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Moderna announced new interim clinical data results for its coronavirus disease 2019 (COVID-19) vaccine candidate from a phase 1 study...The investigational vaccine, called mRNA-1273, was launched...on March 16, making it the first trial to be started in humans for a vaccine for this virus...Tal Zaks, MD, PhD, chief medical officer at Moderna, said in a statement. “When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”...Moderna expects to begin its phase 3 study in July 2020...READ MORE

The FDA abruptly shut down its on-site facility inspections in March, hoping to keep its employees safe during the novel coronavirus pandemic. More than two months into that moratorium, drugmakers are calling for relief—and with some new guidance, the FDA shows it might be willing to accommodate...The agency is working with the U.S. Centers for Disease Control and Prevention to develop a "phased approach" to restarting inspections of domestic and foreign drug manufacturing facilities, the administration said...the plan would likely continue the agency's focus on high-priority inspections taken on a "case-by-case" basis...READ MORE

While Gilead has yet to present a marketing plan for the first coronavirus treatment to have shown clinical benefits in a well-designed randomized study, the Institute for Clinical and Economic Review (ICER)—which routinely weighs in on drug costs—says the drug is cost-effective at $4,460 per course of treatment...Even at $1,000 per patient, less than a quarter of ICER's fair price, Gilead could rake in $1 billion in sales this year...The company’s now bolstering supply with the aim to treat 1 million patients by the end of the year...For now, Gilead is donating remdesivir to the U.S. government for allocation, and it's pledged to continue giving doses away until its current supply chain is exhausted...Drugmakers aren’t obligated to follow ICER’s pricing limits, and they often find themselves at odds with each other...READ MORE

Gilead Sciences can only produce so much of its newly authorized COVID-19 drug remdesivir, so it’s scouting other companies to bolster global supply...Even as it presses ahead with its own remdesivir ramp-up, Gilead says it’s in licensing talks with the “world’s leading chemical and pharmaceutical manufacturing companies” about their ability to produce remdesivir for countries in Europe, Asia and beyond until at least 2022...Remdesivir manufacturing relies on “scarce” raw materials that command their own “lengthy” production timelines, Gilead has said. Moving forward, coordination on producing the drug will be “critical,” the drugmaker says. Disruptions could reduce output or increase manufacturing time...READ MORE

Federal prosecutors turned up the heat in recent months on a generic price-fixing probe that targeted some of the industry's biggest players before COVID-19 slowed the hunt. Teva, the biggest target in that investigation, has reportedly bailed on settlement talks in a decision meant to test the government's resolve...Teva walked away from negotiations with federal prosecutors, daring the U.S. Department of Justice to pursue criminal price-fixing charges against the drugmaker at a time when it's part of the COVID-19 pandemic response...Teva is betting that its role in aiding the U.S. coronavirus response, including donating millions of doses of antimalarial hydroxychloroquine sulfate to hospitals, will put the Justice Department in a bind on its decision to file charges...READ MORE

It is going to take at least a year for a Covid-19 vaccine to be available; in the meantime, drugs, both novel and repurposed, could provide a quicker alternative for the pharma industry to help resolve the ongoing novel coronavirus pandemic...the pharma industry has focused its efforts on leveraging its disease tackling expertise to find medical solutions to this novel viral disease...“A lot of the focus over the past few weeks has been on vaccines,” noted International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) director-general Thomas Cueni...it is highly unlikely a vaccine will be available for at least 12 to 18 months, drug studies are dominating the short-term response to this public health crisis...there are over 130 treatments in the pipeline for Covid-19 – 77 of which are repurposed and 68 are novel – which is “really good news for all of us”. These range from antimalarials and antivirals to anti-inflammatory drugs and plasma-based treatments...READ MORE

The new coronavirus moved around the world with lightning speed. Since December, when it was first identified in Wuhan, China, nearly every country has reported cases of infection...Dozens of drugmakers have started work on vaccines to protect against the virus or medicines to treat COVID-19, the illness it causes. Hundreds of studies are underway in search of an effective treatment, testing mostly repurposed HIV or influenza drugs. One, a U.S. government-led trial of an antiviral drug called remdesivir, showed some hopeful signs of hastening recovery in patients hospitalized with COVID-19...Yet it will likely be months, or even years, before a vaccine or treatment designed specifically for SARS-CoV-2 becomes available. Current treatment consists of supportive care...For the biopharma industry, the virus is disrupting business on a broad scale. Many companies source chemicals or pharmaceutical ingredients from factories across the globe, creating supply chain challenges, while stay-at-home orders have grounded company sales teams. The epidemic's impact on clinical trials has also widened, causing numerous delays to enrollment or postponements to studies of treatments for other diseases...READ MORE

Despite the unprecedented impact of coronavirus disease 2019 (COVID-19) on the economy and society, its impact on the health plan enterprise appears to be practical and functional rather than strategic and financial. This conclusion comes from a pilot study with health plan decision-makers...“business as usual."...READ MORE

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EMA’s human medicines committee (CHMP) has recommended expanding the compassionate use of the investigational medicine remdesivir so that more patients with severe COVID-19 can be treated...In addition to patients undergoing invasive mechanical ventilation, the compassionate use recommendations now cover the treatment of hospitalised patients requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or ECMO (extracorporeal membrane oxygenation)...Although remdesivir is not yet authorised for marketing in the European Union, these recommendations for compassionate use will help some patients with severe COVID-19 access the medicine while EMA evaluates data on its benefits and risks. When the evaluation is complete, EMA will make a recommendation on whether or not remdesivir should receive a marketing authorisation...READ MORE

Gilead was recently hit with an Iranian "password spraying" attack that used fake email login pages in an attempt to access passwords of high-ranking executives...In April, an Iranian hacker group known as "Charming Kitten" sent an email, purportedly from a journalist, to a Gilead legal and corporate affairs executive as part of a scheme to compromise the drugmaker's company email accounts...Earlier this week, the U.K. and U.S. governments warned that "malicious cyber campaigns" were targeting healthcare policymakers and researchers to gain access to corporate emails using "password spraying," or using common passwords to access a number of accounts...READ MORE