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Thursday, February 9, 2023

Labcorp Names Future Independent Clinical Development Business

 Fortrea Will Become a Leading, Pure-play CRO Focused on Driving Innovation and Improving Patient Outcomes Worldwide

Spin-off Remains on Track to Be Completed in Mid-2023

 

LabCorp (NYSE: LH), a leading global life sciences company, today announced that the new company to be formed by the planned spin-off of its Clinical Development business will be known as Fortrea. Upon completion of the spin-off from Labcorp, Fortrea will operate as an independent, publicly traded global CRO that offers comprehensive drug and medical device development services. With over 19,000 people, Fortrea will provide Phase I through IV clinical trial management and commercialization solutions to pharmaceutical and biotechnology organizations around the world.

https://www.biospace.com/article/releases/labcorp-unveils-new-name-for-future-independent-clinical-development-business-fortrea/

Bivalent COVID Vaccines Perform Worse Against Variant Now Dominant In US

 by Zachary Stieber via The Epoch Times (emphasis ours),

The new COVID-19 vaccines don’t work as well against XBB.1.5, the virus variant that’s now dominant in the United States, according to multiple studies.

In one of the papers, researchers found the vaccines boosted neutralizing antibodies, believed to be a measure of protection, but that the antibody levels declined to previous levels within three months.

Compared to the antibody responses to BA.5, the responses to XBB.1.5 were reduced 20-fold.

“Following bivalent mRNA boosting, responses to XBB.1.5 increase but remain low and wane within 3 months back to pre-boost levels. These data suggest that once a year boosters with the current mRNA vaccines may not provide adequate protection for an entire year for those at high risk of complications of COVID-19,” Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at the Beth Israel Deaconess Medical Center and a co-author of the preprint study (pdf), told The Epoch Times via email.

The Moderna and Pfizer vaccines both utilize messenger RNA, or mRNA, technology. The updated versions of the vaccines are bivalent, targeting the Wuhan variant and a sublineage of the BA.4 and BA.5 strain. The new versions were cleared as boosters in the fall of 2022 despite no clinical data being available. They are poised to replace the original vaccines.

Other studies have also found that the bivalents induce a better response than the old, monovalent boosters, but that the response is reduced against XBB.1.5 or its parent, XBB, which comes from BA.2 lineages.

https://www.zerohedge.com/medical/bivalent-covid-vaccines-perform-worse-against-variant-now-dominant-united-states-studies

Biden health officials face Covid response probe

 Wednesday was the first time in nearly two years that administration health officials were called to testify in the House about the COVID-19 pandemic. The new GOP majority made it clear they wouldn’t wait that long again.

 

“The CDC does not need more authority,” House Energy and Commerce Chairwoman Cathy McMorris Rodgers (R-Wash.) told Rochelle Walensky, director of the Centers for Disease Control and Prevention. “It needs robust oversight.”

 

The CDC “has always operated without a congressional authorization and that is going to change,” McMorris Rodgers said.

 

Aside from Walensky, Food and Drug Administration Commissioner Robert Califf and Lawrence Tabak, acting director of the National Institutes of Health (NIH) faced questions ranging from the effectiveness of mask and vaccine mandates to concerns over funding of controversial “gain of function” research, which makes pathogens more dangerous in order to find new cures.

 

Republicans have relaunched an investigation into the pandemic origins and are demanding documents from NIH. 

 

Notably missing from the panel was Anthony Fauci, the former longtime director of the National Institute of Allergy and Infectious Diseases who retired at the end of last year. House Republicans have vowed to bring him in to testify and answer questions about the origins of the coronavirus and his agency’s role in giving funding to the Wuhan Institute of Virology in Wuhan, China. 

 

In his absence, Tabak and the NIH got the brunt of lawmakers’ ire. 

 

In January, a Heath and Human Services Office of Inspector General report found the NIH didn’t effectively monitor or take timely action to address problems with past grants.

 

“For the past two years, we’ve pressed for answers about what kind of research you’re funding with taxpayer dollars and what sort of oversight you’re doing to ensure funds are not being misspent. Your cooperation has been abysmal,” McMorris Rodgers said.


https://thehill.com/newsletters/health-care/3850385-biden-health-officials-face-gop-grilling/

House unanimously approves resolution condemning China for spy balloon

 The House unanimously approved a resolution on Thursday condemning the Chinese Communist Party’s use of a spy balloon over the continental U.S., labeling the situation “a brazen violation of United States sovereignty.”

The resolution — which cleared the chamber in a bipartisan 419-0 vote — came to the House floor five days after the U.S. shot down the Chinese spy balloon off the South Carolina coast, intensifying tensions between Washington and Beijing.

