A patent case against Novo Nordisk in the United States will be allowed to continue, according to a decision from the Patent Trial and Appeal Board of the U.S. Patent Office on Wednesday.
It is the copy producer Viatris that has challenged three of the patents behind Novo Nordisk’s GLP-1 molecule Semaglutide because the copy producer believes that the patents are actually based on the diabetes drug Liraglutide and should therefore be set aside.
Earlier this week, the tribunal refused to conduct an ”inter partes review” of two of the challenges, but on Wednesday it was decided that the case regarding the third challenge will continue.
”Inter partes review” is a special legal process in the US patent system and is a way to challenge the validity of an issued patent. The process allows a third party to request the US Patent Office to examine the validity of a patent.
In an inter partes review, a panel of experts within the patent office reviews the legal requirements that must be met for a patent to be validly issued. The process is faster and cheaper than an actual trial, and the aim is to reduce the number of weak or invalidly issued patents and thus avoid long and expensive court cases.
Robust increases of up to 700-fold over baseline in plasma GCase enzyme activity in first two patients treated with FLT201
Normalization of leukocyte GCase in both patients demonstrates cellular uptake from plasma
FLT201 has been well tolerated, with no serious adverse events
Company to host conference call today at 8 a.m. ET
Freeline Therapeutics will host a webcast presentation at 8 a.m. ET today to discuss these initial clinical data for FLT201 in Gaucher disease.
A live webcast of the event will be available on the Investors section of Freeline’s website at www.freeline.life. Participants may access the event by registering here. While not required, it is recommended that participants join 10 minutes prior to the scheduled start. An archived replay will be available on Freeline’s website for at least 90 days.
Novavax opened this morning at $7.74 per share, a market capitalization of $770 million. It was below $7 when the FDA news came out. NVAX stock dropped about 5% immediately after trading began.
Novavax was a hot stock in 2020 as it competed to create a Covid vaccine. The stock traded as high as $289 per share in early 2021.
But Novavax’s traditional vaccine process, which included an adjuvant to improve its dosage yield, came up short next to Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE), which worked with BionTech (NASDAQ:BNTX) of Germany. Their use of mRNA was the subject of the latest Nobel Prize in Medicine. Novavax eventually moved toward getting approvals and contracts outside the U.S.
While Novavax generated $424 million in sales during the second quarter of 2023 and $58 million, 58 cents fully diluted, in profit, it’s a pittance next to the tens of billions the mRNA makers earned at their height. Novavax expects revenue of $1.3-1.5 billion for fiscal 2024.
It’s hoped the FDA approval and Novavax’s traditional vaccine approach could bring sales in a political environment where anti-vaccine rhetoric is rampant,
especially concerning mRNA.
While the bears have been winners in the Novavax stock market, the stock is now selling at half its annual sales, and the company is profitable. It also has almost three times more cash than debt. By contrast, while Moderna has been battered this year, it’s still worth twice its sales.
Nuvalent, Inc. (Nasdaq:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced preliminary data from the Phase 1 dose-escalation portion of its ongoing ALKOVE-1 Phase 1/2 clinical trial of NVL-655 for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors as reported in an abstract accepted for presentation at the 35th AACR-NCI-EORTC (ANE) Symposium inBoston, Massachusetts. Updated preliminary data will be presented at the conference and during a live webcast and conference call with management onOctober 13that8:00am EDT.
NVL-655 is a novel brain-penetrant ALK-selective tyrosine kinase inhibitor (TKI) created with the aim to simultaneously overcome the clinical challenges of emergent treatment resistance, brain metastases, and off-target central nervous system (CNS) adverse events associated with tropomyosin receptor kinase (TRK) inhibition that may limit the use of currently available ALK TKIs.
NVL-655 is currently being evaluated in the ALKOVE-1 Phase 1/2 clinical trial, a first-in-human study of NVL-655 in patients with advanced ALK-positive NSCLC and other solid tumors (NCT05384626). The Phase 1 dose escalation portion is enrolling ALK-positive NSCLC patients who have previously received at least one ALK TKI and patients with other ALK-positive solid tumors who have been previously treated with at least one prior systemic anticancer therapy. The primary objectives are to determine the recommended Phase 2 dose (RP2D) and if applicable, the maximum tolerated dose (MTD) of NVL-655 in patients with ALK-positive solid tumors. Additional objectives include characterization of the overall safety, tolerability, and pharmacokinetic profile, and evaluation of the preliminary anti-tumor activity of NVL-655.
Details for the presentation are as follows:
Title: Safety and preliminary activity of the selective ALK inhibitor NVL-655 in patients with ALK fusion-positive solid tumors Abstract Number: 35177 Poster Number: B154 Session: Poster Session B Session Date and Time: Friday, October 13, 12:30 pm-4:00 pm EDT Presenting Author: Jessica J Lin, Massachusetts General Hospital (MGH), Boston, MA
Webcast and Conference Call Information
A conference call with management will be held on October 13th at 8:00 am EDT. To access the call, please dial +1 (866) 652-5200 (domestic) or +1 (412) 317-6060 (international) at least 10 minutes prior to the start time and ask to be joined to the Nuvalent call. Accompanying slides and a live video webcast will be available in the Investors section of the Nuvalent website at https://investors.nuvalent.com/events. A replay and accompanying slides will be archived on the Nuvalent website for 30 days.
If you have not yet read the book 1984 by George Orwell, you absolutely must.
I loathed that novel when I read it as a teen, because I hated the entire idea of an authoritarian government controlling its people so deftly. The dystopian world it described was just so depressing, so wrong, from the first page to the last. And yet, here we are, almost 75 years after Orwell first penned the book, and we see how that hellish science fiction novel is now playing out before us.
