Company reaches next clinical trial milestone for treatment of Type 1 Diabetes with the first novel allogenic cellular therapy in the dorsal artery of the pancreas in the United States
https://finance.yahoo.com/news/creative-medical-technology-holdings-announces-130000467.html
Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage biotechnology company specializing in the development of AI-powered immunotherapies and Pantherna Therapeutics GmbH (“Pantherna”), a biopharmaceutical company developing advanced nanoparticle solutions for the delivery and expression of mRNA therapeutics, today announced preclinical proof of concept for the combination of the two companies’ key technologies.
The preclinical data demonstrate that tumor neoantigens identified by Evaxion’s AI platform, PIONEER, drive a strong immune response and lead to complete inhibition of tumor growth in a preclinical model when delivered using Pantherna’s proprietary lipid nanoparticle mRNA platform (PTXΔLNP®, PTXmRNA®).
https://finance.yahoo.com/news/evaxion-pantherna-announce-promising-preclinical-113000370.html
Hoth Therapeutics, Inc. (NASDAQ:HOTH), a patient-focused biopharmaceutical company, today announced proof-of-concept data generated using cognitive and behavioral assessments in an Alzheimer's disease mouse model (aged APP/PS1+/- mice), supporting the therapeutic cognitive potential of HT-ALZ after chronic oral dosing of 20mg/kg and 40mg/kg of HT-ALZ The research was conducted as part of the company's Sponsored Research Agreement with Washington University in St. Louis. HT-ALZ is a therapeutic in development under the 505(b)(2) regulatory pathway for the treatment of dementia related to Alzheimer's disease (AD).
Hoth reports that the longer treatment before beginning of testing is improving performance of more mice in the water maze and appears to have a positive effect on anxiety-like behavior in the elevated plus maze. The groups of mice treated with the higher doses, 20mg/kg and 40mg/kg of HT-ALZ, appear to have the most benefit, with the 20mg group already showing significant improvement in spatial memory in the water maze. The elevated plus maze test is one of the most widely used tests for measuring anxiety-like behavior. The test is based on the natural aversion of mice for open and elevated areas, as well as on their natural spontaneous exploratory behavior in novel environments.
AD is a neurodegenerative disease that is characterized by aggregates of amyloid β (Aβ) plaques and neurofibrillary tangles of Tau protein in the brain, which contribute to the clinical symptoms of the disease such as dementia. Previously Hoth reported study results focused on investigating the effect of orally administered HT-ALZ to reduce the concentration of Aβ in the brain interstitial fluid, using an established Alzheimer's Disease mouse model (aged APP/PS1+/- mice). The initial data from those studies showed a significant decrease in Aβ in both male and female APP/PS1+/- mice after acute treatment with HT-ALZ, compared to placebo-treated animals and baseline Aβ levels.
U.S. President Joe Biden will call for a nationwide cap of $35 a month on out-of-pocket insulin costs during his State of the Union Address on Tuesday, but is unlikely to get his wish as it lacks enough Congressional support.
Democrats failed to pass a similar measure last year when they controlled both the U.S. Senate and House of Representatives. Back then they only needed 10 Republican votes in the U.S. Senate to pass it.
Now that Republicans control the House, its chances are even slimmer, experts say.
"Capping insulin costs for patients is an idea that really resonates with people who are struggling with healthcare costs but it's highly unlikely to pass in a divided Congress," said Larry Levitt, Executive Vice President for Health Policy at the Kaiser Family Foundation.
Around 8.4 million of the 37 million people in the United States with diabetes use insulin, according to the American Diabetes Association (ADA).
Democrats were able to pass the cap for those enrolled in the government's Medicare health program for people ages 65 and older last year as part of Biden's signature Inflation Reduction Act (IRA). That kicked in last month.
They tried, and failed, to extend the benefit to everyone with health insurance when they were voting on the IRA.
