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Wednesday, February 7, 2024

'Biden Administration Official Disputes Rumors Of Imminent Marijuana Scheduling Decision'

Amid swirling rumors about the possibility of an imminent cannabis policy announcement from the White House, a Biden administration official told Marijuana Moment on Tuesday that they’d “wave off” the speculation.

Industry stakeholders and several prominent cannabis journalists have signaled in recent days that an announcement—possibly pertaining to the ongoing review into marijuana scheduling—is coming within days. But that’s not the case, the administration source says.

The U.S. Department of Health and Human Services (HHS) did officially disclose in December that it had advised DEA to move marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA). It made that recommendation following a review under an October 2022 directive from President Joe Biden.

But while high-profile lawmakers on both sides of the marijuana debate have been recently promoting their positions on the scheduling discussion and urging DEA to act accordingly, the Biden administration official who asked not to be named told Marijuana Moment on Wednesday that they’d “wave off” the rumors.

They did not add any additional details about the current timeline for a decision.

It’s possible, of course, that the official who spoke to Marijuana Moment may not be aware of a possible forthcoming announcement. Sensitive disclosures, like the highly anticipated marijuana scheduling decision, are often held close to the vest. But claims of an imminent action have yet to be verified, despite a surge of speculation from the cannabis media and industry space on social media.

One of the most circulated examples came from Adrian Snead, a partner at the law firm Porter Wright Morris & Arthur LLP and former staffer of Sen. Jeff Merkley (D-OR) who helped craft a congressional cannabis banking bill.

In a LinkedIn post on Tuesday, Snead wrote that a “big” marijuana announcement would be coming from the White House “this week.” He cited a “highly placed” Biden administration source.

Others, including Green Market Report’s John Schroyer, Chris Roberts of MJ Biz Daily and The New York Times’ Ashley Southall, have similarly indicated recently that sources told them of a potential announcement within days—or at least by the end of the first quarter of 2024.

To be sure, the idea that the Biden administration will announce a scheduling decision this year has been taken by most observers as a given. That’s based on DEA precedent, as well as the politics of the issue that could give the president a favorability boost ahead of the November election.

But for now, an administration source who spoke to Marijuana Moment is chalking up predictions about imminent policymaking as nothing more than the fruits of an eager rumor mill, driven in large part by cannabis stakeholders who stand to benefit from a Schedule III reclassification that would free them up to take federal tax deductions that they’re currently barred from under the Internal Revenue Service (IRS) code known as 280E.

Adding to the speculation is the fact that congressional lawmakers have been especially active in recent days in their advocacy for action (or inaction) on cannabis scheduling matters.

Last week, for example, a Republican congressman who has long opposed marijuana reform is told DEA that the Food and Drug Administration (FDA) came to a “misguided conclusion” to recommend rescheduling cannabis—challenging the health agency’s scientific standards and imploring DEA to dismiss them as it prepares to make a final determination.

A separate letter sent to DEA Administrator Anne Milgram last week—led by Sens. Elizabeth Warren (D-MA) and John Fetterman (D-PA), along with Senate Majority Leader Chuck Schumer (D-NY) and other champions of marijuana reform—urged DEA to go further than rescheduling by fully removing cannabis from the CSA.

Meanwhile, HHS Secretary Xavier Becerra said last month that his agency has “communicated” its “position” on marijuana rescheduling to DEA and has continued to offer additional information to assist with the final determination.

DEA has steadfastly maintained it has “final authority” over the matter and can make any scheduling determination that it sees fit.

“DEA has the final authority to schedule, reschedule, or deschedule a drug under the Controlled Substances Act, after considering the relevant statutory and regulatory criteria and HHS’s scientific and medical evaluation,” the agency said in a letter to lawmakers last month. “DEA is now conducting its review.”

The statement came in response to an earlier letter from 31 bipartisan lawmakers, led by Rep. Earl Blumenauer (D-OR), that urged the agency to consider the “merits” of legalization as it carried out its review.

Prior to HHS releasing a trove of documents concerning its cannabis recommendation, a coalition of 12 Democratic state attorneys general implored DEA to move forward with federal marijuana rescheduling, calling the policy change a “public safety imperative.”

In another letter in December, 29 former U.S. attorneys called on the Biden administration to leave cannabis in Schedule I.

Also that month, the governors of six U.S. states—Colorado, Illinois, New York, New Jersey, Maryland and Louisiana—sent a letter to Biden calling on the administration to reschedule marijuana by the end of last year.

