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...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

Treatments for peanut allergy and Parkinson’s disease are among U.S. drug launches that have been postponed by the COVID-19 pandemic as drugmakers struggle with disruptions to business...The Food and Drug Administration has approved more than 30 new medicines since January, but at least five drugmakers...have changed their launch plans...Launching drugs is an expensive and complicated process that includes sales representatives talking to doctors, coordinating supplies and treatment with pharmacies and clinics, and advertising campaigns - many of which have become harder during lockdowns or other restrictions to tackle the pandemic...That’s bad news for patients and drugmakers...Delays altogether could cost companies over a quarter of the originally estimated more than $1 billion in 2020 sales for the products approved by the FDA since January...READ MORE

In the recent flap over chloroquine and its relative hydroxychloroquine, drugs seen as promising in many quarters for use in treating COVID-19 patients, one commentator typical of many sternly proclaimed that these compounds “have NOT been proven effective against” the novel coronavirus. Implication: These are drugs no reasonable person would want to take, nor a reasonable doctor prescribe...And yet, as Arizona physician Jeffrey Singer notes, “Doctors around the globe, including the U.S., are using these and other drugs to treat their patients, and reporting on their findings in the peer-reviewed medical literature.” It’s both legal and utterly routine for doctors to prescribe a drug for indications other than the one for which it has been approved — so-called “off-label prescribing.”...In fact, an estimated 20% of pharmaceuticals reach patients that way. And this will be true almost by definition for a newly emergent malady, for which there will be no compounds proven effective yet...READ MORE

Changes in U.S. Food and Drug Administration procedures meant to speed approvals for medications may have resulted in less exacting standards, a new analysis suggests...Congressional acts that changed the way the FDA evaluates drugs have led to less rigorous evaluations, with drug approvals being based on fewer and/or earlier-stage clinical trials that may not be randomized, controlled, blinded or based on traditional measures of efficacy…the good news...points to the increased number of orphan drugs that have been approved...the bad news. “Faster in this case means that less data gets collected,”...“Some drugs may get accelerated approval, on thinner evidence, and wind up not being any better than existing and often cheaper alternatives.”...READ MORE

AbbVie grew Humira into the world’s bestselling medicine in part through price hikes and an aggressive patenting strategy to defend against competition. The company is now deploying similar tactics to bolster Imbruvica, a cancer drug with numerous uses and big sales, experts concluded in a new report...AbbVie has filed for 165 patents on Imbruvica, and officials have granted 88 of them, the Initiative for Medicines, Access & Knowledge reports. The company’s add-on patents have earned AbbVie another nine years of patent protections for a total of 29 years of commercial exclusivity...READ MORE

Following in the footsteps of British Columbia, other Canadian provinces are working to implement their own biosimilars initiatives that would switch patients from some of the most costly reference biologics to biosimilar counterparts...A look at the numbers explains why Canadian provinces are introducing automatic biosimilar switching policies...In Ontario, one of 4 provinces that are moving forward with forced switching, a total of $800,000 was spent on publicly funded biologic medications in 2018, up nearly 3-fold from $259.4 million in 2010, and the projection is for the total to reach $1 billion in 2021...“The Biosimilars Initiative is a result of PharmaCare’s evidence-informed strategy to better optimize our public resources, get the best value for new treatments and services, and improve access to biologic medications for patients,” BC government officials said...READ MORE

Purdue Pharma has requested permission from the U.S. Bankruptcy Court for the Southern District of New York to develop a new product to reverse opioid overdoses...Purdue is seeking authorization for a development agreement between its affiliate, Greenfield Bioventures, and an unnamed pharmaceutical company. The proposed agreement would allow Purdue to grant intellectual property related to the nalmefene injectable to its unnamed partner, which in turn, would license its autoinjector technology to Purdue...READ MORE

The European Commission said on Friday it had given conditional approval for the use of antiviral remdesivir in severe COVID-19 patients following an accelerated review process, making it the region’s first authorised therapy to treat the virus...The move comes just a week after the European Medicines Agency (EMA) gave its go-ahead for the drug...to be used in adults and adolescents...The EU’s green light broadens the use of remdesivir around the world - the United States has cleared it for emergency use and it is also approved as a COVID-19 therapy in Japan, Taiwan, India, Singapore and the United Arab Emirates...The approval is valid for one year in the bloc and can be extended or converted into an unconditional marketing authorisation if all necessary data are available on its efficacy and side effects...READ MORE

The Food & Drug Administration has authorized the use of two drugs championed by President Donald Trump as a means to fight coronavirus...On Sunday night the FDA issued an emergency authorization for the use of two anti-malaria drugs, hydroxychloroquine and chloroquine. Researchers in the United States have begun testing the drugs in some states, like New York, but the drug will now be more widely available...The FDA has allowed for the drugs to be “donated to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible,” the department of Health and Human Services said in a statement...READ MORE

Although control measures are applied, falsified medicines are present in the supply chain in Niger, with solutions requiring cross-country collaboration, says the country’s Ministry of Health...The spotlight was put on the topic of falsified medicines earlier this month with the signing of the Lomé Initiative​, a political declaration under which the governments of seven African countries agreed to act to fight the issue, and improve access to quality medicines for African populations...the smuggling of fake drugs occurring at the country’s borders is the main weak point in the supply chain...harmonization of the legislation...can and needs to be achieved with the establishment of the African Medicines Agency, which would be the African equivalent of the European Medicines Agency, in charge of the evaluation and supervision of medicinal products...READ MORE