Newsom Signs Fast Food Bill Decried As 'California Food Tax'

by Caden Pearsen via The Epoch Times,

California Gov. Gavin Newsom on Monday announced that he signed legislation targeting some fast food franchises to lift minimum wages to $22 per hour and change working conditions. Opponents have described the bill as “hypocritical” and “ill-considered.”

The bill will create a 10-member Fast Food Council appointed by Newsom, a Democrat, and other state lawmakers.

“California is committed to ensuring that the men and women who have helped build our world-class economy are able to share in the state’s prosperity,” Newsom said in a statement.

“Today’s action gives hardworking fast-food workers a stronger voice and seat at the table to set fair wages and critical health and safety standards across the industry. I’m proud to sign this legislation on Labor Day when we pay tribute to the workers who keep our state running as we build a stronger, more inclusive economy for all Californians.”

The council members who are bureaucrats, fast food restaurant employees, franchisees, and franchisors will be appointed by the governor. The state assembly speaker and Senate Rules Committee speaker will each appoint one member as an advocate for fast food restaurant employees, according to the legislation.

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The California Restaurant Association (CRA) argued that the bill unfairly targets some franchises to the detriment of others and the community.

“By signing AB 257 into law, Governor Newsom has not leveled the playing field but instead targeted one slice of California’s small businesses and consumers who rely on counter service restaurants to feed their families,” a statement from the organization reads.

“As individual employers and neighborhood restaurants across the state, we will use every tool at our disposal to protect our consumers, workers, and other job providers from the pain and havoc that will result from enacting this bill.”

CRA also decried the signing of the bill while inflation in the United States is at record high levels, saying that consumers and small business owners will pay a 20 percent increase “to fund the outsourcing of the legislature’s duties to union-led bureaucracy.”

“By arbitrarily singling out a sliver of the restaurant industry, California’s approach imposes higher costs on one type of restaurant while sparing others, putting some workers at a disadvantage and picking clear ‘winners’ and ‘losers.’

“Governor Newsom ignored the arbitrary and haphazard nature of this bill and signed into law a reckless precedent which will have far-reaching harmful impacts beyond the state’s borders,” the organization said.

McDonald’s USA President Joe Erlinger, a California native, said that the state government has been driving businesses out of California with its policies. 

Erlinger said he supports wage increases and noted that McDonald’s operates well in jurisdictions with high minimum wage regulations in the United States and around the world.

But he said that the approach California has taken “targets some workplaces and not others.”

“It imposes higher costs on one type of restaurant, while sparing another. That’s true even if those two restaurants have the same revenues and the same number of employees,” he said in an open letter. 

“If you are a small business owner running two restaurants that are part of a national chain, like McDonald’s, you can be targeted by the bill,” he added.

“But if you own 20 restaurants that are not part of a large chain, the bill does not apply to you. For unexplainable reasons, brands with fewer than 100 locations are excluded. Even more mystifying, the legislation excludes certain restaurants that bake bread. I can only conclude this is the outcome of backroom politicking.”

Erlinger said the bill is “lopsided, hypocritical and ill-considered” and noted that economists have warned that it will “drive up the cost of eating at a quick service restaurant in California by 20 percent at a time when Americans already face soaring costs in supermarkets and at gas pumps.”

https://www.zerohedge.com/personal-finance/gov-gavin-newsom-signs-fast-food-bill-decried-california-food-tax

Paper: Oz has raised ‘legitimate concerns’ about Fetterman’s health

 The Pittsburgh Post-Gazette’s editorial board said that Pennsylvania Senate Republican nominee Mehmet Oz has raised “legitimate concerns” about his Democratic opponent, Lt. Gov. John Fetterman, in an editorial published Tuesday. 

The editorial comes a week after Fetterman announced that he would not participate in a debate with Oz during the first week of September, citing his recovery from a stroke he had in May and statements from Oz’s campaign that Fetterman has said mocked him for having the stroke. 

“If Mr. Fetterman is not well enough to debate his opponent, that raises serious concerns about his ability to serve as a United States senator,” the editorial states. 

Fetterman told the Post-Gazette in July that he felt “really good” following the stroke and has no “physical limits.” 

