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1025
Pliant Therapeutics Announc ←↔es Strategic Collaborati®∏•♣on to Develop Novel Therapies for NAS®¶∏×H and Fibrotic Disease₹ <≥s
Pliant Therapeutics Announces Strat¶↑$φegic Collaboration to Develop Novel Therapies f↔★or NASH and Fibrotic •DiseasesTHURSDAY, OCTOBER 24, 2019Pliant Ther×α₹apeutics, Inc., a clinical ↑↓∞stage biopharmaceutical company focused on di✘♥scovering and developing novel therapies for the™ ★ treatment of fibrosis, today announced iσ♦t has entered into a γπ★strategic collaboration and license agreement ♠with Novartis covering the d←☆evelopment and commercialization of♥✔ Pliant's preclinical prodε ♣uct candidate, PLN-1474 and up to three additionεal integrin targets. PLN-1474 is an internal∏'ly discovered small ₩☆↓molecule selective inhibitor of integrin αVβ1, cuβε≈☆rrently being developed for the treatment ofβ¥÷ liver fibrosis associated with nonalc→γ oholic steatohepatitis (NASH)."Our res←λearch continues to generate c↓® ompelling preclinical evidence that su ≥pports the advancement of PLN-1474 as §± a clinical candidate a£€ Ωnd validates our approach of evaluating αVβ β1 integrin inhibition to treat advanced liver±>®$ fibrosis associated with NASH," said Bernard™'↔ Coulie, M.D., Ph.D., preside₽≤nt and chief executive o>←$≤fficer of Pliant Thera ×peutics. "Pairing Pliant's ©δΩleading integrin biology and drug discovery capab✘Ω£λilities with Novartis, a™↑ world-leader with oneεφ of the broadest pipelines investig★αating mono and combination therapies for©↑₩¥ liver diseases including NASH, will suppoπ↓rt our goal of develop∑₹ ing novel therapies for fibrotic disease₽s and potentially bri&≈ε÷ng meaningful treatment options to patie<₩₩nts."Pliant will initially receive $80 million ≥₩from Novartis, includ✔¥≈≤ing an upfront payment in connection w¥ε ith the collaboration agreement as well aαΩs equity investment co®♣Ωmmitments. The collaboration agreement is for a w£€•γorldwide exclusive license to PLN-1474 and up tΩ₽γ"o three additional product candidates generate€ d under the collaboration. In addition, Nova☆δ₽ rtis will fund Pliant's research and dev∏γ←αelopment activities underΩσ the collaboration. P₽£↑∞liant will be responsibl∏★↔♠e for development ofφ✘ PLN-1474 through Phase 1 after∏• which Novartis will assuε&→me responsibility for all future developme™ ≥nt, manufacturing and commercializat☆& ion. Pliant is eligible to earn milestone ←π¶payments, contingent upon≥γβ the achievement of specified devβ¥∑>elopment, regulatory and comΩ ↑mercial milestones. The agreemπβent also provides for tiered royalties £®₹payable to Pliant rangi↑™ng from the mid-single digits t♦εo low double digits ☆ on product sales upon commer≥₩✔cialization. The transaction is subject to custom¶ary closing conditions, including clearance under→← the Hart-Scott-Rodino Antitrust ≤λImprovements Act.NASH as¥←€sociated cirrhosis is the fa♠∞>stest growing indication for liverφ₩ transplantation in th≤ e United States. Many patie₩←®nts with NASH develop associated liver fibro↓♦ε₽sis, which can lead to complications≈ λφ such as cirrhosis and ultimately liver failure♣. While several investigational agents targe±÷λ↓t mechanisms that impact the γ∞≠♠earlier stages of the NASH continuum, Pliant iδs targeting αvβ1, an integrin that activatesε₹ TGF-β, a putative master regulator of•§≈ hepatic fibrosis. PLN-1474 has shown signi←≈ficant inhibition of fibrosis in livπ∑e human tissue models. Pliant expects to submit∏♣§ an investigational new drug ↑♥(IND) application to the U.