Biden WH Publicizes $450 Million in New Funding To Save Overdose Epidemic Lives

On International Overdose Awareness Day, the Biden-Harris administration announced more than $450 million in new funding that will help to reduce overdose deaths, support in recovery efforts, crack down on illicit drug trafficking and invest in information campaigns aimed at young people.

The funds will go to strengthen prevention, harm reduction, treatment, and recovery support services. In 2022, over 100,000 lives were lost to overdose.

President Biden declared August 27 through September 2 as Overdose Awareness Week, to focus attention on the damage caused by illicit fentanyl and other drugs. The administration is working to provide funding directly to support city, county, and territorial health departments, which is a first according to their fact sheet provided to PoliticusUSA.

Another example of how the funds will be spent is more than $80 million will go to rural communities in 39 states to fund the distribution of naloxone (an opioid antagonist) to prevent fatal overdose, as well as creating and expanding treatment sites and expand access to behavioral health care for young people.

The funds will also spend nearly 19 million for High Intensity Drug Trafficking Areas programs (HIDTA) to help communities stop drug traffickers and prevent drug related gun crimes.

Read more details here: Overdose Awareness Day Fact Sheet

Fentanyl deaths increased in 2022, though it is a “slowing increase,” which is why the administration says the continued resources are necessary. Senior Administration Officials said the deaths are increasing because supplies are more lethal.

In terms of how bad this crisis is, the CDC says the number of people who died from a drug overdose in 2021 was more than six times the number in 1999, more than 16% from 2020 to 2021, and over 75% of the nearly 107,000 drug overdose deaths in 2021 involved an opioid.

“Behind each of these lives are friends, families, and communities torn apart by overdose,” White House Domestic Policy Advisor director Neera Tanden said on a call with reporters Thursday morning.

As we fight one source of overdoses, a new form pops up to replace the old. The CDC reports from 2020 to 2021:

Opioid-involved death rates increased by over 15%.
Prescription opioid-involved death rates remained the same.
Heroin-involved death rates decreased nearly 32%.
Synthetic opioid-involved death rates (excluding methadone) increased over 22%.

The DEA describes fentanyl as “a potent synthetic opioid drug approved by the Food and Drug Administration for use as an analgesic (pain relief) and anesthetic. It is approximately 100 times more potent than morphine and 50 times more potent than heroin as an analgesic.”

Mixing fentanyl with other drugs, including xylazine, heroin, cocaine and methamphetamine, increases risk of overdose and is sometimes done without the user’s knowledge.

“We know the overdose epidemic is a national crisis,” Second Gentleman Doug Emhoff said on a call with reporters Thursday morning. “Far too many families have lost loved ones, their children, their siblings and their partners and there’s so many more Americans who knows someone that has been impacted by this horrible epidemic. Substance abuse disorders impact families across all of our nation and cities and rural areas red states blue states. In short, this impacts everyone.”

Previously, the administration has spent $83 billion on helping people get treatment, save lives and reach recovery, which is a 42% increase over the previous four years, according to a senior administration official.

What else have they done? “We’ve also put a record number of sanctions on cartels and Chinese companies and individuals, primary source of fentanyl shipping to the U.S. We’ve also had a record number of seizures as well as expansion of treatment with telehealth provisions, which are not accessing health to the most marginalized communities in terms of addiction, people who are in rural communities and communities of color,” a senior administration official reported.

Asked why President Biden isn’t using the bully pulpit more to discourage China, which is a primary source of shipping fentanyl to the U.S., a senior administration official told us, “The fact is that I think this President has been tougher in China in terms of making sure that the illicit actors, the private sectors that are shipping these chemicals are – we’re going after. This is why not only did he expand through an Executive Order the ability to not only go after traffickers, but also the enablers. This includes the amount and number of sanctions that are being placed against Chinese chemical companies and Chinese individuals, in addition to Mexican cartels.”

Biden declared fentanyl trafficking a national emergency in a December 15, 2021 Executive Order.

Later this afternoon, the Administration will host family members who have lost loved ones to a drug overdose to listen and collaborate on efforts to save lives. This is said to be a top priority for the Biden-Harris administration, and we know that President Biden has seen the devastation of drug addiction in his own family. It’s sadly likely that almost everyone knows someone who has been impacted in some way.

The drug overdose epidemic is a national crisis ripping through our families and communities, in addition to posing a national security threat. If you or someone you know needs help, SAMHSA’s National Helpline is a 365-day-a-year treatment referral and information service (in English and Spanish): 1-800-662-HELP (4357).

