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 […]
Pharmaceuticals
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 […]
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 […]
FDA issues draft guidance for the use of diagnostics in cancer drug trials
The FDA issued draft guidance this week describing a streamlined submission process to determine whether using an in vitro diagnostic in a cancer drug’s clinical trial poses a significant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 […]
CVS Health launches drug-pricing tool for pharmacies
CVS Health (NYSE:CVS) announced this week that it plans to launch a program to help consumers compare drug prices at the pharmacy counter. The company’s Rx Savings Finder program is designed to enable pharmacists to evaluate individual prescriptions and find the lowest cost option for consumers. The tool is available at all CVS Pharmacy locations, the […]
Mylan acquires fast-acting, non-opioid painkiller
Mylan (NSDQ:MYL) acquired global development and marketing rights to a fast-acting, non-opioid pain relief drug formulated by Prayog Labs, the company announced today. The pharma giant is positioning the medication, Meloxicam, as a non-addictive treatment option for patients experiencing acute pain following dentistry procedures or following a surgery. Prayog Labs has finished initial development work on […]
Inovio snags $56m award for Lassa fever, MERS vaccines
Inovio Pharmaceuticals (NSDQ:INO) inked a $56 million partnership with the Coalition for Epidemic Preparedness Innovations to develop vaccine candidates against Lassa fever and middle east respiratory syndrome. According to the terms of the deal, CEPI is slated to support Inovio’s preclinical and clinical efforts through to Phase II trials of INO-4500, its Lassa fever vaccine, and […]
JDRF tackles insulin consistency, potency at U.S. pharmacies
JDRF is teaming up with the American Diabetes Association and the Leona M. and Harry B. Helmsley Charitable Trust to support research evaluating the consistency and potency of insulin purchased at retail pharmacies in the U.S. The group called for proposals from analytical laboratories to assess the activity of insulin in vials and cartridges, looking […]