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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
The FDA issued a complete response letter (CRL) to Sanofi for sutimlimab, an investigational monoclonal antibody for treating hemolysis in adults with the rare autoimmune condition, cold agglutinin disease. Read More
The FDA published final guidance designed to help drug compounders recognize, prevent and respond to insanitary conditions at their facilities. Read More
The FDA’s Office of Regulatory Affairs (ORA) has determined that general and prioritized inspections will remain preannounced for the foreseeable future in order to ensure the safety of those involved during the pandemic, according to a regulatory official. Read More
The FDA is very likely to grant Emergency Use Authorization (EUA) for Pfizer’s COVID-19 vaccine following a 17-4 advisory committee vote (with one abstention) Thursday in support of emergency clearance, meaning vaccinations of high-risk patients could start as soon as this weekend. Read More
The advocacy group Public Citizen said Wednesday that it had written to the HHS’ Office of Inspector General urging it to “investigate the unprecedented and inappropriate close collaboration” between the FDA and Biogen over the company’s biologics license application (BLA) for approval of the potential blockbuster Alzheimer’s drug aducanumab. Read More
Azurity Pharmaceuticals downplayed the serious risks and overstated the benefits of its leukemia drug Xatmep (methotrexate) oral solution in the text of a promotional email sent to healthcare professionals, according to a Nov. 24 “untitled letter” from the agency’s Office of Prescription Drug Promotion (OPDP). Read More