Author: Mokhtar

The Competition and Markets Authority (CMA) today issued a statement clarifying that certain types of agreements between competing pharmaceutical companies working on ‘combination therapies’ will not be prioritized for research – making it easier for pharmaceutical companies to work together to deliver essential to develop treatments for use in NS. The CMA’s statement comes in response to concerns that the CMA could intervene to stop these types of collaborations under competition law.

Combination therapies combine two or more individual drugs into one treatment and have become increasingly important for the treatment of a range of serious conditions, most commonly cancer. They can produce better health outcomes than individual medications because, in combination, these medications can target the disease more effectively.

These combination therapies can only be approved for use on the NHS if they are shown to be ‘cost-effective’. The Association of the British Pharmaceutical Industry (ABPI) told the CMA that since 2017, half of combination therapies for cancer treatments with branded medicines submitted for review to the National Institute for Health and Care Excellence (NICE) have withdrawn from the list . fully processed or were not assessed as cost-effective.

In some cases, a combination will only be ‘cost-effective’ and commercially viable if there is some form of collaboration between pharmaceutical companies, and companies have expressed concerns that such collaboration could be investigated by the CMA. That’s why the CMA is playing its role in clarifying where and how competing drug manufacturers can work together to give them a better chance of meeting the cost-effectiveness threshold and bringing these essential medicines to market.

The CMA has worked closely with the ABPI, NHS England (NHSE) and NICE to make this public statement, and has worked with relevant bodies in all four countries of Great Britain to ensure that patients can benefit where they are also located. By meeting the conditions set out in the CMA’s statement, pharmaceutical companies will be able to enter into a commercial agreement with the comfort that the CMA will not prioritize this conduct in investigations. However, the information exchanged between pharmaceutical companies must be limited to what is strictly necessary to reach a commercial agreement, and pharmaceutical companies cannot share the confidential price of their individual medicines.

Ann Pope, CMA Senior Director of Antitrust, said:

Tens of thousands of NHS patients are missing out on innovative combination therapies. Competing pharmaceutical companies’ concerns that they will fall foul of competition law if they work together are not the only reason why more of these therapies are unavailable to NHS patients, but the CMA is playing its role in explaining how companies can negotiation and avoidance are explored.

Our statement is intended to provide clarity and comfort to businesses following the rules, and ultimately aims to help more people access essential treatments. It is not a ‘free pass’ and any companies engaging in anti-competitive behavior will be thoroughly investigated by the CMA.”

Fiona Bride, Director of Medicines Value & Access at NHS England, said:

NHS patients are already benefiting from access to combination cancer therapies, but it is clear that industry concerns over competition law could act as a barrier to a wider range of combination treatments reaching patients who could benefit.

This crucial step by the CMA now provides a clear position that, in specific circumstances, commercial deals involving multiple medicines approved by different companies can be struck so that NHS patients can benefit from the latest combination therapies for a range of conditions at a fair price . taxpayers.”

Helen Knight, Director of Medicines Evaluation at NICE, said:

NICE is seeing an increasing number of combination therapies coming through its health technology assessment pipeline, so it was important for us to support the CMA in issuing this statement.

We believe that if companies can work together in these very specific circumstances, the opportunity for these therapies to progress through NICE evaluation will increase. This has the potential to get better treatments to patients faster.”

As well as the benefits to patients that come from having more combination therapies available on the NHS, there are also wider benefits for growth and innovation in the pharmaceutical sector. More companies should have the confidence to invest in and bring combination therapies to market, ultimately delivering better value for money to the NHS. These targets align with the CMA’s annual plan for 2023 to 2024, which puts people, businesses and the UK economy at the heart of its work.

A low-fat vegan diet that includes soy promotes changes in the gut microbiome that reduce postmenopausal vasomotor symptoms, or hot flashes, by 95% overall, according to a new study from the Physicians Committee for Responsible Medicine. A vegan diet also eliminated severe hot flashes, led to a 96% reduction in moderate to severe hot flashes and reduced daytime and nighttime hot flashes by 96% and 94%, respectively. Participants also lost an average of 6.4 pounds.

Women who want to combat hot flashes should nourish the bacteria in their gut with a vegan diet rich in fruits, vegetables, grains and beans, which also leads to weight loss and protects against heart disease and type 2 diabetes.”

Hana Kahleova, MD, PhD, study co-author, director of clinical research at the Physicians Committee for Responsible Medicine

The new research is a secondary analysis of the WAVS study – the Women’s Study for the Alleviation of Vasomotor Symptoms – which the Physicians Committee previously published in the journal Menopause. In the study, 84 postmenopausal women who reported two or more moderate to severe hot flashes daily were randomly assigned to the intervention group that was asked to follow a low-fat vegan diet, including half a cup of cooked soybeans per day, or to the intervention group that was asked to eat a follow a low-fat vegan diet, including half a cup of cooked soybeans per day. the control group who continued their usual diet for twelve weeks.

For the secondary analysis, stool samples from a subgroup of 11 participants were used to perform a gut microbiome analysis at baseline and after 12 weeks on a vegan diet. Changes in the abundance of different families, genera and species of bacteria were found.

