Johnson & Johnson (NYSE:JNJ) today reported first-quarter sales and earnings results, topping analysts’ expectations on Wall Street. The company’s pharmaceutical business delivered “robust growth,” chairman & CEO Alex Gorsky said in a statement; worldwide global sales grew 19.4% to $9.8 billion for the first quarter compared to same period in 2017. Domestic sales were up […]
In reversal, FDA accepts Alkermes’ depression drug for review
In an about-face, the FDA reportedly agreed to review a new drug application for Alkermes‘ (NSDQ:ALKS) depression drug just weeks after the agency said it would only do so if the company conducted additional trials. Alkermes’ once-daily oral medication is a fixed dose combination of buprenorphine and samidorphan, designed for patients with major depressive disorder […]
Avita Medical touts pivotal trial of ReCell burn injury device
Avita Medical (ASX:AVH) said today that a pivotal trial of its ReCell autologous cell harvesting device met its co-primary endpoints. The device, designed to help heal deep, full-thickness burns, demonstrated a statistically significant reduction in donor skin requirements compared to the standard of care and achieved comparable wound closure, Avita touted. “Treatment with the ReCell device […]
MediMergent and FDA team up to tackle medication adherence
Healthcare data analytics company, MediMergent, and the FDA’s Center for Drug Evaluation and Research reportedly gathered stakeholders from biopharma companies, pharmacies, health plans and regulatory agencies to propose strategies regarding medication non-adherence. Approximately half of all Americans with chronic diseases who need lifelong medications do not stick to their prescribed regimen six months after they […]
Bristol-Myers Squibb, Illumina to develop companion diagnostics for immunotherapies
Bristol-Myers Squibb (NYSE:BMY) is joining forces with Illumina (NSDQ:ILMN) to develop and commercialize diagnostic tests to support Bristol’s portfolio of cancer drugs. The companies announced last week that they plan to develop an assay to measure predictive genomic biomarkers, like tumor mutation burden, that could help doctors identify patients that will benefit from Bristol’s immunotherapies. “Through our […]
OncoSec looks to boost effects of immunotherapy with intratumoral delivery
Thousands of cancer patients have been treated with immune checkpoint inhibitors since the first of its kind was approved in 2011. The product is designed to block the production of proteins that prevent the body’s immune system from acting in the presence of cancer. Although checkpoint inhibitors hold immense promise for some patients, many fail to […]
Study: Propeller’s digital asthma tech informs policy, improves health
Results from a large, real-world study of asthma patients found that digital health technology can improve patient outcomes and inform city-planning policy, Propeller Health touted this month. The company teamed up with local government in Louisville, Kentucky and a nonprofit group to assess how environmental conditions can influence asthma symptoms using connected inhalers and a […]
Confer Health raises $9.5m for fertility diagnostic
Confer Health said today that it raised $9.5 million to support its development of affordable, at-home diagnostic devices featuring interchangeable cartridges, a reusable analyzer and a mobile app. The Boston, Mass.-based company’s first urine-based diagnostic test is designed to help couples conceive by tracking three fertility hormones. Confer added that it is also developing an at-home […]
Qiagen launches liquid biopsy tests for lung, prostate cancer
Qiagen (NYSE:QGEN) today launched two liquid biopsy panels designed to evaluate circulating tumor cells isolated from a patient’s blood samples. The company’s lung and prostate cancer diagnostic tests will be introduced at the annual meeting of the American Association for Cancer Research in Chicago, according to Qiagen. “Our AdnaTest liquid biopsy-based portfolio now offers molecular […]
FDA issues draft guidance for the use of diagnostics in cancer drug trials
The FDA issued draft guidance this week describing a streamlined submission process to determine whether using an in vitro diagnostic in a cancer drug’s clinical trial poses a significant or nonsignificant risk. The agency wrote that sponsor should use the proposed pathway when possible “to reduce administrative burden on sponsors and FDA and to maintain […]