☆←S. Food and Drug Administration before the e♣>nd of 2019.informati≤∑↓ on source:pharma focus AsiaThe origin♣♦al link:https://www.pharmafocusasia.••₩↕com/news/pliant-therapeutics-anφ↕λ↔nounces-strategic-collaboration-to-develop-novelδ↑¥-therapies-for-nash-and-fibrotic-diseases2019 As★♦ia-pacific pharma IP Leader Summit: http://en.z÷≥≠enseegroup.com/p/510934/&nbs φ↔p;will be held in Be↑★ijing on November 14-15, andσ will attract more than 50£¥0 industry experts from domestic and foreiσ&φπgn pharmaceutical comp&→anies, biotechnology c↑☆₩₹ompanies, governments, associations, lawΩ®≠ firms, intellectual property agents aφφ®nd other companies to attend.Official registratio§≥£ n and consultation channe₹¶₩ls:Contact：AnnPhone:§€& 021-65650305Email：Marketing@zenseegroup.com×★http://en.zenseegroup.com/p/510934 -
1024
PDS Biotechnology Completes Manufacturing o§✔™f Clinical Batches of PDS0101
PDS Biotechnology Completes Manufacturing of Clin∑αical Batches of PDS010Ω©α1WEDNESDAY, OCTOBER 23, 2019PDS Bio•< technology Corporation, a clinicσ≤al-stage immuno-oncology compa♥&ny pioneering development of multi-functio §Ω&nal novel immunotherapies, today announced "$→×that it has completed manσ€ufacturing of clinical batches of P≠☆®∏DS0101 with its partner BSP Pharmaceuticals S.p.Aπ→β∑, a leading manufacturer of anticance≥Ω♣r drugs.The clinical batches of PDS0101 will be uδ≈♠sed in the Company’s two upcoming P$δ×™hase 2 studies, which are expected t>$£o start in the first quarter of 202∞π0. The trials include¶σ÷¥ a combination study with £Merck to evaluate PDS0101 in comδ≠ αbination with KEYTRUDA∞↑←® in first-line treatment of h✔•ead and neck cancer and a ₩ ©study to evaluate PDS0101 in combinati>☆' on with two novel clinical-stage immunotherapie←s in advanced HPV associated cancers₹< with the National Cancer Inst®φ→itute.“We are pleased to have completed ¶±the manufacturing of the clinical b♣atches of PDS0101 with ★♦our partner BSP Pharmaceuticals and are honoα∑™×red to be collaborating ♣♥®≠with two leaders in the field of immuno-oncology,≤₹” said Dr. Frank Bedu-Aε★₽¶ddo, CEO of PDS. “Based on our recently ≠∞ ♥announced Phase 1 clinical outcome data wh↑↑™ich demonstrated PDS01∞'01’s unique ability to promote the i¶§✔≈n-vivo induction of high leve♣∞ls of HPV-specific CD8+ killer T-cells as well ✘&☆as the regression of pr✔↓e-cancerous lesions in '∑ •60% of patients, we b¥÷£elieve that PDS0101 could expand the clinical ♣∑<efficacy of checkpoint inhibitors such∞↓£σ as KEYTRUDA®. We are now working d≥iligently to qualify clinical sites for our cβ≤>ombination trial with KEYT±÷RUDA® in first line trea♣σ<♥tment of head and neck cancer and loo↔"≠k forward to initiating both our plan✘≤$ned combination trials by theδ♦∞∑ first quarter of 2020.”information source:•&↑pharma focus AsiaThe original link:https://www.p↓harmafocusasia.com/news/pds-biotech©✔nology-completes-manufacturing-of-clinicβ↑₹ al-batches-of-pds01012019 Asia-pacific pharma IP " Leader Summit: http♦β★∏://en.zenseegroup.com/p/404716/ wil★∏l be held in Beijing on Nov↑<ember 14-15, and will attract &δmore than 500 industry experts from domestic and£<σ foreign pharmaceutical companies, ££δbiotechnology companies, governments, γ←associations, law firms, intellectual propertyπ♣←γ agents and other companies to attend.Offε•βicial registration and consultation←> channels:Contact：AnnPhone: 021-656503€≠®γ05Email：Marketing@zenseegroup.comhttp:/• € /en.zenseegroup.com/p/510934 -
