Search This Blog

Monday, September 9, 2019

Horizon Therapeutics’ Teprotumumab nabs accelerated review status

The FDA grants Priority Review Designation to Horizon Therapeutics’ (NASDAQ:HZNP) BLA for teprotumumab, an investigational medicine for the treatment of active thyroid eye disease (TED).
PDUFA action date is March 8, 2020.
Priority Review shortens the review clock to six months from the standard 10 months.
If approved, teprotumumab would be the first FDA-approved medicine for the treatment of active TED.
Posted by at No comments:

Medtronic IN.PACT AV balloon successful in study

Results from the IN.PACT AV Access Study evaluating Medtronic’s (NYSE:MDT) IN.PACT AV drug-coated balloon (DCB) compared to percutaneous transluminal angioplasty (PTA) in patients with de novo or non-stented restenotic arteriovenous (AV) fistulae lesions met the primary efficacy and safety endpoints. The data were presented at the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) annual meeting in Barcelona.
The primary patency (the access site is open and functional) rate at day 180 was 86.1% in the IN.PACT DCB group versus 68.9% in the PTA group (p<0.001). The primary patency rate of the targeted lesion at day 210 was 81.4% for IN.PACT DCM versus 59.0% for PTA (p<0.001).
Patients in the IN.PACT DCB group required 56.0% fewer reinterventions to maintain target lesion patency at day 210 compared to PTA.
On the safety front, the rate of access circuit-related serious adverse events in the IN.PACT DCB cohort was 4.2% versus 4.4% for PTA through day 30.
AV fistulae are AV access sites created by vascular surgeons for short-term use by hemodialysis patients with end-stage renal disease (usually in the neck, chest, or leg in the groin area). Restenosis (abnormal narrowing of the artery or vein) limits the useful life of the access sites which typically require one-to-three maintenance procedures per year in order to restore function.
The device was CE Mark’d in January 2016 for the treatment of failing AV access in patients with end-stage renal disease undergoing dialysis.
Posted by at No comments:

Adaptimmune’s SPEAR T-cells targeting MAGE-A4 an Orphan Drug in U.S.

The FDA has granted Orphan Drug Designation (ODD) to Adaptimmune Therapeutics’ (NASDAQ:ADAP) SPEAR T-cells targeting MAGE-A4 (ADP-A2M4 program) for the treatment of soft tissue sarcomas.
Adaptimmune is currently investigating its ADP-A2M4 SPEAR T-cells in two types of sarcoma: synovial sarcoma and MRCLS.
Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved.
Posted by at No comments:

Alexion inks deal for investigational medicine in Japan

Alexion Pharmaceuticals (NASDAQ:ALXN) and BridgeBio Pharma’s (NASDAQ:BBIO) subsidiary Eidos Therapeutics (NASDAQ:EIDX) have announced an agreement that grants Alexion an exclusive license to develop and commercialize AG10 in Japan.
AG10 is a small molecule designed to treat the root cause of transthyretin amyloidosis (ATTR) – destabilized and misfolded transthyretin (TTR) protein – by binding and stabilizing TTR in the blood.
Eidos is currently evaluating AG10 in a Phase 3 study in the U.S. and Europe for ATTR cardiomyopathy and plans to begin a Phase 3 study in ATTR polyneuropathy in H2 2019.
Under the terms of the agreement, Eidos will receive an upfront payment of $25M and an equity investment of $25M, with the potential for additional Japanese-based milestone- and royalty-dependent payments.
Posted by at No comments:

Acadia Pharma up 68% premarket on positive pimavanserin data

ACADIA Pharmaceuticals (NASDAQ:ACAD) is up 68% premarket on increased volume in reaction to successful results in a Phase 3 clinical trial, HARMONY, evaluating lead drug NUPLAZID (pimavanserin) for the treatment of dementia-related psychosis.
The study met the primary endpoint of a statistically significant longer time to relapse of psychosis compared to placebo based on a planned interim analysis so the study will be stopped early.
The data will be submitted for presentation at future medical conferences. The company expects to file a supplemental marketing application in the U.S. in 2020.
The FDA approved NUPLAZID in April 2016 for Parkinson’s disease psychosis.
A Phase 3 study in schizophrenia patients was unsuccessful.
Management will host a conference call this morning at 8:30 am ET to discuss the results.
Posted by at No comments:

Amgen slips 4% premarket on early-stage MAG 510 data

Amgen (NASDAQ:AMGN) is down 4% premarket on light volume after announcing updated data from a Phase 1 clinical trial evaluating AMG 510 in patients with previously treated KRAS G12C-mutated solid tumors. The results were presented at the World Conference on Lung Cancer in Barcelona.
Investors appear disappointed with the partial response rate of 54% (n=7/13) in the highest dose (960 mg/day) cohort compared to 50% (n=5/10) reported at ASCO in June. The updated disease control rate (responders + stable cancer) was 100% (n=13/13) versus 90% (n=9/10) before.
On the safety front, there were no dose-limiting toxicities and no adverse events (AEs) leading to discontinuation. The rate of mild/moderate AEs was 26% (n=9/34) while the rate of serious AEs was 9% (n=3/34).
AMG 510 is a KRAS G12C inhibitor.
Fellow KRAS G12 inhibitor developer Mirati Therapeutics (NASDAQ:MRTX) is down 4% premarket as well.
Posted by at No comments:

Sunday, September 8, 2019

AAA members could save 85% on meds with GoodRx coupons

GoodRx, a healthcare savings company, will partner with AAA to offer its 59 million members exclusive savings on prescription drugs.
AAA members will have access to coupons and discounts that will help them save up to 85 percent on prescriptions.
The partnership gives AAA members 5 percent to 10 percent more off the price of prescriptions than current coupons and discounts available to other customers.
The coupons are usable at over 70,000 pharmacies across the U.S., including CVS and Walgreens.
Posted by at No comments:
Subscribe to: Posts (Atom)