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1025
Pliant Therapeutics Announces Strategic∞× Collaboration to Devel'α≤→op Novel Therapies for NA ±¶SH and Fibrotic Diseases
Pliant Therapeutics Announce♥ ¥s Strategic Collaboration to Develop±α¥≠ Novel Therapies for NASH and Fibrotic Disea±¶©∑sesTHURSDAY, OCTOBER 24, 2019Pliant T ♦♠herapeutics, Inc., a clinical stage biopharmaceu≠↑πtical company focused on discovσ≈γering and developing n↕ ↓'ovel therapies for the®δ treatment of fibrosis, today announced it ✔'has entered into a strategic coll♦←aboration and license agreement with Novartis c$¥∞∞overing the development and commercializatδ×↔✘ion of Pliant's precl©ε↕≠inical product candidate, PLN-1474 and up to t≤±♣✘hree additional integrin © targets. PLN-1474 is an internally discover☆↕σ↔ed small molecule selective inhibitorδ₩™↓ of integrin αVβ1, currently being developed f$σ±or the treatment of liver fibrosis associated£¶©₩ with nonalcoholic steatohepatitis (NASH)."Our re'©search continues to generate compel₽¶₩×ling preclinical evidence that supp>≥♦"orts the advancement of PLN-147&4 as a clinical candidate and <§validates our approach ÷€of evaluating αVβ1 integrin inhib"↕€♣ition to treat advanced liver fibro∏'φ¥sis associated with NASH," £₽ said Bernard Coulie, M.D., π$♣Ph.D., president and chief executive officer o©→f Pliant Therapeutics. "Pairing Pliant's leading♠₩ integrin biology and drug discovery capabiliφ♣β÷ties with Novartis, a world-∏≠σleader with one of the broade↔"↑st pipelines investiγφΩgating mono and comb™ε ination therapies for liver diseases €≥including NASH, will support our goal of ↕♦₩developing novel therapies for ≠✘§∞fibrotic diseases and potentially bring ≈≈↑₽meaningful treatment options to ♥♠patients."Pliant will initially∑♦ receive $80 million from Novartis, including anφ♣ upfront payment in connecti≈ ♠∏on with the collaboration÷↔ agreement as well as equity investment commiε∏tments. The collaboratio<→n agreement is for a wor ¥←ldwide exclusive license to PL™&×N-1474 and up to three≤→≠" additional product candidates ge☆€nerated under the collaboration. In addition, Nov™£®₹artis will fund Pliant's research and σ✘development activities underσ≤ the collaboration. Pliant will be✘€ responsible for developmen≥×σ∑t of PLN-1474 through Phase 1 after which Novart¶®is will assume responsibil<®¶ity for all future development, manufacturinφ g and commercialization. Pπφ•∞liant is eligible to earn milestone paymentsα®♦δ, contingent upon the achievement of↕∑×≈ specified development, regul•£×≤atory and commercial ✔•milestones. The agreement also provides for tieα±÷red royalties payable to Pliant ranging≈♠ from the mid-single digits to low doublεe digits on product sales "®upon commercialization. The transa€₽ction is subject to customary closing conδ>"ditions, including clearance under the Hart-Sπcott-Rodino Antitrust →λ>₩Improvements Act.NASH associated cirr★∏hosis is the fastest growε >ing indication for l>₹₽∑iver transplantation in the United States. Many ε ♣patients with NASH develop assoc±∏ iated liver fibrosis, which can lead to ∏§× complications such as cirrh≥ osis and ultimately liver failure. While s'♠everal investigationa<®σ★l agents target mechanisms that impact the ear®§lier stages of the NASH continuum, Pliant is ©♦✘targeting αvβ1, an integrin that activates TG€♦F-β, a putative master regulator of hepatic fibro<÷✘≈sis. PLN-1474 has shown significant inhibi✔£αλtion of fibrosis in live human tiss<€ue models. Pliant expects to submit an investiga≠±tional new drug (IND) application to the U.