"This is a very potent talking point, but not something that's likely to result in actual legislation anytime soon," said Levitt, a senior health official during the Clinton administration.
Without Congressional approval, the Biden administration cannot impose the cap on private insurance plans and is unlikely able to create a subsidy for the uninsured, experts said.
Some Medicaid plans for low-income individuals and private insurance plans also cap the monthly cost of insulin at $35.
Monthly out-of-pocket costs for insulin are capped by 20 states and the District of Columbia. In nine of those states and D.C., the cap is $35 or lower, according to the ADA. The White House said Biden would call on Congress to extend the cap to all Americans. It is unclear if his proposal would include those without health insurance, who often have to pay the full price for the life-sustaining drug. Most previous Democratic proposals have not.
Texas sued the administration of U.S. President Joe Biden on Tuesday to prevent it from asking pharmacies to fill reproductive health prescriptions.
The Biden administration said in July 2022 that refusing to fill prescriptions for drugs that could be used to terminate a pregnancy could violate federal law, regardless of various state bans on the procedure.
This guidance from the Biden administration, which involved roughly 60,000 U.S. retail pharmacies, came days after Biden signed an executive order easing access to services to terminate pregnancies after the U.S. Supreme Court overturned the Roe v. Wade ruling that made abortions legal nationwide.
The lawsuit was filed on Tuesday against the U.S. Department of Health and Human Services in the U.S. District Court for the Western District of Texas. The department did not immediately respond to a request for comment late on Tuesday.
"The Biden Administration knows that it has no legal authority to institute this radical abortion agenda, so now it's trying to intimidate every pharmacy in America by threatening to withhold federal funds," Texas Attorney General Ken Paxton said in a statement on Tuesday.
White House officials said in January that 60 anti-abortion bills have been filed in the 2023 legislative session and over 26 million women currently live in U.S. states that have banned abortion.
The Food and Drug Administration said January that abortion pills would become more widely available at pharmacies and through the mail. A legal battle is under way at a federal court in Texas, where abortion opponents have sued to undo the approval of the drugs.
A group of 20 Republican state attorneys general last week told Walgreens Boots Alliance Inc and CVS Health Corp that they risk running afoul of federal and state law if they dispense the abortion drug mifepristone by mail.
Walgreens and CVS have said they intend to become certified and dispense the drug in states where abortion is legal, though neither has yet done so.
https://sports.yahoo.com/texas-sues-biden-administration-asking-010916785.html
Most European countries reporting shortages of antibiotics
*
Low generic drug prices mean razor-thin margins for firms
*
Companies say they cannot boost output enough due to costs
*
Some say making generics in Europe becoming unsustainable
When Ignasi Biosca-Reig heard there were shortages of amoxicillin in Spain, he quickly added shifts at his drug company's factories to boost production of the popular antibiotic. But a few extra shifts was as far as he could go.
Much as he would have liked to significantly increase supplies, Biosca-Reig said he couldn't justify investing millions of euros in new production lines unless he was paid more for the generic drug to cover sharply rising costs.
But, like many European countries, Spain set the price manufacturers are paid for paediatric amoxicillin when the generic version of the drug was first launched in the country two decades ago, and it has barely budged since.
"It's a non-business," said Biosca-Reig, chief executive of Spanish drugmaker Reig Jofre.
"We wanted to react, but we had a problem," he said. "The costs go up, the price remains the same."
While many countries around the world have reported shortages of antibiotics as respiratory infections return with a vengeance after the lifting of pandemic restrictions, the problem in Europe is particularly acute.
With prices for generics regulated, many European drugmakers said they are reluctant to expand capacity at a time when the war in Ukraine has pushed up the cost of everything from energy for factories to cardboard for packaging to aluminium for bottle caps - suggesting more shortages are on the cards.
According to 13 European manufacturers and six generic drug industry associations and trade groups who spoke with Reuters, many firms are struggling to make enough money to justify making antibiotics at all - let alone increase production.
