom to move.” 

https://www.biospace.com/article/ftc-ban-that-would-make-switching-jobs-easier-hits-roadblock/

Ligand grows in cancer again with $100m Apeiron takeover

 Ligand Pharmaceuticals has made its second major acquisition in 2024, agreeing a $100 million deal to buy Austria’s Apeiron Biologics and a royalty stream for brain cancer drug Qarziba.

Qarziba (dinutuximab beta) is on the market in 35 ex-US markets for the treatment of high-risk neuroblastoma in patients aged 12 months and above. It is sold by Recordati in all markets except for China, where BeiGene has rights, with both licensees paying undisclosed royalties.

The deal includes an additional payment to Apeiron shareholders of $28 million if Qarziba royalties exceed a certain threshold by either 2030 or 2034, and is expected to close before the end of the month.

It comes after Ligand paid $75 million to Agenus in order to give it an interest in multiple oncology products across targets and indications, including a royalty stream on botensilimab/balstilimab, also known as bot/bal, which is heading for a phase 3 trial in metastatic, relapsed, or refractory colorectal cancer.

In a statement, Florida-based Ligand said the deal adds the sixth asset to its commercial portfolio since the start of 2023, part of a growth strategy “to invest in high-value medicines that deliver significant clinical value and generate predictable and long-term revenue streams for our investors.”

That list also includes Verona Pharma’s first-in-class chronic obstructive pulmonary disorder (COPD) therapy Ohtuvayre (ensifentrine) – tipped as a future blockbuster – which earned Ligand a $5.8 million milestone on FDA approval last month, with another $13.8 million due on launch, as well as single-digit royalties.

In its first-quarter update, Ligand said it expects to make $90-$95 million in royalties this year out of total revenues of $130-$142 million, with the remainder coming from contract revenues and sales of its Captisol excipient used in pharma formulations. The company expects the new deal to raise its 2024 revenues to the $140-$157 million range.

“Qarziba is the only immunotherapy for high-risk neuroblastoma marketed across Europe and in other parts of the world,” said Ligand's chief executive, Todd Davis. “We believe this drug will be a meaningful contributor to our royalty revenue, which is now driven by a diversified portfolio of 12 key commercial-stage products.”

Ligand is also committing a $4 million investment in a company that has spun off from Apeiron to take forwards early-stage pipeline projects following after Quarziba, and is in line for royalties and milestone payments if they progress.

The spin-off, called invIOs, has three immuno-oncology programmes on the go led by APN401, a Cbl-b-targeting autologous cell therapy in phase 1 testing for solid tumours.

https://pharmaphorum.com/news/ligand-grows-cancer-again-100m-apeiron-takeover

Evotec and Pfizer in drug discovery collaboration

 Evotec and Pfizer have entered a multi-year partnership that will focus initially on early discovery research.

As part of the master research collaboration and option and licence agreement, the two companies will focus on research for metabolic and infectious diseases.

Evotec plans to undertake research activities at its facilities in France, including the advanced Campus Curie research site in Toulouse.

The site is equipped with high throughput screening capacity, in vitro and in vivo biology, metabolomics and proteomics.

Evotec chief business officer Dr Matthias Evers stated: “We are honoured to collaborate with Pfizer to research potential new first-in-class therapeutic approaches.

“Focusing on diseases with severe unmet medical needs and highly innovative therapeutic approaches, we look forward to supporting our partners at Pfizer with integrated R&D [research and development] activities.”

Evotec will benefit from research support funding from Pfizer and may receive potential milestones and royalty payments contingent on the success of the programmes.

Pfizer France vice-president and medical lead Dr Luca Mollo stated: “We are thrilled to collaborate with Evotec to conduct discovery research that may help unlock new approaches to treating pervasive metabolic and infectious diseases that impact millions of patients worldwide.

“France has developed a strong biopharmaceutical ecosystem, which is why we’re thrilled to collaborate with Evotec to build on our shared commitment to advancing scientific discovery for diseases with unmet need.”