The editorial states Fetterman’s campaign has acknowledged lingering struggles with speech but asserts that he will fully recover and is taking the necessary steps to do so in speech therapy. It states that a live debate is the best way to determine if Fetterman is up to the job of senator. 

The editorial board endorsed former President Trump for reelection in 2020, its first time endorsing a Republican for president since 1972. Trump endorsed Oz’s campaign in the spring.

The board said the legitimate point about Fetterman’s health does not excuse the tactics that Oz’s campaign has pursued in deciding that Oz will benefit from “dragging the race deeper and deeper into the muck.” 

Fetterman’s stroke –– which he had in May shortly before winning the Democratic primary –– gained additional attention in the general election campaign after an Oz spokesperson said in a statement to Insider that Fetterman may not have had a stroke if he “had ever eaten a vegetable in his life.” 

Oz’s senior communications adviser made the statement in response to criticism Oz received for a campaign video in which he complained about rising grocery prices making crudité more expensive. His campaign later released a mocking statement in which it noted “concessions” that it would make if Fetterman agreed to a debate, like paying for “additional medical personnel” that Fetterman might need “on standby.” 

Fetterman said Oz has made “abundantly clear that they think it is funny to mock a stroke survivor” and that he would be ready to discuss debating Oz when Oz and his team “are ready to take this seriously.” 

The Post-Gazette said Oz has attempted to distance himself from his campaign’s statements but that spokespeople speak for his campaign and he should fire them if they have “gone rogue.” But the editorial said he can note legitimate concerns about Fetterman being straightforward with his health without “sandbox bullying.”

https://thehill.com/homenews/campaign/3630720-pittsburgh-newspaper-oz-has-raised-legitimate-concerns-about-fettermans-health/

Hoth mRNA Frame-Shifting Therapeutic Shows Potential to Reduce Lung Inflammation in Asthma, Allergy

 Hoth Therapeutics Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced development updates for its novel asthma and allergy maintenance therapeutic, HT-004.

Hoth's innovative approach employs a chemically-stable antisense oligonucleotide to eliminate cell surface high-affinity IgE receptor (FceRI) expression and function on mast cells and basophils, rendering mast cells unresponsive to IgE-mediated activation that occurs during asthma and allergy disorders.

Through a sponsored scientific research agreement with North Carolina State University, the team used the HT-004 FceRI mRNA frame-shifting approach to reduce lung inflammation induced by OVA in mice.  OVA-induced inflammation mice treated with HT-004 via inhalation showed significantly reduced inflammatory cell recruitment in the bronchioles compared to vehicle control and oligonucleotide control OVA-induced mice; the reduction in bronchiolar inflammation in HT-004-treated mice was near the non-OVA stimulated mice. The results of these studies support the use of HT-004 as a novel inhalation maintenance therapy for asthma and allergic disorders.

The results of these studies are a continuation of the 2016 publication by Hoth Scientific Advisory Board member Dr. Glenn Cruse, "Exon skipping of FceRIβ eliminates expression of the high-affinity IgE receptor in mast cells with therapeutic potential for allergy" (www.pnas.org/cgi/doi/10.1073/pnas.1608520113).

Hoth has filed several patent applications to protect this IP throughout the world.  

Hoth is continuing to expand the HT-004 development program through investigating the therapeutic potential of HT-004 in other larger animal models (such as cats and/or dogs) that closely resemble human asthma and allergic diseases.

https://www.biospace.com/article/releases/hoth-therapeutics-mrna-frame-shifting-therapeutic-ht-004-shows-potential-to-reduce-lung-inflammation-in-asthma-and-allergy-disorders/

ALS Thought Leaders Weigh in Ahead of Second Amylyx Adcomm

 Wednesday offers a rare opportunity for Amylyx Pharmaceuticals, which will go before the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee in a second attempt to win recommendation for its amyotrophic lateral sclerosis (ALS) drug, AMX0035.

The FDA provided briefing documents Friday, and despite the unusual second adcomm, it does not appear to be convinced. To be approved, AMX0035 must meet substantial evidence of effectiveness, which “may be derived by either a single very persuasive trial or a single adequate and well-controlled study plus confirmatory evidence,” the documents state.

