Tag Archives: pharmaceutical

Nanobiotix ADRs Jump Over 50% After Agreement With J&J’s Janssen Pharmaceutical – Investopedia

  1. Nanobiotix ADRs Jump Over 50% After Agreement With J&J’s Janssen Pharmaceutical Investopedia
  2. J&J capitalizes on Nanobiotix cash crunch to capture late-phase cancer candidate for $30M upfront FierceBiotech
  3. NANOBIOTIX Announces License Agreement for Worldwide Co-development and Commercialization of Potential First-In-Class Radioenhancer NBTXR3 Yahoo Finance
  4. NBTX Soars On Teaming Up with Janssen for NBTXR3 TipRanks
  5. Nanobiotix’s stock soars after entering licensing, development deal with J&J’s Janssen Pharmaceutica MarketWatch
  6. View Full Coverage on Google News

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Senate Democrats pass Inflation Reduction Act; House to vote next

WASHINGTON D.C. — Democrats pushed their election-year economic package to Senate passage Sunday, a hard-fought compromise less ambitious than President Joe Biden’s original domestic vision but one that still meets deep-rooted party goals of slowing global warming, moderating pharmaceutical costs and taxing immense corporations.

The estimated $740 billion package heads next to the House, where lawmakers are poised to deliver on Biden’s priorities, a stunning turnaround of what had seemed a lost and doomed effort that suddenly roared back to political life. Democrats held united, 51-50, with Vice President Kamala Harris casting the tie-breaking vote.

“It’s been a long, tough and winding road, but at last, at last we have arrived,” said Senate Majority Leader Chuck Schumer, D-N.Y., ahead of final votes.

“The Senate is making history. I am confident the Inflation Reduction Act will endure as one of the defining legislative measures of the 21st century.”

Senators engaged in a round-the-clock marathon of voting that began Saturday and stretched late into Sunday afternoon. Democrats swatted down some three dozen Republican amendments designed to torpedo the legislation. Confronting unanimous GOP opposition, Democratic unity in the 50-50 chamber held, keeping the party on track for a morale-boosting victory three months from elections when congressional control is at stake.

“I think it’s gonna pass,” Biden told reporters as he left the White House early Sunday to go to Rehoboth Beach, Delaware, ending his COVID-19 isolation. The House seemed likely to provide final congressional approval when it returns briefly from summer recess on Friday.

The bill ran into trouble midday over objections to the new 15% corporate minimum tax that private equity firms and other industries disliked, forcing last-minute changes.

Despite the momentary setback, the “Inflation Reduction Act” gives Democrats a c ampaign-season showcase for action on coveted goals. It includes the largest-ever federal effort on climate change – close to $400 billion – caps out-of-pocket drug costs for seniors on Medicare to $2,000 a year and extends expiring subsidies that help 13 million people afford health insurance. By raising corporate taxes, the whole package is paid for, with some $300 billion extra revenue for deficit reduction.

Barely more than one-tenth the size of Biden’s initial 10-year, $3.5 trillion rainbow of progressive aspirations in his Build Back Better initiative, the new package abandons earlier proposals for universal preschool, paid family leave and expanded child care aid. That plan collapsed after conservative Sen. Joe. Manchin, D-W.Va., opposed it, saying it was too costly and would fuel inflation.

Nonpartisan analysts have said the “Inflation Reduction Act” would have a minor effect on surging consumer prices.

Republicans said the measure would undermine an economy that policymakers are struggling to keep from plummeting into recession. They said the bill’s business taxes would hurt job creation and force prices skyward, making it harder for people to cope with the nation’s worst inflation since the 1980s.

“Democrats have already robbed American families once through inflation, and now their solution is to rob American families a second time,” Senate Minority Leader Mitch McConnell, R-Ky., argued. He said spending and tax increases in the legislation would eliminate jobs while having insignificant impact on inflation and climate change.

In an ordeal imposed on all budget bills like this one, the Senate had to endure an overnight “vote-a-rama” of rapid-fire amendments. Each tested Democrats’ ability to hold together a compromise negotiated by Schumer, progressives, Manchin and the inscrutable centrist Sen. Kyrsten Sinema, D-Ariz.

Progressive Sen. Bernie Sanders, I-Vt., offered amendments to further expand the legislation’s health benefits, and those efforts were defeated. Most votes were forced by Republicans and many were designed to make Democrats look soft on U.S.-Mexico border security and gasoline and energy costs, and like bullies for wanting to strengthen IRS tax law enforcement.

