- Exclusive: Chinese-backed hackers targeted COVID-19 vaccine firm Moderna (reuters.com)
Chinese government-linked hackers targeted biotech company Moderna Inc... earlier this year in a bid to steal valuable data...the U.S. Justice Department made public an indictment of two Chinese nationals accused of spying on the United States, including three unnamed U.S.-based targets involved in medical research to fight the COVID-19 pandemic. The indictment states the Chinese hackers “conducted reconnaissance” against the computer network of a Massachusetts biotech firm known to be working on a coronavirus vaccine in January...READ MORE
- Pfizer CEO says it’s ‘radical’ to suggest pharma should forgo profits on COVID-19 vaccine: report (fiercepharma.com)
Pfizer could make a 60% to 80% profit margin on its COVID-19 vaccine, one analyst estimates...Pfizer’s chief business officer John Young said the company wasn’t thinking about a return on investment for its rapidly developed COVID-19 vaccine. Instead, he said, “finding medical solutions to this crisis" was a Pfizer priority...But now that the company has moved into phase 3 trials of its BioNTech-partnered vaccine and scored a $1.95 billion supply deal with the U.S. government, Pfizer seems to be changing its tune....READ MORE
- On eve of first big coronavirus vaccine study, trial leaders brace for ‘unprecedented’ task (biopharmadive.com)Moderna's COVID-19 vaccine candidate moves into late-stage trial (reuters.com)
...Moderna will begin the first clinical trial of its kind, a massive placebo-controlled study to definitively determine whether an experimental vaccine can thwart the disease caused by the novel coronavirus...four other like-sized trials from other coronavirus vaccine developers are also expected to begin in the U.S. Combined, they are looking for a specific group of about 150,000 total volunteers, and aiming to amass enough information from them within months to back potential approvals for emergency use...Other, similarly large trials have been run before to test vaccines. But never have so many been done, simultaneously, for the same disease during a pandemic. Those factors make for one of the most logistically challenging research initiatives in history...READ MORE
- AHA: Half of U.S. hospitals could be operating in the red by end of year (fiercehealthcare.com)
A new report from the hospital industry predicts half of all U.S. hospitals will be operating in the red by the end of the year unless more federal relief is approved...The report...prepared on behalf of the American Hospital Association, paints a grim picture of the impact of the COVID-19 pandemic on hospital operating margins...Hospital margins could sink to negative 7% in the second half of 2020, and half of all hospitals are likely to operate with a negative margin...Hospitals were slammed financially by low patient volume and cancellation of elective procedures to preserve capacity to combat COVID-19...Normally, hospitals overall operate with a 3.5% operating margin. But margins are expected to drop to negative 3% in the second quarter of this year...That drop would have been negative 15% without funding from Congress, which gave providers $175 billion a few months ago...READ MORE
- Pfizer lays out COVID-19 vaccine commercial strategy for pandemic and beyond (fiercepharma.com)
Pfizer's COVID-19 vaccine strategy includes two phases, plus a broader mandate to develop more mRNA platform vaccines...With its trials and pricing set, Pfizer has pulled back the curtain on the long-range commercial strategy for its COVID-19 vaccine. During its earnings call...execs laid out two phases, pandemic and seasonal, with some combination of the two likely to play out over the next several years...READ MORE
- Data show panic and disorganization dominate the study of Covid-19 drugs (statnews.com)
In a gigantic feat of scientific ambition, researchers have designed a staggering 1,200 clinical trials aimed at testing treatment and prevention strategies against Covid-19 since the start of January. But a new STAT analysis shows the effort has been marked by disorder and disorganization, with huge financial resources wasted...If the goal was to optimize the likelihood of figuring out the best treatment options, the system is off course...The findings show...that too often studies are too small to answer questions, lack real control groups, and put too much emphasis on a few potential treatments...READ MORE
- Health IT groups say Trump administration’s efforts to sidestep CDC hampers the COVID-19 response (fiercehealthcare.com)
Leading health IT groups are criticizing the Trump administration's move to abruptly change how hospitals report COVID-19 data, saying it jeopardizes public trust and hampers the industry's ability to respond to the pandemic...the Trump administration directed hospitals to sidestep the Centers for Disease Control and Prevention and send critical information about COVID-19 hospitalizations and equipment to a different federal database set up by the Department of Health and Human Services...The American Medical Informatics Association and the American College of Medical Informatics wrote an open letter claiming this shift in reporting will create data gaps, "hindering efforts to recognize, understand, and evaluate important trends related to COVID-19."...READ MORE
- Roche’s Genentech cuts dozens of sales jobs in move to local healthcare ‘ecosystems’ (fiercepharma.com)
In a move away from a "national strategy" in favor of localized operations, Genentech is planning to part ways with hundreds of staffers over the next few months...Genentech is cutting 474 jobs...While many of the cuts are in clinical operations...44 division managers and 32 territory managers will be affected by the layoffs. Many of the cuts take effect in mid-September, but some employees will depart in August and some in October...A spokeswoman told Fierce Pharma the company this year "launched a new customer-engagement approach that will transform the way we serve patients, physicians, providers, payors and pharmacies across the country."...READ MORE
- NIH to start ‘flurry’ of large studies of potential Covid-19 treatments (statnews.com)
The National Institutes of Health is preparing to launch a “flurry” of large clinical trials to test new approaches to treating Covid-19, according to the agency’s director, hoping to expand what for now remains a limited arsenal of therapies to help people with the disease...Among the trials, he said: studies of antiviral monoclonal antibodies to treat Covid-19 in both hospitalized patients and patients who can be treated at home; studies of drugs to quell overreaction of the immune system that the agency has picked from dozens of approved treatments; and studies of blood thinners in very sick Covid-19 patients to prevent problems caused by blood clots. Those treatment studies will be on top of the work that the NIH is also doing on vaccines...READ MORE
- Health IT groups say Trump administration’s efforts to sidestep CDC hampers the COVID-19 response (fiercehealthcare.com)
Leading health IT groups are criticizing the Trump administration's move to abruptly change how hospitals report COVID-19 data, saying it jeopardizes public trust and hampers the industry's ability to respond to the pandemic...the Trump administration directed hospitals to sidestep the Centers for Disease Control and Prevention and send critical information about COVID-19 hospitalizations and equipment to a different federal database set up by the Department of Health and Human Services...The American Medical Informatics Association and the American College of Medical Informatics wrote an open letter claiming this shift in reporting will create data gaps, "hindering efforts to recognize, understand, and evaluate important trends related to COVID-19."...READ MORE