In March, the PCNSDAC voted 6-4 that the Phase II CENTAUR trial was not sufficient to prove efficacy in ALS. This trial, made up of 137 participants, showed a median overall survival (mOS) rate of 4.8 months compared to placebo.

Amylyx subsequently submitted additional analyses of the survival data from this trial and an open-label extension study. The agency considered this new data a “major amendment” and extended the drug’s review time by three months. Recognizing the “substantial unmet medical need in ALS,” it again convened the PCNSDAC and here we are.

Wednesday's vote carries a higher burden for Amylyx to prove - that the data supporting AMX0035 is sufficient to "support approval".  

The Case 

Amylyx will present new analysis using the Rank Preserving Structural Failure Time Model (RPSFTM) to adjust for the effect of treatment crossover. This refers to patients who swtiched from treatment to placebo following the Phase II trial. In this analysis, the mOS in the intent-to-treat (ITT) population is 9.7 months.

The company also submitted analyses using natural history as a control to estimate survival time, as well as biomarker evidence from the Phase II PEGASUS trial of AMX0035 in Alzheimer’s disease (AD).

While Amylyx is presenting the above as confirmatory evidence, the FDA wrote, “The presented RPSFTM analysis is not independent data and is simply a new method for analyzing the same survival data presented in the original NDA submission."

Of the biomarker analysis, the regulator said, “The submitted biomarker data are not clear evidence of a CNS effect or a potential clinical benefit in patients with ALS.”   

AMX0035 is currently being assessed in a Phase III trial and the FDA expressed an inclination to wait until its completion, which is expected late next year or in early 2024. The PHOENIX trial will enroll approximately 600 individuals across the United States and Europe.

“This places the Agency in a challenging situation of potentially making a regulatory decision that may not be subsequently aligned with the results of the ongoing study,” the FDA stated.  

For its part, Amylyx released the following statement Friday: “AMX0035 is the first drug candidate to show benefit on function and survival in ALS in a randomized, placebo-controlled clinical trial, as a standalone therapy or when added to existing approved treatments.”

Thought Leaders Weigh In

In ALS, which carries a typical death sentence of 3-5 years after diagnosis, any survival increase is enticing, particularly in a space that has seen little progress in recent years. BioSpace reached out to ALS thought leaders and drug developers prior to the adcomm for their perspectives.

“Based on the data presented from their phase II trial, the Amylyx drug appears to offer a benefit in terms of slowing of disease progression and a possible survival benefit,” said Stan E. Abel, CEO of ProJenX Inc., in an email.

ProJenX is in Phase I development with Prosetin, a mitogen-activated protein kinase (MAP4K) inhibitor targeting endoplasmic reticulum (ER) stress, a common feature in sporadic and familiar forms of ALS.

“Given the benign safety profile, it is encouraging to see the FDA take a careful look at all the data…,” Abel continued. This was an area of consensus between Amylyx and the FDA in March, with both concluding AMX0035 did not pose a safety risk to patients.

There is another potential wrinkle in the case of AMX0035. In June, Amylyx notched its first regulatory approval when Health Canada approved the drug, now known as Albrioza, conditional on the results of the PHOENIX trial.

If AMX0035 does not receive approval in the U.S. or other countries, Abel noted it “would add uncertainty and confusion to an already challenging clinical trial environment.” He added that “people living with ALS would likely seek treatment across borders which adds a significant burden to managing their care and [would put] more strain on the drug importation phenomenon.” 

Dr. Merit Cudkowicz, director of the Sean M. Healey & AMG Center for ALS and chief of neurology at Massachusetts General Hospital, shared her thoughts in an email.

“A positive phase II study like Centaur – where there is slowing of loss of function, prolongation of life - a survival benefit - and no safety issues – is something we need to be able to get to our patients in the U.S.,” Cudkowicz said. 

With recent breakthroughs in the space, there is a sense of momentum right now. If AMX0035 is ultimately approved, “it will provide much needed positive news in the space and encourage further investment in other new promising therapies,” Abel said.

