Royalty Pharma to pay Ferring $300 million upfront and a potential $200 million milestone payment in exchange for royalties on the sales of Ferring’s intravesical gene therapy Adstiladrin® (nadofaragene firadenovec-vncg)
Transaction provides Ferring with significant non-dilutive capital to support the manufacturing capacity expansion, commercialization and further clinical development of Adstiladrin for bladder cancer patients in the United States
The U.S. Food and Drug Administration's (FDA) independent experts on Wednesday narrowly voted against recommending the approval of Medtronic's blood pressure treatment device, saying risks tied to using it do not outweigh the benefits.
The same panel on Tuesday voted in favor of rival ReCor's device for use in a surgery called renal denervation in patients whose high blood pressure cannot be controlled by drugs.
When asked if the benefits outweighed the risks of the device, six members each voted for and against it, while one abstained. The chairperson of the panel then had to break the tie to vote against the device.
Separately, while all panel members voted the device was safe to use, 6 of 13 voted against its effectiveness.
The panel's recommendations are not binding, but are usually followed by the FDA.
"We appreciate the robust conversation that occurred prior to the vote," Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business, Medtronic, said in a statement, adding, the company will continue to collaborate with the FDA on bringing a new option.
Japan-based Otsuka Holdings' unit ReCor's device was shown to provide a benefit in lowering blood pressure in clinical trials. Medtronic's device helped to lower blood pressure at the doctor's clinic but not at home, which is considered a more accurate measure of blood pressure monitoring.
Medtronic and the FDA's staff reviewers said before the meeting that additional analyses of the data showed the difference could be due to factors such as use of more drugs by patients treated with a "sham" procedure.
The company was seeking the health regulator's nod for the device indicated for patients whose hypertension, or high blood pressure, cannot be controlled with drugs.
The surgery, which is allowed in Europe and other parts of the world, is not approved in the U.S., after initial studies of older devices used in the procedure failed key studies, and several companies dropped out of the race to develop them
https://finance.yahoo.com/news/1-us-fda-panel-votes-223440031.html
Health insurer Cigna Group said on Thursday it would remove the use of prior authorization or paperwork required to get approval for insurance coverage for 25% of medical services.
Health insurers have come under pressure as physicians claim that the pre-authorization requirements for some procedures are restrictive and increases their paperwork.
"Clinicians and health plans alike agree that more can be done to reduce the administrative burden on clinicians," said Scott Josephs, chief medical officer of Cigna Healthcare.
The prior authorization, or pre-certification process, requires healthcare providers to get coverage approval for certain non-emergency procedures.
UnitedHealth Group said earlier this year that it plans to reduce use of prior authorization requirements by 20% for some non-urgent surgeries and procedures.
https://finance.yahoo.com/news/1-cigna-removes-pre-authorization-102546723.html
Richard Barry, Director, on August 21, 2023, executed a purchase for 18477 shares in Cassava Sciences for $307928.
Fast Track Designation (FTD) is designed to accelerate the development and expedite the review of therapies with potential to address unmet medical needs for a serious or life-threatening condition
TSHA-102 has also received Orphan Drug and Rare Pediatric Disease designations from the United States (U.S.) Food and Drug Administration (FDA) and has been granted Orphan Drug designation from the European Commission
https://finance.yahoo.com/news/taysha-gene-therapies-announces-fast-120000035.html
CABINET trial will be unblinded and stopped early due to a dramatic improvement in efficacy per a unanimous recommendation by The Alliance for Clinical Trials in Oncology independent Data and Safety Monitoring Board –
– Based on positive results, findings will be discussed with the U.S. Food and Drug Administration –
https://finance.yahoo.com/news/exelixis-announces-positive-results-phase-120000195.html
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury® (remdesivir) with no dose adjustments to treat COVID-19 in people with mild, moderate and severe hepatic impairment. This approval further supports the safety profile of Veklury as the first and only approved antiviral COVID-19 treatment that can be used across all stages of liver disease.
The clinical benefit of Veklury in hospitalized populations with COVID-19 is supported by randomized controlled trials, real-world evidence and meta-analyses, but the pharmacokinetics of Veklury had not previously been evaluated in patients with hepatic impairment. This latest approval is based on results from a Phase 1 study of safety and pharmacokinetics in people with hepatic impairment (GS-US-540-9014). No new safety signals were observed. Based upon these results, the label has been updated to reflect that no dose adjustment is required across all stages of liver disease. The label still recommends initial hepatic laboratory testing in all patients, before starting Veklury and during treatment as clinically appropriate, and that discontinuation be considered if alanine transaminase (ALT) levels increase to 10 times the upper limit of normal or if ALT elevation is accompanied by signs or symptoms of liver inflammation.
https://finance.yahoo.com/news/fda-approves-veklury-remdesivir-treat-123000031.html