1023
Moberg Pharma and DongKoo Signαγ Agreement for MOB-01↔↓5 in the Republic ofε• Korea
Moberg Pharma and DongK≈δoo Sign Agreement for MOB-015♠★ in the Republic of KoreaTU¶€&ESDAY, OCTOBER 22, 2019Moberg Pharma AB has₽≠≥ signed a distribution agre☆≈π¥ement with DongKoo Bio & Pharma ♣<>Co., Ltd for MOB-015 in the Repub♥≠lic of Korea. Under t•σhe agreement DongKoo is granted ex₹£÷♣clusive rights to market aβ≤✔nd sell MOB-015 in the Repu≥∞≈blic of Korea. Moberg Pharma assumes product ¶ ion and supply responsibility.DongKoo will c★Ωonduct registration activities in the Republ Ω♣ic of Korea, and will be marketing, distr∏&ibuting and selling MOB-015 in the R≤÷≥∏epublic of Korea upon completion of regist♦'ε•ration."This is the fourth commercial agreement÷• for MOB-015, this time with the m↓¶ arket leader in dermatology in Ko§β₩rea with excellent coverage of the dermatolog§<y clinics. We look forward to work →λ¥'with DongKoo and making MOB-015 availa€σ®ble in Korea, contributi★<β↔ng to our vision of making MOB-015 the le♠ading nail fungus treatment worldwide", sα"Ωays Anna Ljung, CEO of Moberg P£♦±♠harma.According to Moberg Pharma's market ₹÷Ω₹intelligence, the Korean market for topical dr€ ♣ugs for onychomycosis amounts $☆to $40 million (rolling 12m↔ Ω✘ ending June 2019).information source:π←☆pharma focus AsiaThe original link:https:/↕ε>/www.pharmafocusasia.com/news/¶₹λmoberg-pharma-and-dongkoo-sign-agree✔σment-for-mob-015-in-the-republic-of-korea2019↕ε>→ Asia-pacific pharma IP Leader Summit: htt§¶αλp://en.zenseegroup.com/p/510934/ ♦∞;will be held in Beijing &n☆↓₩βbsp;on November 14-15, and will ←♣attract more than 500 industry experts from dom™α¶λestic and foreign pharmaceutical companies, bi<Ωotechnology companies, governments, ass∑$ociations, law firms, intellectual property agent≥→€s and other companies to attend.Offi™₩ ♣cial registration and consultation chann↓±§¥els:Contact：AnnPhone: 021-6565030©↕5Email：Marketing@zenseegroup.comhttp://en.ze±♦★✘nseegroup.com/p/510934 -
1022
Sanofi to conduct precautionary voluntary reca→↓ll of Zantac OTC in U.S. and Canada
Sanofi to conduct precaut✔>™λionary voluntary recall of Zantac OTδ÷Ω C in U.S. and CanadaSATURDAY, OCTOBER ≈ Ω÷19, 2019As a precautionary measure, Saδ©nofi will conduct a voluntary recall o↓®f Zantac OTC (over-the-coun₽₹$ter) in the U.S. and Canada. This recall is being♥₹∏ taken due to possible ✘ ★↕contamination with a nitrosamine im↑♠purity called N-nitroso↕ασdimethylamine (NDMA)''¥. The company is working with heaΩ↕lth authorities to determine the lev'≥el and extent of the®←β≤ recall.On September 13, 2019, the U.S FoΩ₽'₹od and Drug Administ♥→↓ration and Health Canada issued public st$≥≤atements alerting that some ranitidine medicin§γes, including Zantac OT♣¥C, could contain NDMA at low l≤₹♠evels and asked manufactur'♥$ers to conduct testing.Evalu ↔ations are ongoing on≈β↔ both drug substance (active ingredient) and f≤ γinished drug product. Due to incon'÷sistencies in preliminary test results of the act≤♦≈ive ingredient used i✔↑₩n the U.S. and Canadian products, Sanofi ha∑γs made the decision to cond&uct the voluntary recall i'¥←≈n the U.S. and Canada as theβ☆ investigation continues.Active ingredi¶×→ents used in Sanofi's ranitidine products outsideε≥β→ of the U.S. and Canada are sourced frδ®om different suppliers. Sanofi is committed to t€✘ransparency and will cont σ₹inue to communicate results with