Target $15
Wednesday, February 1, 2023
Hunter Biden’s Metabiota Got Tens of Millions in DOD Contracts – Experimented with Bat Viruses
According to USASpending.gov, a database of spending by the US federal government, the Department of Defense (DoD) awarded tens of millions of dollars in contracts to Hunter Biden’s Metabiota labs.
Metabiota is a San Francisco-based health startup known for tracking epidemics. The company is mentioned on the Hunter Biden laptop.
Hunter Biden’s investment firm, Rosemont Seneca, invested $500,000 in Metabiota, and the company went on to raise several million more from investment giants like Goldman Sachs.
The firm has biolabs in several countries, including Ukraine, where Hunter played an important role in the company’s activities.
In their pitches to potential backers, Hunter bragged that they had done more than just get financing for the company; they had also helped it “get new customers,” including “government agencies” in the case of Metabiota, according to Daily Mail.
Government data shows Hunter Biden secured millions in government funding and grants for Metabiota after he became part owner of the firm.
Metabiota was one of the 46 Ukrainian Bioweapon labs that the US government partnered with, per DC Draino.
Hunter Biden’s laptop contains several documents regarding his team’s 50/50 ownership of Metabiota. The Gateway Pundit posted two of those documents from the laptop discussing Metabiota on Tuesday.
See below:
Following Hunter Biden and his company, Rosemont Seneca’s acquisition of a 50% ownership stake in the Metabiota, the government contracts and grants started flowing.
Before the Rosemont Senaca agreement, Metabiota was given a $349,513 contract from the government.
Following Hunter’s involvement, Metabiota was awarded a contract with the Department of Defense worth $23.9 million.
GoodRx pays $1.5 million to settle health privacy allegations
U.S. healthcare firm GoodRx Holdings has agreed to pay $1.5 million to settle allegations that it failed to notify customers that it shared personal health information with Alphabet's Google, Meta's Facebook and others, the Federal Trade Commission said on Wednesday.
Under the terms of the settlement, GoodRx will be barred from sharing user health data with other companies to use for advertising.
"Digital health companies and mobile apps should not cash in on consumer’s extremely sensitive and personally identifiable health information," said Samuel Levine, director of the FTC's Bureau of Consumer Protection, in a statement.
GoodRx, which had more than 55 million people use its website or app in the past six years, is a platform that offers drug discounts while collecting health information from users and their pharmacy benefit managers.
GoodRx promised users it would never share health information with advertisers but gave information to Google, Facebook, Criteo and others, the agency said in their complaint.
GoodRx said in a statement the issue in the settlement was resolved three years ago before the agency began its probe.
"We do not agree with the FTC’s allegations and we admit no wrongdoing. Entering into the settlement allows us to avoid the time and expense of protracted litigation," the company said in a statement.
The settlement is the first under the FTC's Health Breach Notification Rule, the agency said.
Under the settlement, the company is also required to put limits on how long it keeps personal and health information, and to publicly post the retention schedule, the agency said.
https://finance.yahoo.com/news/1-goodrx-pays-1-5-170512569.html
Huntington's Program Bites the Dust as Novartis Cleans House
Novartis is cleaning house, cutting its Huntington’s disease program along with several others. The company announced multiple program stops and delays in its full-year 2022 report Wednesday.
August brought a temporary halt to the Phase IIb trial of branaplam for Huntington’s after the discovery of possible side effects. At the time, the pharma was “gathering more data” to decide the next steps.
It looks like Novartis got that data.
In the year-end report, the company noted that the program was discontinued after a benefit-risk assessment from the VIBRANT-HD study. Early indications of side effects included peripheral neuropathy or nerve pain. The drug was initially developed for spinal muscle atrophy but was dropped for that indication.
The branaplam program is just one of many disappointments for Huntington’s of late, as the fatal disease continues to frustrate biopharma with trial holds and failures.
