Sirolimus News and Research

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Santen announces Phase III results of sirolimus intravitreal injections in non-infectious posterior segment uveitis patients

Santen Inc., the U.S. subsidiary of global ophthalmic pharmaceutical company Santen Pharmaceutical Co., Ltd. (Osaka, Japan), today announced that SAKURA (Study Assessing double‐masKed Uveitis tReAtment) Study 1, the first of two Global Phase III studies evaluating intravitreal injections of sirolimus in patients with non-infectious posterior segment uveitis (NI-PSU), met its primary endpoint.

From Santen Pharmaceutical Co., Ltd. 7 Apr 2014

Transplant drugs may help defeat HIV

Drugs that are currently given to prevent organ rejection in patients who have received a transplant may offer a new approach to curing HIV, say researchers.

3 Apr 2014

Research findings suggest new strategy in fight against HIV infection

New research suggests that drugs commonly used to prevent organ rejection after transplantation may also be helpful for combating HIV. The findings, which are published in the American Journal of Transplantation, suggest a new strategy in the fight against HIV and AIDS.

3 Apr 2014

AB Sciex launches immunosuppressants kit to improve health care

Every organ transplant patient in the world faces the potential danger of his/her body rejecting a new organ, such as a heart, kidney or liver. Immunosuppressant drugs are required to help prevent rejection.

2 Apr 2014

Merck's NOXAFIL injection gets FDA approval for intravenous use

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved NOXAFIL (posaconazole) injection (18 mg/ mL), a new formulation of NOXAFIL for intravenous (IV) use.

16 Mar 2014

Novartis to present updates on broad cancer portfolio at ASH and SABCS symposiums

Novartis will present updates on its broad cancer portfolio with more than 240 abstracts at the upcoming American Society of Hematology (ASH) annual meeting and CTRC-AACR San Antonio Breast Cancer Symposium (SABCS).

4 Dec 2013

Merck announces approval of NOXAFIL delayed-release tablets by FDA

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved NOXAFIL® (posaconazole) 100 mg delayed-release tablets.

27 Nov 2013

FDA approves OLYSIO (simeprevir) for treatment of chronic hepatitis C infection

Janssen Therapeutics, Division of Janssen Products, LP, announced today the U.S. Food and Drug Administration has approved OLYSIO (simeprevir), an NS3/4A protease inhibitor, for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.

23 Nov 2013

FDA accepts Merck's NOXAFIL IV solution NDA for priority review

Merck, known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational intravenous solution formulation of the company's antifungal agent, NOXAFIL (posaconazole), has been accepted for priority review by the U.S. Food and Drug Administration.

18 Nov 2013

Svelte completes enrollment in drug-eluting coronary stent Integrated Delivery System study

Svelte Medical Systems today announced enrollment of the final patient in the DIRECT II (Direct Implantation of Rapamycin-Eluting stents with bioabsorbable drug Carrier Technology) clinical study. DIRECT II is a prospective, randomized study comparing the safety and efficacy of the Svelte drug-eluting coronary stent Integrated Delivery System (IDS) to the Medtronic Resolute Integrity drug-eluting stent in 159 patients at 19 investigative sites.

From Medtronic 14 Nov 2013

Results announced for Phase 3B/4 study of RAPAMUNE in kidney transplant patients

Pfizer Inc. (NYSE:PFE) announced today top-line results from a Phase 3B/4 study of RAPAMUNE® (sirolimus) evaluating kidney transplant patients who transitioned from tacrolimus-based therapy (TAC) to RAPAMUNE® 3 to 5 months after transplant.

12 Nov 2013

FDA approves Astellas' ASTAGRAF XL for prophylaxis of organ rejection in kidney transplant patients

Astellas Pharma US, Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc., announced today that the U.S. Food and Drug Administration has approved ASTAGRAF XLTM (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil and corticosteroids, with or without basiliximab induction.

20 Jul 2013

OrbusNeich introduces COMBO Dual Therapy Stent

OrbusNeich today launched the world's first dual therapy stent – the COMBO Dual Therapy Stent – to address the challenges of delayed healing of the coronary artery associated with monotherapy drug eluting stents, the current standard of care for the treatment of coronary artery disease.

27 May 2013

DESolve bioresorbable coronary scaffold system safe and effective, shows low rates of late lumen loss

The DESolve bioresorbable coronary scaffold system achieves good efficacy and safety with low rates of late lumen loss and major coronary adverse events at six months, show first results from the pivotal DESolve Nx trial reported at EuroPCR 2013 today.

23 May 2013

Elixir Medical receives FDA approval to initiate patient enrollment in EXCELLA III clinical trial in US

Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced today that it has received approval from the Food and Drug Administration to initiate patient enrollment in the EXCELLA III clinical trial in the United States at up to 50 institutions with conditions to be addressed in parallel.

8 May 2013

Targeted therapy prevents rare neurodevelopmental disorder seizures

Rapamycin treatment reduces seizure frequency and improves receptive language in patients with polyhydramnios, megalencephaly, and symptomatic epilepsy syndrome, or Pretzel syndrome, a study finds.

29 Apr 2013

Drug alerts have variable impact on prescribing habits

Direct communication with healthcare professionals, in the form of so-called “Dear doctor” letters, can be effective in reducing inappropriate and unsafe use of medicines, Dutch scientists believe.

29 Apr 2013

Sirolimus effective in treating children with Pretzel syndrome, new study reports

With a better understanding of underlying mechanisms that cause a rare neurodevelopmental disorder in the Old Order Mennonite population, referred to as Pretzel syndrome, a new study reports that five children were successfully treated with a drug that modifies the disease process, minimizing seizures and improving receptive language.

25 Apr 2013

FDA accepts Merck's NDA for NOXAFIL tablets

Merck, known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational, tablet formulation of the company's antifungal agent, NOXAFIL (posaconazole), has been accepted for review by the U.S. Food and Drug Administration.

11 Apr 2013

Delaware District Court rules in favor of Pfizer in RAPAMUNE patent case

Pfizer Inc. said today that the United States District Court for the District of Delaware ruled that Pfizer's patent covering a method for using sirolimus, the active ingredient in RAPAMUNE®, for the inhibition of organ transplant rejection is valid and infringed.

31 Jan 2013