The study is the first to show that a reduction in the abundance of Porphyromonas and Prevotella corporis is associated with the reduction of severe daytime hot flashes. Prevotella corporis has also been found in the intestines of people with rheumatoid arthritis and appears to have pro-inflammatory properties.

The decrease in the abundance of Clostridium asparagiforme was accompanied by a decrease in the total number of severe and intense nocturnal hot flashes. Clostridium asparagiforme also appears to produce trimethylamine N-oxide, a compound associated with an increased risk of cardiovascular disease and type 2 diabetes. Reduced abundance of Clostridium asparagiforme may partially offset the beneficial effects of a plant-based diet on cardiovascular health explain and establish a possible link between hot flashes and incident cardiovascular disease.

Changes in the abundance of other bacteria looked at in the study may play a role in relieving hot flashes by stabilizing estrogen levels, reducing inflammation and increasing satiety, among other things.

The authors say larger randomized clinical trials are needed to further investigate these findings.

The Department of Biomedicine at the University of Basel and the University Hospital Basel announced today that they have delivered the first surgical procedure for the treatment of osteoarthritis in humans. The procedure called Nasal Chondrocyte Tissue-Engineered Cartilage, or N-TEC, offers an innovative alternative for healing limited knee cartilage lesions and addressing degenerative OA cases that have previously required knee joint replacements – prostheses that must be routinely performed. replaced after 15 years. 20 years.

The team in Basel is leading the next generation of human clinical trials that will take place in multiple locations across Europe, including Switzerland, Germany, Italy, Croatia, Sweden, Austria and Poland. The Swiss government and the EU have awarded the N-TEC program $13.1 million in funding for these osteoarthritis clinical trials – and the team continues to seek additional funding to expand these trials and bring this promising regenerative osteoarthritis treatment to other joints then deliver the knees. These clinical trials are open to qualified patients from around the world, including the United States.

According to the U.S. government, 2.5 million joint replacement surgeries take place in the United States each year, and even more patients are looking for alternatives to delay or avoid a prosthesis. Chondrocytes are the cell building blocks for cartilage and the team at the University of Basel uses them to grow new cartilage. Implantation of this tissue-engineered cartilage graft in cartilage defects of the knee could be an alternative for all patients who need more than simple pain relief, but do not want a prosthesis. N-TEC is not suitable for the treatment of rheumatoid arthritis. N-TEC’s current studies will focus exclusively on patellafemeral osteoarthritis, rather than complete knee osteoarthritis.

The N-TEC procedure was developed by an interdisciplinary research team led by biomedical engineer Professor Ivan Martin, PhD, director of the Department of Biomedicine, and Dr. Marcus Mumme, MD, senior orthopedic physician at the University Children’s Hospital Basel.

Regenerative medicine is really in the clinic today

N-TEC goes beyond laboratory and animal testing and has already taken regenerative medicine in the treatment of cartilage damage from a laboratory concept to real clinical success in humans. The University of Basel team is leading an international clinical trial with five centers in Europe and has successfully treated more than 100 patients for focal lesions – 2 to 8 cm² dimensions – in the knee since 2012, and these patients have already returned to robust sporting activities, including skiing and running half marathons. Six years ago, the University of Basel team reached beyond focal lesions and treated two patients with advanced knee osteoarthritis – patients who had planned knee joint replacement. These patients, treated with N-TEC and correction of the leg axis, have reported favorable results (standardized, self-assessed questionnaires) and are still able to perform daily activities six years after surgery, without the need to resort to artificial joint replacement.

To tackle osteoarthritis and cartilage defects in other joints, the University of Basel team is conducting human clinical trials targeting patella-femoral osteoarthritis (PFOA) in the knee and cartilage lesions in the ankle and shoulder joints. They will start trials in the elbow joint in 2024.

“I have always been a very active and sporty person,” says 56-year-old Marlies Ruckstuhl from Basel, Switzerland. “A fall on ice damaged the cartilage in my left knee and left me with significant knee pain – and a reduced quality of life. Exercise was out of the question – and even sitting in my office chair was torture. I was told I needed a knee replacement In May 2017 I underwent the N-TEC procedure, after a year of structured physiotherapy I was able to run again and in the winter of 2018 I started skiing. Today I am back to my old self, pain free and unlimited – enjoying half marathons and trail running. Life is pure enjoyment again. Many thanks to the Basel – Bravo team!”

Nasal cartilage – extracting, growing and attributes

N-TEC is an autologous procedure that uses cartilage cells from each patient’s own body to grow new cartilage grafts that are surgically implanted to repair damaged cartilage in the patient’s joints. The team extracts a 7×7 mm segment of cartilage from the patient’s nasal septum, isolates and expands the cells, and then grows the cells on a collagen membrane in the laboratory to create a newly developed nasal cartilage graft of up to 40 cm.². It takes four weeks to grow the cartilage grafts in the laboratory. The cartilage harvested from the nasal septum does not damage the patient’s nose.