The decision follows an analysis that confirmed a signal of neurotoxicity in the majority of VIBRANT-HD participants, a company spokesperson said in an email to BioSpace.
Novartis’ blockbuster drug Cosentyx was also affected by the decluttering. A Phase III drug trial for active peripheral spondyloarthritis was “terminated due to strategic decision of senior management,” according to clinicaltrials.gov.
Cosentyx is already approved in five inflammatory conditions - plaque psoriasis, ankylosing spondylitis, psoriatic arthritis, non-radiographic axial spondyloarthritis and enthesitis-related arthritis, which garnered a total $4.8B in sales last year for the company.
“We disclosed at Q3 that we have stopped the Cosentyx pSpA trial. We continue to invest in new modes of administration to benefit as many axSpA patients as possible, and we hope to bring an IV formulation to U.S. patients with PsA, AS and nr-axSpA in 2023,” the same spokesperson said.
Other pipeline updates include:
- Crizanlizumab “does not show superiority compared to placebo” for pediatric sickle cell disease, and “health authorities have been informed”
- IgA nephropathy and C3 glomerulopathy program submissions were delayed due to slow recruitment, but readout is confirmed for both in 2023
- Program for membranous nephropathy dropped due to a non-compelling competitive profile
- Breast cancer drug Piqray: canceled plans to add two more indications due to reprioritization
Prime-Time Battles Drive GSK And Novo Nordisk In 2023; Novartis Preps Its Spinoff
GSK (GSK) and Novo Nordisk (NVO) will face prime-time battles this year, an analyst said Wednesday as GSK stock rose and NVO stock fell. Meanwhile, Novartis (NVS) stock skidded on its mixed-bag quarterly report.
The battles pit GSK against Pfizer (PFE) and Novo Nordisk against Eli Lilly (LLY).
Both GSK and Pfizer are approaching Food and Drug Administration review dates for their respiratory syncytial virus vaccines. RSV causes cold-like symptoms in most people, but it can be deadly in infants and older adults with weak immune systems. Novo and Lilly are trading hits in obesity treatment.
But it's anyone's guess which companies will come out on top once the dust settles, says Sebastian Skeet, analyst for research firm Third Bridge. In a note to clients, he said GSK's full-year outlook shows "some increased momentum" while Novo is "forecasting record profits."
In morning trading on the stock market today, GSK stock rose 1% and NVO stock dipped a fraction. Novartis stock skidded 3.2% near 87.70. Novartis stock is forming a flat base with a buy point at 93.41, according to MarketSmith.com.
GSK Stock: Vaccines Remain Key
Bullishly, U.K. pharma giant GSK beat fourth-quarter expectations on Wednesday. Sales grew 4% to roughly $9.08 billion while adjusted earnings increased 10% to about 90 cents per share, according to analysts polled by FactSet.
In constant-currency, sales slipped 3% and adjusted profit fell 6%.
The best growth came from GSK's specialty medicines division where sales surged 37% on a strict, as-reported basis. Behind that, revenue from vaccines and general medicines increased a respective 17% and 5%.
GSK noted exchange rates and an unfavorable comparison due to strong sales of Covid products had an impact on growth. Offsetting that, the company posted record sales of shingles vaccine Shingrix. Shingrix sales surged 72% to about $3.65 billion.
Third Bridge's Skeet says Shingrix is a concern for some GSK stock investors.
"However, GSK note potential re-vaccination after 10 years could extend the U.S. growth runway and certain key non-U.S. markets remain underpenetrated," he said.
For the year, GSK called for 6%-8% sales growth and 12%-15% increase in adjusted earnings. Both measures exclude the potential impact from GSK's Covid products. Wall Street called for about $3.47 in adjusted earnings per share and $35.36 billion in sales.
Obesity Battle Drives NVO Stock
Novo Nordisk posted strong fourth-quarter growth with sales ramping 25.5% to 48.09 billion Danish krone. That translates to about $7.04 billion in sales. Adjusted earnings also surged 26.5% to 6.02 DKK per share — about 88 cents. Both measures beat NVO stock analysts' forecasts.
