VYVGART® (efgartigimod alfa injection) is included for the first time in the NRDL for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive;
NUZYRA® (omadacycline) is included for its oral formulation for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI); and
ZEJULA® (niraparib) is renewed for the maintenance treatment of adult patients with platinum-sensitive, first-line and recurrent ovarian cancer.
The US Supreme Court on Wednesday agreed to review an August decision by an appeals court which cut off access to a widely-used abortion pill, mifepristone, also known as RU-486.
The move comes just 18 months the Supreme Court's decision to overturn Roe v. Wade, ending the constitutional right to abortion.
If the USSC agrees, it could limit abortion access even in states where the practice remains legal. Of note, abortion pills account for more than half of abortions in the US according to the Guttmacher Institute, as noted by Axios.
The decision to take up the case follows a ruling by the New Orleans-based 5th US Circuit Court of Appeals that would end legal usage of the pill, as well as block its distribution and delivery - including telemedicine prescriptions and shipments of the drug. The Court will also hear an appeal by the drug's manufacturer, Danco Laboratories.
The 5th Circuit's decision is currently on hold pending the outcome of the appeal at the Supreme Court in a challenge to the pill brought in Texas by anti-abortion groups and doctors. The justices are expected to hear arguments in the coming months and issue a decision by the end of June in the middle of a heated presidential race. -Reuters
Mifepristone is combined with another drug called misoprostol to perform a medical abortion.
The Biden DOJ, meanwhile, has told the Supreme Court that allowing the 5th Circuit decision to stand would have "damaging consequences for women seeking lawful abortions and a healthcare system that relies on the availability of the drug under the current conditions of use."
As Axios further notes;
The maker of mifepristone, Danco Laboratories, and the Department of Justice in September asked justices to review a 5th U.S. Circuit Court of Appeals ruling that the FDA failed to take into account safety concerns when it made mifepristone more easily accessible in 2016.
Danco cited the ruling's risks and confusion to women and the health system — and the way the challenge to the FDA's authority destabilizes the drug and biotech industries.
The three-judge panel at 5th Circuit partially blocked a lower court ruling that struck the FDA's approval of the drug, which was granted in 2000, in response to a suit from anti-abortion forces.
House Oversight Committee Chairman James Comer got into a heated debate with reporters after Hunter Biden refused to attend a closed-door deposition to face questions over his business dealings, and whether his father Joe Biden was involved with them.
Instead of appearing in accordance with a subpoena, Hunter gave a speech on Capitol Hill in which he said he would testify publicly rather than in a closed depostion.
"But Chairman Comer, do you acknowledge that you haven’t answered that question and that you’ve found no evidence of wrongdoing or criminal conduct?" asked Washington Post congressional investigations reporter Jacqueline Alemany.
"We've found some very serious evidence that--" Comer replied, before Alemany cut him off, saying "But Joe Biden--"
To which Comer shot back: "No, no, no, no. The checks. There’s two checks to Joe Biden from his brother that the money to give Joe Biden was influence-peddling. One was through—no, you asked a question. No, no, listen."
Alemany then tried to argue that the $40,000 check was "law firm money" rather than funds from a Chinese energy firm.
"What do you think? You’re defending him. I mean you’re acting as if—are you positive that that money came from Joe Biden?" Comer shot back. "You’ve raised it. Are you positive? No."
Bank records released by Comer found that Biden received a $40,000 check in September 2017 after the Biden family received money from Chinese business associates. The records show that Hunter Biden, his uncle James and his aunt Sara wired money through several accounts before Sara sent Biden a check as a “loan repayment” less than a month after James Biden’s business relationship with Hudson West III, Hunter’s business venture with CEFC, began.
Ahead of the 2020 presidential election, then-presidential candidate Biden falsely said his son never made money from China. He further said he had never discussed business with son or any of his associates, but it now known he attended two dinners with hs son’s business associates, one with a Russian oligarch in 2014 and another with Burisma executive Vadim Pozharskyi in 2015.