Regulatory Flexibility for ALS

The ALS community has been calling for regulatory flexibility since the FDA approved Biogen's Aduhelm for Alzheimer’s in June 2021.

Of the Sept. 7 adcomm, Stacy Lindborg, Ph.D., EVP and chief development officer at BrainStorm Cell Therapeutics said, “We hope that a positive…recommendation would encourage the FDA to exercise regulatory flexibility.”

BrainStorm is in the final stages of completing a BLA for NurOwn, an ALS candidate made up of autologous mesenchymal stem cells (MSCs) and neurotrophic factors (NTFs). Lindborg noted that the totality of evidence for NurOwn “[brings] to light valuable insights on the nature of ALS research and biomarkers as predictors of clinical response.” 

In June, the FDA unveiled its Action Plan for Rare Neurodegenerative Diseases including ALS. The five-year strategy intends to improve and extend the lives of people living with rare neurodegenerative diseases by “advancing the development of safe and effective medical products and facilitating patient access to novel treatments.” 

Cudkowicz made a comparison to the FDA’s approval process for drugs in serious cancer indications.  

“The oncology branch of FDA approves drugs with smaller effects on survival based on a single study, and it would be a huge step forward in ALS if single studies like this could be approved conditional on future studies,” she wrote in the same email.  

Abel shared his thoughts on both the adcomm and the Action Plan. 

“The action plan for rare neurodegenerative diseases and this second Amylyx adcomm are both important steps that signal the FDA’s willingness to apply thoughtful regulatory standards which take disease-specific considerations into account," he said.

Lindborg concurred, stating, “FDA’s release of the plan is an important step in adopting an outlook that prioritizes action to move potential therapies forward.” 

SVB Senior Research Analyst Marc Goodman provided a summary of his most recent note on Amylyx. 

“Significant unmet need in ALS with only two existing SOC (standard of care) agents that don’t work very well should drive expedited regulatory approvals of AMX0035 and strong uptake, in combination with SOC agents," he wrote.

If AMX0035 does receive FDA approval, Cudkowicz said, “It would strongly encourage more trials of other therapeutic approaches in ALS and would be a huge positive for the field.” A negative opinion, she said, “…would be hugely disappointing for people living with ALS today and for ALS clinicians. It could risk putting the field back with less interest from industry.” 

https://www.biospace.com/article/als-thought-leaders-weigh-in-ahead-of-second-amylyx-adcomm-/

FDA Lifts Hold on Sarepta's DMD Trial Following Protocol Adjustments

 The FDA removed the clinical hold on Sarepta Therapeutics' investigational Duchenne muscular dystrophy (DMD) therapy Tuesday after the company agreed to adjust its clinical trial protocols to include expanded monitoring of urine biomarkers. 

The FDA ordered a halt in June to the United States arm of the Phase II trial assessing the safety and efficacy of SRP-5051 (vesleteplirsen) after a serious safety signal was detected.  A trial participant developed a dangerously low level of serum magnesium, a condition known as hypomagnesemia. 

The FDA lifted the hold after Cambridge, Mass.-based Sarepta agreed to adjust the trial's protocols to expand the monitoring of urine biomarkers. 

“We will implement the changes in the protocol to resume dosing in the U.S. as quickly as possible,” said Louise Rodino-Klapac, the company's executive vice president and chief scientific officer, in a press release. “Our monitoring plan is designed to mitigate the risks of hypomagnesemia." 

Sarepta spokesperson Tracy Sorrentino told BioSpace the trial’s adjusted protocols will also require spot urine assessments of patients prior to visits. Sorrentino said the new requirement should “help minimize intra-patient variability of the urine biomarkers.” 

The trial, dubbed MOMENTUM, continued to enroll patients in Canada and the European Union not covered by the FDA's hold. Sarepta said it expects to complete enrollment in part B of the 60-patient study by the end of the year. 

Part A of the trial, completed last year, showed that 12 weeks of monthly SRP-5051 infusions led to an eight-fold increase in dystrophin in the skeletal muscle compared to eteplirsen. Cases of reversible hypomagnesemia were also detected in part A. 

