The EMA’s CHMP granted a positive opinion for Humira (adalimumab) for the treatment of chronic non-infectious anterior uveitis in pediatric patients from 2 years of age.
Artificial intelligence generated plenty of chatter amongst the pharma marketing intelligentsia in 2018. Will 2019 be the year when the industry fully embraces it as more than just a tactic?
The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.
Leadership representing the 2018 Manny Award agency and network winners and finalists share their views on various healthcare industry trends and developments.
The top pharmaceutical companies are trying to proactively tackle, through shifts in R&D strategy and other tactics, the healthcare demands of the future.
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.
FDA granted orphan-drug exclusivity for Haegarda for the prevention of hereditary angioedema attacks.
(Reuters) – European regulators on Friday recommended approving Pfizer Inc and Merck KGaA’s immuno-oncology drug Bavencio to treat a rare type of skin cancer called Merkel cell carcinoma. In May, Bavencio was approved by the U.S. Food and Drug Administration to treat bladder cancer and in March to treat Merkel cell carcinoma. (bit.ly/2vIbPPG) Bavencio, known […]
ZURICH (Reuters) – A European Medicines Agency (EMA) panel recommended on Friday approval of a new Novartis drug to be used against a tough-to-cure form of blood cancer as the Swiss drugmaker makes headway on refreshing its oncology portfolio. The EMA’s Committee for Medicinal Products for Human Use (CHMP) backed Rydapt against acute myeloid leukemia […]
A breast cancer drug at the center of a prolonged pricing row in Britain will now be paid for routinely following a discount deal between Roche and the NHS.
Roche’s seven-year-old rheumatoid arthritis drug Actemra is being linked to hundreds of deaths due to undisclosed side effects.
While data help manufacturers fix plant-floor problems and trace quality issues to their source, it also can prevent recalls. Why not proactively use data to attain an end-to-end view of operations so that product quality can be ensured while reducing recalls?
Roche is investigating a case of a German patient diagnosed with a deadly brain infection called PML after taking one dose of the company’s new MS drug Ocrevus.
The world needs greater transparency on the pricing of medicines – and an overhaul of some approaches – in order to increase access to life-saving drugs, global health experts said.
Life expectancy for young HIV-positive adults has risen by 10 years in the United States and Europe.