©±S. Food and Drug Administration before the end↔↑ of 2019.information sour₽ ®>ce:pharma focus Asia™←The original link:htt♦✔ps://www.pharmafocusasia.com/ne€±"ws/pliant-therapeutics-announces-strate×σ✘αgic-collaboration-to-deve♠>lop-novel-therapies-for-nash-and-fibro∑" tic-diseases2019 Asi£<♥a-pacific pharma IP Leader Su✘₹®mmit: http://en.zenseegroup.com/p/510934/&nα"♠×bsp;will be held in&nbsα★p;Beijing on∞☆π November 14-15, ≥♥and will attract more than 500 indδΩustry experts from domestic and foreig"₽©¥n pharmaceutical companies♠≤, biotechnology companies, government≠ ♥s, associations, law firms, intellectua×"l property agents and other compani↓φes to attend.Official registration and co• nsultation channels:Contact：AnnPho★✘♦<ne: 021-65650305Email：Marketing@zenseegroup.co'✘mhttp://en.zenseegrou↔≈p.com/p/510934 -
1024
PDS Biotechnology Completes Manufacturing of Cli$✔ nical Batches of PDS0101
PDS Biotechnology Completes Manufacturing o" f Clinical Batches of PDS0101WEDNESDAY, OC§€$☆TOBER 23, 2019PDS Biotec₽<→←hnology Corporation, a clinica¶✘εl-stage immuno-oncology ₩>₹company pioneering development ofε∑Ω¥ multi-functional novel imm®Ω☆πunotherapies, today anno☆∑unced that it has completed manufacturing≤ε of clinical batches of PDS01₩¥01 with its partner BSP ᥩ↓Pharmaceuticals S.p.A, a leading manuf ¥≤€acturer of anticancer drugs.The clin"π÷≥ical batches of PDS0101 will be used in the Com↕∑±'pany’s two upcoming Phase 2 studies, which are ex±pected to start in the first quarter of 2020. '$The trials include a combination₽§↑ study with Merck to evaluate PDS0101 in combin÷ ←ation with KEYTRUDA® in first-line treatmen∏&♥t of head and neck caε ↑ncer and a study to evaluate PDS0101 in →₹combination with two novel clinical-stage immu€πnotherapies in advanced HPV associated cancers ☆with the National Cancer☆¶∑ Institute.“We are pleased to have complet∞×♣ed the manufacturing of the clinical ba₹ ×tches of PDS0101 with our p♣$artner BSP PharmaceutδπΩ<icals and are honored to be collabo ✘±↔rating with two leaders in the fiel↔✔↑d of immuno-oncology,” sβ<πaid Dr. Frank Bedu-Add↓↑o, CEO of PDS. “Based αε'↓on our recently announced Phase 1 clinical outco§§₩≥me data which demonst>φrated PDS0101’s unique abi&®lity to promote the in-vi$π®←vo induction of high levelsα of HPV-specific CD8+ killer T-cell ☆s as well as the regression of pre-c÷σancerous lesions in 60% of patients, we bel∞ ≥≠ieve that PDS0101 could±↕ expand the clinical effi± £cacy of checkpoint inhibitors such ₹♥♣as KEYTRUDA®. We are ↕✔±✔now working diligently to quali ≈↑γfy clinical sites for our combination trial w∑∑ith KEYTRUDA® in first line treatment of head andσα neck cancer and loo∞©k forward to initiating both our planned$λ combination trials by the first quarterσ of 2020.”information source:γ♦Ω$pharma focus AsiaThe oγ riginal link:https://www.Ω∏♦pharmafocusasia.com/news/pds-biotechnology-☆'∞completes-manufacturing-of-clinical-batches-of-p•∏ ¶ds01012019 Asia-pacific pharma IP Le™• ader Summit: http://en.zenseegroup.com/p/404♦≠716/ will be held in Beijin↔© ♣g on November 14-15, and wi£∞σ↕ll attract more than 500 induγ® stry experts from domesticφπ® and foreign pharmaceutical companies, biotechn¶™ology companies, goveγ→←≈rnments, associations, law ♦ firms, intellectual property ¶♠agents and other companies to attend.Officia₹≠l registration and consulta₩'<tion channels:Contact：AnnPhone: 021"↓-65650305Email：Marketing@zenseegroup.comhtt∑¶§p://en.zenseegroup.com/p/510934 -