Hurricane Idalia slams into Florida, heads to Georgia

Hurricane Idalia barreled in southern Georgia after hitting Florida’s Gulf Coast with life-threatening storm surges, leaving at least two people dead and hundreds of thousands without power.

More than 280,000 people in Florida were without power as of early afternoon, according to PowerOutage.US. At least two people died in weather-related car crashes in Alachua and Pasco counties, police said. 

At least 30 of Florida’s 67 counties issued some type of evacuation order prior to the storm. People who did not evacuate should shelter in place, according to the state’s emergency management agency.

Idalia made landfall in the morning as a catastrophic Category 3 storm at Keaton Beach on the Big Bend coast, less than 90 miles southeast of the state capital of Tallahassee. The hurricane has since weakened to a Category 1 storm with maximum sustained winds of 90 miles per hour, according to the National Hurricane Center. 

Idalia is expected to weaken further as it moves inland but will remain a hurricane as the storm moves across southeastern Georgia and southern South Carolina this afternoon or evening, according to the latest forecast. 

Makatla Ritchter (L), and her mother, Keiphra Line, wade through flood waters after having to evacuate their home when flood waters from Hurricane Idalia inundated it in Tarpon Springs, Florida, Aug. 30, 2023.

Joe Raedle | Getty Images

Idalia is expected to become a tropical storm by the time it heads toward the coast of North Carolina on Wednesday night and Thursday, according to the forecast.   

The river gauge at the small town of Steinhatchee on the Big Bend coast surged from 1 foot to 8 feet in an hour, according to the National Weather Service in Tallahassee. Life-threatening storm surges will remain through the afternoon, according to the NWS. 

“Don’t mess with this storm, don’t do anything that’s going to put yourself in jeopardy,” Florida Gov. Ron DeSantis said at a morning press conference.

The Florida National Guard is currently conducting search and rescue operations in Florida’s western coastal counties, said Maj. Gen. John Haas, who leads the force. The Guard is fully mobilized with more than 5,000 service members supporting the emergency response, Haas said at a press conference. South Carolina and Tennessee are sending additional National Guard forces to help with the response, he said.

American Airlines has suspended operations in Tampa; Sarasota; Tallahassee; Gainesville; and Savannah, Georgia, with 167 flights canceled so far. The airline is planning to continue normal operations in Ft. Myers, Key West, Orlando and Daytona Beach.

A truck passes through flooded streets caused by Hurricane Idalia passing offshore in Tarpon Springs, Florida, Aug. 30, 2023.

Joe Raedle | Getty Images

DeSantis said Tampa airport will reopen at 4 p.m. today to incoming flights and fully reopen at 3 a.m.. Gainesville airport will reopen tonight and Tallahassee airport will first thing in the morning, the governor said.

President Joe Biden approved an emergency declaration Monday for Idalia in anticipation of the hurricane making landfall. The declaration allows the U.S. Department of Homeland Security and the Federal Emergency Management Agency to coordinate disaster relief efforts.

FEMA Administrator Deanne Criswell said she will travel to Florida Wednesday, where she will meet with DeSantis Thursday to see first hand how much damage Idalia has left in its wake.

Criswell told reporters during a briefing at the White House that it will take several days to get an initial assessment of how much damage Idalia has done.

Listed below are the Eight trades and three price-target modifications we made throughout a busy week

Traders work during the opening bell at the New York Stock Exchange (NYSE) on Wall Street in New York City on August 16, 2022.

Angela Weiss | AFP | Getty Images

Our portfolio experienced a flurry of adjustments in a week dominated by Nvidia’s (NVDA) quarterly results Wednesday evening and Federal Reserve Chairman Jerome Powell’s Jackson Hole address Friday.

Here’s a day-by-day look at the trades and price-target changes, and what motivated each decision.

TV Stars Who Returned to the Hit Exhibits They Left

After Kim Cattrall‘s shocking cameo in the And Just Like That season two finale, we couldn’t help but wonder: What other major TV stars have returned to the shows that made them famous?

Given Cattrall’s infamous decision not to reprise her iconic Sex and the City character Samantha Jones for a third movie or the first season of its Max spinoff, fans weren’t expecting to see the 67-year-old back in the Big Apple. And yet, Samantha had a small but pivotal role in the Aug. 24 episode, despite not interacting with Sarah Jessica Parker or any of her other former co-stars. 

Samantha made her grand return via a phone conversation with Carrie, calling her old friend to let her know she wouldn’t be able to make her flight from London to New York City to attend “the Last Supper,” a.k.a. the final party Carrie was throwing in her apartment.

