PharmaFocus Today – Page 275 – media

Novocure Fails Phase III Ovarian Cancer Trial for Tumor Treating Fields Therapy

By Tristan Manalac Pictured: Magnifying glass focusing on a tumor in an ovary/iStock, Mohammed Haneefa Nizamudeen In the Phase III INNOVATE-3 trial, Novocure’s investigational ovarian cancer therapy Tumor Treating Fields was unable to significantly improve overall survival, the company announced Monday. Patients who received Tumor Treating Fields (TTFields) treatment combined with paclitaxel had a median overall survival (OS) of 12.2 months, which was only marginally higher than the 11.9-month median OS in comparators treated with paclitaxel alone. In terms of safety, TTFields remained well-tolerated and showed no new signals of concerns or systemic toxicities. Its adverse event profile in INNOVATE-3 was consistent with what had previously been reported. TTFields is an investigational oncology therapy that uses electric fields that act via many different mechanisms to kill cancer cells. Because it works via several pathways, the approach can be combined with other treatment modalities—such as PARP inhibitors and immune checkpoint inhibitors—to ...
- Source: drugdu
- 273
- August 31, 2023
US announces first ten drugs up for Medicare price negotiation

Medicare will soon be able to negotiate the prescription drug prices for the first time, under US President Joe Biden’s Inflation Reduction Act (IRA), which was enacted last year. Earlier today, the US Department of Health and Human Services (HHS) released a list of ten drugs that will be up for price negotiations. Aimed at driving down healthcare costs and increasing patient power, the IRA allows the Centers for Medicare and Medicaid Services (CMS), the US Government’s national insurance programme, to provide drugs at reduced prices. The price negotiation process will consider elements like the drug’s clinical benefit, the unmet clinical need, and the costs associated with the drug’s production. The negotiations with manufacturing companies will occur in 2023 and 2024, with any price changes rolling in by 2026. Blockbuster drugs are aplenty on the list. Bristol-Myers Squibb (BMS) and Pfizer’s co-developed drug Eliquis (apixaban) and Amgen’s Enbrel (etanercept) are ...
- Source: drugdu
- 100
- August 31, 2023
CMS

The day drugmakers have been dreading has arrived: Tuesday, the Centers for Medicare & Medicaid Services (CMS) unveiled its list of 10 drugs up for the first price negotiations under the Inflation Reduction Act (IRA). The drugs that made the price negotiation cut are Johnson & Johnson’s Imbruvica, Stelara and Xarelto plus Bristol Myers Squibb’s Eliquis, Merck & Co.’s Januvia, Novartis’ Entresto, Eli Lilly’s Jardiance, AstraZeneca’s Farxiga, Novo Nordisk’s Fiasp and Amgen’s Enbrel. Together, the drugs accounted for more than $45 billion in Medicare Part D spending from June 2022 to May 2023, according to a CMS fact sheet (PDF). Next up, these companies will get a chance to submit data and information on their medications to CMS by Oct. 2. Meanwhile, many of the companies are challenging the legality of the IRA in court. It remains to be seen whether any of those efforts can stop the IRA process ...
- Source: drugdu
- 91
- August 31, 2023
New dementia risk score ‘calculator’ shown to strongly identify disease risk

A new study has revealed that a new dementia risk score ‘calculator’ can strongly predict the chances of people developing dementia within the next 14 years. Based on 11 mostly modifiable risk factors in people in the middle stages of life and onwards, the UK Biobank Dementia Risk Score (UKBDRS) outperformed three additional widely used risk sources, according to the results from the study published in the British Medical Journal. Around 50 million people are thought to be living with dementia worldwide, with numbers expected to triple by 2050. Targeting key risk factors could potentially avert around 40% of dementia cases, and various risk scores have been devised to predict a person’s chances of developing the disease while preventive measures are still possible. However, these scores have been shown to be unreliable across different age groups and geographies, and some are reliant on expensive and invasive tests. After analysing two ...
- Source: drugdu
- 114
- August 31, 2023
Study reveals gut conditions could be early sign of Parkinson’s disease

New research published in the journal Gut suggests that certain gastrointestinal symptoms could be an early warning sign of Parkinson’s disease. Symptoms including constipation, dysphagia (difficulty swallowing) and irritable bowel syndrome (IBS) are suspected to drive the development of Parkinson’s disease, along with cerebrovascular disease (CD), such as a stroke or brain aneurysm, and Alzheimer’s disease (AD). Parkinson’s is one of the fastest-growing neurodegenerative diseases in the world and affects around 145,000 people in the UK. There is currently no cure for the condition. Researchers analysed the US medical records of 24,624 people with Parkinson’s and compared them to 19,046 people with AD, 23,942 with CD, and 24,624 with healthy brains to determine whether patients with Parkinson’s experienced gut issues six years prior to diagnosis and whether they had a higher chance of developing the condition. The gastrointestinal tract possesses millions of nerve cells that communicate with the brain. Researchers ...
- Source: drugdu
- 117
- August 31, 2023
3M reaches $6B settlement to resolve combat earplug lawsuits

