Business

Novartis’ Pluvicto Shows Mixed Results in Early Prostate Cancer

(CTN News) – Pluvicto, Novartis’ radiotherapy, has high hopes. Despite the Swiss pharma’s efforts to move the drug into an earlier prostate cancer treatment setting, it has posted mixed trial results that cast a cloud of uncertainty over its regulatory road ahead.

Pluvicto reduced the risk of disease worsening or death by 57% compared with a change in androgen receptor inhibitor in PSMA-positive, metastatic castration-resistant prostate cancer patients without taxane therapy.

At the 2023 Congress of the European Society for Medical Oncology, the results of the phase 3 PSMAfore trial were presented.

In the world of oncology, a 50%+ improvement in progression-free survival should be celebrated. But Pluvicto’s readout was tempered by a worrying sign about patients’ lives.

Researchers found that Pluvicto’s use was linked to a 16% increased risk of death in PSMAfore, contrary to the big tumor progression showing.

According to Jeff Legos, Ph.D., Novartis’ global head of oncology and hematology development, the overall survival results are confounded and influenced by the fact that 84% of patients whose disease progressed in the control arm actually received Pluvicto.

Compared to the control group, Pluvicto showed a 20% reduction in the risk of death after adjusting for crossover treatments.

In the overall survival analysis, Pluvicto’s pre-taxane phase was compared with the radiotherapy itself used later, although the trial wasn’t designed to test that sequencing scenario prospectively, Legos said.

As a post-taxane therapy, Pluvicto is already approved by the FDA. Although crossover-adjusted analysis is the prespecified method for overall survival in PSMAfore, it does not reflect real-world practice.

The current overall survival data were derived from PSMAfore’s second interim analysis. A primary endpoint of the trial was met after 7.3 months of follow-up. Compared with control, pluvicto reduced progression or death by 59%. Novartis, however, did not apply for FDA approval since it wanted a more mature analysis of overall survival.

The FDA would be concerned about a negative trend in overall survival. In spite of the fact that the readout does not necessarily mean Pluvicto caused more harm, the FDA generally does not tolerate the possibility of a potential detriment to a patient’s survival.

A bit of a mystery remains as to why Pluvicto’s large tumor Novartis progression benefit didn’t translate into longer overall survival. Aside from tumor shrinkage, quality of life and safety, all factors related to directly assessing Pluvicto’s benefit are favorable.

The Pluvicto arm experienced 34% of adverse events of grade 3 or higher, while the control arm experienced 44%. Only 1% of Pluvicto patients had grade 3 or higher dry mouth. Around 6% of patients in both arms suffered from high-grade anemia. In the two trial arms, 5.7% and 5.2% of patients discontinued due to side effects.

The Pluvicto sequencing question remains open, but Legos argued that “requiring patients to take a second androgen pathway inhibitor that is inferior based on these data does not make much sense.” Zytiga, Pfizer, and Astellas’ Xtandi were the antiandrogens used in PSMAfore.

According to analysts at Leerink Partners, the PSMAfore data shows Pluvicto is better than switching antiandrogen strategies, and the Novartis drug can be used prechemo.

It was less clear, however, whether Pluvicto can replace chemotherapy docetaxel or a PARP inhibitor in patients with BRCA-mutated tumors, according to Christopher Sweeney from the University of Adelaide, who was invited by ESMO to discuss the PSMAfore data. Sweeney called switching antiandrogen therapy a “weak control” that’s easy to defeat during his presentation at ESMO.

According to Leerink analysts, despite this caveat, Pluvicto is poised to become the new standard in pre-chemo mCRPC.

On Tuesday, Novartis will share its regulatory plan from here.

According to Novartis, Pluvicto could generate peak sales of more than $2 billion. According to Pluvicto, moving into a taxane-naive setting would triple the number of patients it can reach.

Earlier this year, radiotherapy sparked a shortage for a few months in the post-taxane setting. Pluvicto beat analysts’ expectations by $451 million in the first half of 2023.