1023
Moberg Pharma and DongKoo Sign A 'πλgreement for MOB-015 in the Republ ♠★δic of Korea
Moberg Pharma and Doβ×ngKoo Sign Agreement for MOB-015 in the Repuβ♣☆blic of KoreaTUESDAY, OCTO∞Ω±BER 22, 2019Moberg Pharma AB has signed a diφ ≤≈stribution agreement ₩ with DongKoo Bio & Pharma C☆ φ←o., Ltd for MOB-015 inδε the Republic of Korea. Uα€ ☆nder the agreement DongKoo is granted exclusive ←∏≥rights to market and sell MOB-015 in the Republi↑•£c of Korea. Moberg Pharma assumes producti ✔←on and supply responsibility.DongKoo will conduct>₹ε registration activities in the Republic of©→≤ Korea, and will be mar↑φ™keting, distributing and selling MOB-015 in th∑'e Republic of Korea upon completion of registra←✔≠tion."This is the fourth commerci>÷al agreement for MOB-015, this time with the >✔¶ market leader in dermatology ♠±™in Korea with excellent co♥'verage of the dermatology clinics. We look fo&€ Ωrward to work with Donλ↕£☆gKoo and making MOB-015 a$≤α→vailable in Korea, contributing to our vis ≈±ion of making MOB-015 the leading na♠✔×il fungus treatment worldwide", says Anna Ljun↓≥∏g, CEO of Moberg Pharma.According to Mα ♦oberg Pharma's market intelligence, the©÷φ Korean market for topical drug<®→s for onychomycosis amounts to $40 ©→million (rolling 12m endiπδ☆ng June 2019).information☆• source:pharma focus AsiaThe origina←≥l link:https://www.pharmaf₹ε¶σocusasia.com/news/moberg∏¶-pharma-and-dongkoo-δσ¥γsign-agreement-for-mob-015-in-th≠&e-republic-of-korea2019 Asia-pacific p★≈'±harma IP Leader Summit:§ http://en.zenseegroup.com/p/510934/ will beγ∑₩≤ held in Beijing ©≠;on November 14-15,↓γ&± and will attract more than 500 ±™industry experts from d♠≤omestic and foreign ph↕γ↕♥armaceutical companies, biotechnology com•™•panies, governments, assoφ¥♥ciations, law firms, int≤×ellectual property agents and other compaδ'nies to attend.Offic←✔✔φial registration and consultation channels↑✔±:Contact：AnnPhone: 021-65650305Emai£∏≈₽l：Marketing@zenseegroup.comhttp://e→σ n.zenseegroup.com/p/510934 -
1022
Sanofi to conduct precautiona☆δ≠πry voluntary recall of Zantac OTC in U.S. an→γd Canada
Sanofi to conduct precautionary∏€₹β voluntary recall of Zantac OTC in U₩σ .S. and CanadaSATURDAY, OCTOBER 19, 2019As <> a precautionary measure, Sanofi will conduc δt a voluntary recall of Zantac OTC (over-λ∑✔φthe-counter) in the U.S. and Canada. This"← recall is being taken due to p↑←ossible contamination w♠™ ith a nitrosamine impur±€®ity called N-nitrosodimetγ×hylamine (NDMA). The company is workin♦£g with health authorities to determine the level ≤'and extent of the re∞&₩call.On September 13, 2019, the U.±>¶<S Food and Drug Administration and Health Cana↔✘da issued public stateme≥nts alerting that some ranitidine mα≥♥edicines, including Zantac OTC, could con∑₩λtain NDMA at low levels and asked manuf→≠★acturers to conduct testing.Evaluations ©☆≥are ongoing on both drug substance (active in&gredient) and finished drug product. Due to i¥₹© nconsistencies in preliminary test results of t♦∞∑δhe active ingredient↕> used in the U.S. and Cana ≈dian products, Sanofi has made the decis&¥ion to conduct the voluntary recall in the U.S. a"δnd Canada as the investigation↕₩α continues.Active ingred® ∏ients used in Sanofi's ranitidine products↑☆¥ outside of the U.S. and Canada are sourced fro'←✘$m different suppliers. Sanofi is committed t≤←∏♣o transparency and w★¶•ill continue to communicate results wi✔¶"εth health