“An event like this, Mr. Speaker, must not happen again. And it cannot go unanswered,” Rep. Michael McCaul (R-Texas), the chairman of the House Foreign Affairs Committee and sponsor of the measure, said on the House floor during debate Thursday.

“They only understand one thing and that is force, and that’s projecting power, and we need to project power and force and strength against the Chinese Communist Party,” he added. “They must understand that we do desire peace, but infringing upon our sovereignty leads us down a dangerous path. Our adversaries must believe that any future incursion into American airspace by a spy balloon or any other vehicle will be met with decisive force. And that is why the House should pass this resolution.”

The Pentagon last week announced that it was tracking a high-altitude Chinese surveillance balloon floating over the U.S., prompting widespread media coverage. On Saturday, the U.S. shot down the object over water off the coast of South Carolina, and the American military is now working to recover the debris.

The situation prompted Secretary of State Antony Blinken to postpone his trip to Beijing. 

Republicans were quick to criticize President Biden for waiting days to shoot down the balloon, which allowed the object to float across several states in the U.S. The president said he ordered the Pentagon last week to shoot down the balloon “as soon as possible,” and his national security officials determined that “the best time to do that was when it got over water.”

Despite the criticism, McCaul this week said he wanted the resolution to be a bipartisan effort rather than a partisan measure that knocked the Biden administration.

“It’s too important of an issue,” McCaul told reporters on Monday. “We want to stand strong together against China instead of having our internal fights.”

The resolution calls on the Biden administration to continue keeping Congress apprised of developments through “comprehensive briefings on this incident” that include a timeline of when the balloon was first detected to when it was shot down, an assessment of surveillance data the People’s Republic of China was potentially able to collect or send, a detailed account of measures taken to mitigate the intelligence collection threat from the balloon, a description of options to mitigate the situation, and an account of diplomatic communications between Washington and Beijing on the matter.

The resolution also requests information on previous times the People’s Republic of China used surveillance balloons across the world.

And it denounces Beijing for its “efforts to deceive the international community through false claims about its intelligence collection campaigns” that violated American sovereignty. Beijing has insisted the object was a civilian weather balloon that went off course and mistakenly entered U.S. airspace.

https://thehill.com/homenews/house/3851173-house-unanimously-approves-resolution-condemning-china-for-spy-balloon/

Former White House Physician Demands Biden Undergo Immediate Cognitive Examination

 by Paul Joseph Watson via Summit News,

Former White House physician Ronny Jackson has called for Joe Biden to be subjected to an immediate cognitive examination after the president appeared to be lost on stage yet again.

Texas Congressman Jackson demanded an evaluation of Biden’s mental acuity after another clip showed Biden bumbling around in front of an audience at the Laborers’ International Union of North America (LIUNA) training center.

“You know, uh…” Biden stammered before appearing to look confused.

He then looked vacant before placing down his microphone, picking it up again and mumbling, “you guys over here.”

“WOW! What is going on with Biden here??? He’s TOTALLY lost. This man needs a cognitive exam NOW. There’s NO WAY he’s ok!!” tweeted Jackson.

During the same speech, Biden also struggled with reading words from his teleprompter.

Jackson, who served on the White House medical team in the mid-2000s and served as personal physician to both Barack Obama and Donald Trump, previously predicted that Biden wouldn’t finish his second term.

“Biden won’t finish his term. EVERYONE knows he’s unfit for the job. His mind is too far gone. This can’t go on any longer. He needs to RESIGN!” he asserted.

Jackson was previously scolded by Barack Obama for Barack Obama for questioning Biden’s cognitive ability.

“I have to express my disappointment at the cheap shot you took at Joe Biden via Twitter,” Obama wrote in a letter, adding, “It was unprofessional and beneath the office that you once held. It was also disrespectful to me and the many friends you had in our administration.”

“You were the personal physician to the President of the United States as well as an admiral in the U.S. Navy,” Obama noted, asserting, “I expect better, and I hope upon reflection that you will expect more of yourself in the future.”

