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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

As President Trump wrestles with trying to rein in the high cost of medicine in the United States, he is contemplating an executive order and a proposed rule from the Center for Medicare & Medicaid Services that would set Medicare Part B prescription drug costs based on an International Pricing Index (IPI). The problem is that the IPI includes countries that utilize socialized medicine and artificial price controls. Here, President Trump is mistakenly focused upon the symptom rather than the cause of the problem.  The symptom is the cost, the cause is the incredible barriers to approval and pernicious middle-men known as Pharmacy Benefit Managers which make medicines more expensive...READ MORE

Never before have prospective vaccines for a pathogen entered final-stage clinical trials as rapidly as candidates for Covid-19...The colossal impact of the coronavirus is motivating the speed, opening a spigot of funding and inspiring research teams around the world to join the hunt. But the astonishing pace of the progress is also a consequence of the virus itself: It is, scientifically speaking, an easier target for potential vaccines than other pathogens, and a prime candidate for cutting-edge vaccine platforms new to scientists’ toolkits...Vaccines typically take years, if not decades, to reach people; the record now is four years for the mumps vaccine. Here’s what has propelled the Covid-19 endeavor to eclipse prior efforts so far...READ MORE
A familiar family
An acute, not chronic infection
Cutting-edge approaches
Money, money, money
Regulatory nimbleness
The challenges ahead

Only days after three governments said Russian hackers were targeting groups conducting COVID-19 vaccine research, the U.S. has indicted two Chinese nationals for hacking hundreds of companies, governments and other organizations in the U.S. and beyond, including those working to combat the pandemic...A grand jury in Washington state returned an 11-count indictment against Li Xiaoyu and Dong Jiazhi for a 10-year “hacking campaign” targeting high-tech industries in the U.S. and several other countries. Recently, the hackers shifted their focus to companies researching COVID-19 vaccines, drugs and tests, according to authorities...READ MORE

When President Trump unveiled Operation Warp Speed in May, he declared that it was “unlike anything our country has seen since the Manhattan Project.”...Operation Warp Speed is largely an abstraction in Washington, with little known about who works there other than its top leaders, or how it operates. Even pharmaceutical companies hoping to offer help or partnerships have labored to figure out who to contact...Now, an organizational chart of the $10 billion initiative...reveals the fullest picture yet of Operation Warp Speed: a highly structured organization in which military personnel vastly outnumber civilian scientists...that many of the Warp Speed discussions take place in protected rooms used to discuss classified information...“This is a massive scientific and logistical undertaking,”...“We are weeks away, at most, a month or two away from having at least one safe and effective vaccine.”...READ MORE

Hundreds of drug companies, medical device manufacturers, and universities owe the public a decade’s worth of missing data from clinical trials, federal officials warned last week...New rules issued last week in the wake of a federal court ruling in February instructed clinical trial sponsors to submit missing data for trials conducted between 2007 and 2017 “as soon as possible.” For years, many trials conducted during that span have largely been exempted from reporting their data to ClinicalTrials.gov, a public database, meaning a decade of data about approved drugs and medical devices has never been made public...The court’s ruling, and the federal government’s decision not to appeal it and instead to urge trial sponsors to submit the missing information, represent a major win for transparency advocates, who for years have fought to recover the decadelong gap in publicly available clinical trial data...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

Researchers at Karolinska Institutet in Sweden have identified a small neutralizing antibody, a so-called nanobody, that has the capacity to block SARS-CoV-2 from entering human cells. The researchers believe this nanobody has the potential to be developed as an antiviral treatment against COVID-19...READ MORE

As countries scramble to test for the novel coronavirus, a Chinese company has become a go-to name around the world...BGI Group, described in one 2015 study as “Goliath” in the fast-growing field of genomics research, is using an opening created by the pandemic to expand its footprint globally. In the past six months, it says it has sold 35 million rapid COVID-19 testing kits to 180 countries and built 58 labs in 18 countries. Some of the equipment has been donated by BGI’s philanthropic arm, promoted by China’s embassies in an extension of China’s virus diplomacy...But as well as test kits, the company is distributing gene-sequencing technology that U.S. security officials say could threaten national security. This is a sensitive area globally. Sequencers are used to analyse genetic material, and can unlock powerful personal information...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