Despite not being able to attend the event, Samantha still wanted to pay her respects, asking Carrie to put her on speaker phone. “Thank you for everything,” Samantha said, “you f–king fabulous, fabulous flat.”

Hey, we’ll take what we can get.

China uncommon earths dominance makes U.S. provide chains susceptible

China’s dominance in rare earths makes U.S. supply chains vulnerable, U.S. Trade Representative Katherine Tai said in an exclusive interview Saturday with CNBC’s Martin Soong.

Rare earth metals are used in high-tech products such as electric car motors. Over the decades, China has built up its ability to process the metals — giving it enormous pricing power in a critical global market.

“What I want to draw your attention to is not just the vulnerabilities around China’s investments [overseas], but the fact that China’s dominant position in the world market now in [rare earths] means that it is able to turn on the faucet and turn off the faucet,” Tai said.

“And until we are able to access and create additional supply chains we remain entirely vulnerable to that leverage,” the U.S. trade representative said. Tai was speaking in New Delhi, India, on the sidelines of B20, the official business dialogue forum of the G20.

Tai pointed out that about a decade ago, China raised rare earths prices so high that some U.S. mines were able to operate in the industry again, only to have to close once China cut prices.

The U.S. held a majority stake in the rare earths metals market prior to the 1980s. But lower labor costs overseas, as well as less pressure on environmental standards, helped send the rare earths industry out of the U.S.

Meanwhile, Beijing supported the industry.

“The advantage in terms of China’s dominance isn’t necessarily a natural advantage,” Tai said. “It’s not that they have more rare earths but that they were able to pursue coordinated industrial and trade policies that allowed them to corner the market.”

The Chinese government sets economic plans at least every five years, with some goals — such as boosting self-sufficiency in technology and reaching carbon neutrality — set years earlier in advance.

While such top-down planning isn’t guaranteed to achieve results, the electric car industry has become an example of where Chinese industry has been able to capture significant market share across the supply chain, including the end product.

The level of U.S. reliance on China-based manufacturing came to the forefront during the Trump administration, and accelerated when the Covid-19 pandemic in 2020 disrupted global supply chains. The Biden administration has announced multibillion-dollar initiatives to encourage companies to develop and manufacture critical technologies in the U.S.

“Where we are in terms of our supply chains today is not where we want to be,” Tai told CNBC on Saturday. “We know that we’re vulnerable. Where we want to be is in a place where our supply chains are more diversified, where we have more confidence in them, where we just have more options.”

Australia's trade with China won't return to normal until restrictions are removed, minister says

In the case of rare earths, Tai pointed out that China has a monopoly in the global market. She noted that in the case of Australia’s lithium production, China is also the only buyer — giving Beijing another point of market leverage.

While lithium is a key component of electric car batteries, it isn’t one of the 17 metals scientifically categorized as rare earths.

This year, U.S. and European government officials have talked of de-risking, or reducing the level of dependency on China alone. In a speech to global business leaders in June, Chinese Premier Li Qiang said de-risking is a false proposition because global economic interests are so entwined.

‘Phase one’ trade agreement

Just before the pandemic began, the U.S. and China signed a “phase one” trade agreement which called for China to increase its purchases of U.S. goods as a way to offset the massive U.S. trade deficit with China.

When asked Saturday about where the agreement stands, Tai said the U.S. is still looking at China’s shortfalls in meeting those purchase targets.

She said another aspect to that discussion is the degree to which U.S. trade with China is “imbalanced.”

Official U.S. data said the country’s trade deficit with China rose by 8.3% to $382.9 billion in 2022.

U.S. Secretary of Commerce Gina Raimondo is set to visit China from Sunday to Wednesday, as high-level U.S. official trips to the country have resumed this summer after a lull.

U.S.-India relations

Tensions between the U.S. and China have escalated over the last several years, starting with trade and spilling over into tech and finance.

Many businesses have increasingly started to look for opportunities in India, while the country’s relationship with the U.S. has improved.

On Saturday, Tai also met with India’s Minister of Commerce and Industry Piyush Goyal, and raised concerns about India’s import license requirements for tech equipment, a release said.

“The stars really are aligning between the United States and India and that’s across all of the policy areas,” Tai told CNBC. She described the relationship as “experiencing new heights.”

She said in her area of economics and trade, the potential for working more with India was always there, but previously, “we just couldn’t figure out how to tap it.”

— CNBC’s Samantha Subin contributed to this report.

ADHD drug market faces back-to-school provide pressure

Ten milligram tablets of the hyperactivity drug, Adderall, made by Shire Plc.