"We cannot keep this capped pricing when all of our production, logistics and regulatory compliance costs are increasing at double digits or more," said Adrian van den Hoven, director general of lobby group Medicines for Europe, which represents makers of generic drugs in the region.
The companies Reuters spoke with declined to disclose margins for specific generics for competitive reasons.
THE COST OF CHEAP GENERICS
Before launching tenders, many European governments compare the price of a generic medicine to other markets in the region, or to similar drugs at home, to set a reference price which then serves as the benchmark in negotiations with suppliers.
They typically award contracts to manufacturers offering the lowest price, which then results in further downward pressure on prices in subsequent tenders, drugmakers say.
Generic medicines now account for about 70% of all dispensed medicines in Europe, but only 29% of the money spent on drugs by national health agencies, according to Medicines for Europe.
European generic drugmakers say the tender system and regulated prices have fuelled a race to the bottom, and European firms are being undercut by suppliers from Asia.
Over the past decade, this has forced some European companies to either cut output or move manufacturing of generics and active pharmaceutical ingredients (APIs) needed to make them to India and China, where costs are much lower.
Industry executives now say an overhaul of pricing schemes is the only way to reinvigorate manufacturing in Europe, both to avoid shortages in the future and to prevent the continent becoming even more dependent on Asia for essential medicines.
"There's a growing awareness that we may have to pay more to ensure our supplies of these medicines is secure and not dependent on other regions, for our own health and national security," said Rena Conti, a drug pricing expert and professor in the department of markets, public policy and law at Boston University's Questrom School of Business.
BRUSSELS, WE HAVE A PROBLEM
The European Medicines Agency (EMA) and European Union lawmakers acknowledge there is a problem.
The EMA and the European Commission have met repeatedly with drugmakers and trade groups since the shortages were first reported in October, but no major action has yet been announced, all the parties involved said.
EMA chief medical officer Steffen Thirstrup told Reuters last month that it was fairly unusual to see so many countries reporting shortages of the same products, but forecast demand would ease as warmer weather approaches.
In the interim, alternative medicines could be used where amoxicillin is unavailable, Thirstrup said.
A number of patient groups warned last month, however, that substitutions were now squeezing supplies of other drugs.
The European Commission is scheduled to table revisions to the bloc's pharmaceuticals law in March.
It is proposing measures including requiring manufacturers to hold larger reserve supplies and to give early warnings about shortages, but executives want Brussels to also back their calls for governments to change tender and pricing systems.
"The key long-term issue is not the production cost, it's the overall European market framework, which doesn't allow us as a producer to adjust prices flexibly to reflect change in input costs, especially on essential medicines," said Giovanni Barbella, global supply chain head at Sandoz, the generic division of Swiss pharmaceutical giant Novartis.
In Spain, the price of paediatric amoxicillin was set at 98 cents ($1.05) for 60 ml in 2003. In 2013, that became the price for 40 ml but it hasn't changed since. Half the generic medicines sold in Spain are priced below 1.60 euros per box or bottle, the country's generics manufacturing association said.
Prices of antibiotic generics in Britain are on a par with Spain, according to drug pricing expert Melissa Barber, while in Germany, the biggest generics market in Europe, the average amount manufacturers receive has fallen 66% over the past decade, Germany's generic drug association Pro Generika said.
Elisabeth Stampa, a member of Spanish pharmaceutical company Medichem's advisory board, said in most European countries there was no mechanism to review prices, link them to inflation, or justify an increase because APIs have become scarce.
"It's extremely difficult to keep the same products you launch competitive after 10 years," said Stampa, who was previously Medichem chief executive.
NO SPARE CAPACITY
Some countries are promising to take action.
Germany's parliament is due this year to consider legal changes to its tender system for generic drugs while Spain's Health Ministry told Reuters last month the government was considering changes to its pricing system that could result in temporarily paying higher prices for drugs such as amoxicillin.
