Akebia Momentum of Commercial Launch of Vafseo® (vadadustat)

 

• Akebia regains full rights to sell Vafseo® (vadadustat) Tablets in the U.S. following the execution of a royalty-based termination agreement with CSL Vifor to simplify operational execution and improve economics
• Announced Vafseo WAC pricing of $1,278 for a 30-day supply
• Submitted TDAPA application for Vafseo in June 2024 and expects designation on January 1, 2025

Akebia to host investor conference call at 8:00 a.m. ET on July 11, 2024

Conference Call Information
Akebia will host a conference call on Thursday, July 11, 2024 at 8:00 a.m. Eastern Time to discuss Vafseo commercial updates. To access the call, please register by clicking on this Registration Link, and you will be provided with dial in details. To avoid delays and ensure timely connection, we encourage dialing into the conference call 15 minutes ahead of the scheduled start time.

A live webcast of the conference call will be available via the "Investors" section of Akebia's website at: https://ir.akebia.com/. An online archive of the webcast can be accessed via the Investors section of Akebia's website at https://ir.akebia.com approximately two hours after the event.

https://www.biospace.com/article/releases/akebia-therapeutics-provides-update-on-continued-momentum-of-commercial-launch-of-vafseo-vadadustat-tablets/

ADM Korea Niclosamide Anticancer Drug Trial Targets 'Prostate Cancer Resistant to Hormone Therapy'

 

• IND for clinical study for combination therapy with hormone therapy in prostate cancer patients to be submitted in August, 2024.
• Niclosamide-based metabolic anticancer drug aims to block signaling pathways that allow cancer cells to evade anticancer effects, potentially solving the issue of drug resistance.

https://www.biospace.com/article/releases/adm-korea-announces-niclosamide-based-metabolic-anticancer-drug-s-first-clinical-trial-target-as-prostate-cancer-patients-resistant-to-hormone-therapy-/

FTC to Sue ‘Big Three’ PBMs for Setting Insulin, Other Drug Prices: WSJ

 The U.S. Federal Trade Commission is gearing up to take the three largest pharmacy benefit managers to court over their alleged price negotiation practices for drugs including insulin, according to exclusive reporting Wednesday from The Wall Street Journal.

The Federal Trade Commission (FTC) is targeting CVS’ Caremark, UnitedHealth’s OptumRx and Cigna’s Express Scripts, which allegedly have been pushing patients away from choosing cheaper medicines. The FTC’s case will focus on these companies’ business practices related to rebate agreements with drug manufacturers.

The FTC’s legal actions come after its interim report, released last week, detailed how these pharmacy middlemen “wield enormous power” over patients and their ability to afford prescription drugs. According to the FTC, this power allows pharmacy benefit managers (PBMs) to “significantly influence what drugs are available and at what price.”

Launched in 2022, the FTC investigation found that the PBM market has become increasingly concentrated, with the largest players now also vertically integrated with dominant health insurers and pharmacies. In 2023, the three largest PBMs processed almost 80% of the nearly 6.6 billion prescriptions in the U.S., while affiliated pharmacies accounted for close to 70% of all specialty drug revenue.

PBMs “appear to have the ability and incentive to prefer their own affiliated businesses, creating conflicts of interest that can disadvantage unaffiliated pharmacies and increase prescription drug costs” while “steering patients to their affiliated pharmacies and away from smaller, independent pharmacies,” according to the FTC.

The FTC’s investigation also revealed that vertically integrated PBMs and brand drug manufacturers negotiate prescription drug rebates “some of which are expressly conditioned on limiting access to potentially lower-cost generic and biosimilar competitors” and enter into “agreements to exclude lower-cost competitor drugs from the PBM’s formulary in exchange for increased rebates from manufacturers.”

FTC Chair Lina Khan in a statement last week said that the agency’s report detailed “how PBMs can squeeze independent pharmacies that many Americans … depend on for essential care,” adding that the business practices of PBMs “can hike the cost of drugs.”

