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Wegovy maker Novo Nordisk said on Tuesday (Aug 8) a large study had shown the highly effective obesity treatment also had a clear cardiovascular benefit, boosting the Danish company's hopes of moving beyond its image as a lifestyle drug. The increasingly popular Wegovy has transformed the weight-loss market since its U.S. launch in June 2021, capturing the attention of patients, investors and celebrities worldwide. Novo's news lifted shares in Europe's second-most valuable listed company after LVMH by more than 17 per cent to record highs. They have now surged almost 165 per cent over the past two years. The results of the late-stage trial may help persuade insurers in the U.S. and cost-conscious health authorities in Europe to cover the cost of Wegovy, which is $1,300 a month in the United States, for a wider range of patients. U.S. law classifies weight-loss treatments as lifestyle drugs and bars the Medicare health plan for older Americans from covering them and experts said the new data could lead the U.S. government to reassess that.

Weight loss drug Wegovy has transformed the obesity market and pharmaceutical companies with existing treatments are hoping the resulting demand will boost demand for their older, less effective but cheaper, drugs. A weekly injection of Wegovy, which was launched in the U.S. in June 2021, leads to an average weight loss of around 15%, alongside changes to diet and exercise. Its impact has captured the attention of patients, investors and even celebrities. But supply issues for Wegovy manufacturer Novo Nordisk means the Danish drugmaker has struggled to meet surging U.S. demand, delaying a launch in most of Europe. Insurers and some national governments have also baulked at its cost, while a minority of patients do not respond to it. Vivus and Currax Pharmaceuticals, U.S.-based developers whose treatments have been on the U.S. market for around a decade, hope to benefit from the attention and supply shortage. But scientists and investors say that lower efficacy plus side effects could continue to hold the treatments back.

The first big breakthrough in 30 years of Alzheimer's research is providing momentum for clinical trials of "cocktail" treatments targeting the two hallmark proteins associated with the mind-robbing disease, according to interviews with researchers and pharmaceutical executives. Drugmakers Eisai and Biogen reported in September that their therapy lecanemab could slow progress of the disease by 27% over 18 months compared with a placebo. The finding validates the theory that clearing the amyloid protein that forms clumps in the brains of Alzheimer's patients could slow or halt the disease and has strengthened the support from some scientists for simultaneously targeting another notorious protein linked to Alzheimer's: tau. Eisai and Biogen are scheduled to present full data from their lecanemab study on Tuesday at the Clinical Trials on Alzheimer's Disease conference in San Francisco. The U.S. Food and Drug Administration is expected to make a decision by early January on the companies' application for accelerated approval. If approved on an accelerated basis, the companies said they would immediately apply for full U.S. regulatory approval which could help secure Medicare coverage.

Japanese pharmaceutical firm Eisai Co plans to seek full approval of its experimental Alzheimer's drug lecanemab in the United States, Europe and Japan armed with data showing it can slow the brain-wasting disease for people with early symptoms, potentially getting the treatment to patients next year. It remains unclear how widely the drug developed with U.S. biotech Biogen Inc will be used due to uncertainty over insurance coverage, including the U.S. government's Medicare plan for people age 65 and over, potential side effects and cost. One Wall Street analyst told Reuters news agency that he is not counting on measurable sales until 2024. Several estimated lecanemab may be priced at around $20,000 per year. "Most people who this (drug) would apply to are on Medicare, and most private payers look to Medicare as they make their own (coverage) decisions. So there's a massive roadblock in the way of all who could benefit from this treatment," said Robert Egge, Alzheimer's Association chief public policy officer. Eisai confirmed on Tuesday (November 30) that lecanemab - an antibody designed to remove sticky deposits of a protein called amyloid beta from the brain - reduced the rate of cognitive decline on a clinical dementia scale by 27% compared to a placebo. It also gave new details on side effects including a dangerous type of brain swelling and brain bleeding.