Jb Reed | Bloomberg | Getty Images

It’s been 10 months since the Food and Drug Administration first announced a nationwide shortage of Adderall — one of the most widely used medications for attention deficit hyperactivity disorder — and the supply strain could potentially worsen in the months ahead.

While some supply issues have improved, many Americans are still struggling to find and fill prescriptions for the drug and other medications for ADHD that they often rely on to stay focused and complete daily tasks.

Drug-shortage experts told CNBC that it’s extremely difficult to forecast how much longer the shortages will last because of the lack of transparency in the pharmaceutical industry — and some are concerned about market conditions as children, who are commonly affected by ADHD, head back to school. 

“Unfortunately, we might see the shortage worsen. We are heading into back-to-school time, so I am worried about it worsening as we go into that season,” Erin Fox, a pharmacist at the University of Utah and leading expert on U.S. drug shortages, told CNBC.

Adderall is one of more than 300 drugs in short supply in the U.S. as of June, according to a list from the American Society of Health-System Pharmacists, which represents pharmacists in a variety of health-care settings. That list also includes Adderall alternatives like methylphenidate, which is commonly known under the brand names Ritalin or Concerta. 

Adderall and alternative ADHD medications apart from other drugs are Schedule 2 controlled substances. 

That means the federal government regulates how those drugs are made, prescribed and dispensed because they’ve been deemed to have a high potential for abuse and could potentially lead to severe psychological or physical dependence. The designation also means that patients need to get new prescriptions for those drugs every one to three months. 

Millions of Americans in the U.S. use the drugs to help them concentrate, control their impulses and manage their schoolwork, employment or relationships with others. ADHD is usually diagnosed in childhood and often lasts into adulthood.

An estimated 6 million children have been diagnosed with ADHD, and 60% were being treated with medication as of 2016, according to the Centers for Disease Control and Prevention. Meanwhile, around 8 million adults have been diagnosed with the condition, but only about a quarter of that number are getting treatment for it.

Back-to-school supply strain 

Many children and young adults with ADHD often take the summer off medication and primarily rely on it during the school year. That could lead to even more demand in the months ahead that may not be met. 

Historically, prescriptions for ADHD medications increase as the school semester starts around the U.S. — and “there is no indication this year will be different,” according to David Margraf, a pharmaceutical research scientist at the University of Minnesota’s Center for Infectious Disease Research and Policy. 

Some drugmakers have said they expect to resupply a few ADHD products in August or September, according to an FDA database on shortages. But Margraf said “we need to be cautiously optimistic” because drugmakers don’t disclose exact numbers of how much stock they’ll have available by then. 

30mg tablets of Shire Plc’s Adderall XR.

Jb Reed | Bloomberg | Getty Images

That reflects a bigger issue with the ongoing shortages. It’s nearly impossible to know when they will end — or what exactly can be done to resolve them — because of the lack of transparency in the pharmaceutical industry. 

“Very little factual information is out there. I think this is one of the biggest issues,” says Ozlem Ergun, a mechanical- and industrial-engineering professor at Northeastern University and an expert in pharmaceutical supply chains. “When you don’t have transparency or information sharing, how can you understand and resolve a problem that is complex?” 

“This really, really hurts the users and the hospitals and the health-care system. They have pretty much no vision of what the future looks like,” Ergun added.  

Teva Pharmaceuticals, Amneal Pharmaceuticals, Novartis’s planned spinoff Sandoz and Purdue Pharma subsidiary Rhodes Pharmaceuticals, which all manufacture drugs targeting ADHD, don’t need to publicly share information about where they manufacture medications, how much of them they make, where ingredients are sourced and their overall production capacities. 

And the Drug Enforcement Administration — the federal agency that regulates controlled substances — shares little information about the production quotas it sets for each manufacturer of Adderall and other ADHD medications.

The DEA specifically limits the amount of raw ingredients, such as amphetamine, a drugmaker can get to manufacture those drugs.

“We don’t have the quota amount that each company is given. And we also don’t have the amount that each company is actually producing and if they’re meeting those quotas,” said Fox of the University of Utah. “There’s no way to understand which company maybe isn’t doing the job and which companies are, so we just don’t know exactly what’s going on.” 

Production limitations

Ending the shortages of Adderall and other ADHD medications is no easy task.

“It’s not as simple as a free market where you just boost up production and meet demand,” said Michael Ganio, the senior director of pharmacy practice at the American Society of Health-System Pharmacists. 

Many manufacturing plants operate at or near capacity and create multiple drug products. That means increasing the production of one drug could potentially require reducing production — and potentially impacting supply — of another drug, according to Ergun. 

