Updated U.S. guidelines on heart health advise more personalized assessment of risk as well as two newer types of cholesterol-lowering drugs for people at particularly high risk of heart attack or stroke.
There were as many billion-dollar brands in 2017 as there have been in any other calendar year despite the cratering effects of massive patent cliffs in 2012 and 2015.
Current health systems built to evaluate and pay for traditional drugs are going to struggle with gene and other unusual therapies – but manufacturers can take steps before launch to define how manufacturers assess and value these new products.
This yearly review analyzes recent developments, trends and outlooks in the areas of biotechnology, biosimilars, biopharmaceuticals, biologics, biomarkers and biobanks.
A recent study of DTC advertising appearing in the Journal of General Internal Medicine concluded that few broadcast ads are compliant with FDA’s guidelines. The reality, though, might not be so cut and dried.
As more innovative – yet even more expensive – therapies enter the U.S. market, brand marketers will have to find equally new and innovative ways to prove the value of their medicines to payers and patients, especially as insurance plans continue to put more of the cost burden on patients.
On Oct. 28, 2016, my mother, Joan Biamonte, died of complications from metastatic carcinoma of the lung. Despite having her original tumor characterized and going through a regimen of chemotherapy allegedly tailored to her tumor type, her cancer proliferated and spread into her liver and brain.
Novartis’ Sandoz division recalled one lot of losartan tablets after finding traces of a probable carcinogen in the blood pressure drug.
Coherus BioSciences Inc. will price the company’s biosimilar to Amgen Inc.’s infection-fighting treatment Neulasta at a 33 percent discount.
Amgen Inc., looking to boost use of the U.S. biotechnology company’s potent cholesterol drug Repatha, cut the medication’s U.S. list price by 60 percent to $5,850.
Medical treatment would be more widely available to opioid abusers under a rare bipartisan measure aimed at tackling the U.S. addiction crisis expected to be signed into law by President Trump.
U.S. Food and Drug Administration Commissioner Scott Gottlieb announced that the regulatory agency is relaunching the Drug Competition Action Plan in 2019 with some additional initiatives.
The U.S. Food and Drug Administration rejected Novartis’ bid to repurpose canakinumab, a drug already approved for rare inflammatory diseases, for use in a group of heart attack survivors.
Prices for two dosages of the blood pressure drug valsartan rose more than any other drug in the United States during September 2018, following a recall of much of the drug’s supply.
The U.S. government, in an effort to increase pressure on drugmakers to lower costs for U.S. consumers, will propose requiring companies to include the price of Rx medicines in TV ads.
President Donald Trump signed a bill into law that requires pharmaceutical companies to provide details of biosimilar deals to the Federal Trade Commission for antitrust scrutiny.