Recently, Novartis won FDA approval for a radioligand therapy manufacturing facility in Millburn, New Jersey. Another facility is expected to open in Indianapolis in the coming months, pending FDA approval.

Business

PepsiCo Reduces Revenue Projections As North American Snacks And Key International Markets Underperform.

(VOR News) – In the third quarter of this year, Pepsi’s net income was $2.93 billion, which is equivalent to $2.13 per share. This was attributed to the company.

This is in stark contrast to net income of $3.09 billion, which is equivalent to $2.24 per share, during the same period in the previous year. The company’s earnings per share were $2.31 when expenses were excluded.

Net sales decreased by 0.6%, totaling $23.32 billion. Organic sales increased by 1.3% during the quarter when the effects of acquisitions, divestitures, and currency changes are excluded.

Pepsi’s beverage sales fell this quarter.

The most recent report indicates that the beverage and food sectors of the organization experienced a 2% decline in volume. Consumers of all income levels are demonstrating a change in their purchasing habits, as indicated by CEOs’ statements from the previous quarter.

Pepsi’s entire volume was adversely affected by the lackluster demand they encountered in North America. An increasing number of Americans are becoming more frugal, reducing the number of snacks they ingest, and reducing the number of times they purchase at convenience stores.

Furthermore, Laguarta observed that the increase in sales was partially attributed to the election that occurred in Mexico during the month of June.

The most significant decrease in volume was experienced by Quaker Foods North America, which was 13%. In December, the company announced its initial recall in response to a potential salmonella infection.

Due to the probability of an illness, the recall was extended in January. Pepsi officially closed a plant that was implicated in the recalls in June, despite the fact that manufacturing had already been halted.

Jamie Caulfield, the Chief Financial Officer of Pepsi and Laguarta, has indicated that the recalls are beginning to have a lessening effect.

Frito-Lay experienced a 1.5% decline in volume in North America. The company has been striving to improve the value it offers to consumers and the accessibility of its snack line, which includes SunChips, Cheetos, and Stacy’s pita chips, in the retail establishments where it is sold.

Despite the fact that the category as a whole has slowed down in comparison to the results of previous years, the level of activity within the division is progressively increasing.

Pepsi executives issued a statement in which they stated that “Salty and savory snacks have underperformed year-to-date after outperforming packaged food categories in previous years.”

Pepsi will spend more on Doritos and Tostitos in the fall and winter before football season.

The company is currently promoting incentive packets for Tostitos and Ruffles, which contain twenty percent more chips than the standard package.

Pepsi is expanding its product line in order to more effectively target individuals who are health-conscious. The business announced its intention to acquire Siete Foods for a total of $1.2 billion approximately one week ago. The restaurant serves Mexican-American cuisine, which is typically modified to meet the dietary needs of a diverse clientele.

The beverage segment of Pepsi in North America experienced a three percent decrease in volume. Despite the fact that the demand for energy drinks, such as Pepsi’s Rockstar, has decreased as a result of consumers visiting convenience stores, the sales of well-known brands such as Gatorade and Pepsi have seen an increase throughout the quarter.

Laguarta expressed his opinion to the analysts during the company’s conference call, asserting, “I am of the opinion that it is a component of the economic cycle that we are currently experiencing, and that it will reverse itself in the future, once consumers feel better.”

Additionally, it has been noted that the food and beverage markets of South Asia, the Middle East, Latin America, and Africa have experienced a decline in sales volume. The company cut its forecast for organic revenue for the entire year on Tuesday due to the business’s second consecutive quarter of lower-than-anticipated sales.

The company’s performance during the quarter was adversely affected by the Quaker Foods North America recalls, the decrease in demand in the United States, and the interruptions that occurred in specific international markets, as per the statements made by Chief Executive Officer Ramon Laguarta.

Pepsi has revised its forecast for organic sales in 2024, shifting from a 4% growth rate to a low single-digit growth rate. The company reiterated its expectation that the core constant currency profitability per share will increase by a minimum of 8% in comparison to the previous year.

