Morning Briefing
Summaries of health policy coverage from major news organizations
More Large COVID Contracts For Drug Companies
The U.S. government has awarded $486 million to AstraZeneca Plc to develop and secure supplies of up to 100,000 doses of Covid-19 antibody treatment, a similar class of drug that was used in treating President Donald Trump. The agreement, under the Trump administration鈥檚 Operation Warp Speed, is for developing a monoclonal antibody cocktail that can prevent Covid-19, especially in high-risk population like those over 80 years old, the U.S. Department of Health and Human Services said. (10/12)
Two pharmaceutical companies issued voluntary recalls Monday for metformin, an anti-diabetes drug, due to high levels of a cancer-causing compound, according to a release from the U.S. Food and Drug Administration. Metformin is used to treat type 2 diabetes, according to Mayo Clinic, and is distributed under the following brand names: Fortamet, Glucophage, Glucophage XR, Glumetza and Riomet. (Mitchell, 10/9)
South Korean drugmaker Celltrion Inc 068270.KS said on Monday it has received regulatory approval for Phase 3 clinical trials of an experimental COVID-19 treatment. The approval comes as the company plans to seek conditional approval for its antibody drug, CT-P59, for emergency use by the end of this year. (Cha, 10/12)
In other pharmaceutical and biotech news 鈥
Mallinckrodt filed for bankruptcy protection on Monday, saddled with lawsuits alleging it fueled the U.S. opioid epidemic and after it lost a court battle to avoid paying higher rebates to state Medicaid programs for its top-selling drug. The company listed both assets and liabilities in the range of $1 billion to $10 billion in a filing with the U.S. Bankruptcy Court for the District Of Delaware. (10/12)
The Covid-19 pandemic has wreaked havoc across the globe 鈥 including upending the process of drug development.聽That has been especially true in clinical trials for oncology, which come with a complex set of considerations. Patients often have to come into the clinic or be hospitalized for treatment. They also have to be protected against possible infections that could devastate a weakened immune system.聽(Spinelli, 10/9)
When patients sign up for the newest kind of therapy at the Mental Health Center of Denver, here鈥檚 what comes in their welcome packet: A biofeedback device that clips to their ear to measure pulse and blood-oxygen levels. A phone stand to prop up a smartphone during therapy sessions. And directions for downloading an app to chat with a therapist. It鈥檚 a new era in technology for the community mental health center, a key step toward 鈥減reparing for the next generation,鈥 said Alires Almon, the center鈥檚 director of innovation. The 12-week, virtual therapy program isn鈥檛 meant to replace traditional face-to-face counseling 鈥 it鈥檚 a contemporary option for people who would rather work on their mental health at home with their smartphone than walk into a mental health center. (Brown, 10/11)