An East Bay company's 16-year goal to deliver drugs through tiny needles on an adhesive patch comes to an end in bankruptcy court.
Nearly 30 months ago, Zosano Pharma Corp. won a date for an FDA decision on its microneedle-packed patch to soothe migraines. Last week, the company closed its sale out of bankruptcy court for $1 million.
In addition to the sale price, Emergex could pay up to $250,000 to cover the dismantling and removal of Zosano assets. Zosano's program used a proprietary formulation of the drug for people who have five or more migraines a month, showing through clinical trials that its product could provide migraine pain relief within 30 minutes.
But when that time rolled around, the FDA rejected the drug-device, citing inconsistent exposure levels of the drug in five of 774 patients who received different lots of the drug in clinical trials. The agency also noted inadequate"pharmacokinetic bridging" between drug lots that made interpretation of some safety data unclear.
France Dernières Nouvelles, France Actualités
Similar News:Vous pouvez également lire des articles d'actualité similaires à celui-ci que nous avons collectés auprès d'autres sources d'information.
Moderna booster application goes to FDA for authorizationThis updated formulation is a bivalent vaccine that will combine the original vaccine with one that targets omicron sublineages BA.4 and BA.5.
Lire la suite »
Trump staffers pushed unproven COVID treatment at FDA: PanelOfficials in the Trump White House tried to pressure U.S. health experts into reauthorizing a discredited COVID-19 treatment.
Lire la suite »
Moderna booster application goes to FDA for authorizationThis updated formulation is a bivalent vaccine that will combine the original vaccine with one that targets omicron sublineages BA.4 and BA.5.
Lire la suite »
Moderna booster application goes to FDA for authorizationThis updated formulation is a bivalent vaccine that will combine the original vaccine with one that targets omicron sublineages BA.4 and BA.5.
Lire la suite »
FDA Plans To Authorize Updated Covid Boosters Around Labor DayThe Food and Drug Administration plans to authorize updated versions of Pfizer-BioNTech’s and Moderna’s Covid boosters around Labor Day, NBC News reported, citing two people familiar with the discussions. The Biden administration is preparing to distribute the updated booster shots to teenagers and adults as part of its fall booster campaign. Both Pfizer’s and Moderna’s reformulated shots target the BA.4…
Lire la suite »