Executives and trade groups also said that they were often unaware when there was a risk of shortages because there was no central EU system that tracks supplies of essential generic drugs in each country, as is the case for patented medicines.
"You get what you pay for. With price being the decisive criterion in tenders, you are sending a message that security of supply, quality and environmental standards are less important," said Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers & Associations.
Years of price pressures on manufacturers has forced many smaller firms to get out of the business and only a few generics makers service much of Europe for drugs such as amoxicillin.
Five companies - Britain's GSK, Sandoz, American drug company Viatris, India's Aurobindo, and France's Servier - have nearly 60% of the amoxicillin market in Europe, according to market researcher IQVIA.
In Germany, for instance, Sandoz has a 70% market share for amoxicillin drugs, says Pro Generika.
When the shortfalls became apparent, some companies ramped up production, but not by enough to meet immediate demand.
"There has been a decline in European capacity and right now in this situation, there is not the spare capacity to really respond to these shortages," said Rex Clements, chief executive of Dutch API maker Centrient Pharmaceuticals.
Sandoz told Reuters that by adding extra shifts at its Austrian factory, it aims to increase production of amoxicillin by a double-digit percentage this year compared with 2022, and an expanded facility will also come on stream in 2024.
GSK also hired new staff and added shifts at its amoxicillin plants in Britain and France, a spokesperson said.
But companies with smaller market shares, such as Israel's Teva, which has 5% of the region's amoxicillin market according to Medicines for Europe, are constrained.
"There is no way we can increase our capacity in order to fill the market gap," said Erick Tyssier, Teva's head of government affairs in Europe. "It's just not possible."
https://sports.yahoo.com/insight-why-europes-drug-shortages-060000103.html
Following are reactions from analysts and investors to U.S. President Joe Biden's State of the Union speech on Tuesday, in which he challenged Republicans to lift the debt ceiling and support tax policies that are friendlier to middle class Americans.
In his first address to a joint session of Congress since Republicans took control of the House of Representatives in January, Biden hammered corporations for profiteering from the pandemic, and ran through a wish list of economic proposals, such as a minimum tax for billionaires, and a quadrupling of the tax on corporate stock buybacks.
TINA TENG, MARKETS ANALYST, CMC MARKETS, AUCKLAND
"President Biden faces multiple well-known issues that the economy is encountering, such as decades-high inflation, rising interest rates, the endless raising debt ceiling, a shortage of oil supply and deteriorated US-China relations.
"Obviously, he will not get Republicans to agree with all the above matters regarding his policy orientation. With a divided government, President Biden will face a big challenge in the election next year.
"Financial markets are usually pro a Republican government rather than a Democratic government regarding economic growth, monetary policy (though this is independent of the Fed), and diplomatic affairs."
DAMIEN BOEY, CHIEF MACRO STRATEGIST, BARRENJOEY, SYDNEY
"The most important caveat is that you gotta pass this gridlock that is at the house and the senate.
"That is particularly topical because you're going to hit the debt ceiling when you get to August. Obviously Biden is clearly pitching to the Republicans is that they wanna work together. Most people anticipate that is not going to be an easy promise as you get there."
"There is also redistribution of things where you get the rich to pay more tax. That's not going to help with consumption a lot.
"So Biden's whole pitch is about inflation coming down, but it is not my problem because it is here before I got here. But the risk is that if you overstimulate, while you have a tight labor market, that is going to be a problem for short-term rates.
"Does this change the investment themes when the yield curve is still inverted? People are still arguing for hard landing risks, portfolio managers are concerned about everything moving up and down together? No it doesn't."
NAKA MATSUZAWA, CHIEF STRATEGIST, NOMURA, TOKYO
"I expected some more hawkish comments on China. Biden should be clearer about how they are going to develop the supply chain away from China. Trade with China is still increasing, rather than decreasing, at this moment. In that sense, he wasn't hawkish enough."
https://www.yahoo.com/entertainment/investors-reactions-bidens-state-union-035528988.html