Dive Brief 3M has agreed to pay $6 billion to settle more than 250,000 lawsuits brought by U.S. military service members who allegedly suffered hearing loss after using its combat earplugs, the company announced on Tuesday. The settlement could avoid a larger liability related to Dual-Ended Combat Arms earplugs, products that 3M acquired in its 2008 takeover of Aearo Technologies and sold through 2015. Bloomberg and Reuters reported earlier this week that the company was nearing an agreement, based on anonymous sources. Shares in 3M rose in the wake of the reports as investors digested news of a settlement that could see the company pay much less than the $10 billion forecast by analysts. Dive Insight 3M and Aearo have maintained that the earplugs were safe and effective when used properly, but have faced lawsuits from hundreds of thousands of claimants. The company has lost 10 of the16 cases that ...
- Source: drugdu
- 91
- August 31, 2023
ARAMIS trial finds no benefit of anakinra in acute myocarditis

The largest randomized controlled trial of patients with acute myocarditis has found that anakinra is safe but does not reduce complications. The late breaking research presented in a Hot Line session today at ESC Congress 2023. Acute myocarditis is an inflammation of the myocardium that can cause permanent damage to the heart muscle and lead to myocardial infarction, stroke, heart failure, arrhythmias and death. The disease can occur in individuals of all ages, but is most frequent in the young. There are no specific therapies, and patients are generally treated with beta-blockers, ACE inhibitors and sometimes steroids, in accordance with an ESC expert consensus. Anakinra is an interleukin-1 receptor antagonist that works by targeting the interleukin-1β innate immune pathway. While anakinra is effective in pericarditis, there are only case reports of successfully treated acute myocarditis. ARAMIS was the largest randomized controlled trial of acute myocarditis and the first to evaluate ...
- Source: drugdu
- 111
- August 31, 2023
Pfizer telegraphs 4th-quarter production restart at North Carolina plant damaged by tornado

With many medicines from Pfizer’s Rocky Mount, North Carolina, production plant relegated to an emergency ordering list following a devastating tornado last month, hospitals and government health officials are likely eager for the massive injectables facility to restart production. Now, Pfizer has clarified the timeline by which it expects manufacturing to resume. “There are many sequential steps and variables to restart operations and Pfizer is making significant progress,” the company said Monday. The company signaled (PDF) its intention to restart manufacturing at Rocky Mount by the fourth quarter of 2023. After the tornado struck the plant July 19, Pfizer says it reopened parts of the facility Aug. 7. Current efforts to resume production remain “on track,” the company said, with several functions—such as packaging and quality laboratories—now operational. To help with product storage, Pfizer has also locked down a temporary warehouse location and received a certificate of occupancy. The tornado ...
- Source: drugdu
- 118
- August 30, 2023
FTC pulls back on legal challenge to Amgen’s $28B bid for Horizon

By objecting to Amgen’s deal for Horizon, the FTC put to the test new ideas about how drugmaker mergers can harm consumers. Typically, regulators have maintained that overlaps between competing products can give combining companies a more powerful market position, and have sought divestments as a resolution. However, in this case, the FTC argued that Amgen could use rebates and discounts on established drugs like Enbrel to secure favorable insurance coverage for Horizon drugs like Tepezza and Krystexxa. The FTC claimed Amgen has a history of using such “cross-market bundling” practices. The Horizon acquisition was one of the first major opportunities for the FTC to apply the new framework for reviewing pharmaceutical mergers, which agency leadership laid out early in the Biden administration. A pre-trial settlement could reveal the evidence regulators have compiled to support their case, and indicate whether they believe they can prevail in court. In a statement ...
- Source: drugdu
- 113
- August 30, 2023
Pfizer’s RSV vaccine granted EC approval to protect infants and older adults

Pfizer’s respiratory syncytial virus (RSV) vaccine has been approved by the European Commission (EC) to protect both infants and older adults against RSV-caused lower respiratory tract disease (LRTD). The EC’s decision allows Abrysvo to be given as a single dose to adults aged 60 years and older, and those who are 24 to 36 weeks into their pregnancy to protect their babies from birth until they are six months old. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can cause severe illness in young infants and older adults. In the EU, about 245,000 yearly hospital admissions have been associated with RSV in children aged under five years, while the virus is estimated to cause more than 270,000 hospitalisations in older adults each year. The EC’s decision, which follows a recent recommendation from the European Medicines ...
- Source: drugdu
- 122
- August 30, 2023

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