health&α"€ authorities from the ongoing testing, an♥♣←d work with them to make informed decisε$≠ions based on available data and evi¶✘←dence.Sanofi encourages anyone usinα™φg Zantac OTC to speak with their health☆ care providers or pharmacists € if they have any additφ↔☆ional questions.information sourc§€☆£e:pharma focus AsiaThe ☆ ↑ original link:https:htt>÷ps:https://www.pharmafocusasia.com/news/sanofi-to≈'×>-conduct-precautionary-voluntary-recall-o≠βf-zantac-otc-in-us-and-canada2019≈↑ Asia-pacific pharma IP Leader Summit: http:// en.zenseegroup.com/p/510934/ will be hel λδd in Beijing on Nove•↕→mber 14-15, and will attγract more than 500 industry experts from domeφγstic and foreign pharmaceutical companies, •β×'biotechnology companies, governm↕λ±ents, associations, law firms, intelle✘✘ ctual property agents and other companies to at ¶tend.Official registration and consultation£© channels:Contact：AnnPh♥§€one: 021-65650305Email：Ma¶≥₩©rketing@zenseegroup.com¶£™&http://en.zenseegroup.com/p/510934 -
1018
HitGen Enters into DNA-Encoded Library Based D§≤rug Discovery Research'↓∑♦ Collaboration with Galapagos NV
HitGen Enters into DNA-Encoded Library Based Dr£♥♥ug Discovery Research Collaboration wit× πh Galapagos NVTHURSDAY, OCTOBER 17, 2≈§©019HitGen Inc. todayσ> announced that it has entered into a drug ≤ discovery research collaboration with Galapag÷'os NV to identify potential smal§∏l molecule leads against targets of •δ∞ interest to Galapagos NV. In th÷±≈is collaboration, HitGen wil★↓l apply its technology platform★&σ≥, based on DNA-encoded lib₩'¶®rary design, synthesis and interrogation÷<, to discover novel lea&π∞♣ds. Under the terms of the ag✔±∏reement, HitGen will receive &&an undisclosed upfront payment and will be elig↓©©≤ible for milestone paym"¥ents from Galapagos N↕₩'βV.“We are delighted to enter₩₹← this collaboration wit₽↓h Galapagos NV, a leading biotech₩♠nology company, specializing in the discovery ₹' •and development of s₹≤mall molecule medici♣×≤nes with novel modes of a"παction. We believe the collaboα→ration reinforces the role of Hφ≥↕itGen’s platform in the rapidly ♦☆developing field of DNA ₩←-encoded chemistry. We wα¶←✔ill work closely with Galapagos¥↓ NV scientists to generate new small-&₩molecule lead compounds for t↑∑®δheir research programs to help bring tra€≠₽nsformative medicines to patients,” said Dr. Jin&±φ Li, Chairman of the Board and Chief Executive Ofε"ficer of HitGen.“We look forward to working wi&§βφth HitGen and tap into thei r established DEL technology platform to complem±↓↔ent our internal screening✘™↓ and drug discovery technologies.” said Romain ∏ δGosmini, Director Medicinal Chemistry a£σ≈t Galapagos.information source:pha÷♣rma focus AsiaThe original link:htt↕≠Ωps:https://www.pharmafocusas∞£™ia.com/news/hitgen-enters-into-dna-e≥π¥ ncoded-library-based-drug-disc¶®overy-research-collabora€π₩tion-with-galapagos-n✘€εv2019 Asia-pacific pharma IP Leader ♦÷¶Summit: http://en.zenseegro♦>Ωup.com/p/510934/ wi¶×↓ll be held in Beijing on&nb←&sp;November 14-15, and will attract m∞§ore than 500 industry experts §©✘©from domestic and foreign pharmaceutical co→ ∏∏mpanies, biotechnology companies, governments, "↓©↕associations, law firms, intel$♥lectual property agents and other companies✔§ to attend.Official registration and cσ✔β↑onsultation channels:Contact：AnnPhone: 021-656503↑↔<05Email：Marketing@zenseeg★&roup.comhttp://en.zenseegroup.com/p∑✔/510934
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