The FTC’s probe into PBMs and legal action against them are part of its recent campaign to help lower drug prices and make treatments more affordable and accessible. In July 2023, the antitrust watchdog—alongside the Department of Justice—released new guidelines on mergers within the pharma industry.

In November 2023, the FTC also started targeting patents that it considered to be improperly listed on the FDA’s Orange Book, ultimately aiming to open up the market to competition that could lower drug prices. The FTC’s opening salvo focused on inhalers, multi-dose bottles and EpiPens, before expanding the scope in May 2024 to include drugs like Ozempic (semaglutide) and Victoza (liraglutide).

https://www.biospace.com/article/ftc-to-sue-big-three-pbms-for-setting-insulin-other-drug-prices-wsj/

How Satisfied Are Americans With Their Finances?

 Global governments extreme monetary and fiscal responses to the coronavirus pandemic (and its actual logistics issues), and the war in Ukraine were and still are the main drivers of macroeconomic changes around the world, from rising energy and food prices to hundreds of thousands of jobs cut due to pandemic-induced hiring sprees by big tech firms in particular.

Four years after the outbreak of corona and two years since the beginning of Russia's war on its Western neighbor, economic worries for U.S. residents seem to be easing again.

As Statista's Florian Zandt details below, a Consumer Insights survey shows that at the start of 2024, roughly one quarter of respondents claimed their personal economic situation was negative or very negative, while 18 percent had a very positive outlook on their finances, up two percent year-over-year.

A third of survey participants claimed that they saw their country's economic performance as negative or very negative, down two percent from the previous period in 2023 as well.

Changes in perspective were especially pronounced from 2022 to 2023.

Since the survey waves analyzed ended in March of the corresponding year, respondents were still optimistic due to the easing of coronavirus restrictions, with 46 percent having a positive or very view of their finances and only 28 percent claiming that their country was in a bad or very bad place in financial terms.

This shifted drastically after Russia's attack on Ukraine on February 28, 2022, and the resulting energy price spikes in the following fall and winter, which is evident in the results for 2023.

https://www.zerohedge.com/personal-finance/how-satisfied-are-americans-their-finances

Kudlow On Trump's Pro-Growth, 'America First' Platform

 by Larry Kudlow via RealClearPolitics.com,

Forget the Biden circus — the real headline story today is a pro-growth, “America First” Trump platform a week ahead of the Milwaukee convention.

At the moment, the major press frenzy is whether President Biden is going to drop out of the race. For what it’s worth, I don’t think he will.

In Mr. Biden’s words, “The Lord almighty is not coming.” Let me add: you can bet on that.

All this Biden speculation, though, should not be permitted to obscure the fact that the Republican National Committee, a week ahead of the Milwaukee convention, has just adopted and released President Trump’s 2024 Republican Party platform.

This is today’s real headline story. The platform carries the same kind of message that Trump has been successfully talking about for the last several years.

It’s pro-growth and pro-opportunity, aims to close the southern border and restore an “America First” standing in the world. Peace through strength.

The document is short, pithy, and right to the point.

Some of the highlights include worker tax cuts and no tax on tips. Stopping Bidenflation. Restoring energy dominance. Ending unfair trade deals. 

Keeping the dollar as the world’s reserve currency — this is especially important for high growth and low prices — Wall Street, will you finally listen?

Restoring America’s status as the dominant world energy producer and canceling the electric vehicle mandate. Cutting all costly and burdensome regulations.

Sealing the border, stopping the illegal migrant invasion, and deporting illegals.

Keeping men out of women’s sports, and radical, racial, and sexual woke policies out of schools.

The platform also states, and I quote, “unite our country by bringing it to new and record levels of success.”

These are the message points that have proved so popular on the campaign trail.

These are exactly the themes that Trump has used to organize a working-class coalition of Black Americans, Hispanics, Asians, young people, and women.