But the real focus is on Wegovy, Third Bridge's Skeet said in a separate note. Wegovy is Novo Nordisk's treatment for obesity. The same chemical behind it, semaglutide, sells in other formations for diabetes treatment. Likewise, Lilly is testing tirzepatide in obesity. The same compound sells in diabetes as Mounjaro.
"Whilst Eli Lilly's Mounjaro appears to be superior to Novo Nordisk's Wegovy on weight loss and other clinical outcomes, the market is so large and underpenetrated that there is more than enough room for the two competitors," Skeet said.
To that point, Wegovy sales catapulted 213% to 2.45 billion DKK in the fourth quarter. That comes out to about $358.3 million. NVO stock analysts are watching the company's efforts to basically relaunch Wegovy in the U.S., where supply constraints caused shortages.
For the year, Novo Nordisk predicted 13%-19% sales growth, excluding the impact of exchange rates. NVO stock analysts called for earnings of 30.01 per share Danish krone and sales of 198.84 billion Danish krone — or about $4.42 and $29.06 billion, respectively.
Novartis Stock Dinged On Light Sales
For Novartis stock, investors focused on light fourth-quarter sales, which skidded 4% to $12.69 billion during the fourth quarter. Core earnings, on the other hand, rose 9% to $1.52 per share. Excluding the impact of exchange rates, earnings surged 19% while sales moved 3% higher.
Novartis confirmed its plan to spin off its generic medicines division Sandoz in the second half of the year. During the quarter, Sandoz sales slipped 8% to $2.3 billion. Revenue from what Novartis calls its innovative medicines division also fell 3% to $10.4 billion.
In constant currency sales were flat and grew 3%, respectively.
For the year, Novartis called for sales to grow by a low-to-mid single-digit percentage. Analysts who follow Novartis stock predicted earnings of $6.47 a share and $52.46 billion in sales.
https://www.investors.com/news/technology/gsk-stock-novartis-stock-nvo-stock-q4-2022-earnings/
Is Bivalent Covid Booster Any Better Than Original? Studies Ho-Hum So Far
Jeremy Faust, MD, editor-in-chief of MedPage Today, discusses his recent article
diving into new studies on the effectiveness of the COVID-19 bivalent booster versus the monovalent booster.
The following is a transcript of his remarks:
One thing that people are really interested in right now is this question as to whether the bivalent booster is better than what we had before.
Certainly, it was marketed as we have these mRNA vaccines, we can swap out very easily what's in that vaccine, and make changes and keep up. And therefore, this fall, the FDA rolled out the bivalent booster, which had some of the original Wuhan spike protein recipe and some of Omicron; that's the "bivalent" part.
What we now are looking at is laboratory data of people who got boosted either with the monovalent or the bivalent, and what we're seeing here is that the monovalent works, the bivalent works, in terms of antibody responses, and the bivalent may work better, but if it does, it's not by very much.
You've got really two kinds of studies: some studies that showed really no difference between the bivalent booster and the monovalent booster in terms of antibody levels, and then you have some studies that are suggesting that the bivalent booster did better and has a higher antibody response.
The problem with the studies that show an increase -- that the bivalent is better than monovalent -- really comes down to a couple of things. The first thing is that the increase isn't that much. It's not a 10-fold or 100- or even 1,000- or 10,000-fold difference, which we could expect to see. It was literally to the tune of a doubling or so, which is really not that impressive when you've swapped out entire parts of the vaccine in order to make a change. We were hoping for much more. We don't even think that's a clinically relevant finding.
The two studies
that came out in the New England Journal of Medicine last week didn't really find much in the way of any increase at all. There's really these two kinds of studies: there's the study that says there's really no difference, and then there's the kind of study that says, "Well, there's some difference, but it's very small."
