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Moderna, a biotech advancing one of the leading COVID-19 vaccine candidates, has faced questions for several months over its patents and intellectual property. Responding to investor questions, the company now says it won't enforce its vaccine patents against other companies during the pandemic...company President Stephen Hoge said Moderna is “quite studiously not asserting infringement.” Without naming names, the biotech says other COVID-19 vaccines in development might be using Moderna-patented technology...“We’re not interested in using that IP to decrease the number of vaccines available in a pandemic,”...Further, the company is open to licensing its technology after the pandemic. Moderna made the pledge in response to investor questions around its patents...READ MORE

Cancer cells could play a key role in the delivery of tumor-fighting drugs, thanks to a new DNA transport system that keeps its therapeutic payload locked away until it comes into contact with diseased cells...Scientists at the Technical University of Munich and the KTH Royal Institute of Technology...say they’ve developed a synthetic DNA transport system for targeted delivery of cancer drugs...the team has created a nano-carrier using mucin, glycerol and synthetic DNA, which wraps up cancer drugs in a secure package that can only be unlocked by a certain RNA sequence unique to diseased cells...READ MORE

After a somewhat chaotic initial rollout by the U.S. government, Gilead Sciences is now taking distribution of COVID-19 drug remdesivir into its own hands...Starting Thursday, Gilead will directly sell remdesivir, branded as Veklury, to American hospitals, ending a five-month phase when the U.S. Department of Health and Human services was responsible for allocating it...AmerisourceBergen will remain the sole U.S. distributor through the end of the year...READ MORE

Pharmaceutical Care Management Association president and CEO JC Scott issued the following statement on today’s hearing in the House Committee on Oversight and Reform on pricing practices for prescription drugs: “We appreciate the House Oversight Committee keeping a spotlight on drug manufacturers’ pricing practices. While drug manufacturers are solely responsible for setting and increasing prescription drug prices, pharmacy benefit managers, PBMs, are the only entity reducing prescription drug costs. PBMs keep prescription drug costs and premiums in check by negotiating lower costs with drug makers and pharmacies...We share President Trump’s intention to keep Medicare premiums affordable...PBMs will continue working with policymakers to advance solutions that encourage greater competition to reduce drug costs for every consumer.”...READ MORE

Patients are asking to join clinical trials of antibody-based COVID-19 drugs after U.S. President Donald Trump was treated last week with an experimental therapy from Regeneron Pharmaceuticals Inc...Medical experts said more data is needed to assess the treatment’s efficacy before wider use should be allowed...The company said...that it has submitted a request to the U.S. Food and Drug Administration for an emergency use authorization for its antibody combination...READ MORE

...Presidential Proclamation 10051 suspended immigration into the United States for anyone holding H-1B, J-1, and L visas, and suspended granting new ones. Most worrisome for the pharmaceutical industry is the ban on H-1B visas, because it will limit, and in some instances entirely prevent, biopharma companies from recruiting the specialized talent they need...the suspension and limitation are aimed at ensuring “that the presence in the United States of H-1B nonimmigrants does not disadvantage United States workers.” The proclamation ends on Dec. 31, at which point the limitations will cease or the administration may extend them as it sees fit...READ MORE

Medical specialists have elected to start Remdesivir therapy for President Donald Trump...Trump has completed his first dose of the drug and is resting comfortably...He is not requiring any supplemental oxygen...Later in the day he was also transported to Walter Reed military hospital for a few days' of treatment as a precautionary measure, though officials said he is expected to remain on the job...READ MORE

As one of few COVID-19 therapeutics with global regulators on board, Gilead Sciences' remdesivir saw immediate U.S. demand that has somewhat tapered off in recent months. But in the EU, some nations have seen spot shortages, and Gilead is stepping in with more supply...Gilead has shipped enough doses of its antiviral Veklury (remdesivir) to the EU to treat 3,400 patients—or 20,300 doses—after countries reported rationing and shortages of the COVID-19 therapy, a Gilead spokeswoman confirmed Wednesday. That $8.2 million order would be enough to meet roughly one to two weeks of treatment supply...READ MOVE

Researchers have developed an algorithm that is able to accurately predict sex differences in drug response through the implementation of pharmacogenomic data...The study...presented AwareDX, a resource that uses machine learning to understand sex-specific adverse drug effects with the potential for use in drug discovery, repositioning, and pharmacogenetic studies, as well as for further analyses of electronic health records and clinical trials, according to investigators...Women are twice as likely as men to develop adverse drug reactions to a drug, partly due to differences in pharmacokinetics and pharmacodynamics that induce increased drug bioavailability and sensitivity to medication and women [remain] severely underrepresented in clinical trials...READ MORE

Time is running out to secure a post-Brexit trade deal or a “bare minimum” agreement on drugs so as to avoid significant delays to supplies to the UK, MPs have been warned...Experts from the drug, chemical, and aerospace industries have underlined the potential problems ahead after the end of the Brexit transition period in December if no trade deals are secured between the UK and the EU before then. Representatives of these industries appeared before the House of Commons Committee on the Future Relationship with the European Union during an evidence session for its inquiry held on 30 September...READ MORE