By Tristan Manalac www.biospace.com Pictured: FDA Building/courtesy of Grandbrothers/Adobe Stock The FDA has placed Mersana Therapeutics’ UP-NEXT and UPGRADE-A trials on partial clinical hold, the company announced Thursday. Both studies evaluate Mersana’s investigational antibody-drug conjugate upifitamab rilsodotin in platinum-sensitive ovarian cancer. The regulatory pause was triggered by an aggregate safety report containing information from around 560 patients who had received upifitamab rilsodotin (UpRi). Mersana’s data showed a higher rate of serious bleeding events, though most of these episodes were low-grade. Still, five cases of serious bleeding were fatal. The exact causes of bleeding are still unknown and are currently being investigated. Mersana’s stocks fell 60% in pre-market trading Thursday in response to the news. The FDA has yet to provide Mersana with a formal written communication regarding the partial clinical hold. However, the company expects the regulator to request a more comprehensive evaluation of UpRi’s safety data. Mersana is working ...
A statistics manager at specialist biometrics contract research organization (CRO) Phastar, has been chosen to receive the DIA 2023 Global Inspire Award for Community Engagement. Stephen Corson said it was a ‘fantastic bonus’ to be recognized by the DIA community and says it is already privilege enough to share his knowledge. The award recognizes outstanding contribution of DIA Community Chairs who ‘consistently drive engagement and promote knowledge sharing, while advancing thought leadership within the membership community’. He said: “The DIA Community is such a constructive, collaborative space with everyone inspired by their work which can really benefit people. It already feels a privilege to be able to share what knowledge I can bring to the table, so it is a fantastic bonus to be recognized by the DIA community. “Education around data science is crucial to making clinical trial processes more efficient and I get such a buzz from working ...
House Democrats on Thursday called on Walmart, Costco, Kroger, Safeway and Health Mart to publicly commit to sell the prescription abortion pill mifepristone at their retail pharmacies. Pending lawsuits have jeopardized mifepristone’s approval in the U.S. For now, it is the most common method to terminate a pregnancy in the country. The five companies have been silent for months on whether they will get certified to sell mifepristone under a Food and Drug Administration program that monitors how the medication is distributed and used by patients. “It is unconscionable that five of the largest retail pharmacies in the country are refusing to declare whether they will receive certification to provide basic, legal, FDA-approved medication abortion health care for Americans,” Rep. Dan Goldman, D-NY, said in a statement Thursday. Goldman and Rep. Judy Chu, D-Calif., sent a letter asking the companies’ CEOs to confirm by June 23 whether their pharmacies will ...
Health insurer stocks dropped Wednesday after UnitedHealth Group warned of higher medical costs as older Americans start to catch up on surgeries they delayed during the Covid-19 pandemic. Shares of UnitedHealth, the largest U.S. health-care provider by market value, closed around 6% lower. Medicare-focused insurer Humana declined 11%. Elevance Health closed roughly 7% lower, and CVS Health, which owns insurer Aetna, slid nearly 8%. Insurance companies have benefited in recent years from a delay in nonurgent procedures due to hospital staffing shortages and the pandemic, which saw hospitals inundated with Covid patients. Hospitals at that time were widely seen as too risky to enter for elective procedures. But on Tuesday, UnitedHealth executives indicated that trend may be reversing. The company has recorded “strong outpatient care activity” throughout April, May and the early part of June, Chief Financial Officer John Rex said at a Goldman Sachs health-care conference. Most of the ...
Merck & Co – known as MSD outside the US and Canada – has said its investigational GLP-1/glucagon receptor co-agonist, efinopegdutide (MK-6024), has demonstrated promising results in nonalcoholic fatty liver disease (NAFLD). NAFLD is a chronic and progressive condition in which fat builds up in the liver. It is known as a silent disease with few or no symptoms, however, certain health conditions such as obesity, metabolic syndrome and type 2 diabetes, increase the likelihood of developing NAFLD. There is not currently any approved medicine that can treat NAFLD, with treatment options focused on managing the problems associated with the condition. The findings, which will be presented at the European Association for the Study of the Liver (EASL) annual congress, include new data from a phase 2a randomised, open-label study evaluating the compound’s efficacy in liver fat reduction and safety against Novo Nordisk’s semaglutide in NAFLD patients. The candidate was ...
