Opioid drug abuse cost the U.S. economy as much as $504 billion in 2015, White House economists said in a report.
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.
Peptidream Inc. scored another billion dollar-plus agreement to develop peptide-based therapies aimed at the treatment of multiple disease targets.
In the world of developing and manufacturing cell-based therapeutics an approved medication for any indication is only part of the business plan. The other aspect is delivering the product to patients. That’s where logistics companies like CryoPort Inc. come into play.
The committee responsible for U.S. vaccination schedules gave a preferential recommendation to GlaxoSmithKline’s newly approved shingles vaccine Shingrix over Merck’s established product Zostavax.
For the pharmaceutical industry, 2016 brought new blockbusters onto the market to ease the pain of patent expirations.
Tecentriq has lost market share to Merck & Co.’s rival Keytruda since a study showed Roche’s immunotherapy drug failed to improve overall survival in bladder cancer.
House Committee on Oversight and Government Reform Democrats are launching an investigation into why prices for MS treatments have nearly quadrupled since 2004.
Radicava (edaravone), an intravenous therapy indicated for all adult patients diagnosed with Lou Gehrig’s disease, has been launched in the U.S. by Mitsubishi Tanabe.
AbbVie’s biologic therapy Humira for autoimmune disorders continues to dominate the sales landscape; Gilead’s once-daily hepatitis C treatment Harvoni in 2016 repeated its performance as the world’s second-best-selling prescription medicine.
Just like 2016 and the year before, specialty drugs dominate the 2017 list of top performers in the most recent first year after launch class.
The good news … is that innovation is addressing diseases with high-unmet need such as oncology, autoimmune diseases, and central nervous system (CNS) disorders. But, there is a complicating factor in the economic story: the patient population benefiting from launch brands is becoming smaller.
First Year After Launch: New molecular entities launched in the U.S. during 2015 that generated 2016 sales of at least $200 million
A listing of the the new molecular entities launched in the United States during 2015 that generated 2016 sales of at least $200 million
South Korea’s Samsung Bioepis started U.S sales of its copy of Johnson & Johnson’s blockbuster rheumatoid arthritis drug Remicade.
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.
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?