“In general, it is difficult to increase the manufacturing capacity for a drug,” she said. “There isn’t much unutilized capacity anywhere.”

It’s even harder to scale up the production of tightly controlled ADHD medications.

Drugmakers can request for the DEA to increase their production quotas if necessary, but it takes “a lot of push” for the agency to actually approve that, according to Margraf. 

And even if the DEA does approve a quote change, it could take months to do so: “It’s not just flipping a switch and boosting your output by 20%,” ASHP’s Ganio said. 

Members of the Drug Enforcement Administration raided two homes side-by-side, in an assumed illegal marijuana operation, on January 31, 2019 in Commerce City, Colorado.

RJ Sangosti | MediaNews Group | The Denver Post via Getty Images

Some drugmakers have suggested that DEA quotas are contributing to the ADHD medication shortages or making it harder to alleviate them. That includes Aytu BioPharma, which makes an ADHD drug that used to be in shortage. 

In a CNBC op-ed in February, Aytu CEO Josh Disbrow said the DEA could potentially cause widespread drug shortages if it underestimates demand and fails to increase quotas in a “timely manner in response to new information.” 

However, the DEA and FDA pointed to a different problem in a joint letter released earlier this month. 

The agencies said an internal analysis found that drugmakers fell 30% short of meeting the full quota for amphetamine medications in 2022, leaving about 1 billion potential drug doses on the table. They added that there’s a “similar trend” occurring this year. 

The DEA and FDA said they called on manufacturers to confirm they are working to increase production to meet their allotted quotas.

“There’s obviously a lot of finger-pointing going on here between the agencies and manufacturers,” Fox said. 

Surging demand for Adderall

The shortages of Adderall and generic versions of the drug kicked off last August, when major manufacturers reported that their medications were on back-order. 

Manufacturers are required to notify the FDA of a shortage, but not the cause of the interruption. However, the FDA pointed to “ongoing intermittent manufacturing delays” at Teva when it first announced the Adderall shortage. 

Teva previously said the manufacturing slowdown was partly tied to a labor shortage, which was quickly resolved. Teva did not immediately respond to CNBC’s request for comment about the state of its Adderall manufacturing. 

A surge in demand for Adderall and other ADHD medications seems to have played a significant role, too. 

U.S. prescriptions for Adderall rocketed to 41.4 million in 2021, a more than 10% increase from 2020, according to IQVIA, a health industry analytics firm. 

One possible factor sending demand up, according to experts, was the increased use of telehealth services during the Covid public health emergency that may have allowed for more relaxed prescribing standards for ADHD medications.

The pandemic also created a perfect storm of distractions — such as the shift to remote work and a thrum of anxiety, stress and grief over the uncertainty of Covid — that may have exacerbated some ADHD patients’ symptoms or convinced more people that they have the condition, prompting them to seek treatment. 

The increased demand for Adderall amid shortages of the drug likely resulted in a domino effect, too, with health-care providers and patients being driven to turn to alternative medications, triggering shortages of those drugs as well.

CDC expects new photographs to be accessible in mid September

A sign advertises COVID-19 (coronavirus) vaccine shots at a Walgreens Pharmacy in Somerville, Massachusetts, August 14, 2023.

Brian Snyder | Reuters

The Centers for Disease Control and Prevention expects updated Covid vaccines from Pfizer, Moderna and Novavax to be available to the public in mid-September, an agency official told reporters Thursday. 

That amounts to the most specific timeline to date. Federal officials have said the new shots could arrive around September. CDC Director Mandy Cohen had previously provided a later timeline, telling NPR that the vaccines could be available by the “early October time frame.”

Those shots still need approvals from the Food and Drug Administration and the CDC, which will set eligibility guidelines for the jabs. An independent panel of advisors to the CDC is meeting on Sept. 12 to vote on a recommendation for those guidelines. 

Officials from the CDC and FDA said the agencies will encourage Americans to receive an updated Covid shot and other key vaccines ahead of the fall, when respiratory viruses typically begin to spread more widely. That includes the annual flu shot and recently approved jabs that protect older adults and infants from respiratory syncytial virus.

“Our goal, our imperative, our task is to make sure we’re using those tools,” the CDC official said. “Vaccination is going to continue to be key this year because immunity wanes and because the Covid-19 virus continues to change.”

A staff member draws up a syringe with the Comirnaty vaccine from Biontech and Pfizer adapted to the Omicron-BA.1 variant at the Mainz vaccination center.

