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Rhizen Pharmaceuticals AG Announces That Its Partnered Asset, Umbralisib (UKONIQ™), Has Received US FDA…

first_img WhatsApp WhatsApp By Digital AIM Web Support – February 8, 2021 Facebook Facebook Rhizen Pharmaceuticals AG Announces That Its Partnered Asset, Umbralisib (UKONIQ™), Has Received US FDA Accelerated Approval for Adult Patients With Relapsed or Refractory MZL & FL Previous articleMcCormack helps unranked KU beat No. 23 Oklahoma St. 78-66Next articleCirelli scores twice as Tampa Bay beats Predators 4-1 Digital AIM Web Support BASEL, Switzerland–(BUSINESS WIRE)–Feb 8, 2021– Rhizen Pharmaceuticals, a clinical-stage oncology-focused biopharmaceutical company, today announced that its novel next generation PI3K-delta inhibitor, Umbralisib, which was licensed to TG Therapeutics (NASDAQ:TGTX), has secured US FDA accelerated approval for the treatment of: adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen, andadult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. Accelerated approval was granted for these indications, under a priority review (MZL), based on the results of the Phase 2 UNITY-NHL Trial (NCT02793583); in MZL, an ORR of 49% with 16% complete responses and in FL an ORR of 43% with 3% complete responses were achieved, respectively. Umbralisib was earlier granted Breakthrough Therapy Designation (BTD) for the treatment of MZL and orphan drug designation (ODD) for the treatment of MZL and FL. Umbralisib is a novel, next generation, oral, once daily, inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon and was discovered by Rhizen Pharma and subsequently licensed to TG Therapeutics (NASDAQ:TGTX) at an IND stage (TGR 1202) in 2012. In 2014, both parties entered into a licensing agreement as a part of which TGTX obtained worldwide rights and Rhizen has retained commercialization rights for India while also being the manufacturing and supply partner for Umbralisib. Swaroop Vakkalanka, President & CEO of Rhizen Pharmaceuticals said: “Umbralisib’s approval offers MZL & FL patients a new treatment option and is a huge validation of Rhizen’s drug discovery & development capabilities. This is a momentous occasion in Rhizen’s journey as a successful biotech that speaks of the true ability of our team to discover & develop safe and effective therapies that can last the rigors of drug development. Further, we are keen to bring Umbralisib to Indian patients and we plan to initiate activities towards registration and approval there soon.” Pranav Amin, Chairman, Rhizen Pharmaceuticals & Managing Director of Alembic Pharmaceuticals Ltd said: “We are extremely proud of this historic milestone for Rhizen, and of the fact that Umbralisib is the first NCE discovered by Indian scientists to secure a US FDA approval. We are committed to working together with TG Therapeutics and Rhizen Pharma to ensure uninterrupted supply of UKONIQ™. Umbralisib is the first discovery asset to come out of Rhizen’s R&D efforts and this approval heralds the promise of the rest of Rhizen’s deep pipeline and continuing efforts.” About Umbralisib: Umbralisib is the first and only oral inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon. PI3K-delta is known to play an important role in supporting cell proliferation and survival, cell differentiation, intercellular trafficking and immunity and is expressed in both normal and malignant B-cells. CK1-epsilon is a regulator of oncoprotein translation and has been implicated in the pathogenesis of cancer cells, including lymphoid malignancies. Umbralisib is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. These indications are approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. More information on Umbralisib or UKONIQ™ can be found at https://www.tgtherapeutics.com/prescribing-information/uspi-ukon.pdf. About Alembic Pharmaceuticals Ltd: Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic’s state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic’s products that are marketed through a marketing team of over 5000 are well recognized by doctors and patients. Information about Alembic can be found at http://www.alembicpharmaceuticals.com/. (Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLL TD) (BSE: 533573) About Rhizen Pharmaceuticals A.G.: Rhizen Pharmaceuticals is an innovative, clinical-stage biopharmaceutical company focused on the discovery and development of novel onco-therapeutics. Since its establishment in 2008, Rhizen has created a diverse pipeline of proprietary drug candidates targeting several cancers and immune associated cellular pathways. Rhizen is headquartered in Basel, Switzerland. For additional information, please visit www.rhizen.com. View source version on businesswire.com:https://www.businesswire.com/news/home/20210208005742/en/ CONTACT: Samyukta Bhagwati Manager, Corporate Affairs & Communications Rhizen Pharmaceuticals AG +41 32 580 0113 [email protected] KEYWORD: EUROPE SWITZERLAND UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: SCIENCE BIOTECHNOLOGY RESEARCH PHARMACEUTICAL ONCOLOGY HEALTH FDA CLINICAL TRIALS SOURCE: Rhizen Pharmaceuticals AG Copyright Business Wire 2021. PUB: 02/08/2021 11:45 PM/DISC: 02/08/2021 11:45 PM http://www.businesswire.com/news/home/20210208005742/encenter_img Twitter Pinterest Twitter Pinterest TAGS  Local NewsBusinesslast_img read more