Digital health startup STAT Health has designed a device to help people better understand why they’re experiencing symptoms like dizziness, fainting and brain fog. STAT Health on Tuesday announced its new in-ear wearable, the STAT, which measures blood flow to the head. When users stand up, the earpiece automatically tracks changes in their heart rate, blood pressure trend and blood flow, which are useful insights for patients who commonly experience dizziness and fainting spells as a result of illnesses like long Covid and postural orthostatic tachycardia syndrome (POTS), among others. Users can track their metrics in an app on their cellphone and glean insights into how their lifestyle choices affect their symptoms. The STAT earpiece has also proven to predict fainting minutes before it happens, according to peer-reviewed findings published in Journal of the American College of Cardiology this year. STAT Health CEO Daniel Lee said the wearable is not ...
Republican lawmakers, state attorneys general and several advocacy groups have voiced their support for Illumina’s acquisition of cancer-test developer Grail while the Federal Trade Commission fights to unwind the deal. The groups filed 14 amicus briefs Monday urging the U.S. 5th Circuit Court of Appeals to reverse an FTC order that would have Illumina undo the $7.1 billion Grail deal over concerns that it stifles competition. Last week, the San Diego-based DNA-sequencing company appealed the agency’s ruling. Proponents of the deal argued in the court filings that the FTC overstepped its authority in trying to unwind the tie-up that closed nearly two years ago. They added that blocking the companies from merging could harm the development of life-saving technology. “Unaccountable federal agency power undermines liberty, and overzealous, unfair agency enforcement impedes technological advancements benefitting citizens’ wellbeing,” attorneys general from 12 states said in one of the briefs. Those states are ...
By Connor Lynch Pictured: Person holding a cell phone in front of computer with stock data/iStock Just two days after releasing late-breaking Phase I/II data for one of its flagship drugs, biopharma Kura Oncology on Tuesday announced plans for a $100 million underwritten public offering. The company intends to use the public offering to fund the development of its three candidate drugs, in invest pipeline research and development, and provide a source of general working capital. According to first-quarter 2023 financial results, Kura has roughly $406 million in cash, cash equivalents and investments, which the company expects will fund current operations until the fourth quarter of 2025. The pre-market share value slipped by 8.1% to $11.7 after the public offering. The offering’s bookrunning managers are BofA Securities, Jefferies and SVB Securities. The lead managers are Cantor and BTIG, while JMP Securities—a Citizens Company—and H.C. Wainwright, are the co-managers. The announcement ...
Megan Brooks Mounting evidence supports that chronic environmental exposure to low levels of lead, cadmium, and arsenic contribute significantly to cardiovascular disease (CVD), the American Heart Association (AHA) says in a new scientific statement. “In reality, identifying a new type of cardiovascular risk factor leads to more questions than answers,” Gervasio A. Lamas, MD, chair of the statement writing group, told theheart.org | Medscape Cardiology. “For the most part, as cardiologists, we are used to risk factors, we can manage with antihypertensives, statins, weight loss, exercise, and avoidance of smoking. Unfortunately, the ubiquity of toxic metals and their multiple sources increases the complexity of potential treatment,” said Lamas, chairman of medicine and chief of the Columbia University Division of Cardiology at Mount Sinai Medical Center in Miami Beach, Florida. The statement addressing contaminant metals as CV risk factors was published online June 12 in the Journal of the American Heart ...
Dive Brief U.S. consumers doubled their use of wearable healthcare devices, including smartwatches, wearable monitors and fitness trackers, between 2020 and 2021, according to a new survey from AnalyticsIQ. Among wearable monitors, blood pressure devices were the most popular, used by 59% of survey respondents, followed by sleep monitors (21%) and ECG monitors (11%). Biosensors such as glucose monitors, hormone monitors, fall detectors and respiratory monitors were used by 8% of consumers in the survey, followed by use of smart clothing items at 6%. The wearable biosensors niche alone grew from $150 million globally in 2016 to $25 billion in 2021, the data analytics firm said. Dive Insight The use and variety of consumer health technology devices has increased dramatically over the past two decades. Scientists at AnalyticsIQ developed a survey to find out how people are incorporating health tech into their lives, asking about 8,000 Americans across the country ...
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