The company’s shares declined by less than one percent during premarket trading. The following discrepancies between the company’s report and the projections of Wall Street were identified by LSEG in a survey of analysts:

SOURCE: CNBC

Business

Old National Bank And Infosys Broaden Their Strategic Partnership.

(VOR News) – Old National Bank, a commercial bank with its headquarters in the Midwest, and Infosys, a firm that specializes in information technology, have recently entered into a strategic expansion of their link, which has been in place for the past four years.

This expansion is more likely to take place sooner rather than later, with the likelihood being higher.

For the purpose of making it possible for Old National Bank to make use of the services, solutions, and platforms that are offered by Infosys, the objective of this expansion is to make it possible for the bank to transform its operations and processes through the application of automation and GenAI, as well as to change significant business areas.

This lets the bank leverage Infosys’ services, solutions, and platforms.

Old National Bank Chairman and CEO Jim Ryan said, “At Old National, we are committed to creating exceptional experiences for both our customers and our fellow employees.”

This statement is applicable to Old National Bank. Infosys is carefully managing the business process innovations that it is putting us through, putting a strong emphasis on efficiency and value growth throughout the process to ensure that it is carried out efficiently.

This is a routine occurrence throughout the entire operation. Because of Infosys’ dedication to our development and success, we are incredibly appreciative of the assistance they have provided.

Old National has been receiving assistance from Infosys in the process of updating its digital environment since the year 2020, according to the aforementioned company.

Ever since that time, the company has been providing assistance. The provision of this assistance has been accomplished through the utilization of a model that is not only powerful but also capable of functioning on its own power.

Infosys currently ranks Old National thirty-first out of the top thirty US banks.

This ranking is based on the fact that Old National is the nation’s largest banking corporation.

It is estimated that the total value of the company’s assets is approximately fifty-three billion dollars, while the assets that are currently being managed by the organization are valued at thirty billion dollars.

Dennis Gada, the Executive Vice President and Global Head of Banking and Financial Services, stated that “Old National Bank and Infosys possess a robust cultural and strategic alignment in the development, management, and enhancement of enterprise-scale solutions to transform the bank’s operations and facilitate growth.”

This remark referenced the exceptional cultural and strategic synergy between the two organizations. Dennis Gada is the one who asserted this claim. This was articulated explicitly concerning the exceptional cultural congruence and strategy alignment of the two organizations.

We are pleased to announce that the implementation of Infosys Topaz will substantially expedite the transformation of Old National Bank’s business processes and customer service protocols. We are exceedingly enthusiastic about this matter. We are quite thrilled about this specific component of the scenario.

Medium-sized banks operating regionally will continue to benefit from our substantial expertise in the sector, technology, and operations. This specific market segment of Infosys will persist in benefiting from our extensive experience. This phenomenon will enable this market sector to sustain substantial growth and efficiency benefits.

SOURCE: THBL

Business

American Water, The Largest Water Utility In US, Is Targeted By A Cyberattack

The largest regulated water and wastewater utility company in the United States stated Monday that it had been the target of a cyberattack, forcing the company to halt invoicing to consumers.

American Water, The Largest Water Utility In US, Is Targeted By A Cyberattack

American Water, based in New Jersey and serving over 14 million people in 14 states and 18 military facilities, said it learned of the unauthorized activity on Thursday and quickly took precautions, including shutting down certain systems. The business does not believe the attack had an impact on its facilities or operations and said employees were working “around the clock” to determine the origin and scale of the attack.

water

The corporation stated that it has alerted legal enforcement and is cooperating with them. It also stated that consumers will not be charged late fees while its systems are unavailable.

According to their website, American Water operates over 500 water and wastewater systems in around 1,700 communities across California, Georgia, Hawaii, Illinois, Indiana, Iowa, Kentucky, Maryland, Missouri, New Jersey, Pennsylvania, Tennessee, Virginia, and West Virginia.

SOURCE | AP