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Lukas Prize Project Awards announced for 2010

first_imgThe Nieman Foundation at Harvard and the Columbia University Graduate School of Journalism recently announced this year’s recipients of the J. Anthony Lukas Prize Project Awards for exceptional nonfiction.The Lukas Prizes, established in 1998 and selected by committee members from Harvard and Columbia, recognize excellence in nonfiction writing that exemplifies the literary grace and commitment to serious research and social concern that characterized the work of the awards’ Pulitzer Prize-winning namesake J. Anthony Lukas, who died in 1997.Winners for 2010 include David Finkel, for his up-close examination of the human costs of making war; James Davidson, for his study of the homoerotic culture of ancient Greece; and Jonathan Schuppe, for his account of life in inner-city Newark, N.J., which focused on the efforts of an ex-con and former drug dealer to help impoverished children in the city’s most depressed neighborhood.To read the full story, visit the Neiman Foundation Web site.last_img read more

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Other Sports Pro Kabaddi League: Puneri Paltan scores 31-23 win against Bengaluru Bulls

first_img For all the Latest Sports News News, Other Sports News, Download News Nation Android and iOS Mobile Apps. Chennai: Puneri Paltan registered a 31-23 win against defending champions Bengaluru Bulls in a Pro-Kabaddi League match at Jawaharlal Nehru Indoor Stadium here on Wednesday.A heavily bandaged Surjeet Singh at the centre was the leader (6 tackle points) in the defensive unit for Puneri Paltan, never allowing the league’s best raider, Pawan Sehrawat, to weave his magic.Sagar Krishna came in for a struggling Girish Ernak as coach Anup Kumar made the changes to a faltering Pune side while the Bengaluru Bulls went in with an extra defender in the line-up buoyed by the performances of their two raiders in Pawan Sehrawat and Rohit Kumar.It was the Pune team which started off well, consistently tackling Bengaluru Bulls raiders, with Sagar Krishna justifying his inclusion with an incredible body block on Rohit Kumar six minutes into the match.The defensive units matched each other tackle for tackle, as the raiders, including Punes Nitin Tomar struggled to impress.A low-scoring, heavy tackling first half, which also saw Sehrawat reach 100 points for the season, ended with scores even at 10-10. Bengalurus decision to play just two raiders backfired as Paltans improved defence thwarted any raider who ventured into their territory.Pune inflicted the game’s only All-Out on Bengaluru Bulls in the sixth minute of the second half to open up an 8-point gap. Manjeets clever raids in do-or-die situations were also vital for Pune as they raced to a two-digit lead.The defence held firm, as Surjeet Singh completed a personal milestone of 250 points in Pro Kabaddi League, and secured a very important victory that pushed his team up to 10th in the league standings.Bengalurus loss meant they lost out on an opportunity to go to the top of the points table. last_img read more

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