Health authorities in England agreed with Novartis to fast-track access to the Swiss drugmaker’s expensive CAR-T cell therapy Kymriah and make it available to children and young people with aggressive leukemia when other drugs have failed.
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.
A cutting-edge CAR-T cell therapy for otherwise untreatable forms of blood cancer is too expensive to justify its use on Britain’s state-funded health service, the country’s healthcare cost agency NICE said.
The U.S. Food and Drug Administration approved Kala Pharmaceuticals Inc.’s treatment for reducing inflammation and pain following an eye surgery.
A new AstraZeneca inhaler for chronic lung disease proved worse than a rival GlaxoSmithKline product in a clinical trial.
A toxin inadvertently produced in the manufacture of a widely prescribed medicine but not spotted for years raises questions about regulators’ ability to detect risks in a sprawling global drug supply chain increasingly reliant on factories in China.
Heart drugs containing an active ingredient from a second Chinese company are being recalled from the European market after detection of a toxic impurity that may cause cancer.
U.S. Health and Human Services Secretary Alex Azar said it was within his agency’s power to eliminate rebates on prescription drug purchases, a key element of the Trump administration’s plan to lower prescription medicine costs.
Japan’s Eisai Co. Ltd. will price the company’s cancer drug Lenvima at about $16,000 for a month’s supply before discounts, after the U.S. Food and Drug Administration approved the product’s use in patients with a common form of liver cancer.
The Trump administration said it was proposing that U.S. pharmaceutical companies cut production of the six most abused opioids by 10 percent next year.
Biogen’s muscle disease treatment Spinraza has been deemed too expensive for use on Britain’s state-run health service, even after a price discount offered by the U.S. drugmaker.