And as promised, Hunter now faces contempt of Congress...
Meanwhile, what does Biden think about people who defy Congressional subpoenas now?
* * *
Hunter Biden's legal team set up a podium on Capitol Hill Wednesday, where the First Son decided to make his case in the court of public opinion, as opposed to appearing in a closed-door deposition by House investigators.
"Let me state as clearly as I can," said Hunter. "My father was not financially involved ion my business. Not as a practicing lawyer. Not as a board member of Burisma. Not in my partnership with a Chinese private businessman. Not in my investments at home nor abroad, and certainly not as an artist."
Watch:
Watch the entire speech below:
Last week, House Oversight Committee Chairman James Comer and House Judiciary Committee Chairman Jim Jordan warned Hunter that he would face contempt of Congress if he skips out on today's closed-door deposition, after his lawyer demanded it to "prevent selective leaks, manipulated transcripts, doctored exhibits, or one-sided press statements."
"Contrary to the assertions in your letter, there is no ‘choice’ for Mr. Biden to make; the subpoenas compel him to appear for a deposition on December 13. If Mr. Biden does not appear for his deposition on December 13, 2023, the Committees will initiate contempt of Congress proceedings," reads the letter, issued a week after his attorney, Abbe D. Lowell suggested that Hunter should instead be allowed to testify publicly.
Hunter was subpoenaed on Nov. 8 to appear for a deposition before the committee. In response, Comer said: "Hunter Biden is trying to play by his own rules instead of following the rules required of everyone else," adding "Our lawfully issued subpoena to Hunter Biden requires him to appear for a deposition on December 13."
Comer and Jordan are investigating extensive evidence that the Biden family was running an international influence peddling scheme, raking in tens of millions of dollars from foreign business partners despite no obvious product or service in exchange.
House lawmakers are also seeking testimony from Hunter's uncle James Biden, as well as multiple former business associates.
Since The Fed's last meeting (on Nov 1st), the markets have been extreme to say the least. The dollar (and gold) are lower as Bitcoin has soared higher and stocks and bonds both surged...
Source: Bloomberg
For context, that 9%-plus rally in the S&P 500 is the best inter-meeting performance since June-August 2009.
Even more extreme is the fact that the rally in bonds and stocks and decline in the dollar has sparked an almost unprecedented easing of financial conditions since Nov 1st.
Source: Bloomberg
This is particularly noteworthy because The Fed explicitly mentioned the fact that “Tighter financial... conditions...are likely to weigh on economic activity, hiring, and inflation" with the 'the market is doing The Fed's job for it' narrative being espoused by all.
Well, all that good work by The Fed has now been undone!
And with its usual lag, the previous tightening appears to have indeed weighed down macro data...
Source: Bloomberg
The market has pushed dramatically more dovish, pricing in 125bps of rate-cuts next year (from around 75bps at the last Fed meeting)...
Source: Bloomberg
And, as we have been highlighting, this means the market is now pricing in an expectation that every single member of The Fed is wrong (too hawkish) about rates next year...
Source: Bloomberg
Which leads us to the crux of today's FOMC statement and press conference, which is - just how much will they (hawkishly) push back against the easing of financial conditions or (dovishly) adjust their dots to meet the market's demand?
As Mohamed El-Erian noted just ahead of the statement:
Fascinating to see markets push yields further down ahead of this afternoon's announcement/remarks.
Either they are comfortable that there will be a January 2019 repeat or are bluntly ignoring the longstanding mantra of "don't fight the Fed".
And so, what did we get?
No change in policy rates as fully expected - the third consecutive meeting in this "temporary pause."
But, then unleashed the doves in the statement:
FOMC softens stance toward further hikes by adding one word to the statement, saying officials will consider the extent of “any” additional policy firming that’s needed
Fed also acknowledges that “inflation has eased over the past year but remains elevated,” and says that economic growth has slowed from the third quarter’s “strong pace”
The dots went uber-dovish, with the median dot suggesting 75bps of cuts next year (consensus was for 50bps). There are 5 Fed officials below that media point (seeing 100bps of cuts)...