Sebastian Christoph Gollnow | dpa | Picture Alliance | Getty Images

The arrival of updated vaccines offers some reassurance to Americans as the U.S. sees a slight uptick in Covid cases and hospitalizations. But those metrics remain below the summer peak that strained hospitals last year, the CDC official noted. 

The current surge appears to be fueled by newer strains of the virus like EG.5, or Eris, an omicron subvariant that accounted for 17.3% of all cases as of last week, according to the CDC. 

Pfizer, Moderna and Novavax designed their updated vaccines to target the omicron subvariant XBB.1.5, which is slowly declining in prevalence nationwide. But initial trial data from all three drugmakers suggest the new shots will still protect against EG.5. 

“One of the manufacturers have already made it clear that when testing their vaccine against the EG.5 that it looks like the neutralization is robust,” an FDA official told reporters Thursday. 

But it’s unclear how well the new shots will protect against another new omicron strain of the virus called BA.2.86, which has been identified in a very small number of cases in the U.S., U.K., Denmark and Israel.

“I think it’s too early to know for sure about BA.2.86 in terms of exact data,” the FDA official said, adding that more information will be available in the coming weeks. 

However, the official noted that the new vaccines will likely protect against any severe outcomes from catching the Covid virus.

Last week, the World Health Organization and the CDC said they are tracking BA.2.86 because it has 36 mutations that distinguish it from XBB.1.5. So far, there is no evidence that BA.2.86 spreads faster or causes more serious infections than previous versions. 

CVS Well being, Sandoz companion on low cost Humira biosimilar

Rafael Henrique | Lightrocket | Getty Images

CVS Health is partnering with drugmaker Sandoz to produce a near identical version of the blockbuster arthritis treatment Humira that will sell for 80% below the price of the brand-named drug.

The move is part of the company’s new venture focused on securing, and in some cases co-producing, biosimilar drugs, which are the equivalent of generic versions of complex gene or protein-based therapies known as biologics.

“We’ve invested in committing to certain volumes for the U.S. marketplace so that we have a durable supply of product. We want to ensure that once we bring this into the U.S. marketplace, we don’t have any supply issues, we have a high-quality biosimilar product available, and it’ll be launched at a much lower … price than the originator molecule that exists,” said Prem Shah, CVS Health EVP and chief of pharmacy.

CVS is already one of the leading players when it comes to sourcing generic drugs through Red Oak, its joint venture with Cardinal Health. But it’s looking to strengthen its foothold in the biosimilars market, which is expected to grow to $100 billion over the next six years.

The company said Wednesday it’s launching a new subsidiary called Cordavis, which will specialize in securing supply of the new biosimilar drugs and will partner with Novartis Pharmaceuticals‘ generic manufacturing unit, Sandoz.

Sandoz, currently a unit of Novartis, is expected to be spun off as an independent publicly traded firm later this year.

CVS did not disclose the terms of the agreement for the new biosimilar, trademarked Hyromiz.

The company pledges that the list price of Cordavis Hyromiz will be more than 80% lower than the current list price of Humira, which is made by drugmaker Abbvie. It will launch in the first quarter of 2024.

The first FDA-approved biosimilar for Humira, Amgen’s Amjevita, went on sale in January. Eight more biosimilars are expected to come online within the next year, including Hyromiz.

Amgen executives have said demand for the company’s biologic appears to be growing, but that securing coverage from health insurers has posed a challenge.

“We’re obviously very early innings still in this biosimilar market with Amjevita. And we’re seeing clearly what is new payer behavior in light of such a large product having biosimilar competition,” said Murdo Gordon, Amgen EVP of commercial operations, on the company’s second-quarter earnings call. “The clarity of how pharmacy benefit works with biosimilar uptake, or lack thereof, is becoming clear to us and to other biosimilar manufacturers and other onlookers.”

Abbvie reported more than $4 billion in Humira sales in its most recent quarter, which was slightly better than expected. The company says it continues to be offered on health insurer plans at parity with the new biosimilars.

The launch of Cordavis has long been in the works, before the news last week from Blue Shield of California that it was dropping CVS as its pharmacy benefits manager and switching to Mark Cuban’s Cost Plus Drug Company, Amazon Pharmacy and others in an effort to save on drug costs.

The news sent CVS shares plunging, but analysts like John Ransom of Raymond James say the selloff was overblown. 

At this point, the potential threat from upstarts is not as big as some might fear, especially when it comes to the current biosimilar market for drugs like Humira, Ransom said.

“They either get a big rebate from Abbvie, or they get a big discount from one of the competing biosimilar manufacturers. And that’s really where they have the advantage,” said Ransom.