Meanwhile, six former DEA heads and five former White House drug czars sent a letter to the attorney general and current DEA administrator voicing opposition to the top federal health agency’s recommendation to reschedule marijuana. They also made a questionable claim about the relationship between drug schedules and criminal penalties in a way that could exaggerate the potential impact of the incremental reform.

Signatories include DEA and Office of National Drug Control Policy heads under multiple administrations led by presidents of both major parties.

In October, Advocates and lawmakers who support cannabis reform marked the one-year anniversary of Biden’s mass marijuana pardon and scheduling directive by calling on him to do more—including by expanding the scope of relief that his pardon had and by expressly supporting federal legalization.

Two GOP senators, including the lead Republican sponsor of a marijuana banking bill that cleared a key committee in September, also filed legislation late last year to prevent federal agencies from rescheduling cannabis without tacit approval from Congress.

A coalition of 14 Republican congressional lawmakers, meanwhile, separately urged DEA to “reject” the top federal health agency’s recommendation to reschedule marijuana and instead keep it in the most restrictive category under the CSA.

A recent poll found that about one-third of marijuana consumers say they would go back to the illicit market if cannabis was rescheduled and only made legally available as a Food and Drug Administration- (FDA) approved prescription drug.

Another recent survey found that President Joe Biden stands to make significant political gains if marijuana is rescheduled under his administrative directive. Of course, Biden doesn’t directly control the final outcome.

The president has routinely touted his 2022 scheduling directive, as well as a mass pardon he granted for people who’ve committed federal marijuana possession offenses. He followed up on that action in December with a renewed and expanded pardon proclamation. The Justice Department has already begun issuing certifications for people who applied under the second round.

Last weekend, meanwhile, Vice President Kamala Harris said the administration’s move to pardon people for federal marijuana possession offenses is an example of how it is delivering for Americans, particularly young and Black voters who could be key to Biden’s reelection bid this year.

https://www.marijuanamoment.net/biden-administration-official-disputes-rumors-of-imminent-marijuana-scheduling-decision-amid-heightened-speculation/

Regenxbio Pivotal Trial of RGX-121 for MPS II Achieves Primary Endpoint

 

  • Results support BLA submission in 2024 using the accelerated approval pathway
  • Primary endpoint of patients achieving reduction in CSF biomarker of MPS II disease was met with statistical significance (p value of 0.00016)
  • Patients treated with RGX-121 have showed continued improvement in neurodevelopmental skill acquisition up to four years and discontinued intravenous enzyme therapy
  • Company plans to discuss these results as part of a full rare disease program update on its conference call today, Wednesday, February 74:30 p.m. ET

As part of a full rare disease program update, REGENXBIO will host a conference call today, Wednesday, February 7 at 4:30 p.m. ET and will be joined by Dr. Harmatz and Raymond Wang, M.D., Children's Hospital of Orange County to discuss the CAMPSIITE trial pivotal phase topline results and the expedited plan for filing a Biologics License Application using the accelerated approval pathway in 2024.

Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A copy of the slides being presented will be available via the Company's investor website. Those who plan on participating are advised to join 15 minutes prior to the start time. A replay of the webcast will also be available via the Company's investor website approximately two hours after the call's conclusion.

https://www.prnewswire.com/news-releases/regenxbio-announces-pivotal-trial-of-rgx-121-for-the-treatment-of-mps-ii-achieves-primary-endpoint-302056283.html

I-Mab sheds China footprint to complete transformation into US-based biotech

 I-Mab Biopharma’s plan to become a U.S.-focused biotech took a stride forward with the news that the company is divesting its China operations.

As a result, the company’s work in China—which is headquartered in Shanghai—will be handed over to an “unconsolidated affiliate” of the company and a group of China-based investors. In return, I-Mab will get $80 million while retaining the right of first negotiation on the ex-China rights to “three future investigational new drug candidates.”

In a Feb. 7 release, I-Mab, which will remain listed on the Nasdaq, described the move as a key marker in its previously stated ambition to become a U.S.-based biotech. The company has already established operations in Rockville, Maryland, and in San Diego.

The biotech will keep the rights to its entire portfolio outside of China, including eftansomatropin alfa, a long-acting recombinant human growth hormone that scored a phase 3 win last year in children with growth hormone deficiency. The company had been preparing to launch the drug in China.

I-Mab’s portfolio also includes the anti-CD47 antibody lemzoparlimab. AbbVie handed back the ex-China rights to the drug in September, more than a year after the Big Pharma scrapped a pair of clinical trials for the therapy.

