FDA Issues New Approvals For Leukemia, Ovarian Cancer Medicines
The Food and Drug Administration approves a new Pfizer drug to treat a rare, fast-progressing form of leukemia. The agency also expands the use Lynparza, sold by AstraZeneca and Merck & Co, to treat recurrent ovarian cancer. In other pharmaceutical news, changes to 340B program are delayed and a biopharma executive encounters challenges when trying to fund his own project.
The Associated Press:
FDA OKs Pfizer Drug For Rare, Fast-Killing Type Of Leukemia
The Food and Drug Administration has approved a new medicine for use against a rare, rapidly progressing blood cancer after other treatments have failed. The agency approved Pfizer Inc.’s Besponsa for patients with a type of advanced acute lymphoblastic leukemia. By then, life expectancy is low. (Johnson, 8/18)
Reuters:
FDA Expands Use Of AstraZeneca/Merck Ovarian Cancer Drug
The U.S. Food and Drug Administration on Thursday expanded the use of Lynparza, sold by AstraZeneca Plc and Merck & Co Inc, to include ongoing treatment of patients with recurrent ovarian cancer who have responded to platinum-based chemotherapy. The agency also approved a new two-tablet regimen for the drug, regardless of whether patients test positive for BRCA genetic mutations associated with high risk for the cancer. (8/17)
Modern Healthcare:
Changes To 340B Drug Discount Rule Delayed Until July 2018
A rule that would set new ceiling prices in the 340B drug discount program has been delayed until July 2018, HHS announced Thursday. The rule, which was supposed to take effect in April would also authorize HHS to levy fines against drug manufacturers that intentionally charge a hospital more than the ceiling price. The 25-year-old program requires drug companies to provide discounts to hospitals and clinics, with the goal of providing low-income patients greater access to medications. (Lee, 8/17)
Stat:
A Veteran Biopharma Executive Tries To Fund His Own Product — And Sees Firsthand How Hard It Is
After two decades as an executive at well-known drug companies, he’s used to navigating the ups and downs of raising money on the public market. But Greg Mayes has never faced a fundraising challenge like this before. Galvanized by his teenage son’s epilepsy diagnosis, Mayes started a new company to try to shepherd a promising inhaler technology for epilepsy through a key clinical trial. Now, he’s racing against the clock to convince venture capital firms and private investors to help him move forward. He needs a total of $21 million by the end of this month — and he still has a third of the way to go. (Robbins, 8/17)