Cuban’s Cost Plus doesn’t have the scale to buy generic or enough shelf space from the manufacturers, he said.

Correction: CVS Health subsidiary Cordavis will partner with Sandoz on biosimilar drugs. An earlier version mischaracterized the relationship.

Key Witness Recanted False Testimony And Implicated Trump

Trump Employee 4 who is a key witness in the classified documents case recanted his previous false testimony after Trump’s effort to destroy video surveillance footage after he dumped a Trump paid for attorney and got a new lawyer.

According to page 4 of the filing:

District Court for District of Columbia (Boasberg, C.J.), who presides over grand jury matters in that district. The Government notified this Court on the same day, by sealed notice, of the filing in the District of Columbia. See ECF Nos. 45, 46. Mr. Woodward raised no objection to proceeding in the District of Columbia regarding Trump Employee 4. In fact, he responded that he “welcome[d] the Court’s inquiry into [his] representation of” Trump Employee 4, Response at 1, In re Grand Jury Subpoena, No. 23-GJ-46 (D.D.C. June 30, 2023), but asserted that he had no “information to support the Government’s claim that [Trump Employee 4] has provided false testimony to the grand jury,” and that “even if [Trump Employee 4] did provide conflicting information to the grand jury such that could expose him to criminal charges, he has other recourse besides reaching a plea bargain with the Government. Namely, he can go to trial with the presumption of innocence and fight the charges as against him.” Id. at 3. According to Mr. Woodward, if Trump Employee 4 “wishes to become a cooperating Government witness, he has already been advised that he may do so at any time.” Id.

Chief Judge Boasberg made available independent counsel (the First Assistant in the Federal Public Defender’s Office for the District of Columbia) to provide advice to Trump Employee 4 regarding potential conflicts. On July 5, 2023, Trump Employee 4 informed Chief  Judge Boasberg that he no longer wished to be represented by Mr. Woodward and that, going forward, he wished to be represented by the First Assistant Federal Defender. Immediately after receiving new counsel, Trump Employee 4 retracted his prior false testimony and provided information that implicated Nauta, De Oliveira, and Trump in efforts to delete security camera footage, as set forth in the superseding indictment.

The Government anticipates calling Trump Employee 4 as a trial witness and expects that he will testify to conduct alleged in the superseding indictment regarding efforts to delete security Case 9:23-cr-80101-AMC Document 129 Entered on FLSD Docket 08/22/2023   footage. Trump Employee 4 will very likely face cross-examination about his prior inconsistent statements in his grand jury testimony, which occurred while Mr. Woodward represented him, and which he disavowed immediately after obtaining new counsel.

Trump doesn’t pay for lawyers for his employees and other witnesses that get caught up in his schemes out of the goodness of his heart. He pays for lawyers to control the testimony of witnesses. Anyone who accepts a lawyer from Trump needs to understand that the lawyer is working for Donald Trump.

Employee # 4 is the Cassidy Hutchinson situation all over again. After Hutchinson dumped her Trump lawyer, she had a different story to tell to the 1/6 Committee.

Trump uses lawyers to tamper with witnesses.

The fact that the IT employee changed his testimony when he got a new lawyer implicates Trump in witness tampering and obstruction of justice.

Jaylan Banks Seeks Full Custody Amid Falynn Pina’s DV Claims

On Sunday (Aug. 20), Jaylan Banks revealed he filed for full custody of his daughter Emma against ex-girlfriend Falynn Pina, he exclusively told The Shade Room.

Banks submitted paperwork via Odyssey eFileGA, categorized mandatory for e-filing for Fulton County State and Superior Court on Gerogia’s Judicial Council website. A screenshot of the online filing classified it under OTHER with no file description.

His statement to The Shade Room’s Maya M. on the filing was brief. Banks said:

“…I don’t feel as she is in the right head space for our child, and I am praying for her.”

This isn’t the first time that Jaylan has expressed concerns about Falynn parenting their daughter. Last week, the “Relationships Matter Podcast” published an episode featuring Banks. During that talk, Jaylan Banks said Falynn “groomed him” into a relationship by negatively portraying her ex-husband Simon Guobadia.

Later in that interview, he claimed that one of Falynn’s children is already calling another man “dad.” He added that his ex’s trauma makes him “scared to let [his] daughter be raised like that.”

However, Banks has not presented material examples or evidence of incidents indicating trouble in Falynn’s caretaker abilities.

After the interview went live, Pina teased him with a “groomer” t-shirt. The crop top sparked backlash for perceived insensitivity. In response, Banks released a statement clarifying that he meant to highlight Falynn’s alleged manipulative behaviors—not misuse the term grooming or belittle that experience.