Importantly, the nasal cartilage is made up of cells derived from the neural crest – the type of cells that create better functioning organs, such as the brain and eyes. These cells are superior to cells from other parts of the body in terms of regenerative capacity and so-called environmental plasticity – namely the ability to adapt to different environments and conditions. In particular, nasal chondrocytes, even from older donors, can be reproducibly used to develop N-TEC cartilage patches that possess structural and mechanical properties typical of articular cartilage tissue.

Although replacing damaged cartilage in a joint is remarkable, it is not sufficient to repair degenerative joint conditions such as osteoarthritis. Osteoarthritis is associated with wear and tear on the joint, as well as a significant amount of inflammation in damaged joints. This inflammation is a risk factor for the breakdown of new cartilage, just like with the original cartilage. Laboratory and animal experiments have shown that N-TEC nasal cartilage possesses anti-inflammatory properties that resist harmful inflammation in repaired joints. N-TEC has also proven its durability in the treatment of osteoarthritis knee cartilage, which was performed six years ago.

Surgical procedure

The N-TEC graft is placed in the joint during open surgery – and the team tailors the new cartilage graft in the operating room to the shape and size of the cartilage defect. The surgeons attach the graft to the surrounding cartilage tissue. The cartilage then integrates with the surrounding cartilage and subchondral bone. Patients are hospitalized for three to five days and the leg is immobilized for the first week after surgery. The patients then walk with crutches for another six weeks, during which the leg is mobilized and freedom of movement is increased. After another week, patients put their full weight on the leg and continue physical therapy to strengthen the leg. The patient can return to light sports (non-impact sports), such as swimming and cycling, after three months, and return to full robust exercise, including sports, after a year.

N-TEC has shown overwhelming success in human clinical trials to date. Thanks to generous government funding and collaboration with other excellent teams, we will now expand clinical trials to investigate N-TEC under more challenging conditions so that it may one day become a regular bedside procedure for many patients suffering from joint pain caused by cartilage loss. .”

Ivan Martin, PhD, professor of tissue engineering at the Department of Biomedicine, University of Basel and University Hospital Basel

“The amazing N-TEC procedure is funded by grants from the Swiss National Science Foundation and the European Union – and private donors can step up to donate and accelerate N-TEC’s path to the bedside,” said Steve O Keeffe, founder of Angry @Arthritis, a nonprofit organization focused on attacking and eliminating osteoarthritis, headquartered in Alexandria, Virginia, in the United States. “When the doctor told me I had arthritis, it felt like my life, as I knew it, was over. The team at the University of Basel is giving new hope to people like us. They actually inspired me to start Angry@Arthritis – and begin my journey to finding and financing treatments for osteoarthritis.”

Listen to Professor Ivan Martin’s story about N-TEC on the Angry@Arthritis podcast – https://www.angryarthritis.org/podcasts/. Also available on the major streaming platforms – Spotify, Apple, etc. You can donate to expand N-TEC’s clinical trials at https://www.angryatarthritis.org/.

Patients with autoimmune rheumatic diseases, including rheumatoid arthritis and other chronic conditions that cause inflammation, are at increased risk for SARS-CoV-2 infection and death from severe COVID-19. Many patients receive disease-modifying antirheumatic drugs (DMARDs) to treat these conditions, but this treatment has been associated with a blunted response to COVID-19 vaccines. The U.S. Centers for Disease Control and Prevention recommends that patients receiving DMARDs receive a fourth dose of the mRNA vaccine in addition to the primary three-dose series to protect against COVID-19. A new study led by researchers at Mass General Brigham suggests that this recommendation saved lives and reduced hospitalizations among patients in this risk group. Results are published in The Lancet Rheumatology.

To conduct their study, the researchers used observational data from Mass General Brigham’s health care system to compare rheumatic patients who took DMARDs and received a fourth dose of the mRNA vaccine with those who did not. The study included data from 4,305 patients. They found that patients who received the fourth dose had a 41 percent reduction in risk of infection and a 65 percent reduction in admission/death compared to those who did not.

A fourth dose of COVID-19 mRNA vaccine provides significant protection against any SARS-CoV-2 infection and severe COVID-19 in patients with systemic autoimmune rheumatic diseases taking DMARDs. These patients should be encouraged to remain current on COVID-19 mRNA vaccines, including boosters after the primary vaccination series.”

Zachary Wallace, MD, MSc, co-corresponding author of the Division of Rheumatology, Immunology and Allergy at Massachusetts General Hospital (MGH), a founding member of the Mass General Brigham health care system

Since the start of the pandemic, researchers from across Brigham and Women’s Hospital (BWH) and MGH have been working together to pay special attention to this group of patients to uncover insights that can help inform their treatment and the care of broader patient populations. .

“At the very beginning of the pandemic, we joined forces to identify every rheumatic patient with COVID we see in our institutions so we could monitor their clinical course and collect examination and blood data,” said co-corresponding author Jeffrey Sparks, MD, MMSc, ​​of the Division of Rheumatology, Inflammation and Immunity at BWH. “Working together, we will find important clues that can help better protect patients against infections and serious diseases.”