These were policies to successfully build on Trump’s first term as President. Policies that Art Laffer, has called one of the best policies of any first term president.

Tax cuts, deregulation, energy independence, superb Supreme Court picks, good trade deals, strong national security — including the Abraham Accords.

Today, amid 20 percent Bidenflation, we have an affordability crisis with falling real wages and high mortgage and credit card borrowing costs, the nationwide crime and public safety ravages of Mr. Biden’s illegal immigration catastrophe, and raging fires overseas — most folks know that they were better off four or five years ago.

That’s Trump’s message. Success is the best uniter.

https://www.zerohedge.com/markets/kudlow-trumps-pro-growth-america-first-platform

Pfizer Shares Advance On "Encouraging" Data From Once-Daily Weight Loss Pill

 Shares of Pfizer Inc. are rising in premarket trading in New York following news that the drugmaker is progressing with its once-daily anti-obesity pill, 'danuglipron' in clinical trials. 

"Pfizer plans to conduct dose optimization studies in the second half of 2024 evaluating multiple doses of the preferred modified release formulation to inform the registration enabling studies," the big pharma company wrote in a press release Thursday about its drug danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist. 

Here's further color on the danuglipron clinical:

• Clinical evaluation of several modified release once-daily formulations of danuglipron resulted in encouraging pharmacokinetic data for several candidates with one showing the most favorable profile

• The company plans to conduct dose optimization studies with a focus on the preferred formulation to inform the registration enabling studies

In December, Pfizer discontinued a twice-daily version of danuglipron after patients experienced tolerance issues. The company indicated that phase one trial data on the once-daily version would "inform a path forward."

"Obesity is a key therapeutic area for Pfizer, and the company has a robust pipeline of three clinical and several pre-clinical candidates. The most advanced of them, danuglipron, has demonstrated good efficacy in a twice-daily formulation, and we believe a once-daily formulation has the potential to have a competitive profile in the oral GLP-1 space," Mikael Dolsten, MD., PhD., Chief Scientific Officer & President, Pfizer Research and Development, wrote in a statement. 

Dolsten continued, "Following a thorough analysis of our previous Phase 2b data and trial design, we believe that with the preferred modified release formulation and future trial design optimization, we can advance a competitive oral GLP-1 molecule into registration enabling studies, with the goal of addressing the present and persistent medical needs of people living with obesity."

In markets, shares of Pfizer are up 3% to around the $29 handle. Shares have been halved in recent years, falling to early 2013 lows, following the end of the virus pandemic that sent Covid vaccine demand plunging. 

Companies with exposure to GLP-1s are continuing to march higher. 

Pfizer is a handful of drugmakers trying to carve out a slice of the GLP-1 market to tackle obesity in the West. Wall Street analysts have projected the industry could be worth $100 billion by the end of the decade.

In June, CEO Albert Bourla said GLP-1s are only "scratching the surface of what we will see in obesity."

Instead of GLP-1s, perhaps consumers should try intermittent fasting, eating healthy, and daily exercise. 

Meanwhile, "New Study Reveals Ozempic, Wegovy Linked To' Potentially Blinding Eye Condition'"... 

https://www.zerohedge.com/markets/pfizer-shares-advance-encouraging-data-once-daily-weight-loss-pill

Consumer Prices 'Deflated' Most Since COVID Lockdowns In June; Core Prices Continue To Rise

 Expectations for more 'evidence' of a return to disinflationary trends were high heading into today's CPI and they were more than satisfied by a 0.1% MoM decline in headline consumer prices in June (below the +0.1% MoM exp) - the biggest MoM drop since May 2020. That pulled the headline YoY CPI down to +3.0%...

Source: Bloomberg

This is the third consecutive 'miss' for CPI - prompting calls for July rate-cuts - with 3m and 6m annualized inflation declining...

But July odds remain low still for now...

