SAN ANTONIO--(BUSINESS WIRE)--Acelity, a global advanced wound care and regenerative medicine company, announced today that BIOSORB™ Gelling Fiber Dressing is now available in the United States and has Conformité Européenne (CE) Mark in Europe, where it will be available in the coming months. The BIOSORB™ Dressing is a unique wound dressing that forms a gel when it comes into contact with an exuding wound. This dressing offers increased absorbency and the ability to hold its shape, allowing for intact removal which is designed to make dressing changes less painful for patients. The dressing can be used for a variety of exuding wounds including leg ulcers, pressure ulcers, diabetic foot ulcers, surgical wounds that exude fluid, partial thickness burns, traumatic and oncology wounds.
Second Sight Announces Two Exclusive Distribution Agreements to Bring the Argus II Retinal Prosthesis to Taiwan and Iran
SYLMAR, Calif.--(BUSINESS WIRE)--Second Sight Medical Products, Inc. (NASDAQ:EYES) ("Second Sight" or "the Company"), a developer, manufacturer and marketer of implantable visual prosthetics to restore some useful vision to blind patients, today announced plans to expand into Taiwan with Orient Europharma Co, Ltd. and Iran with Arshia Gostar Darman Co, Ltd. through exclusive agreements to distribute the Argus® II Retinal Prosthesis System ("Argus II").
Pfizer Announces Positive Top-Line Results from Pivotal Phase 3 Maintenance Trial of Oral XELJANZ® (Tofacitinib Citrate) in Ulcerative Colitis
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today top-line results from Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) Sustain, the third Phase 3 study of XELJANZ® (tofacitinib citrate) being investigated in patients with moderately to severely active ulcerative colitis (UC). OCTAVE Sustain is a 52 week study that evaluated oral tofacitinib 5 mg and 10 mg twice daily (BID) as a maintenance treatment in adult patients with moderately to severely active UC who previously completed and achieved clinical response in either the OCTAVE Induction 1 or OCTAVE Induction 2 studies.
PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that it has received scientific advice from the European Medicines Agency (EMA) in connection with the company's OMS721 Phase 3 program for the treatment of atypical hemolytic uremic syndrome (aHUS). Based on this EMA advice, the company plans to run the same, single Phase 3 clinical program to support OMS721 marketing approval applications in both the U.S. and in the European Union for the treatment of aHUS. OMS721 is Omeros' lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) program for the treatment of thrombotic microangiopathies (TMAs), including aHUS and hematopoietic stem cell transplant-related (HSCT) TMAs, and for the treatment of complement-related renal diseases. Omeros plans to commercialize OMS721 initially for administration as a subcutaneous injection.
Akcea Therapeutics Receives Orphan Designation in Europe for Volanesorsen for the Treatment of Familial Partial Lipodystrophy (FPL)
PRNewswire/ -- Akcea Therapeutics, a wholly-owned subsidiary of Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), announced today that the European Commission (EC) has designated volanesorsen as an orphan medicinal product for the treatment of familial partial lipodystrophy (FPL). FPL is a rare lipid disorder characterized by abnormal fat distribution across the body and a range of metabolic abnormalities, including severe type 2 diabetes, high triglycerides, and accumulation of fat in the liver. The EC's approval follows a positive opinion in June from the European Medicine Agency's (EMA) Committee for Orphan Medicinal Products. Volanesorsen is being developed for the treatment of two rare, genetic cardiometabolic diseases: familial chylomicronemia syndrome (FCS) and familial partial lipodystrophy.
Neurocrine Announces Initiation of a Long-Term Phase II Clinical Study of VMAT2 Inhibitor Valbenazine in Tourette Syndrome
PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that it has initiated a Phase II clinical trial for NBI-98854 (valbenazine), a highly selective small molecule Vesicular Monoamine Transporter 2 (VMAT2) inhibitor, in children, adolescents and adults with Tourette syndrome.This study is an open-label, fixed-dose, study of up to 180 male and female patients with Tourette syndrome, consisting of up to 90 children and adolescents and up to 90 adults. The primary purpose of the study is to assess the long-term safety and tolerability of valbenazine. Enrollment in this long-term study is limited to subjects who have completed either the ongoing placebo-controlled T-Force GREEN or T-Forward studies. Patients will receive once-daily dosing during a twenty-four week treatment period to assess the safety and tolerability of valbenazine.
/PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today confirmed enrollment of the first patient in the company's Phase 3 clinical study to evaluate the efficacy and safety of terlipressin (for injection) in subjects with Hepatorenal Syndrome (HRS) type 1."Patients diagnosed with HRS type 1 typically have a very poor prognosis, and there is a significant unmet need for an approved treatment," said lead investigator Thomas D. Boyer, M.D., Director, Liver Research Institute, University of Arizona College of Medicine – Tucson. "I am excited to work with my colleagues in the hepatology community and with Mallinckrodt on this study of a potentially important therapy for U.S. patients."
AbbVie Announces Initiation of Phase 3 Study of Venetoclax in Patients with Relapsed or Refractory Multiple Myeloma
PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the initiation of a Phase 3 clinical trial to study the safety and efficacy of venetoclax in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome inhibitors and have received one to three prior lines of therapy. The combination of venetoclax, bortezomib and dexamethasone will be compared to treatment with bortezomib, dexamethasone and placebo.1 Bortezomib, a proteasome inhibitor, and dexamethasone, a corticosteroid, are both common therapies used to treat symptomatic multiple myeloma.3