There is also givastomig, a Claudin 18.2 x 4-1BB bispecific antibody that I-Mab said in August had shown “encouraging findings of monotherapy efficacy” against tumors in a phase 1 trial. Also in the pipeline is uliledlimab, a CD73 monoclonal antibody being studied in a phase 2 trial in combination with Shanghai Junshi Biosciences’ Loqtorzi, and TJ-L14B, a PD-L1 x 4-1BB bispecific antibody in phase 1 development for PD-L1 antibody-resistant tumors.

“This agreement to divest our operations in China marks an important milestone for I-Mab in bringing a greater focus on the U.S. and ex-China markets,” CEO Raj Kannan said in the release. “Importantly, we believe that this transaction allows us to reduce significant operational costs and enables us to reallocate our capital on current key priorities and new potential opportunities in further strengthening our portfolio while maintaining a strong balance sheet."

I-Mab was founded in 2014 with the goal of taking advantage of the growing biologics market in China. The biotech opened its first U.S. outpost in Maryland in 2018, followed by the San Diego office in 2021.

https://www.fiercebiotech.com/biotech/i-mab-sheds-china-footprint-complete-transformation-us-based-biotech

‘Likely’ Ecuador source of recalled applesauce contamination found: FDA

 Ecuadorian officials identified a processor that is likely behind the contaminated applesauce products tied to hundreds of possible lead poisoning cases around the U.S., the Food and Drug Administration said on Tuesday. But U.S. health officials say they "cannot take direct action."

In an updated notice about the ongoing investigation into WanaBana, Schnucks, or Weis-brand apple cinnamon pouches, the FDA said Carlos Aguilera of Ecuador "is the likely source of contamination and is not in operation at this time."

According to officials, Carlos Aguilera was the processor of the ground cinnamon supplied by Negasmart to Austrofoods, which manufactured the pouches. 

Additionally, officials in Ecuador said the unprocessed cinnamon sticks used in recalled products that were sourced from Sri Lanka were "found to have no lead contamination."

The FDA said in the updated notice that it has "limited authority over foreign ingredient suppliers who do not directly ship product to the U.S." because the food undergoes further manufacturing and processing before being exported. 

contaminated applesauce

FDA expands investigation into applesauce contaminated with lead. (FDA / Fox News)

"Thus, the FDA cannot take direct action with Negasmart or Carlos Aguilera," the agency said. 

Ecuadorian officials said the "investigation and legal proceedings to determine ultimate responsibility for the contamination are still ongoing."


In December, as illnesses continued to climb nationwide, the FDA warned it was exploring the possibility that the high lead levels in the pouches were the "result of economically motivated adulteration." 

The agency had until Feb. 2 to detail in a briefing to members of the House Energy and Commerce Committee why it believes the lead contamination in the recalled applesauce pouches could have been intentional and the steps it has taken to investigate the matter, as well as prevent future illicit food contamination in the supply chain. 

In a recent statement to FOX Business, the FDA maintained that this is just one theory it is exploring and that additional investigation needs to occur before the agency can reach any conclusion. 

"The FDA remains committed to working in good faith with Congress to provide information," it said. 

The agency has received about 90 reports of possible lead poisoning cases as of Jan. 22. 

As of Feb 2., the Centers for Disease Control and Prevention, which is also investigating the outbreak, received a total of 413 cases from 43 different states, of which 100 are confirmed.

https://www.foxbusiness.com/lifestyle/likely-source-recalled-applesauce-contamination-found-fda-says

Medvedev Warns Russia Has 'No Choice' But To Unleash Nuclear 'Apocalypse' If Attacked By NATO

 Not for the first time, former Russian president Dmitry Medvedev has warned that a direct war between Moscow forces and NATO would lead to nuclear apocalypse.

The current deputy chairman of Russia’s Security Council issued the warning on Telegram Wednesday, in response to recent statements and reports that some European leaders are telling their populations to 'prepare for war'. For example, just last month UK Army chief General Patrick Sanders called on authorities to "mobilize the nation" to prepare for war with Putin, and that the population needs a "shift" in thinking to be ready.

Medvedev mocked this and other examples of NATO leaders accusing Moscow of seeking a broader war as but "dangerous drivel". He said that this all about trying to bolster support for sending more weapons to Kiev amid what's become war fatigue among Western publics.

According to Russian media translation of his words, Medvedev said this is part of efforts to prop up Ukraine—"a dying country that is foreign to taxpayers"—while ignoring problems at home. "Therefore, every day the leaders of these countries broadcast: We need to prepare for war with Russia and continue to help Ukraine," he wrote.