Headline CPI Breakdown:

The all items index rose 3.0 percent for the 12 months ending June, a smaller increase than the 3.3- percent increase for the 12 months ending May. The energy index increased 1.0 percent for the 12 months ending June. The food index increased 2.2 percent over the last year. The index for gasoline fell 3.8 percent in June, after declining 3.6 percent in May, more than offsetting an increase in shelter. The energy index fell 2.0 percent over the month, as it did the preceding month. The index for food increased 0.2 percent in June. The food away from home index rose 0.4 percent over the month, while the food at home index increased 0.1 percent

• The gasoline index decreased 3.8 percent in June. (Before seasonal adjustment, gasoline prices fell 3.9 percent in June.)
• The electricity index decreased 0.7 percent over the month and the fuel oil index decreased 2.4 percent.
• The index for natural gas rose 2.4 percent in June.
• The energy index increased 1.0 percent over the past 12 months. The gasoline index fell 2.5 percent over this 12-month span. The index for electricity increased 4.4 percent over the last 12 months and the index for natural gas rose 3.7 percent

A deflation in Energy costs and core goods dominated the data in June...

Both Goods and Services inflation fell on a YoY basis (Goods deflation at its biggest since Feb 2004)

Core CPI also 'missed', rising just 0.1% MoM (vs +0.2% exp), dragging the YoY Core CPI down to +3.27% - its lowest since April 2021...

Source: Bloomberg

Goods deflation also dominates core prices disinflationary trend...

Core CPI:

The index for all items less food and energy rose 0.1 percent in June - the smallest increase in this index since August 2021 - after rising 0.2 percent the preceding month. Indexes which increased in June include shelter, motor vehicle insurance, household furnishings and operations, medical care, and personal care. The indexes for airline fares, used cars and trucks, and communication were among those that decreased over the month.

• The shelter index increased 0.2 percent in June. The index for rent rose 0.3 percent over the month, as did the index for owners’ equivalent rent; these were also the smallest increases in these indexes since August 2021. The lodging away from home index decreased 2.0 percent in June, after falling 0.1 percent in May.
• The medical care index rose 0.2 percent in June after rising 0.5 percent in May. The index for physicians’ services rose 0.1 percent over the month, as did the index for hospital services. The prescription drugs index was unchanged in June.
• The motor vehicle insurance index rose 0.9 percent in June, following a 0.1-percent decrease in May.
• The index for household furnishings and operations increased 0.5 percent over the month.
• The indexes for personal care, education, recreation, and apparel also increased in June.
• The index for airline fares fell 5.0 percent in June, following a 3.6-percent decrease in May.
• Over the month, the used cars and trucks index fell 1.5 percent, the communication index decreased 0.2 percent, and the new vehicles index declined 0.2 percent.

We do note that Core consumer prices have still not seen a single monthly decline since Bidenomics began.

Core consumer prices are up just under 18% since Bidenomics began (+4.9% per annum) - that is dramatically higher than the 2.0% per annum Americans experienced under Trump...

Core consumer prices have never been higher.

The much-watched SuperCore CPI rose on a MoM basis but declined (back below 5.0%) on a YoY basis (but obviously remains extremely elevated)...

Source: Bloomberg

Transportation Services are seeing prices fall...

Removing auto insurance would cut SuperCore CPI in half... if only we didn't actually have to pay that!

Finally, we can't help but get a sense of deja vu all over again here. What if... The Fed cuts (because bad - recession - data), Biden loses (because dementia), and inflation re-accelerates (just like in the 80s)...

Source: Bloomberg

Who do you think gets the blame for the re-inflation? Well, 'economists' have already begun claiming Trump's tariff plan will prompt spiralling higher prices... so we have our answer.

There are no coincidences in Washington.. or Washington-based data.

https://www.zerohedge.com/markets/consumer-prices-deflated-most-covid-lockdowns-june-core-prices-continue-rise