During another event last month in Springfield, Virginia, Biden joked about people thinking he was “stupid” before making yet another embarrassing verbal gaffe.

poll conducted by Issues & Insights/TIPP last August found that 59 per cent of Americans are concerned about President Biden’s mental health.

https://www.zerohedge.com/political/former-white-house-physician-demands-biden-undergo-immediate-cognitive-examination

Abbvie puts (some) numbers on expected Humira erosion

 During Abbvie’s fourth-quarter earnings call today the big question on everyone’s mind was: just how quickly will Humira sales erode following the recent US entrance of biosimilar competition? Abbvie put out some surprisingly detailed guidance, at least for this year, for its ageing mega-blockbuster. The group expects Humira to sell $13.7bn in 2023, which equates to US sales shrinkage of 37%. While this looks like a big drop, it is in fact at the lower end of the group’s previous erosion projection of 35-55%. Still, earnings guidance disappointed, with the group pencilling in 2023 adjusted diluted EPS of $10.70-11.10, versus sellside consensus of $11.63. $10.70 will also be the floor for EPS in 2024, execs said today. Despite being asked numerous times, they would not put a number on expected Humira revenue next year. In 2025 and beyond, Humira should have reached a “stable tail”, Abbvie’s chief executive, Rick Gonzalez, said. The pressure is on the likes of Skyrizi and Rinvoq to pick up the slack – if the former meets 2023 expectations, it will be well on the way to selling $10bn by 2025, as predicted by Abbvie.

Abbvie's 2023 guidance for selected products
Product2023e sales ($bn)
Humira13.7
Skyrizi7.4
Rinvoq3.7
Imbruvica3.5
Venclexta2.2
Total sales52.0
Source: Approximate assumptions given during company Q4 earnings call.

https://www.evaluate.com/vantage/articles/news/snippets/abbvie-puts-some-numbers-expected-humira-erosion

Astra tentatively takes Tigit pivotal

 The Tigit mechanism has much to prove this year, but Astrazeneca has apparently seen enough to push on. The PD-1/Tigit bispecific rilvegostomig, previously codenamed AZD2936, will move into pivotal development this year, the developer announced today.

Rilvegostomig is currently being tested in the phase 1/2 Artemide-01 trial – Astra has guided to readout in 2024 – but the trial is open label and the developer has presumably gleaned promising signals. A much bolder plan was unveiled for volrustomig, its PD-1/CTLA-4 bispecific, which is heading into five new phase 3 studies in 2023.

The more cautious approach with rilvegostomig is understandable given Tigit’s unproven potential. Susan Galbraith, Astrazeneca’s head of oncology R&D, acknowledged that overall survival data are awaited, presumably a reference to the Roche Skyscraper-01 study of tiragolumab.

She told a press conference that the next wave of immuno-oncology combinations are likely to result in greater patient segmentation, and that the Tigit-blocking pathway could become particularly important at the higher end of PD-L1 expression. Astra is also betting that bispecifics, rather than molecules that hit a single target, will be more convenient.

“You don’t get an added toxicity penalty and that enables further combination, which is an important part of our strategy overall,” she said.

That combination approach is likely to be on show when the pivotal programme for volrustomig, formerly called MEDI5752, is unveiled. The project is currently in two phase 1 trials in various solid tumours – again, the drugmaker has guided to data in 2024 – while pivotal settings will include NSCLC.

Astrazeneca's bispecific push 
ProjectOngoing trialsData?Pivotal plan
Volrustomig (PD-1/CTLA-4)Advanced renal cell carcinoma, + Inlyta or Lenvima; advanced solid tumours, +/-chemo2024Five phase 3s planned in 2023 across key tumour types, incl NSCLC (vs SOC regimens)
Rilvegostomig (PD-1/Tigit)Artemide-01 (NSCLC monotherapy in CPI experienced and naïve)2024New phase 3 planned in 2023
AZD7789 (PD-1/Tim3)NSCLC and other tumours; R/R Hodgkin lymphoma >2024None detailed
Source: Company communications.

Another new combination trial unveiled today will see Imfinzi plus the Daiichi Sankyo-partnered ADC datopotamab deruxtecan against Keytruda in first-line NSCLC. The study, called Avanzar, will stratify for a Trop2 biomarker. Readout of the second-line Tropion-Lung01 study, which tests the ADC versus docetaxel, is probably the biggest catalyst for the drug maker, and its Japanese partner, this year.

Other notable pipeline updates today include the dropping of a second IL-12 asset, the phase 1 gene therapy MEDI9253; a Moderna-partnered projected was ditched last year. Ms Galbraith said neither project was showing appropriate efficacy to push on, and that the moves do not reflect any disbelief in IL-12 as an important cytokine. This is notable considering Bristol Myers Squibb also exited this area this week.

Outside of oncology, Mene Pangalos, head of biopharmaceuticals R&D, confirmed that Astra would not be pursuing roxadustat for anaemia associated with chronic kidney disease in the US. Fibrogen had hinted as much in filings last year, and given the FDA’s reluctance to approve these agents, and the huge burden of proof that would be required to change the agency's mind, the decision is not entirely surprising.

Astrazeneca has plenty of other places to put its money – it plans to start more than 30 phase 3 trials in 2023. 

https://www.evaluate.com/vantage/articles/news/corporate-strategy/astra-tentatively-takes-tigit-pivotal