Before debate began Saturday, the bill’s prescription drug price curbs were diluted by the Senate’s nonpartisan parliamentarian. Elizabeth MacDonough, who referees questions about the chamber’s procedures, said a provision should fall that would impose costly penalties on drug makers whose price increases for private insurers exceed inflation.

It was the bill’s chief protection for the 180 million people with private health coverage they get through work or purchase themselves. Under special procedures that will let Democrats pass their bill by simple majority without the usual 60-vote margin, its provisions must be focused more on dollar-and-cents budget numbers than policy changes.

But the thrust of their pharmaceutical price language remained. That included letting Medicare negotiate what it pays for drugs for its 64 million elderly recipients, penalizing manufacturers for exceeding inflation for pharmaceuticals sold to Medicare and limiting beneficiaries out-of-pocket drug costs to $2,000 annually.

The bill also caps Medicare patients’ costs for insulin, the expensive diabetes medication, at $35 monthly. Democrats wanted to extend the $35 cap to private insurers but it ran afoul of Senate rules. Most Republicans voted to strip it from the package, though in a sign of the political potency of health costs seven GOP senators joined Democrats trying to preserve it.

The measure’s final costs were being recalculated to reflect late changes, but overall it would raise more than $700 billion over a decade. The money would come from a 15% minimum tax on a handful of corporations with yearly profits above $1 billion, a 1% tax on companies that repurchase their own stock, bolstered IRS tax collections and government savings from lower drug costs.

Sinema forced Democrats to drop a plan to prevent wealthy hedge fund managers from paying less than individual income tax rates for their earnings. She also joined with other Western senators to win $4 billion to combat the region’s drought.

Several Democratic senators joined the GOP-led effort to exclude some firms from the new corporate minimum tax.

The package keeps to Biden’s pledge not to raise taxes on those earning less than $400,000 a year.

It was on the energy and environment side that compromise was most evident between progressives and Manchin, a champion of fossil fuels and his state’s coal industry.

Clean energy would be fostered with tax credits for buying electric vehicles and manufacturing solar panels and wind turbines. There would be home energy rebates, funds for constructing factories building clean energy technology and money to promote climate-friendly farm practices and reduce pollution in minority communities.

Manchin won billions to help power plants lower carbon emissions plus language requiring more government auctions for oil drilling on federal land and waters. Party leaders also promised to push separate legislation this fall to accelerate permits for energy projects, which Manchin wants to include a nearly completed natural gas pipeline in his state.

Copyright © 2022 by The Associated Press. All Rights Reserved.



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A Pharmaceutical Scientist Explains How Drugs Know Where to Go in The Body

When you take aspirin for a headache, how does the aspirin know to travel to your head and alleviate the pain?

The short answer is, it doesn’t: Molecules can’t transport themselves through the body, and they don’t have control over where they eventually end up.

 

But researchers can chemically modify drug molecules to make sure that they bind strongly to the places we want them and weakly to the places we don’t.

Pharmaceutical products contain more than just the active drug that directly affects the body. Medications also include “inactive ingredients,” or molecules that enhance the stability, absorption, flavor and other qualities that are critical to allowing the drug to do its job.

For example, the aspirin you swallow also has ingredients that both prevent the tablet from fracturing during shipping and help it break apart in your body.

As a pharmaceutical scientist, I’ve been studying drug delivery for the past 30 years. That is, developing methods and designing nondrug components that help get a medication where it needs to go in the body.

To better understand the thought process behind how different drugs are designed, let’s follow a drug from when it first enters the body to where it eventually ends up.

How drugs are absorbed in the body

When you swallow a tablet, it will initially dissolve in your stomach and intestines before the drug molecules are absorbed into your bloodstream. Once in the blood, it can circulate throughout the body to access different organs and tissues.

Drug molecules affect the body by binding to different receptors on cells that can trigger a particular response.

 

Even though drugs are designed to target specific receptors to produce a desired effect, it is impossible to keep them from continuing to circulate in the blood and binding to nontarget sites that potentially cause unwanted side effects.

Drug molecules circulating in the blood also degrade over time and eventually leave the body in your urine. A classic example is the strong smell your urine might have after you eat asparagus because of how quickly your kidney clears asparagusic acid. Similarly, multivitamins typically contain riboflavin, or vitamin B2, which causes your urine to turn bright yellow when it is cleared.