Online retail giant Amazon said on Tuesday (January 24) it is offering a $5 monthly subscription plan for U.S. Prime members that will cover a range of generic drugs and their doorstep delivery, furthering the ecommerce giant's push into healthcare. The program, named RxPass, includes more than 50 medications addressing over 80 chronic conditions such as high blood pressure, anxiety, diabetes and male pattern baldness, Vin Gupta, Amazon Pharmacy's chief medical officer, has said. However, customers enrolled in Medicare, Medicaid or any other government healthcare program will not be able to enrol in Amazon Pharmacy's RxPass service. The average Prime member would save about $100 per year with RxPass, John Love, vice president of Amazon Pharmacy, said. Amazon Prime members in most U.S. states can sign up for the program from January 24. The flat $5 charge would be without insurance and on top of the Prime membership fee, which costs $139 per year in the United States.

A recent study suggests that U.S. clinicians spend more time on EHRs than physicians in other countries. This research is also a reflection of administration inconsistencies in the U.S. healthcare system.

The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services has announced relaxation in HIPAA rules for covered entities and business associates who participate in good faith in the COVID-19 testing site operation. It doesn't stop there, but HIPAA penalties won't apply to covered healthcare providers for practicing telehealth medicine using third-party applications such as Skype or Facebook Messenger

The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services has announced relaxation in HIPAA rules for covered entities and business associates who participate in good faith in the COVID-19 testing site operation.

Researchers from the University of Oxford today (December 8) started recruiting for a clinical trial to test novel antiviral Covid-19 treatments for early use in the illness by people in the community and those who are at higher risk of complications. Partnering with the National Institute for Health Research (NIHR), colleagues in several UK universities, and the NHS UK-wide, the Platform Adaptive trial of NOvel antiviRals for eArly treatMent of Covid-19 In the Community (PANORAMIC), is a national priority trial, and will be open to participants from across the UK. The first treatment to be tested by the UK Antiviral Taskforce will be molnupiravir, a Covid antiviral pill already licensed by the MHRA. Britain became the first country in the world to approve molnupiravir, which was jointly developed by U.S.-based Merck & Co Inc and Ridgeback Biotherapeutics, in November.

Despite significant sales growth in the quarterly results, high street chemist Boots is moving forward with its plan to close 300 stores in the UK. The move, aimed at improving profit margins amid rising costs and competition, will reduce the chain's portfolio from around 2,200 to just 1,900. Last month, the U.S.-based Walgreens Boots Alliance, the parent company of Boots, announced upcoming store closures within the next year. However, the company assured that there will be no job losses as all employees will be given the opportunity to be redeployed to nearby shops. The following sites are confirmed for closure on the specified dates: Heathside Rd, Woking (end of July) UEA campus (end of July) Hamlet Ct Rd, Westcliff-on-Sea (August 1) Windhill Road, Wakefield (October 6) Upper Warrengate, Wakefield (October 7) Glastonbury (October 13) Guildford Road, Woking (end of October) Boots stores at Salford Shopping Centre in Greater Manchester, Church Street in Malvern, The Port Arcades Shopping Centre in Ellesmere, and King William Street in London have already closed since spring.

Capitalising on strong demand for its obesity therapies, Novo Nordisk's growing appetite for deals has fuelled a bet on a U.S. gene-editing company called Life Edit Therapeutics. The Danish drugmaker's collaboration with Durham, North Carolina-based Life Edit Therapeutics - owned by ElevateBio, a cell and gene therapy company in Waltham - is focused on up to seven programs for rare genetic disorders as well as cardiometabolic diseases. At the heart of the tie-up is Life Edit's technology, called base editing, which is designed to make precise changes to the human genome by tweaking one base - or letter - into a different one without affecting other letters. Single-letter mistakes, called point mutations, can give rise to genetic diseases.