Even the left-leaning Wikipedia describes the book as a “cautionary tale” whose theme centers on “the consequences of totalitarianism, mass surveillance and repressive regimentation of people and behaviours within society.” Modeled on the authoritarian states of Stalin’s Soviet Union and of Nazi Germany, the book takes a deep dive into the role of truth within a society, and the ways in which truth and facts can be manipulated by government to control the population.
What you saw and heard with your own eyes and your own ears, the government denied and demanded you cast it aside and not believe it.
“The Party told you to reject the evidence of your eyes and ears. It was their final, most essential command.”
― George Orwell, 1984
Through the Ministry of Truth, the government (referred to in the book as “Big Brother” or “the Party”) engages in endless propaganda, intense surveillance, and the open and obvious negating of historical fact. Individual thought, and questioning of authority led to immediate persecution. Why deny facts and rewrite history? Well, as Orwell says in the book,
“Who controls the past controls the future. Who controls the present controls the past.”
― George Orwell, 1984
Now let’s fast-forward to the present day. I will begin with this profound statement that keeps churning over in my head:
They must really think we are stupid!
The “they” is our government (federal and state). The “we” is you and me, and the other 300+ million Americans across our country.
Alas, here we are, entering the final quarter of 2023, and we have the United States government, and many state governments (including New York’s former Governor Andrew Cuomo, current left-wing Governor Kathy Hochul, and the super-majority Dem legislature) proclaiming for all to hear that they did not force anyone to do anything detrimental these past 3.5 years. UNBELIEVABLE! Did you hear this? They are actually saying with straight faces that they didn’t force you to wear a mask, or lock down and shutter your businesses, or choose between taking an experimental drug or losing your job… Nope! They did none of that. And you – well, you are flat out crazy if you think they did. You are lying. You are exaggerating and totally overreacting.
Unfortunately for Big Brother, ooops, I mean unfortunately for our 100 percent reliable, never-lies-to-us government, we have actual documents (including lawsuits), news stories, social media posts, and videos of the government at all levels mandating and forcing us to do all of those things, and more. Here’s just one example of Biden himself, the “Big Guy,” mandating the C19 shot:
Biden is not alone. No, no. His entire administration is right there with him. His head of OSHA, Douglas Parker, is also now lying through his teeth about the OSHA mandate that REQUIRED (not suggested) that all employers in the entire nation with 100 or more employees force their employees to get the C19 shot, otherwise they had to wear a mask and test constantly for C19. (That OSHA mandate was struck down by SCOTUS last year because it was unconstitutional, by the way). Then there’s the head of HHS, Xavier Becerra, saying there was never a mask mandate. What?! Another blatant lie.
Please take the 2 minutes to watch this Congressman Kevin Kiley clip. You truly won’t believe your ears with the bullsh#* these Biden agency heads are spewing! As Congressman Kiley says in the video, the government is trying to tell us that “2 + 2 doesn’t equal 4.” You don’t get much more Orwellian than that!
Why are they backtracking now?
Easy answers: 1) they didn’t have the authority to do any of it (all of it was unconstitutional) so they can’t justify and defend it now, and 2) if they can convince you they didn’t do it before, then you won’t mind as much when they do it again.
This should make your blood boil. It’s particularly infuriating to those of us who were speaking out from basically day one trying to tell people that the lockdowns, the masking, the shots, the limited number of people at your wedding or at your Thanksgiving table were all violations of the Constitution and our basic human rights! My colleague, Jeffrey Tucker, who is the founder and President of Brownstone Institute, where I am a Fellow, wrote an article the other day on this topic. At the end of it, he concluded:
The major media is tacitly conspiring with the political establishment, the corporate sector, and the administrative state to pretend like that fiasco was completely normal and also entirely forgettable, not even worth naming. We did the best we could with the information we had so just stop complaining about it!
This is not going to work. It is too close to living memory for this level of gaslighting to be effective. The more these official institutions engage in this crazy form of denialism, the more they discredit themselves.
Bobbie Anne, a 2023 Brownstone Fellow, is an attorney with 25 years experience in the private sector, who continues to practice law but also lectures in her field of expertise - government over-reach and improper regulation and assessments.
Moderna on Wednesday said its combination vaccine to protect against both COVID-19 and influenza generated a strong immune response compared to individual shots for the viruses in an early-stage study.
Moderna said the combination generated antibodies similar to or greater than currently marketed flu vaccines, and was similar to its previous standalone COVID booster shot against the coronavirus.
The vaccine, called mRNA-1083, appeared to be effective against all four A and B strains of the flu in older adults when compared with widely used flu shots from GSK and Sanofi , according to the company.
Moderna also said the combination was found to be safe and tolerable, and that rates of adverse side effects were similar to those experienced by people who received its COVID-19 vaccine during the study.
The company said it plans to start a late-stage trial for the combination shot later this year.
“It's hypothetically possible that it could be approved towards the end of the year, but more likely we're talking about the 2025 fall season for the flu-COVID combination. So two years from today," Moderna President Stephen Hoge said in an interview.
The latest data is based on two arms of a larger study that involved around 1,000 people - one against GSK’s Fluarix in adults aged 50 to 64 and another against Sanofi’s Fluzone HD in people 65 to 79 years of age. Fluzone is the high-dose vaccine for older people.
In September, Moderna announced that its standalone flu vaccine had generated a stronger immune response against all four A and B strains of the influenza virus than available flu shots in a late-stage trial.
Moderna said on the same day that it was scaling down manufacturing of its COVID vaccine to align with lower post-pandemic demand and to help the company hit its target of 75%-80% gross margin growth sooner.