That's when he said that people in the West have to be told the blunt truth. Medvedev underscored that the Russian response to attack by NATO would without doubt be "asymmetrical". He explained:

"Since our military capabilities are incomparable, we will simply have no choice. The response will be asymmetrical. To protect the territorial integrity of our country, ballistic and cruise missiles with special warheads will be used... This will be the proverbial ApocalypseThe end of everything."

This is certainly not the first time that Medvedev, known for this bellicose and hawkish rhetoric, has warned of nuclear apocalypse. But it is the clearest he has ever spelled out that the Kremlin would not hesitate to activate its nuclear arsenal if Russian territory is directly threatened by NATO. 

His comments also come at a very dangerous moment where Ukraine security services are increasingly targeting oil refineries on Russian soil with drone and missile attacks, sometimes at long ranges.

Below: UK Prime Minister Rishi Sunak says Britain ready for war....

If Russia turns its guns in our direction, is Great Britain ready to defend itself?

"Yes. And my task is to ensure everyone's safety."

Moscow has accused Western and NATO intelligence services of assisting with such attacks. Recently it has accused France of maintaining mercenaries in the northern city of Kharkiv, in order to mount attacks on nearby Belgorod Oblast. There are rising fears that this 'indirect' fighting or proxy war could drift into direct 'live fire' between Russia and NATO countries, but so far this has been narrowly avoided.

https://www.zerohedge.com/geopolitical/medvedev-again-warns-russia-has-no-choice-unleash-nuclear-apocalypse-if-attacked-nato

Amazon Major Job Cuts In One Medical And Pharmacy Units To Save $100M

 Amazon.com Inc 

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 has announced that it will lay off hundreds of employees at its One Medical and Pharmacy units as part of a major cost-cutting initiative.

What Happened: These layoffs are part of a significant cost-saving drive intending to save One Medical $100 million, as reported by a Business Insider on Tuesday. The layoffs are taking place within Amazon’s healthcare units, which include One Medical and Amazon Pharmacy.

The layoffs will affect a “few hundred roles,” confirmed an Amazon spokesperson. The total number of job cuts is still uncertain, with estimates ranging from 115 to 400 positions. The layoff announcement was initially scheduled before Feb. 1 but was postponed due to Amazon’s recent earnings report and other internal considerations.

Amazon did not immediately respond to Benzinga's request for comment

The layoffs are part of a broader company mandate to lower One Medical’s fixed cost structure. Amazon’s leadership has tasked the healthcare company with drastically reducing its operating losses and achieving an additional $100 million in savings this year. In 2022, One Medical reported an operating loss of $420 million.

Amazon Health Services Senior Vice President Neil Lindsay confirmed the layoffs in an email to Business Insider, stating that the company is grateful for the contributions of the affected employees and will support them in their next steps.

Amazon acquired One Medical during the pandemic, but the expected growth due to Covid did not materialize as anticipated, leading Amazon to take aggressive cost-cutting measures.

Why It Matters: This announcement comes on the heels of significant changes at One Medical. In September, CEO Amir Dan Rubin departed the company after six years, and COO Trent Green succeeded him.

Furthermore, in November, Amazon launched a new healthcare benefit for its Prime members in partnership with One Medical. This initiative aimed to make healthcare more accessible and integrated for Prime members, offering 24/7 virtual care and in-person appointments at One Medical’s numerous locations across the U.S..

https://www.benzinga.com/general/biotech/24/02/36971965/amazon-implements-major-job-cuts-in-one-medical-and-pharmacy-units-to-save-100m

Cassava: Positive 2-year Alzheimer's study

 Cassava Sciences, Inc. 

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 shares are trading higher Wednesday after the company reported top-line results of a two-year clinical safety study of simufilam, an investigational oral drug for the proposed treatment of Alzheimer’s disease dementia.

The Details:

The top-line results showed no decline in cognition scores in patients with mild Alzheimer's disease who received simufilam continuously for 24 months. 

“We’re fighting Alzheimer’s disease by testing simufilam, a new type of drug that has a completely different mechanism of action from monoclonal antibody drug treatments,” said Remi Barbier, CEO of Cassava. 

“Stable ADAS-Cog scores over 2 years is clearly a desirable clinical outcome in Alzheimer’s. Our data in mild patients may emphasize the importance of treating patients early in the disease.”

Cassava Sciences shares have grabbed the attention of retail investors and short-sellers alike. The stock is one of the top trending tickers on Stocktwits, and a remarkable 33.49% of available shares are being sold short. 

https://www.benzinga.com/general/biotech/24/02/36985335/why-alzheimers-drug-developer-cassava-sciences-stock-is-trending