Britain plans to launch a pilot programme exploring how new weekly weight-loss shots such as Novo Nordisk's Wegovy can be given to obese patients by general practitioners even as the drug's market launch remains unclear. The government's announcement on the £40 million pilot programme comes after drug cost-effectiveness watchdog NICE in March recommended the use of Wegovy in adults with at least one weight-related condition and a body mass index of 35, but only within the NHS specialist weight management scheme. The timing of Wegovy's launch in Britain - which would be only the fourth country to use it - is uncertain, however, after Novo last month rationed starter doses to secure supply to U.S. patients already on the regimen, after it was overwhelmed by demand there. British Prime Minister Rishi Sunak said on Wednesday (May 7) the pilot and fighting obesity-related diseases could reduce pressure on hospitals. It would also support "people to live healthier and longer lives, and helping to deliver on my priority to cut NHS waiting lists". The NHS endured a tough winter in England in particular, with waiting lists hitting record highs and staff striking for higher pay amid double-digit inflation.

The widely-held concept that levels of "good" cholesterol in the blood can indicate heart disease risk is not equally true for Blacks and whites, and the measure itself may be of less value than previously thought, according to a U.S. study published on Monday (November 21). Various types of cholesterol are thought to have either healthy or unhealthy effects. Low levels of so-called "good" high-density lipoprotein (HDL) cholesterol were linked with higher odds for developing cardiac problems in the long-term study - but only in white participants, the study published in the Journal of the American College of Cardiology found. In contradiction to what has generally been assumed, low HDL levels did not confer any higher risk of heart disease in Black people, researchers said. Among white people, however, those with HDL levels below 40 milligrams per deciliter had a 22% higher risk for coronary heart disease compared with those whose HDL levels were higher. High HDL levels (above 60 mg/dL), which are thought to be protective, were not linked with lower coronary heart disease risks in either race, researchers found.

Sun Pharma has announced that it will acquire all outstanding shares of Concert Pharmaceuticals through a tender offer for an upfront payment of $8.00 per share of common stock in cash, or $576 million in equity value. The upfront payment of $8.00 per share of common stock in cash represents a premium of approximately 33% to Concert's 30-day volume weighted average price as of January 18, 2023, the last trading day prior to today's announcement. Concert is a late-stage biotechnology company pioneering the use of deuterium in medicinal chemistry. Concert has an extensive patent portfolio, including its lead product candidate deuruxolitinib - an oral inhibitor of Janus kinases JAK1 and JAK2 for the treatment of Alopecia Areata, an autoimmune dermatological disease - which is in late-stage development. It has completed the evaluation of the efficacy and safety of deuruxolitinib in adult patients with moderate to severe Alopecia Areata in its THRIVE-AA Phase 3 clinical program and two open label, long-term extension studies are ongoing in North America and Europe. Sun Pharma's immediate focus would be to follow Concert's plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the first half of 2023.

New GSK raised its 2022 forecast for the second time this year, after third-quarter earnings and sales topped estimates, continuing its strong start as a standalone prescription medicine and vaccine business since carving out its consumer health division Haleon. After years of underperformance relative to its peers and missing out on the lucrative market for the first set of COVID-19 vaccines, GSK has delivered a string of strong results. The latest is led by a record quarter for its blockbuster shingles vaccine Shingrix and higher-than-expected revenue from its COVID therapy, Xevudy. Having survived a revolt by activist investors Elliott and Bluebell last year, GSK's prospects have been boosted by clinical trial success, though concerns remain around U.S. litigation over heartburn drug Zantac. Thousands of lawsuits have been filed in the United States against a raft of drugmakers over allegations the heartburn drug contains a probable carcinogen.

British drugmaker AstraZeneca said on Thursday (June 1) it would stop developing its drug brazikumab to treat inflammatory bowel diseases, including Crohn's disease and ulcerative colitis. The company said the discontinuation was due to a delay in the drug's development timeline, affected by global events and "the context of a competitive landscape". AstraZeneca regained the rights to brazikumab from Allergan in 2020 following U.S. drugmaker AbbVie's $63 billion tie-up with Allergan. AbbVie will stop funding the drug's development, AstraZeneca said. AbbVie's Skyrizi also treats Crohn's disease.

