- Kodak Pharmaceuticals lands $765m US loan (outsourcing-pharma.com)
The Eastman Kodak Co. (traditionally associated with cameras, film, printers and other imaging technology) announced the launch of its new Kodak Pharmaceuticals arm, which will produce various pharmaceutical ingredients. The $765m funding is the first action occurring under the president’s executive order, which authors the International Development Finance Corp. (DFC) and Department of Defense (DoD) to collaborate on COVID-19 response...”Kodak is stepping up to help onshore pharmaceutical production and this DPA action will allow the modernized Strategic National Stockpile to have domestic resiliency. Once Kodak ramps up we will have the ability to tap into that capacity for domestic use."...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
- AstraZeneca to be exempt from coronavirus vaccine liability claims in most countries (reuters.com)
AstraZeneca has been granted protection from future product liability claims related to its COVID-19 vaccine hopeful by most of the countries with which it has struck supply agreements...With 25 companies testing their vaccine candidates on humans and getting ready to immunise hundred millions of people once the products are shown to work, the question of who pays for any claims for damages in case of side effects has been a tricky point in supply negotiations...“This is a unique situation where we as a company simply cannot take the risk if in ... four years the vaccine is showing side effects,” Ruud Dobber, a member of Astra’s senior executive team, told Reuters...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
- 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