It turns out there were people who thought the differences came down to what kind of assays and tests were being done. It doesn't seem like it comes down to the assay, and the reason that I think that is, is the most rose-colored-glasses-view study, the one that showed the biggest impact for bivalent over monovalent, came out of a pseudovirus study. Also, pseudovirus was the platform for the studies that showed no difference, and then live virus had some small changes.
So, really, it doesn't seem to come down to the virus or assay that's chosen. All the scientists that I've spoken to, including the authors of the studies, David Ho, Dan Barouch, and others have said that pseudovirus and live virus are pretty interchangeable, so we don't have to worry that the differences are due to the platform.
It seems like the big difference comes down to timing, that people who got the bivalent boosters in the studies that made the bivalent booster look good had a different amount of time compared to the monovalent groups. In other words, the interval between when people had their last dose and when they got their most recent dose was different across the groups, making it more likely that the people who were in the bivalent side of these studies would be expected to have a higher response. That doesn't prove the bivalent is better, that just proves that the timing was better.
So, there's been this sort of online and siloed debate about whether the booster is a bust or whether it's really better. You really have two sides, you've got the Paul Offit side with the New England Journal of Medicine perspective saying that the bivalent booster story is a cautionary tale. It's not that it doesn't work, it's that we went to all this great effort and it might not even be that much better.
In fact, keeping any part of the Wuhan virus in the new bivalent booster might be bad, because our immune systems have seen the Wuhan strain so many times and that's not even around anymore. We have Omicron and we have Omicron subvariants. We don't want to be in a situation in which our immune systems are imprinted for Wuhan and then when they see Omicron, they shrug it off as nothing it needs to worry about.
On the other hand, you've got Team Topol, Eric Topol's folks, who are saying that the bivalent is clearly better because of how well it did in these assays -- look how important it is, look at the Israeli data. I think that those arguments don't hold up.
But what I think is important though, and what I think Dr. Topol has right, is that there is a group of people, high-risk people in particular, who need to stay up-to-date with their boosters. Whether it's bivalent or monovalent, it doesn't matter, because we don't want to discourage those people who need it the most from getting boosted going forward.
I think a monovalent, Omicron-only booster is probably going to be the better choice, but we're waiting for the FDA and for Pfizer and Moderna to announce where they're headed. I hope that's what they do.
One Diet Appeared Tops for Short-Term Seizure Control in Pediatric Epilepsy
In children with drug-resistant epilepsy, the modified Atkins and ketogenic diets were more effective than usual care in achieving large short-term reductions in seizures and short-term seizure freedom, a systematic review and network meta-analysis found.
Across 12 randomized trials, all three dietary interventions evaluated -- ketogenic, modified Atkins, low glycemic index therapy (LGIT) -- showed a short-term benefit (3 months or less) in seizure reductions of at least 50% compared with usual care, reported Dipika Bansal, DM, of the National Institute of Pharmaceutical Education and Research in Punjab, India, and colleagues.
But as described in JAMA Pediatrics
, only the modified Atkins and ketogenic diets were effective for short-term seizure reductions of 90% or more compared with usual care (OR 5.1, 95% CI 2.2-12.0, and OR 6.5, 95% CI 2.3-18.0, respectively) and for achieving short-term freedom from seizures (OR 4.4, 95% CI 1.3-14.5, and OR 5.0, 95% CI 1.3-19.5).
These may be more meaningful outcomes for children with a very high burden of daily seizures, such as those with drug-resistant epilepsy, according to the researchers.
While direct comparisons showed no significant differences, they concluded that with its better tolerability, the modified Atkins diet "may be a sounder option than ketogenic diet."
Across dietary interventions, pooled results showed that 36% of children achieved short-term seizure reductions of 50% or more, 17% had reductions of 90% or more, and 10% achieved short-term seizure freedom. Data on intermediate outcomes were more mixed and only one study examined long-term outcomes.
Modified Atkins and ketogenic diets were both associated with more adverse event-related discontinuations versus usual care (OR 6.5, 95% CI 1.4-31.2, and OR 8.6, 95% CI 1.8-40.6, respectively). Adverse events included constipation, lack of energy, and vomiting.
