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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

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

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

The stunning growth of specialty pharmacies in the 340B Drug Pricing Program has accelerated a troubling trend: Patients covered by commercial insurance and Medicare Part D are footing the bill for 340B savings...That's the uncomfortable reality of the 340B program’s hidden prescription economics...Whenever a prescription is eligible for 340B pricing, an insured patient could pay thousands of dollars out of pocket—even as the 340B hospital and its contract pharmacy generate substantial profits. Meanwhile, private health plans and Medicare pay full price for drugs that are sold to 340B covered entities at deep discounts, further subsidizing hospitals and PBM-owned specialty pharmacies...340B Health, which lobbies for hospitals that participate in the 340B Drug Pricing Program, argues that the program “does not cost taxpayers any money.” Be wary of this misleading half-truth. The harsh reality is that patients and payers are funding the savings that flow back to 340B covered entities and their contract pharmacies...This fundamental unfairness is discussed rarely if ever. Rather than touting how hospitals spend their 340B savings, it’s time to start asking where those savings come from...READ MORE

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 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

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

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

Drug companies refused to attend a White House meeting on drug prices...President Donald Trump seems to have hit a nerve with his Friday executive orders on drug pricing. As drug companies work to battle the pandemic, executives declined to attend a White House meeting today on drug prices...When he touted the executive orders Friday, the president said Tuesday's meeting would facilitate talks with pharmaceutical executives on an issue important to many Americans. But the major industry trade groups declined to send representatives...Industry representatives weren't sure it would have been a "productive meeting,"...READ MORE

...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