Because how efficiently drug molecules can cross the intestinal lining can vary depending on the drug’s chemical properties, some of the drugs you swallow never get absorbed and are removed in your feces.

Because not all of the drug is absorbed, this is why some medications, like those used to treat high blood pressure and allergies, are taken repeatedly to replace eliminated drug molecules and maintain a high enough level of drug in the blood to sustain its effects on the body.

 

Getting drugs to the right place

Compared with pills and tablets, a more efficient way of getting a drug into the blood is to inject it directly into a vein. This way, all the drug gets circulated throughout the body and avoids degradation in the stomach.

Many drugs that are given intravenously are “biologics” or “biotechnology drugs,” which include substances derived from other organisms.

The most common of these are a type of cancer drug called monoclonal antibodies, proteins that bind to and kill tumor cells. These drugs are injected directly into a vein because your stomach can’t tell the difference between digesting a therapeutic protein and digesting the proteins in a cheeseburger.

In other cases, drugs that need very high concentrations to be effective, such as antibiotics for severe infections, can be delivered only through infusion.

While increasing drug concentration can help make sure enough molecules are binding to the correct sites to have a therapeutic effect, it also increases binding to nontarget sites and the risk of side effects.

One way to get a high drug concentration in the right location is to apply the drug right where it’s needed, like rubbing an ointment onto a skin rash or using eyedrops for allergies. While some drug molecules will eventually get absorbed into the bloodstream, they will be diluted enough that the amount of drug that reaches other sites is very low and unlikely to cause side effects.

Similarly, an inhaler delivers the drug directly to the lungs and avoids affecting the rest of the body.

 

Patient compliance

Finally, a key aspect in all drug design is to simply get patients to take medications in the right amounts at the right time.

Because remembering to take a drug several times a day is difficult for many people, researchers try to design drug formulations so they need to be taken only once a day or less.

Similarly, pills, inhalers, or nasal sprays are more convenient than an infusion that requires traveling to a clinic for a trained clinician to inject it into your arm.

The less troublesome and expensive it is to administer a drug, the more likely it is that patients will take their medication when they need it.

However, sometimes infusions or injections are the only effective way that certain drugs can be administered.

Even with all the science that goes into understanding a disease well enough to develop an effective drug, it is often up to the patient to make it all work as designed.

Tom Anchordoquy, Professor of Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

 

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DNA nanotechnology could speed up pharmaceutical development while minimizing costs

A new tool speeds up development of vaccines and other pharmaceutical products by more than one million times while minimizing costs. The method works by using soap-like bubbles as nano-containers. With DNA nanotechnology, multiple ingredients can be mixed within the containers. Credit: Nikos Hatzakis, University of Copenhagen

A new tool speeds up development of vaccines and other pharmaceutical products by more than 1 million times while minimizing costs.

In search of pharmaceutical agents such as new vaccines, industry will routinely scan thousands of related candidate molecules. A novel technique allows this to take place on the nano scale, minimizing use of materials and energy. The work is published in the journal Nature Chemistry.

More than 40,000 molecules can be synthesized and analyzed within an area smaller than a pinhead. The method, developed through a highly interdisciplinary research effort in Denmark, promises to drastically reduce the amounts of material, energy, and economic cost for pharmaceutical companies.

The method works by using soap-like bubbles as nano-containers. With DNA nanotechnology, multiple ingredients can be mixed within the containers.

“The volumes are so small that the use of material can be compared to using one liter of water and one kilogram of material instead of the entire volumes of water in all oceans to test material corresponding to the entire mass of Mount Everest. This is an unprecedented save in effort, material, manpower, and energy,” says head of the team Nikos Hatzakis, Associate Professor at the Department of Chemistry, University of Copenhagen.

“Saving infinitely [on] amounts of time, energy and manpower would be fundamentally important for any synthesis development and evaluation of pharmaceuticals,” says Ph.D. Student Mette G. Malle, lead author of the article, and currently Postdoc researcher at Harvard University, U.S..

Results within just seven minutes

The work has been carried out in collaboration between the Hatzakis Group, University of Copenhagen, and Associate Professor Stefan Vogel, University of Southern Denmark. The project has been supported by a Villum Foundation Center of Excellence grant. The resulting solution is named “single particle combinatorial lipidic nanocontainer fusion based on DNA mediated fusion”—abbreviated SPARCLD.

