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1025
Pliant Therapeutics Announces Strategic π♥Collaboration to Develop Novel Therapies for £ NASH and Fibrotic Diseases
Pliant Therapeutics Anno★∞unces Strategic Collabora✘≥Ωtion to Develop Novel Therapies for NASH an↑>σ≤d Fibrotic DiseasesTHURSDAY, OCTOBER 24, 2019Pli ₩ant Therapeutics, Inc., a ✔✘→εclinical stage biopharmaceutical company focused©✘↕ on discovering and φ≈¶developing novel therapies for the treatment®¶•∑ of fibrosis, today aγ"nnounced it has entered in×✔™♣to a strategic collaboration and license agreeme•nt with Novartis coveringε the development and commercialization of P↓¶≤γliant's preclinical product $¥candidate, PLN-1474 and® > up to three additionalΩ✘ββ integrin targets. PLN-1474 is an internally&∑$ discovered small mol↓ ♥ecule selective inhibitor of integr✔£in αVβ1, currently being develo✘≤♦λped for the treatmen®δλφt of liver fibrosis associated with nonal'÷¥₩coholic steatohepatit♣§↑is (NASH)."Our research continues to ↕★generate compelling preclinical evid₹←ence that supports the a✘↓dvancement of PLN-1474 as€★☆α a clinical candidate anλ÷d validates our approach of ev∏ε↑aluating αVβ1 integrin £₩inhibition to treat advanced liver fibrosis associated w÷∏γ¶ith NASH," said Bernard Coulie, M.D., Pσ✔h.D., president and chief executive ≈™officer of Pliant Therapeutics. "Pairing Pli←₹σδant's leading integrin biology♥$γ and drug discovery capabilities w✔≠₩☆ith Novartis, a world-leader with one ←>of the broadest pipelines iπ®™nvestigating mono and combination therapies f©β or liver diseases including NASH, will <∑←support our goal of developing novel th≠∞♣£erapies for fibrotic diseases and p♦↕otentially bring meaningful treatment o€★♠☆ptions to patients."Pliant will initially receiv'∑ πe $80 million from Novartis,★π₽ including an upfront φ♣payment in connection with thδ<§≈e collaboration agreement as well as eqγπ₽uity investment commitments. The c ollaboration agreement is for a worldwide e↔γxclusive license to PLN-1474 and up to three add£φ↑πitional product candidates generated un♣ der the collaboration. InΩα±× addition, Novartis willε÷₩ fund Pliant's research and development activ&Ω λities under the collaboration. Pliant ≠εwill be responsible for developm<$ent of PLN-1474 through Phase 1 aft₩¥φ≠er which Novartis will assume responsibil®★∑ity for all future development, manufacturiγ>Ω≥ng and commercialization. ∞§×Pliant is eligible to earn milestone payment∏Ω≥γs, contingent upon the achievement of spec÷δ↕ified development, regu ≤±→latory and commercial milestones. The agree¥σ®ment also provides for tiered ro✔•yalties payable to Pliant ranging from →the mid-single digits to low doub©'le digits on product sales upon commer♥♣♥βcialization. The transaction is subject σ©∑to customary closing conditions, including c€®∏αlearance under the Hart-Scott-Rodino Antitrust→β≈¶ Improvements Act.NASH associated cirrhosi∑™ s is the fastest growing in ♠dication for liver transplantation in the Un✘↔ited States. Many patients with NASH de↕→§↓velop associated liver fibrosis, ≥>₹which can lead to complicati↑☆ons such as cirrhosis and ultimately ÷¥™liver failure. While several investiga₽tional agents target mechanisms that i ↕✘mpact the earlier stages of the NASH c→××♠ontinuum, Pliant is targeting αvβ1, an integri•÷n that activates TGF-σ β, a putative master regulator of hepaσ©tic fibrosis. PLN-1474 has shown sign↑∏ificant inhibition of fibrosisε"₽≤ in live human tissue models↕×. Pliant expects to submit an investigation★>εal new drug (IND) application to the U.S. Fooα>£•d and Drug Administration before the end of 2019.'λinformation source:pharma focus AsiaThe orig ε₹→inal link:https://www.pharmafocusa>↑sia.com/news/pliant-therapeutics-announces-₹≥¥♠strategic-collaboration-→£$to-develop-novel-therapies-for-nash-♥₽★and-fibrotic-diseases2019₩£ Asia-pacific pharma IP Leader Summi₽σ>t: http://en.zenseegroup.coφm/p/510934/ will be h₽♥•eld in Beijing ±< ↔; on November 14-15, and will attr↕§σact more than 500 industry experts from domeβ$♥↑stic and foreign pharmaceut♥©ical companies, biotech✘☆≠nology companies, governments, associations¶×™×, law firms, intellectual property agents aγ≠nd other companies to attend.Official regist¶✔✔ration and consultation channels:Contact：AnnP↔ ±¥hone: 021-65650305Email §α：Marketing@zenseegroup.co"¶mhttp://en.zenseegroup.com/p/510934 -
1024
PDS Biotechnology Completes Manufacturing of C &₹linical Batches of P♥σ§DS0101
