Mylan’s chief executive officer, Heather Bresch, defended the rising cost of EpiPens on Wednesday when she testified before Congress. She explained that the company pays a majority of the list price in the form of rebates and fees. “I think many people incorrectly assume we make $600 off each EpiPen. This is simply not true,”…
Lasker Awards Given to Researchers in Virology, Physiology
The Albert and Mary Lasker Foundation today named seven scientists as winners of its annual awards, which honor basic medical research, clinical research and special achievement. Each category will receive $250,000. The Lasker-DeBakey Clinical Medical Research Award went to two virologists — Ralf F. W. Bartenschlager of the University of Heidelberg in Germany and Charles…
Merck Seeks FDA Approval for Keytruda as First-Line Treatment
The U.S. Food and Drug Administration will review the immuno-oncology drug Keytruda as a first-line therapy for non-small cell lung cancer (NSCLC), Merck announced Wednesday. Keytruda won a breakthrough therapy designation and priority-review status based on data from the Phase 3 Keynote-024 trial, released in June, which showed that the PD-1 checkpoint inhibitor had significant…
Mylan Responds to Pressure, Will Offer Cheaper, Generic EpiPen
Following the waves of criticism Mylan faced last week from patients, doctors and politicians, the company announced on Monday that it will launch a generic version of the EpiPen, which will cost half the price of the current product. The drugmaker said the generic EpiPen, which will be identical to the branded version, will be…
EpiPen Price Hike Sparks Concern Amid New Reports
The EpiPen’s manufacturer, Mylan, is drawing heavy criticism this week from consumers and lawmakers for raising the price of its auto-injector by more than 400 percent over the last eight years. The device, which precisely calibrates the dosage of epinephrine to counteract severe allergic reactions, costs some consumers more than $600 for a two-pack. Turns…
Mylan’s EpiPen Price Hike Draws Criticism
The pharmaceutical company Mylan holds a virtual monopoly on epinephrine injections. In 2007, the company acquired the EpiPen, an auto-injector that precisely calibrates the dosage of epinephrine, used to treat severe allergic reactions in an emergency situation. But a two-pack of EpiPens cost about $57 when Mylan acquired the devices. Since then, the price of…
FDA Approves Heron Therapeutics Chemo Anti-Nausea Drug
Heron Therapeutics Inc.’s injectable therapy, Sustol (granisetron), for chemotherapy-induced nausea and vomiting (CINV) was approved by the U.S. Food and Drug Administration Wednesday. Sustol is the first approved product that uses Heron’s Biochronomer drug-delivery technology, which maintained effective levels of the medication for at least five days, covering the acute and delayed phases of CINV.…
AstraZeneca Drug Candidate Fails in Lung Cancer Study
The cancer field has experienced another setback this month. AstraZeneca’s experimental drug selumetinib failed to meet its primary goal in a late-stage lung cancer trial. When the drug, an MEK 1/2 inhibitor, was combined with chemotherapy it did not slow lung cancer progression or prolong overall survival, the London-based drugmaker announced Tuesday. The Phase 3…
TauRx Alzheimer’s Drug Fails in Late-Stage Trial
The recent results of a late-stage trial have delivered yet another hit to the Alzheimer’s scientific community. TauRx’s experimental drug, LMTX, fared no better than a placebo at improving cognitive and functional skills in patients with mild to moderate Alzheimer’s disease. The Phase 3 study involved 891 patients. The drug, LMTX, targets the protein tau,…
Larger-Scale HIV Vaccine Trial to Launch in South Africa
A larger-scale HIV vaccine trial will begin in South Africa later this year, scientists announced this week at the International AIDS conference in Durban, South Africa. The modified vaccine is based on the results of a small trial, known as HVTN 100, which took place in South Africa in 2015 to test the safety and…
Roche Fails Phase 3 Trial in Non-Hodgkin’s Lymphoma
Juno Therapeutics Cancer Drug Trial Allowed to Continue
A CAR-T therapy trial by Juno Therapeutics that was halted last week following the death of three patients has been allowed to resume, the company announced. Last week the U.S. Food and Drug Administration abruptly halted Juno’s clinical trial of an experimental treatment for leukemia after three patients died from swelling in the brain. The…
Sage Therapeutics’s Postpartum Depression Drug Shows Positive Results
Sage Therapeutics announced that its drug, SAGE-547, alleviated symptoms of severe postpartum depression, meeting the primary endpoint of a small Phase 2 study and sending the company’s shares soaring more than 44 percent Tuesday in early trading. What’s especially significant is the drug’s ability to statistically reduce symptoms of postpartum depression at 60 hours. Currently,…
FDA Panel Recommends Label Change for Lilly’s Jardiance
A U.S. Food and Drug Administration (FDA) panel on Tuesday voted yes, that the diabetes drug Jardiance, manufactured by Eli Lilly and Boehringer Ingelheim, also reduces the risk of cardiovascular death — and that its label should be updated to include this claim. The panel’s vote was narrow, coming in at 12 to 11. Next,…
Inovio’s Zika Vaccine Is Approved for Clinical Trials
The U.S. Food and Drug Administration on Monday for the first time granted clinical trial approval for an experimental Zika vaccine. The vaccine, called GLS-5700, is manufactured by Inovio Pharmaceuticals of Plymouth Meeting, Pa. and GeneOne Life Science, of Seoul, South Korea. Earlier today, the companies announced they will begin within the next few weeks…
Antibody-Based Drug Improved ALL Outcomes
Juno, Kite Pharma Aim for 2017 CAR-T Therapy Approvals
AbbVie’s Drug Rova-T Shows Promise — But Not Enough — in SCLC
Experimental drug rovalpituzumab tesirine (Rova-2) was effective in treating patients with advanced small cell lung cancer (SCLC), according to data from a first-in-human clinical trial, presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago. And although the results are preliminary, that’s good news: Rova-2 could be the first treatment to make an…