RELATED: Jaylan Banks Reacts After Falynn Pina Teases His ‘Grooming’ Claim With T-Shirt: ‘This Behavior Raises Concerns’

Falynn Pina Alleges Jaylan Banks Never Paid A Bill And Physically Abused Her

Now that he’s escalated his concerns to court, it’s unclear what Falynn’s reaction will be. However, in response to the podcast episode, Pina joined the hosts of The Baller Alert Show to tell her side of their relationship woes. She has not publicly commented on Jayland Banks allegedly filing for full custody.

For the most part, Pina says that Jaylan Banks is the “liar” who engaged in physical abuse toward her, driving her to the other man he spoke about.

About 17 minutes into the interview, Falynn said she never planned to air Jaylan Banks out because he was her daughter’s father. However, she declared Jaylan put her in a position to defend herself.

RELATED: RHOA Alum Falynn Pina And Jaylan Banks Announce End Of Their Relationship

The Real Housewives of Atlanta alum was adamant that Banks “never paid for anything, ever.” She added that despite being “a great daddy” to their child, he never paid a single bill. Instead, Pina says she showered her ex with gifts, including two trucks she allegedly took back when the relationship ended.

“I took it back cause there was cheating. There are abuse, there was domestic violence. “There’s was a lot that I put up with in just two years of being with him. It got to a point where, I mean, he was putting his hands on me and we weren’t even together anymore.”

Falynn alleges she discovered he was cheating after he came home at 8 a.m. one day, after another usual night of being out. She says she searched his phone and realized he was sharing his location with another woman and vice versa.

Pina revealed that they lived together for months after the breakup–though she didn’t give a specific time frame. The former couple announced a miscarriage in January and their split the following month. She says they hadn’t been sleeping in the same bed but were working out the kinks of going their separate ways.

Their domestic situation allegedly turned dark when he found out Falynn had moved on. But it wasn’t the first time he had gotten physical. Falynn claims that happened while she was still pregnant with their daughter Emma.

“When [Jaylan Banks] found out that I finally was like moving on, you know, taking those steps toward seeing other people, I’ll never forget it. He came home, it was four in the morning. He came bussing in the door, he just, he choked me out, and I had to calm him down cause after that he said he couldn’t forgive himself cause he said he’d never hit me again.”

Later in the interview, Falynn admitted that she’s the type of mother that will introduce her kids to her new beau early on. Her comment responded to Jaylan’s claims that her nine-year-old was calling someone dad fresh after they split. But Pina insists that the accusation Banks made isn’t that simple.

“I know in his interview he said that I just up and left with a man and now my kids are calling another man dad. And it’s like no, I had to call that man cause I don’t have family that could be there for me. And I had to call that man to come protect me and my kids and get us outta there safely. I had to call the police. It was dark. It got really dark, it got really bad and all I kept thinking was I don’t deserve this and my daughter doesn’t deserve to grow up seeing a man put their hands on her. The only reason I put up with it is because I watched my mom go through the same thing.”

Falynn Reveals Her New Man Is An Actor, Pleasure P Posts Photo Of Them Days Later

As for the groomer t-shirt, Pina said she doesn’t think “grooming is very funny at all.” She said she was “actually groomed” during a relationship with someone 30 years older than her, presumably Simon.

Instead, the reality TV star says she made a lot of excuses on Jaylan’s behalf until she learned to stop “saving people’s image.”

“To say that I was a groomer knowing damn well I held you down. I paid for everything. I allowed the media and everyone, my own family, that you were a real man and you were taking care of business in the household when in all actuality, you weren’t doing anything. I cooked, I cleaned. Not that he didn’t cook ever, but most of the time. He would play his game for 16 hours a day because he fell into depression and would not be there for me and the children.”

One claim Falynn confirmed is that she’s moved on with another man. She says he’s an actor and boxer but refuses to reveal his identity. Her interview preceded an unexpected post from RSVP’s Pleasure P. On Saturday, Pleasure uploaded a boo’ed up photo featuring Falynn.

She hasn’t publicly commented on that. But Pleasure appeared smitten, given the caption, which reads, “@falynn I need more of you every moment #galaxy.” 

If you were wondering, Banks left a series of laughing emojis under The Shade Room’s repost. Meanwhile, a source close to the situation tells TSR that Pleasure P is not the man Falynn allegedly resides with.

RELATED: EXCLUSIVE: RSVP Talks Debut Album, Making Man-Bands Cool Again & Previews New Single ‘Mr. Nasty Time’