Researchers found that opioid agonist therapy was the most cost-effective method for HIV prevention among injection drug users, according to a study in PLOS Medicine. It was found to be more cost-effective than needle exchanges and test-and-treat programs.
Compounding pharmacies could help ease the shortage of high-demand drugs such as sodium bicarbonate, said International Academy of Compounding Pharmacists President Baylor Rice. IACP is communicating to Congress its stance that the FDA should revise its December 2016 guidance blocking 503A
pharmacies from office-use compounding.
Pfizer's biosimilar to Amgen's Epogen, or epoetin alfa, has been recommended by the FDA's Oncologic Drugs Advisory Committee for all indications. Pfizer has an agreement with Vifor Pharma for the marketing of the drug.
Results from an early-stage study to test the safety of Trovagene's blood cancer candidate PCM-075 showed reversible toxicities including thrombocytopenia and neutropenia. A Phase I/II study is also being planned to test the drug in patients with acute myeloid leukemia.
America's Health Insurance Plans sent a letter to Senate Finance Committee Chairman Orrin Hatch, R-Utah, reinforcing calls for swift action to ensure continued funding of cost-sharing reduction payments and emphasizing the need for clarity on individual market provisions to keep insurers in markets and premiums down. AHIP President and CEO Marilyn Tavenner also called on Senate Republicans to guard against disruptions in Medicaid funding and retain protections for those with pre-existing conditions "including guaranteed issue, community rating, and barring pre-existing condition exclusions."
Sens. Ron Johnson, R-Wis., Bill Cassidy, R-La., and John Cornyn, R-Texas, said Republican leadership staff and committee staff will be drafting health care legislation while the Senate is on break, and Johnson said a discussion draft should be ready for distribution among Republican senators after the recess. The staff will only be working on base language as senators have yet to reach final agreement, Cornyn noted.
Specialty-drug makers that have relied on high prices could be in for trouble if FDA Commissioner Scott Gottlieb implements policies to reduce drug prices by increasing competition in the marketplace, Max Nisen writes. The FDA could relax restrictions on communications between drugmakers and payers before drugs are approved, be more flexible about drug approvals, approve generic drugs faster and prioritize approval of biosimilars.
Anika Therapeutics said it anticipates completion of its supplemental late-stage trial of Cingal for osteoarthritis-related knee pain in 2018 and FDA approval in 2019. The company has enrolled its first patient in the trial.
The cancer research community "galvanized around" former Vice President Joe Biden's National Cancer Moonshot initiative, including basic researchers, the private sector and advocates, says Dinah Singer, acting deputy director of the National Cancer Institute. Since the program's inception, three large data-sharing initiatives have been launched and a new platform was developed to facilitate clinical trial enrollment, but budget cuts, continuing EHR interoperability challenges and soaring drug prices threaten progress.
A Series B financing round raised $45 million for Harpoon Therapeutics. The company will use the funds to develop its antibody-based trispecific T-cell-activating construct platform and to launch clinical studies for its two lead candidates based on the technology.