AstraZeneca said on Monday (June 27) two of its existing therapies were recommended for treating patients with some forms of high-risk breast cancers in the European Union, in a boost to the company's oncology portfolio. Lynparza, a cancer drug developed jointly with U.S.-based Merck, was backed for standalone use or in combination with endocrine therapy in adults with a form of genetically mutated early-stage breast cancer. The drug, which has received a similar recommendation in the United States in March, is a key asset for AstraZeneca. It was recommended in patients with low-to-normal levels of a protein known as HER2 that is the target of several new therapies. Enhertu - developed jointly with Japan's Daiichi Sankyo (4568.T) - was the other drug that was endorsed by the European Medicines Agency for treating an aggressive form of breast cancer characterised by a high rate of HER2.

American biotechnology company Novavax said on Monday (February 28) it would pursue full approval of its Covid-19 vaccine in the second half of this year and forecast total revenue of between $4 billion and $5 billion for 2022. "We expect to gain additional authorizations where we have already filed, including in the US. We will pursue full approval of our vaccine including filing our BLA (biologics license application), in the second half of 2022," CEO Stanley Erck said during a post-earnings call. Novavax late last month filed for emergency use authorization of the shot in U.S. adults, a much-awaited step following months of struggles with development and manufacturing problems. Novavax said it has completed delivery of around nine million vaccine doses to Indonesia, 6 million to Australia and two million to South Korea and expects to supply 69 million doses to Europe in the first half of this year.

Pfizer said on Tuesday it will pay $11.6 billion to buy Biohaven Pharmaceuticals, making a big bet on its ability to boost sales of the top-selling pill in a new class of migraine drugs. The boards of both companies have approved the deal, they said. Biohaven shares jumped 70 per cent to $141.31, while Pfizer was up slightly at $48.83. Pfizer is flush with cash from a once-in-a-lifetime surge in revenue from Covid-19 vaccines and therapeutics and has said it is looking to buy companies or drugs that could add at least $25 billion in annual sales by the end of the decade. "The CGRP oral medications, though still somewhat newer entrants in a deeply entrenched space, continue to make steady inroads in disrupting the broader migraine market in the U.S.," said BioHaven chief executive Vlad Coric. Biohaven forecast Nurtec sales of $825 million to $900 million in 2022. Pfizer said it expects the pills to eventually overtake the shots.

Clinical trials for BioNTech's cancer vaccines should start this year in Britain, marking an important step towards their possible sale on the open market, the German company's top executive Ugur Sahin told magazine Der Spiegel. BioNTech, known for its COVID vaccine with U.S. partner Pfizer, is currently deciding which types of cancer it wants to test its personalized cancer immunotherapies on and the locations where it will conduct the trials, Sahin said. The company wants these therapies, which are based on messenger RNA (mRNA) technology similar to the one that underpins its COVID-19 vaccine, to soon become a regular treatment for cancer patients. "We believe that this should be possible for large amounts of patients before 2030," Sahin said.

AstraZeneca on Wednesday (April 5) said a combination of its cancer drugs Imfinzi and Lynparza met the main goal in a late-stage trial in patients with advanced ovarian cancer. The drugmaker said treatment with a combination of those drugs, along with chemotherapy and bevacizumab - the existing standard of care - improved progression-free survival in newly diagnosed patients with advanced ovarian cancer without certain mutations. Lynparza is jointly developed with U.S.-based Merck & Co as a treatment for breast cancer in early stage with certain mutations. Imfinzi alone, along with chemotherapy and bevacizumab, did not reach statistical significance in its interim analysis, the drugmaker added. Philipp Harter, director, Department of Gynaecology and Gynaecologic Oncology, Evangelische Kliniken Essen-Mitte, Germany and principal investigator for the trial, said: "DUO-O showcases the power of academia and industry collaboration in advancing new treatment combinations for patients with ovarian cancer. I'm grateful for the academic cooperative study groups and patients around the world that made this trial possible and look forward to sharing the results with the clinical community." Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, said: "While there has been significant progress for patients with advanced ovarian cancer, an unmet need still remains. These data from the DUO-O trial provide encouraging evidence for this this Lynparza and Imfinzi combination in patients without tumour BRCA mutations and reinforce our continued commitment to finding new treatment approaches for these patients. It will be important to understand the key secondary endpoints as well as data for relevant subgroups."