Author: healthadmin

Earlier this year, when the FDA asked Amgen to pull its rare disease drug Tabneos from the market, the California drugmaker rejected the request. Now, U.S. regulators are applying even more pressure. The FDA’s Center for Drug Evaluation and Research (CDER) has proposed rescinding approval of Amgen’s oral drug, citing new information showing that data was “manipulated” to facilitate the green light for Amgen’s oral drug. In the letter (PDF), CDER also singled out Amgen subsidiary Chemocentrics, saying Tavneos is ineffective and that its application for approval as a treatment for ANCA-related vasculitis contains false statements. Additionally, CDER noted cases…

After recalibrating its production strategy in the late 2010s to better align with the realities of the CAR-T market, Gilead Sciences’ Kite Pharma is gearing up to hit the ground running for approval of its next-generation multiple myeloma cell therapy later this year. And looking further afield, Kite is eyeing the potential of in vivo CAR-T, which could further simplify the manufacturing and logistical constraints of this class and bring medicine to more patients, said Laura Alquist, Kite’s senior vice president and global head of technology operations, when she spoke with Fierce at the recent U.S. Biomanufacturing Summit in San…

NASA’s Curiosity rover has identified a wide range of organic molecules on Mars, including compounds that scientists believe are key ingredients in the origin of life on Earth. The discovery came from the first chemical experiment performed on another planet. The results showed that the surface of Mars can store molecules that could serve as potential signs of ancient life. However, this experiment cannot determine whether these organic compounds came from past life on Mars, natural geological processes, or meteorites that hit Mars. To see real evidence of past life, scientists will need to bring Martian rock samples back to…

AstraZeneca’s three-in-one inhaler Breztri Aerosphere has passed another significant milestone, inching towards the British drugmaker’s goal of reaching $80 billion in sales by 2030, after breaking the blockbuster sales benchmark in 2025. On Tuesday, the FDA approved Breztri for a second indication, approving the triple combination of budesonide, glycopyrrolate, and formoterol fumarate as maintenance treatment for asthma in adults and children 12 years and older. Breztri was first approved in the United States in 2020 as a maintenance treatment for chronic obstructive pulmonary disease (COPD). The new agreement opens up a substantial market for Breztri, one of several respiratory products…

Tory Starr worries about the people who receive medical care at Open Door Community Health Center on California’s north coast. “These are people who work in restaurants. They’re teacher’s aides,” said Starr, a registered nurse who became Open Door’s chief executive officer more than six years ago. These patients are “the very heart and soul of rural America,” he says. He said patients could quickly lose services if remote medical centers don’t get a share of the billions of dollars Congress has allocated to reform health care in rural America. About 50% of Opendoor’s 60,000 patients are on Medicaid. Medicaid…

Haleon has launched a soccer-focused marketing campaign ahead of the FIFA World Cup in the United States, putting midfielder Tyler Adams at the center of an advertisement about the support its products provide. The consumer health company, which spun off from GSK in 2022, sells products such as painkiller Advil and antacid Tums. Haleon is introducing the brand in a 30-second ad created as part of the company’s “For the Assist” campaign in partnership with the U.S. Soccer Federation. The federation oversees the U.S. men’s national team, which will compete in June’s FIFA World Cup. In the Haleon ad, a…

Novartis CEO Basu Narasimhan is doubling down on Pluvicto’s $5 billion peak sales forecast, even though the company has given up on expanding the label in Europe. Novartis has withdrawn its application to the European Medicines Agency for Purvict as a pre-chemotherapy treatment for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), the companies announced on Friday. Narasimhan told reporters on a conference call Tuesday that the withdrawal “reflects a different perspective on what is an appropriate comparison in a pre-taxane situation.” Although the PSMAfore trial tested Pluvicto against a modified androgen receptor pathway inhibitor, some doctors argue that chemotherapy should be…

Analysis of National Youth Longitudinal Survey data examined the types of family formation transitions people experience. They found that women who frequently attend religious services or belong to conservative denominations were most likely to marry before cohabiting with a partner or having children. The paper was published in. Religious Science Research Journal. Family-forming events are life events in which people create, expand, or redefine family units. Usually includes marriage, cohabitation, and childbirth. Decades ago, most women in the United States married without cohabiting. These days, however, approximately 75% of young women live with a partner at some point in their…

Can compounds found in everyday soy-based foods help alleviate COPD symptoms? A new study reveals how diet, particularly isoflavones, plays a role in shaping respiratory health and disease burden in ex-smokers. Research: Isoflavone intake is associated with reduced incidence of chronic obstructive pulmonary disease. Image credit: Makistock/Shutterstock.com In recent research, Chronic obstructive pulmonary disease We evaluated whether increased dietary isoflavone intake was associated with improvement in respiratory disease in ex-smokers with chronic obstructive pulmonary disease (COPD). Dietary patterns and their impact on COPD risk and progression COPD is a progressive lung disease characterized by persistent airflow obstruction and chronic respiratory…

Many liver diseases have a common feature: fibrosis, the progressive accumulation of scarring in liver tissue. Those scars (the liver’s response to sustained damage or attack) can prevent the organ from functioning properly. Fibrosis affects millions of people worldwide and is a crucial step in the progression to cirrhosis, a fatal condition that can develop into liver cancer. Now, a new study by the National Cancer Institute (CNIO) natural metabolismidentified an important mechanism in the development of liver fibrosis. This discovery represents a further step towards developing personalized treatments that can help prevent its progression. More than just carrying bile…