Additionally, median projections for inflation tick down in 2024 and 2025, while unemployment forecasts are little changed, indicating Fed officials’ growing confidence they can cool price gains without big job losses.
And now we wait for Powell's presser, which UBS wittily described as follows:
"The meeting will be followed by Fed Chair Powell delivering the full benefit of his economic insight at the press briefing (this should not take long).
Powell will try to prevent markets from expecting earlier rate reductions.
This task would be a lot easier had Powell not trashed the Fed’s reputation for forward guidance."
U.S. employers facing surging costs from paying for Novo Nordisk’s Wegovy and similar obesity drugs are hiring virtual healthcare providers like Teladoc to implement weight-loss management programs, a dozen consultants, pharmacy benefit managers, analysts, and providers told Reuters.
These programs may require diet and exercise before granting access to the medicines, and in some cases will become employees' sole covered option for medications like Wegovy and Eli Lilly’s rival therapy Zepbound, which have list prices of more than $1,000 a month.
They could help companies cut costs by limiting employees to small networks of less expensive providers or by delaying prescriptions with lifestyle change mandates, one of the benefits consultants said.
Another consultant touted the benefits of such programs, saying diet and exercise regimens could lead to long-term improvements in patient health.
“Many (employers) were skeptical about the cost of these drugs at the beginning of the year, but that mindset has shifted. Employers and health plans are now increasingly more willing to cover them, with the right programs in place,” Teladoc executive Ananth Balasubramanian said in an interview.
More than a quarter of 152 employers surveyed by the Business Group on Health said they would use virtual providers to oversee obesity drug prescriptions next year.
Boeing, Hilton, and Fortune Brands are among companies that have signed up for or expanded deals with virtual healthcare providers, according to sources familiar with the matter.
Truist analyst Jailendra Singh forecast the market for virtual obesity drug management could reach $700 million in 2024 and grow to as much as $9 billion longer term, assuming providers charge around $30 per member, per month, and $50 for physician appointments.
Reuters reported in June that the popularity of obesity medicines had U.S. employers rethinking insurance coverage, but most only required special authorization or had stopped covering diabetes drugs off-label for weight loss.
A single course of treatment with an Alzheimer's drug developed by Japanese company Eisai and U.S. firm Biogen will cost around 2.98 million yen ($20,500) per year in Japan and will be largely covered by public health insurance, a health ministry body said Wednesday.
The highly-anticipated drug, lecanemab, will be launched in Japan on Dec. 20, the companies said. The drug won approval in September as the country's first that can slow the progression of the debilitating neurodegenerative disease's symptoms by removing a protein believed to be the cause.
As the drug, branded Leqembi, will be covered by public health insurance, those undergoing treatment will pay 10% to 30% of the cost out of their own pocket, depending on their age and income.
The drug is also expected to be covered under a system in Japan that sets a ceiling on the amount a patient can pay in a year.
A patient aged 70 or above with an annual income of 1.56 million yen to around 3.7 million yen, for example, will pay no more than 144,000 yen annually for the drug under the payment cap.
The drug treats those experiencing early-stage Alzheimer's and mild cognitive impairment. It is estimated up to 32,000 patients could access the drug each year in Japan, translating to a market of 98.6 billion yen, the body said.
The dosing of the drug is based on a patient's weight. The annual cost of 2.98 million yen per year is calculated on the basis of a sufferer weighing 50 kilograms.
atients will be administered 10 milligrams per 1 kg of body weight via an intravenous injection every two weeks, for up to 18 months.
In the United States, the drug is priced at $26,500 a year per patient.
The drug utilizes an antibody that targets a protein called amyloid beta. The plaque-like protein, which accumulates inside the brain and destroys nerve cells, is considered the cause of the disease.
Eisai said clinical trials demonstrated the drug curbed the progression of symptoms like memory loss and impaired judgment by 27% compared with a placebo.
However, some patients administered the drug experienced side effects like brain swelling and bleeding, it said.
