Israeli startup Synchrony Medical Ltd. is gearing up to begin a U.S. clinical trial testing an airway clearance method developed at Israel’s Sheba Medical Center. The Libairty device is designed to support chronic lung disease patients to clear mucus with a short home-based daily treatment.
The U.S. FDA is hailing two revised draft guidances it released July 5 as “critical steps” toward implementing the electronic drug tracing requirements of the Drug Supply Chain Security Act.
A U.S. federal jury breathed new life into so-called pay-for-delay settlements when it found that a 2010 agreement between Endo International plc and Impax Laboratories LLC was procompetitive as it allowed Impax to launch its generic version of Opana ER, an opioid pain drug, before key patents expired.
The University of Central Florida (UCF) and Orlando Health are testing new medical technology designed to identify blood clots more quickly in surgery. The monitoring device consists of a small optical fiber that uses red blood cells to track the process of blood coagulation in patients so doctors can watch for life threatening blood clot formation.
The U.S. FDA’s guidance to COVID-19 vaccine manufacturers, announced June 30, that they should develop modified bivalent boosters that include an omicron BA.4/5 spike protein component marks the beginning of a new era in the pandemic in which manufacturers are no longer driving the development of the vaccines.
GE Healthcare issued a class I recall for Carescape R860 ventilators that covers more than 4,000 units distributed in the U.S., which was necessitated by problems with the battery backup component. No injuries or deaths have been reported in connection with the problem.
If timing is everything, Femasys Inc.’s Fembloc has everything on its side. While the company’s dual tracks addressing infertility and providing permanent contraception may appear at odds, they both serve to put greater control of reproductive decisions and treatment in the hands of women. A permanent contraceptive, Fembloc offers an alternative to surgical tubal ligation by encouraging scar tissue growth in the fallopian tubes in an office-based procedure.
Pfizer Inc. and Biontech SE have signed a deal with the U.S. government to supply up to 300 million doses of COVID-19 vaccines in a deal worth more than $3.2 billion. Depending on the U.S. FDA, the vaccine doses fulfilling the order may include the companies’ omicron-adapted candidate, which they reported June 25 demonstrated a high immune response against the omicron BA.1 subvariant of SARS-CoV-2, when given as a fourth booster.
The U.S. FDA has put five phase III studies of Sanofi SA’s potential multiple sclerosis and myasthenia gravis blockbuster tolebrutinib on partial clinical hold after several cases of liver injury were identified after exposure to the drug. Sanofi said new recruitment in the U.S. is paused and participants who have been part of the trial for fewer than 60 days should stop taking tolebrutinib, although those taking the drug for longer can continue.
The COVID-19 pandemic completely rewrote the script for government responses to communicable diseases, and thus the Biden administration is wasting no time reacting to the emergence of the monkeypox virus. The administration announced June 28 that it has developed a plan to allocate the distribution of large volumes of vaccines, but the CDC has shipped tests to five major commercial lab companies, thus putting the U.S. on a strong footing to respond to the outbreak.
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