The breakthrough involves integration of elements from normally quite distant disciplines: synthetic biochemistry, nanotechnology, DNA synthesis, combinational chemistry, and even Machine Learning, which is an AI (artificial intelligence) discipline.

The method works by using soap-like bubbles as nano-containers. With DNA nanotechnology, multiple ingredients can be mixed within the containers. Credit: Nikos Hatzakis, University of Copenhagen

“No single element in our solution is completely new, but they have never been combined so seamlessly,” explains Nikos Hatzakis.

The method provides results within just seven minutes.

“What we have is very close to a live read-out. This means that one can moderate the setup continuously based on the readings adding significant additional value. We expect this to be a key factor for industry wanting to implement the solution,” says Mette G. Malle.

‘Had to keep things hush-hush’

The individual researchers in the project have several industry collaborations, yet they do not know which companies may want to implement the new high-throughput method.

“We had to keep things hush-hush since we didn’t want to risk for others to publish something similar before us. Thus, we could not engage in conversations with industry or with other researchers that may use the method in various applications,” says Nikos Hatzakis.

Still, he can name some possible applications:

“A safe bet would be that both industry and academic groups involved in synthesis of long molecules such as polymers could be among the first to adopt the method. The same goes for ligands of relevance for pharmaceutical development. A particular beauty of the method [is] that it can be integrated further, allowing for direct addition of a relevant application.”

Here, examples could be RNA strings for the important biotech tool CRISPR, or an alternate for screening and detecting and synthesizing RNA for future pandemic vaccines.

“Our setup allows for integrating SPARCLD with post-combinatorial readout for combinations of protein-ligand reactions such as those relevant for use in CRISPR. Only, we have not been able to address this yet, since we wanted to publish our methodology first.”


New method may improve prostate cancer and high cholesterol treatments


More information:
Stefan Vogel, Single-particle combinatorial multiplexed liposome fusion mediated by DNA, Nature Chemistry (2022). DOI: 10.1038/s41557-022-00912-5. www.nature.com/articles/s41557-022-00912-5
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University of Copenhagen

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A million times faster: DNA nanotechnology could speed up pharmaceutical development while minimizing costs (2022, April 4)
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Pfizer to acquire Park City pharmaceutical company for $6.7 billion

Pfizer is spending $6.7 billion to buy a Utah drugmaker with no products on the market and a focus on developing treatments for inflammatory conditions like Crohn’s disease, the pharmaceutical giant said Monday. (Mark Lennihan, Associated Press)

Estimated read time: 1-2 minutes

PARK CITY — Pfizer announced on Monday that it plans to acquire Utah-based Arena Pharmaceuticals for $6.7 billion.

Arena, based in Park City, is a clinical stage company that develops immunotherapies to treat inflammatory diseases.

Mike Gladstone, global president and general manager of Pfizer Inflammation and Immunology, said that the acquisition will complement the capabilities and expertise of both companies.

“Utilizing Pfizer’s leading research and global development capabilities, we plan to accelerate the clinical development of etrasimod for patients with immuno-inflammatory diseases,” he said.

A press release issued by both companies states that the $6.7 billion includes paying $100 for each of Arena’s outstanding shares, as well as plans to pay for the acquisition in cash.

Arena’s share price increased 80% between Friday, when it was $49.94, and Monday morning, when it was over $91. Through Tuesday, the price has remained between $89 and $92.

The Silicon Slopes Newsroom said that there are potentially 3.75 million potential patents for Pfizer/Arena if the potential therapies get clearance from the U.S. Food and Drug Administration, leading to a large financial benefit to Pfizer’s Inflammation and Immunology practice.

The companies’ statement said that Arena has “diverse and promising development-stage therapeutic candidates in gastroenterology, dermatology, and cardiology.”

They have two phase 3 studies for ulcerative colitis, a phase 2 trial of three programs for Crohn’s disease and other things, and three other studies that will take over 10 years, but are over halfway through their development.

“Pfizer’s capabilities will accelerate our mission to deliver our important medicines to patients. We believe this transaction represents the best next step for both patients and shareholders,” Arena President and CEO Amit D. Munshi said.

The acquisition is expected to close during the first half of 2022.

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