State officials from New Jersey took aim at Johnson & Johnson subsidiary Janssen by filing a lawsuit pertaining to the marketing of opioids.
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.
Antibiotics are used far more in some countries than in others, a survey by the World Health Organization showed, suggesting that urgent action was needed to slash unnecessary consumption of the medicines.
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.
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.
Mental health disorders are on the rise in every country in the world and could cost the global economy up to $16 trillion between 2010 and 2030 if a collective failure to respond is not addressed, according to an expert report.
Merck & Co. CEO Kenneth Frazier, speaking with the Economic Club of New York, joined a growing list of pharmaceutical chiefs in criticizing the role of middlemen in rising drug prices.
Seattle Genetics and development partner Takeda Pharmaceutical announced stellar Phase III data from the ECHELON-2 clinical trial of Adcetris (brentuximab vedotin) for peripheral T-cell lymphoma.
Dr. Robert Redfield, the new head of the U.S. Centers for Disease Control and Prevention, boldly predicted in April 2018 that the AIDS epidemic can be defeated by 2025. Merck, Janssen and Gilead Sciences all released clinical data for HIV treatments that could make Redfield’s prediction a reality.
Two Americans and a Briton won the 2018 Nobel Prize for Chemistry for harnessing the power of evolution to generate novel proteins.
Frustrated by delays in new medicines reaching their own country, a small but growing number of patients are turning to an online broker that bills itself as a legal version of the Dallas Buyers Club.
Swiss drugmaker Roche is breaking into hemophilia A treatment, a $10 billion global market dominated by rivals who have cultivated close ties to sufferers of the genetic bleeding disorder.
U.S.-listed shares of GW Pharmaceuticals rose 8 percent as the company’s marijuana-based treatment Epidiolex cleared the last hurdle after the Drug Enforcement Administration labeled the drug as having a low abuse potential.