Part B's protocols include the lab tests that detected the serious hypomagnesia case. The patient also reported mild-to-moderate tingling of the extremities and muscle cramps and was found to have low serum potassium levels. Protocol-prescribed supplementation resolved the patient's symptoms within three days, including the return to normal magnesium levels.   

In the U.S., DMD patients have very limited treatment options. 

SRP-5051 is a next-generation peptide-conjugated phosphorodiamidate morpholino oligomer. The treatment is being developed for patients with DMD who are amenable to exon 51 skipping. 

https://www.biospace.com/article/fda-lifts-hold-on-sarepta-s-dmd-trial-following-protocol-adjustments/

FDA Okays Imfinzi as First Immunotherapy for Advanced Biliary Tract Cancer

 The FDA approved AstraZeneca’s Imfinzi (durvalumab) plus with gemcitabine-cisplatin chemotherapy as the first immunotherapy for adult patients with locally advanced or metastatic biliary tract cancer. 

Results from the Phase III TOPAZ-I trial supported Monday’s regulatory green light. The data, published last June in the New England Journal of Medicine, showed the Imfinzi-containing treatment regimen suppressed the risk of death by 20% compared to chemotherapy alone.

After two years of follow-up, nearly a quarter of patients who received Imfinzi were still alive, while the survival rate in the placebo arm was 10.4 percent. On the Kaplan-Meier curve, the survival benefits of Imfinzi became apparent six months after treatment initiation. The combination then continued to durably demonstrate superiority over placebo.

Biliary tract cancer (BTC) describes a group of rare malignancies that develop along the biliary tract, including the bile ducts, the gallbladder and the ampulla of Vater. BTCs are typically aggressive, and survival rates peak at 15%. 

The global TOPAZ-I study combined Imfinzi plus gemcitabine with cisplatin for the first-line treatment of 685 patients with unresectable and advanced or metastatic BTC. Aside from overall survival, Imfinzi’s efficacy was also assessed through progression-free survival (PFS). Tolerability was evaluated according to toxicities and treatment side effects.

Patients treated with Imfinzi also showed better PFS, with the drug cutting the risk of disease progression by some 25%.

Almost all patients in both treatment arms saw at least one adverse event of any severity. Grade 3 or 4 side effects arose in 75.7% of patients treated with Imfinzi and 77.8% of placebo comparators. Discontinuation rates remained low, at 13.0% and 15.2%, respectively. Twelve patients in the Imfinzi group died due to treatment toxicities, as did 14 patients given placebo.

Imfinzi is a human monoclonal antibody that prevents the PD-L1 protein from interacting with the PD-1 and CD80 receptors, stopping cancer cells from evading the immune system. Imfinzi has also earned regulatory approval for non-small cell lung cancer, extensive-stage small cell lung cancer and bladder cancer.

Regulatory review for Imfinzi for locally advanced or metastatic BTC is underway in Australia, Brazil, Canada, Singapore, Switzerland, Israel and the U.K.

Monday’s regulatory win for Imfinzi comes 18 months after the high-profile failure of bintrafusp alfa, which had been developed under a now-dissolved partnership between Merck and GSK. In a Phase II study, bintrafusp alfa showed promising efficacy as a single-agent second-line treatment for BTC but fell short of predefined thresholds to support a regulatory filing.

https://www.biospace.com/article/astrazeneca-s-imfinzi-scores-first-immunotherapy-approval-for-advanced-biliary-tract-cancer/

FSD Pharma OKd to Proceed with Phase 2 Trial of Antiinflammatory

 FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRE: 0K9A) ("FSD Pharma" or the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions to address ailments affecting millions worldwide, today announces that it received "Study May Proceed" letter for the Investigational New Drug ("IND") application from the U.S. Food and Drug Administration ("FDA") and "Notice of Authorization" from Health Canada for its Phase 2 clinical trial of FSD201. The corresponding study protocol is titled "A Randomized, Double-Blind Placebo Controlled Parallel Group Study of Safety and Efficacy of FSD201 in Patients with Chronic Widespread Musculoskeletal Nociplastic Pain Associated with Idiopathic Mast Cell Activation Syndrome (Disorder)".

https://finance.yahoo.com/news/fda-health-canada-clear-ind-123000337.html