Company Overview and News
Clinuvel Pharmaceuticals (CLVLY) held their annual general shareholder meeting (AGM) on November 28th, 2017, revealing new pockets for growth and a re-positioning of the company.
Clinuvel Pharmaceuticals, after many, many years, finally became a commercial operation with the introduction of Scenesse as the first treatment for EPP.
SCENESSE has been developed for the treatment of erythropoietic protoporphyria (EPP), a rare genetic enzymatic disorder causing lifelong absolute light intolerance. Clinuvel will submit the modular dossier on SCENESSE on a rolling basis during the first half of 2017. After the completion of the submission of the dossier, the FDA will observe a validation period of two months. Notably, a positive benefit-risk assessment of SCENESSE by the FDA is expected to make the drug available as the first systemic photoprotectant for adult EPP patients.
Clinuvel Pharmaceuticals Ltd (ASX:CUV) has fulfilled an important FDA requirement by demonstrating the safety of its drug SCENESSE in combination with ultraviolet light for the pigmentation disorder vitiligo. The company will now engage with the FDA regarding the upcoming vitiligo trials and progress clinical development of the combination therapy. Clinuvel had completed one Phase II clinical trial of SCENESSE in vitiligo patients in the U.
Clinuvel Pharmaceuticals Ltd (ASX:CUV) is a global biopharmaceutical company committed to developing drugs for the treatment of a range of severe skin disorders.
A tanning agent that hadn’t seen the light of day since the 1980s is getting a lot of attention now that it has been transformed into a medicinal product with photoprotective and repigmentary capabilities. The medicinal product, which represents a new way of treating rare, light-sensitive skin disorders, has a sizeable global market—an estimated 45 million patients suffer disorders that make them potential candidates.
2018-05-25 - Asif
Overview Heron is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments that address some of the most important unmet patient needs. Heron Therapeutics is developing novel, patient-focused solutions that apply its innovative science and technologies to already approved pharmacological agents for patients suffering from cancer or pain. On August 9, 2016, its first commercial product, SUSTOL, was approved by the FDA. The company developed SUSTOL for the prevention of chemotherapy-induced nausea and vomiting (“CINV”). SUSTOL is indicated, in combination with other antiemetics, in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (“MEC”) or anthracycline and cyclophosphamide (“AC”) combination chemotherapy regimens. The company commenced commercial sales of SUSTOL in the U.S. in October 2016. On November 9, 2017...
2018-05-25 - Asif
Overview The company's mission is to deliver high-speed coherent optical interconnect products that transform communications networks, relied upon by cloud infrastructure operators and content and communication service providers, through improvements in performance and capacity and reductions in associated costs. By converting optical interconnect technology to a silicon-based technology, a process the company refer to as the siliconization of optical interconnect, the company believe Acacia Communications is leading a disruption that is analogous to the computing industry’s integration of multiple functions into a microprocessor. The company's products include a family of low-power coherent digital signal processor application-specific integrated circuits, or DSP ASICs, and silicon photonic integrated circuits, or silicon PICs, which Acacia Communications has integrated into families of optical interconnect modules with transmission speeds ranging from 100 to 400 gigabits per ...
2018-05-21 - Asif
Overview Anthera Pharmaceuticals, Inc. is a biopharmaceutical company focused on advancing the development and commercialization of innovative medicines that benefit patients with unmet medical needs. The company currently have two compounds in development, Sollpura and blisibimod. The company licensed Sollpura from Eli Lilly & Co (“Eli Lilly”) in July 2014. Sollpura is a novel non-porcine investigational Pancreatic Enzyme Replacement Therapy (“PERT”) intended for the treatment of patients with Exocrine Pancreatic Insufficiency (“EPI”), often seen in patients with cystic fibrosis and other conditions. The company licensed blisibimod from Amgen, Inc. (“Amgen”) in December 2007. Blisibimod targets B-cell activating factor, or BAFF, which has been shown to be elevated in a variety of B-cell mediated autoimmune diseases, including Immunoglobulin A nephropathy, or IgA nephropathy. Sollpura The exocrine pancreas is responsible for synthesis and secretion of digestive en...