Participants also withdrew from the diets for reasons including "inefficacy, parental unhappiness, behavioral food refusal, dissatisfaction with randomization results, and food texture," Bansal and co-authors noted. "This echoes with the fact that parental food habits
and feeding strategies determine their child's eating behavior."
Dietary therapies have long been used to treat the nearly 30% of pediatric epilepsy patients who are resistant to antiseizure medication, but investigations into the comparative efficacy of various interventions, along with their safety, have been lacking.
"Although epilepsy surgery is a curative treatment option for surgically amenable DRE [drug-resistant epilepsy], alternative modalities such as dietary therapies are often used on the failure of two or more appropriately chosen antiseizure medications while awaiting epilepsy surgery, in nonsurgical DRE, and specific neurometabolic disorders," wrote Bansal and colleagues.
In addition to patient-specific factors such as primary diagnosis and child/family dietary preferences, selection of a drug-resistant epilepsy diet should take into account the interactions of different dietary therapies, including the possible adverse effects of carbonic anhydrase inhibitors and valproic acid in patients on a ketogenic diet, the group advised.
For their systematic review and network meta-analysis, the researchers identified 12 eligible randomized trials (11 open-label, one single-blinded) involving patients ages 18 years and younger with drug-resistant epilepsy, according to criteria
of the International League Against Epilepsy (failure of two or more appropriately chosen antiseizure medications).
Trials were conducted in multiple countries -- India, Iran, Korea, The Netherlands, and the U.K. -- and compared the three dietary interventions with each other or with usual care, which included ongoing use of antiseizure medications. Dietary interventions included the ketogenic diet (classic ketogenic diet or the medium-chain triglyceride ketogenic diet [MCT-KD]), modified Atkins, and LGIT.
Ketogenic diets "have been used for over a century with promising results," according to the researchers, but adherence difficulties have limited their use.
"The classic KD [ketogenic diet], with a ketogenic ratio of 4:1, derives 80% of total energy intake from fat (mostly long-chain triglycerides; medium-chain triglycerides in MCT-KD) and the rest from carbohydrate and protein combined," the authors explained. Less restrictive diets assessed included modified Atkins and LGIT, which use low-glycemic index foods to limit daily carbohydrate intake to 10-20 g and 40-60 g, respectively, without any fixed ketogenic ratios.
Overall, 907 patients in the studies were randomized (676 to dietary interventions, 257 to care as usual). Two-thirds of the children were boys, and the average age at enrollment was 4.6 years (SD 2.4). Initiation of dietary therapies was delayed to an average age of over 4 years in seven studies.
Mean age at seizure onset was 1.4 years (SD 1.6) and the mean seizure frequency was 27.1 per day (SD 31.8), ranging from 4 to 59.5 per day due to different seizure types in all likelihood, according to the researchers.
As noted, short-term seizure reductions of 50% or more was achieved with all three interventions when compared with usual care:
- LGIT: OR 24.7 (95% CI 5.3-115.4)
- Modified Atkins: OR 11.3 (95% CI 5.1-25.1)
- Ketogenic: OR 8.6 (95% CI 3.7-20.0)
Limitations, the team noted, included within-study bias due to the open-label nature of most of the trials, the "clinical heterogeneity" of patients involved, and the "imprecision and unavailability of robust evidence for indirect comparison between different dietary interventions and for intermediate- and long-term outcomes."
They added that "direct head-to-head comparison studies in the future are needed to confirm these findings further."
Disclosures
Bansal and co-authors reported no conflicts of interest.
Primary Source
JAMA Pediatrics
Source Reference: Devi N, et al "Efficacy and safety of dietary therapies for childhood drug-resistant epilepsy: a systematic review and network meta-analysis" JAMA Pediatr 2023; DOI: 10.1001/jamapediatrics.2022.5648.
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