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The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 8-4 on Wednesday, with one abstention, that findings from a study sponsored by the National Institutes of Health (NIH) could support new heart failure indications for the generic drug spironolactone. Read More
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 12-1 yesterday that study data presented by Novartis to support a new indication for its blockbuster heart failure drug Entresto (sacubitril/valsartan) provided enough evidence. Read More
The European Medicines Agency (EMA) said it will complete its review of the Pfizer/BioNTech COVID-19 vaccine by Dec. 21 — a week ahead of schedule — and the EU is poised to grant emergency approval by Dec. 23, allowing vaccinations to begin by year’s end. Read More
Over two dozen state attorneys general penned a letter to HHS Secretary Alex Azar this week urging him to levy fines against a number of big pharma companies that have refused or threatened to refuse 340B drug discounts to contract pharmacies. Read More
Pharmaceutical industry trade group PhRMA pulled in a whopping $526.6 million in revenue in 2019, $68 million more than the non-profit took in the year before, according to federal tax disclosures made public this month. Read More
New drugs for breast cancer, leukemia, hepatitis B and myelofibrosis may be available to European patients soon, as the European Medicines Agency’s Committee for Medicinal Products for Human Use (EMA/CHMP) recommended that the agency approve 15 new drugs, including two biosimilars and four generics, at its Dec. 7-10 meeting. Read More
A coalition of hospital groups has filed a lawsuit alleging that HHS failed to ensure that drugmakers offer discounted medications to covered entity hospitals under the 340 drug discount program. Read More
The World Trade Organization (WTO) has agreed to continue deliberating a proposal made by India and South Africa to temporarily suspend intellectual property (IP) rights protecting COVID-19 therapies and vaccines during the pandemic. Read More
Pharmacies won and pharmacy benefit managers (PBMs) lost when the Supreme Court decided 8-0 Thursday that states can regulate the amounts that PBMs reimburse pharmacies and could, over the long term, help lower drug prices. Read More
Boehringer Ingelheim (BI) Pharmaceuticals has filed a petition with the FDA arguing that the agency’s use of the word “strength” squelches competition from makers of biosimilars and runs afoul of FDA’s Biologics Price Competition and Innovation Act (BPCIA). The company has asked the FDA to change its interpretation of the word. Read More
President Trump signed a stopgap funding bill Friday that averts a government shutdown until the end of the week and keeps the FDA at its current fiscal 2020 funding levels. Read More