We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Under the deal, 105 low- and middle-income countries will gain access to the treatment, following authorization from the World Health Organization and/or national regulators. Read More
Sesen Bio received an FDA warning letter Oct. 27, knocking the company over a 4-year-old personnel issue that came to light in a recent biologics license application (BLA) review of Vicineum for treatment of bladder cancer. Read More
The FDA’s Office of Prescription Drug Promotion (OPDP) is aiming to understand how “targeted” mechanism of action (MoA) advertising affects how healthcare workers and consumers view a drug and is soliciting public comment on its research proposal. Read More
Novartis has received a request from the Department of Justice (DOJ) asking for information about the marketing and pricing of Entresto, the company’s blockbuster combination sacubitril/valsartan drug for heart failure. Read More
President Biden has dropped all provisions aimed at lowering prescription drug prices from what is the scaled-down $1.75 trillion Build Back Better Act framework negotiated between the White House and congressional Democrats. Read More
Houston-based Empower Clinic Services, doing business as Empower Pharmacy, has been sent a lengthy warning letter from the FDA that listed multiple violations — the company’s second warning letter in six years. Read More
Merck has struck a licensing pact with the Medicines Patent Pool (MPP), a United Nations-supported public health organization serving the developing world, to expand access to its experimental COVID-19 antiviral pill, molnupiravir, co-developed with Ridgeback Biotherapeutics. Read More
Johnson & Johnson (J&J) has agreed to pay $297 million to Texas by year’s end to settle claims over the company’s alleged role in the state’s opioid epidemic if enough local governments approve the settlement. Read More
Rumors abound that President Biden is soon to nominate former FDA Commissioner Robert Califf as the nominee to replace acting commissioner Janet Woodcock. Read More