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Mylan NV said...it would launch a generic version of Gilead Sciences Inc’s COVID-19 antiviral remdesivir in India at 4,800 rupees ($64.31), about 80% below the price tag on the drug for wealthy nations...California-based Gilead has signed licensing deals with several generic drugmakers in an effort to make remdesivir available in 127 developing countries...two Indian drugmakers, Cipla Ltd and privately-held Hetero Labs Ltd, also launched generic versions of the treatment. Cipla will price its version, Cipremi, at less than 5,000 rupees, while Hetero has priced Covifor at 5,400 rupees...Gilead...priced remdesivir at $2,340 per patient for rich nations and agreed to send nearly all of its supply of the drug to the United States over the next three months...READ MORE

Public health experts...criticized the U.S. for securing a large supply of the only drug licensed so far to treat COVID-19...The U.S. government announced this week that it had an agreement with Gilead Sciences to make the bulk of their production of remdesivir for the next three months available to Americans. The Department of Health and Human Services said it had secured 500,000 treatments through September...Ohid Yaqub, a senior lecturer at the University of Sussex, called the U.S. agreement “disappointing news.”...“It so clearly signals an unwillingness to cooperate with other countries and the chilling effect this has on international agreements about intellectual property rights,” Yaqub said...READ MORE

Coronavirus vaccine developers now have some advice from the FDA: To win approval, any vaccine must be at least 50% effective in preventing the disease...FDA Commissioner Stephen Hahn plans to roll out that guidance...It sets a bar about on par with a flu shot's performance in a good year—but it falls short of some expert recommendations for arresting the virus' spread...The agency also won’t approve a shot based on its ability to create antibodies in patients’ blood...Despite the urgency of this particular vaccine hunt, the FDA “will not reduce its standards or cut corners in its review to approve a vaccine,”...READ MORE

The World Health Organization, together with partner organizations, aims to secure 2 billion doses of coronavirus vaccines by the end of 2021, unveiling...a creative plan to ensure high-risk groups around the world have access to any vaccine that's successfully developed... Through the WHO's plan, countries would be able to pool their resources to invest in the development a broad portfolio of experimental vaccines, obtaining in return a guaranteed share of the resulting supplies. The idea is to lessen the risk of betting on any one vaccine, while creating a mechanism by which doses are fairly allocated during the initial stages of a vaccine's availability...READ MORE

Doctors at Henry Ford Health System in southeast Michigan said that 26% of patients who did not receive the antimalarial drug died, compared to 13% of patients who received hydroxychloroquine during their stay in the hospital...The team published their findings in the International Journal of Infectious Diseases, adding that patients who were given hydroxychloroquine alone did even better than the ones who received this drug along with azithromycin...Other studies have shown no benefits of taking hydroxychloroquine for COVID-19, and some said that it may increase the risk for cardiovascular complications...“Our results do differ from some other studies,” Dr. Marcus Zervos, division head of infectious diseases at Henry Ford, said. “What we think was important in ours is that patients were treated early. For hydroxychloroquine to have a benefit, it needs to begin before the patients begin to suffer some of the severe immune reactions that we have with COVID-19,”...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

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

...CureVac has reportedly snared a big partner to help build its game-changing RNA "printers" that could turn global interest back in its favor...Tesla CEO Elon Musk tweeted Thursday that the electric carmaker had signed on with CureVac to make portable molecular RNA printers—what Musk called "RNA microfactories"—to help produce doses of the German vaccine maker's COVID-19 shot candidate...CureVac has previously touted its work on portable "printers" for its mRNA-based vaccines, which would allow the company to produce shots at scale in farflung locations without the standard logistical concerns...CureVac says its mRNA vaccine candidates direct cells to make proteins or antigens against various diseases. The platform encapsulates mRNA in a shell of lipid nanoparticles to protect it for delivery. The RNA printer itself—essentially a vaccine production device—can make “more than a hundred thousand doses” in a couple of weeks, the biotech says. It could work in a hospital pharmacy to help produce personalized medicines, for instance, as well as in outbreak regions...READ MORE

Auro Pharmacy has had a number of run-ins with FDA investigators...The FDA has had a long and troubled history with compounding pharmacies...sometimes those facilities bring it on themselves...Auro Pharmacies operated a veritable house of horrors at its...outsourcing facility, with ants in the sterile production areas and visibly dirty work surfaces, FDA investigators found during an August 2018 inspection...Those poor conditions could have produced supposedly sterile drugs that were "contaminated with filth,"...The FDA knocked Auro with a 10-observation Form 483 in August, 2018 that led to a voluntary recall of all the pharmacy's affected drugs and a stoppage to all sterile production...Even worse for Auro, the FDA followed up its August 2018 look-in with another round of inspections in September of last year that turned up most of the same sanitary issues, including "filth" on the end of hood-cleaning wands, and cracked and scratched production hoods...That inspection lead to a separate 11-observation Form 483 sent in October...READ MORE

The company’s SoteriaRx platform offers on-dose technology and detection services for authenticating a broad range of medications...(which)...protect patients from counterfeit products...on-dose authentication provides a powerful tool for tracking medicines from plant to patient and provides a level of supply chain authenticity and transparency not previously available. By incorporating microtags, the pill itself effectively becomes a barcode which can be digitally read and recorded, providing instant authentication...the incorporation of microtags essentially turns the pill itself into a barcode. This can be digitally read and recorded for authentication..READ MORE.