authorities from the ongoing testing☆>β↔, and work with them to make informed deci↑'sions based on available data and evidence.Sanofi≤♥ encourages anyone using↔✔∏ Zantac OTC to speak with∞ε® their health care providers or pharmacists ±∑εif they have any additional questions.i•Ωnformation source:pharma focus AsiaThe ori↓♥ginal link:https:https:https§δ://www.pharmafocusasia.com/ne✘&₹ws/sanofi-to-conduct-prec™$autionary-voluntary-recall-of-zantac-otc-in-us-an✔™€d-canada2019 Asia-pacific € pharma IP Leader Summit: http://en&σ ←.zenseegroup.com/p/510934/ will be hel≈₩λd in Beijing on&n¥←✘bsp;November 14-15, an< ≥d will attract more than 500 industry e'←xperts from domestic and foreign pharmaceutical cΩ÷¶>ompanies, biotechnology companies, governm∑ε♣✔ents, associations, law fiε₹rms, intellectual property agents an☆ §d other companies to attend.Officγβαial registration and consulta↔✘↔♠tion channels:Contact：AnnPπ♠hone: 021-65650305Em£<ail：Marketing@zenseegroup.comhttp:/∑↑&✘/en.zenseegroup.com/p/510934 -
1018
HitGen Enters into DNA-Encoded Library Based Drug₩✔×∞ Discovery Research ¶×Collaboration with Galapagos N★✘✔V
HitGen Enters into DNA-Encoded Library Based Drφ♣×≥ug Discovery Research Collabo¶→∑ration with Galapagos NVTHσURSDAY, OCTOBER 17, 2019Hit§↕Gen Inc. today announced that it has entered in'εto a drug discovery research collaboratiσΩ✘<on with Galapagos NV to identify pote♥α¥ntial small molecule l←₩×eads against targets of interest to Galaαφ♥πpagos NV. In this co→'₩εllaboration, HitGen will a<Ω §pply its technology plat↔±≥form, based on DNA-encoded library de←≤sign, synthesis and interrogation, to disc☆↓over novel leads. Under the terms of the ag ±₹reement, HitGen will receive an undisclosed upfr&π♦ont payment and will be eligible for milestone pφδayments from Galapagos NV.“We are delight αed to enter this collaboration wiεεth Galapagos NV, a leading ®σbiotechnology company, special↓izing in the discovery and development o→>♥f small molecule medicines with novel mode÷₽s of action. We believe ↕¶←₩the collaboration reinfoλ₽♦ rces the role of HitGen’s♣÷♥ platform in the rapidl®£y developing field of DNA-encoded chemist¥∏≤ry. We will work closely with Galapaε♥γδgos NV scientists to generate ne♥♠w small-molecule lead αβcompounds for their research programs to≠Ω↓ help bring transformative medicin♦©es to patients,” said Dr. Jin Li, C÷ ¶"hairman of the Board and Chief Ex€∑ecutive Officer of Hit£'π↕Gen.“We look forward to wor¶↔&£king with HitGen and tap into their establishe∞×Ωd DEL technology platform α®∑to complement our internal screening and drug discovery technologies.” said R♦≥omain Gosmini, Director Medicinal Chemi≥↑✔stry at Galapagos.information&nbs•₩↔"p;source:pharma focus AsiaThe¶★ original link:https:β https://www.pharmafocusasia.com/news/hi÷εtgen-enters-into-dna-encoded-library-ba→₽α≥sed-drug-discovery-resear₹←ch-collaboration-with-galapago↔§₩∞s-nv2019 Asia-pacific pharma IP Le× ader Summit: http://en.zens© eegroup.com/p/510934/ will be held in&nbsλ€♦p;Beijing onΩ→ November 14-15, and will attract 'δαmore than 500 industry e α∞∑xperts from domestic and for∏π↓§eign pharmaceutical companies,∞& biotechnology compa$ π♦nies, governments, associations₹≠☆, law firms, intellecε≠γtual property agents and other compan€"ies to attend.Official registration and consultβ♠★ation channels:Contact：AnnPhone: 021-65650305Emai↕Ωλ"l：Marketing@zenseegroup.comht←☆δtp://en.zenseegroup.com/p/510934
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