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In its effort to combat fraudulent medical products that claim to prevent or treat COVID-19, FDA has issued 42 warning letters, as of May 7, 2020, to companies promoting unproven products claiming to prevent, treat, diagnose, or even cure COVID-19...The agency’s Operation Quack Hack has discovered hundreds of fraudulent drugs, testing kits, and personal protective equipment sold online. FDA has sent numerous abuse complaints to domain name registrars and Internet marketplaces, who the agency says have voluntarily removed the identified postings. “We will continue to monitor the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic. We encourage anyone aware of suspected fraudulent medical products for COVID-19 to report them to the FDA,” the agency said in a press release...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

India, one of the largest drug exporters in the world, has been hit hard by the novel coronavirus pandemic as global lockdowns have complicated daily operations. On one measure—the FDA's nearly two-month ban on foreign inspections—Indian drugmakers are pushing back. And they may have come up with a novel solution...Major Indian pharmaceutical companies are asking the FDA to conduct "desk reviews" or virtual facility inspections during the pandemic in order to "ensure the continuous supply of much-needed drugs in the United States," according to a letter from the Indian Pharmaceutical Alliance...The group also requested the FDA consider recognizing inspections by foreign regulators and temporarily waiving on-site inspections "based on past inspection history and the critical nature of products, such as drug shortages or products that do not currently have generic alternatives."...READ MORE

Under pressure to expand public access to new medicines, diagnostic tests, and other medical products needed to detect and treat patients struck by COVID-19, FDA has issued more than 100 Emergency Use Authorizations since early February, compared to fewer than 75 during the 10 previous years. While this activity reflects the imperative for fast action by federal agencies and manufacturers to address the pandemic crisis, it also generates questions about the vetting of these requests and how well FDA can follow up with sufficient tracking of the safety and efficacy of these products. And some observers fear that political interference in the process may erode confidence in the scientific basis for FDA regulatory decisions...READ MORE

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

Congressional leaders are developing the next version of the 21st Century Cures Act, including provisions to advance research related to the COVID-19 crisis as part of initiatives for bringing innovative therapies to market faster. A concept paper for a Cures 2.0 legislative package was recently unveiled by Reps. Diana DeGette (D-Col) and Fred Upton (R-Mich), who sponsored the Cures bill of 2016. It calls for a national COVID-19 testing and response strategy, with specifics for developing and administering vaccines and therapeutics and for modernizing and expanding US biopharma manufacturing capacity to provide needed treatments for patients on a timely 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