In April 2024, Evotec and Variant Bio teamed up to detect a treatment for ailments caused by fibrosis.

The alliance will combine Variant Bio’s genomic discovery expertise and its VB-Inference platform with Evotec’s antifibrotic drug discovery capabilities.

https://finance.yahoo.com/m/59147f7b-e880-3717-b096-12f0afc9cd72/evotec-and-pfizer-announce.html

Milestone Scientific Favorable Medicare Pricing for Epidural System

 Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today announced at the Sixth Annual American Society of Pain & Neuroscience Conference in Miami Beach that First Coast Service Options Inc. (FCSO), a Jurisdictional Medicare Administrative Contractor (“JMAC”), has granted favorable Medicare Part B physician price assignment across Florida for use of the Company’s CompuFlo® Epidural System under the American Medical Association’s (AMA) technology-specific Category III CPT® code CPT0777T (real-time pressure-sensing epidural guidance system when used in conjunction with a primary ESI procedure). Additionally, the Company reports that it is making progress on its reimbursement strategy in additional JMAC regions.

https://www.globenewswire.com/news-release/2024/07/10/2911114/15852/en/Milestone-Scientific-Announces-Favorable-Medicare-Pricing-for-its-CompuFlo-Epidural-System-within-First-JMAC-Region-Covering-Florida.html

House Oversight Subpoenas Top Biden Handlers To Find Out Who's Running The Country

 The House Oversight Committee subpoenaed three top White House aides on Wednesday, and has demanded that they sit for depositions concerning President Joe Biden's health - and who's actually running the country.

Aide Annie Tomasini, who referred to Hunter Biden as a 'brother' in emails, has been subpoenaed.

As Axios reports, Oversight chair James Comer (R-KY) subpoenaed First Lady Jill Biden's top aide Anthony Bernal, deputy chief of staff Annie Tomasini, and senior adviser Ashley Williams, who the outlet described as "low-profile but very influential" inside the White House.

According to Wednesday letters, Comer cites Bernal and Tomasini's access to the first family's residence - which White House residence staff found 'unusual,' as 'political staffers often don't have such access.'

According to one former Biden aide, these three employees – Annie Tomasini, Anthony Bernal, and Ashley Williams – have created “a protective bubble around” President Biden and he is “staffed so closely that he’s lost all independence.” -House Oversight Committee

Comer also writes that the committee is "concerned" that each official is "one of several White House staffers who have taken it upon themselves to run the country while the President cannot."

In his letter to Bernal — whose influence extends well beyond the first lady's office — Comer wrote: The "Committee seeks to understand the extent of Mr. Bernal's influence over the President and his knowledge of whether the President is personally discharging the duties of his office." -Axios

Tomasini, a close friend of the Biden family, maintained close relations with Hunter throughout the Obama administration - sometimes referring to him as her "brother," and often ending emails with "LY" (Love You), according to emails dating from 2010 to 2016.

"The White House has shielded three key aides from testifying about President Biden’s mishandling of classified documents and now we’ve learned through reporting these same aides are also seeking to cover up President Biden’s declining cognitive state inside the White House. President Biden is clearly unfit for office, yet his staff are trying to hide the truth from the American people. Key White House staff must come before our committee so we can provide the transparency and accountability that Americans deserve," said Comer in a statement.

https://www.zerohedge.com/political/house-oversight-subpoenas-top-biden-handlers-find-out-whos-running-country

'Cook says Fed would respond if unemployment starts to rise more quickly'

  The Federal Reserve is closely watching changes in the unemployment rate and would respond if it starts a quick climb, Fed Governor Lisa Cook said on Wednesday.

With a 4.1% unemployment rate "the labor market is still robust," Cook said at an event in Australia. "But we are very attentive to what is happening with the unemployment rate ... The situation could change very quickly and we would be responsive."

https://www.reuters.com/markets/us/cook-says-fed-would-respond-if-unemployment-starts-rise-more-quickly-2024-07-11/