In May of this year, the Trump White House issued its “Blueprint to Lower Drug Prices” in response to the Administration’s views that excessively high drug prices “burdening the American people” were in part caused by “foreign freeloading” and a system currently rigged “to reward list price increases.” The policy document, which was open...
In September 2015, Martin Shkreli, then CEO of Turing Pharmaceuticals, sparked widespread outrage in the United States when the company raised prices on an off-patent treatment for toxoplasmosis, Daraprim, by over 5,000%, just one month after Turing acquired the drug. That action catapulted the medicine’s price from $13.50 to $750 per pill. But journalists found...
Market analyst firm Evaluate released their annual report, “EvaluatePharma World Preview 2018: Outlook to 2024,” last month. The report predicts that worldwide prescription drug sales will grow to over $1.2 trillion over the next six years. Novartis is projected to be 2024’s leading prescription drug company with $53.2 billion in overall sales, followed by Pfizer...
The Institute for Clinical & Economic Review (ICER) recently ruled that all three of Vertex’s cystic fibrosis (CF) drugs are considerably overpriced. ICER analyzed the prices for Kalydeco, Orkambi, and new treatment Symdeko based on a metric called “quality-adjusted life year,” which factors in both the quantity and the quality of life lived. While ICER...
The immuno-oncology (IO) field has a lot to be thankful for as the year comes to a close. Not only are PD-1/PDL-1 inhibitors being rapidly approved, their use is being extended into new indications and tumor types well beyond what people expected. From melanoma and lung cancer to bladder, gastric and liver cancer, drugs...
On July 27, AstraZeneca (AZ) disappointed their investors and many immuno-oncology watchers with the results of their MYSTIC trial combining two immunotherapies targeting PD-L1 (durvalumab/Imfinzi) and CTLA-4 (tremelimumab) in newly diagnosed Stage-IV lung cancer patients. The AZ combination therapy failed to show a benefit compared to chemotherapy in a primary endpoint of “Progression-free Survival (PFS).”...
On July 12, Novartis’ CAR-T therapy, CTL019 (tisagenlecleucel), received a unanimous recommendation for approval from the reviewing U.S. Food and Drug Administration’s advisory panel for use in the treatment of children and young adults with advanced acute lymphoblastic leukemia (ALL). The FDA is now expected to make its final decision by October 3. CTL019...
New technologies tend to go through cycles of interest and attention. Initial excitement about the potential of a technological advance too often builds to over-blown hype, followed by a quick reversal of interest in the aftermath of a big disappointment. But if continued research later produces truly encouraging results, interest can build again as time...
On March 29, the US Food and Drug Administration approved Roche’s Ocrevus (ocrelizumab) for the treatment of either relapsing multiple sclerosis (MS), or primary progressive MS (PPMS). The approval was particularly noteworthy as Ocrevus is the first therapeutic approved for the treatment of PPMS, a form of the disease that accounts for 10-15% of MS...
The U.S. Food and Drug Administration has issued its first drug approval to a treatment for patients with a specific genetic biomarker, rather than based on an initial tumor location, such as breast cancer. On May 23, the agency granted an accelerated approval to Merck’s Keytruda (pembrolizumab) for the treatment of adult and pediatric patients...