PDS Biotechnology Completes Man £ufacturing of Clinical Batches of PDS0101WEDN≠§↓♥ESDAY, OCTOBER 23, 2019PDS Biotechnology Corpor♦γation, a clinical-stage immuno-oncolo↔$gy company pioneering development>←≈↓ of multi-functional novel immunotherapies, t≈§¶oday announced that it"$©♣ has completed manufacturing of clinicalΩ→ batches of PDS0101 with its partner Ω€BSP Pharmaceuticals ↑₽S.p.A, a leading manufacturer of anticancer dru≤φgs.The clinical batches of PDS0101 will be used i±"↑n the Company’s two upcoming Phase 2 studies,φ" which are expected to start in the firσσ st quarter of 2020. The trials include a combin≈♥♦ation study with Mer↓✔γck to evaluate PDS0101 in÷↑ combination with KEYTRUD∏φA® in first-line treatment of head and ♥₩neck cancer and a study to evaluate PDS0101 in€σ combination with two n∑☆ovel clinical-stage immunotherapies in ad≤λvanced HPV associated c☆♠ancers with the National Canc₽¥λer Institute.“We are pleased to have com£₩∑↓pleted the manufactur↔•ing of the clinical batches of PDS010≥≥1 with our partner BSP Pharmaceut¶☆±icals and are honored &§δ↕to be collaborating with two leader©↓≤¶s in the field of immuno-oncology,” said Dr. → §Frank Bedu-Addo, CEO of PDS. “Based on our recent≥£≥ly announced Phase 1 clinical outcome data whi✔♠ch demonstrated PDS0101’s unique ab↔÷ility to promote the in-♥φvivo induction of high levels of HPV-spe←β>↔cific CD8+ killer T-cells as well as the regress§<γion of pre-cancerous lesions in 60% of¥$↔γ patients, we believe that PDS0∞'101 could expand the clinical efficacy of checkpπ§oint inhibitors such as KEYTRUDA®. We are now wo↑£rking diligently to qualify cliΩ£λnical sites for our combination tr£β≠ial with KEYTRUDA® in first line treatme÷☆Ωnt of head and neck cancer↔€§→ and look forward to initiating ★βboth our planned combination trials by the≠π∑© first quarter of 2020.”informa>εtion source:pharma focus Asi™Ω★aThe original link:https://ww★₹w.pharmafocusasia.com/news/pds-biotechnology-comp<₽←letes-manufacturing-of-clin♥≠ical-batches-of-pds01012019 Asia-pacific p₹♠↓<harma IP Leader Summit: http://en.zenseegr∑§₹$oup.com/p/404716/ will§₩€ be held in Beijing on÷ $ November 14-15, and will ≥γattract more than 500 in" $σdustry experts from domestic anπ"♠d foreign pharmaceutical companies, bi®♦otechnology companies, governments, associ≤'γ•ations, law firms, intellectual property agent→s and other companies to attend.Official r ±∑egistration and consul★✔&tation channels:Contact：AnnPhone: 021-6565030φ∑★5Email：Marketing@zenseegroup.co€€mhttp://en.zenseegroup.com/p/51×£0934 -
1023
Moberg Pharma and DongKoo Sign Agreement fo&♥Ωr MOB-015 in the Repu↕'✘←blic of Korea
Moberg Pharma and DongKoo S≤β ®ign Agreement for MOB-01>♠•5 in the Republic of KoreaTUES≥↕DAY, OCTOBER 22, 2019Moberg Pharma AB has sign§&ed a distribution agreement with DongKoo Bio &$♥amp; Pharma Co., Ltd for MOB-015 in the Republ§σקic of Korea. Under the agreement DλongKoo is granted excl✘ usive rights to market and ÷sell MOB-015 in the Republic of Korea. Mober↔☆g Pharma assumes production a""λnd supply responsibility.DongKoo will cond♥ ↔uct registration activities in the R€♣€☆epublic of Korea, and will be marketing, distr¶∞εibuting and selling MOB-015 in th♦€e Republic of Korea up★↕∏≠on completion of registration."This is th♥σe fourth commercial agreement for'α MOB-015, this time with ★αthe market leader in dermatolo✔εgy in Korea with excellent £®™coverage of the dermatol>'γαogy clinics. We look forward to work with Don←•φgKoo and making MOB-015 available in §✔∞Korea, contributing to our vision of making ✘¥×≥MOB-015 the leading nail fungus treatmΩ ←ent worldwide", says Ann&®∏a Ljung, CEO of Moberg ♠₽$¥Pharma.According to Moberg Pharma's market intell≤<igence, the Korean market for topic✘≤§al drugs for onychomycosis amounts to $40 millδ→ εion (rolling 12m ending June 2019).inform±±✔ation source:pharma focus Asi∞ΩaThe original link:https://www.pharma ≠focusasia.com/news/moberg-pharma-and÷ -dongkoo-sign-agreement-for-mob-01÷φ± 5-in-the-republic-of-k♥αorea2019 Asia-pacific pharma IP Lβ eader Summit: http://en.zenseegrou€™←p.com/p/510934/ will be held in Beijing÷≤•♥ on Novem×₩♦ber 14-15, and will attract more than 500 indust≠Ωry experts from domestic and foreign pharm©€aceutical companies, biotechnology companies, g뙥overnments, associations, law firms, §₽←≠intellectual property agents a nd other companies to attend.Official registra≥↑tion and consultation channels:Contact：AnnPhonβ≤πe: 021-65650305Email：Market↓→₩Ωing@zenseegroup.comhttp://en.zensee∏∑βgroup.com/p/510934 -
1022
Sanofi to conduct precautionar₹∑€y voluntary recall of Zantac OTC in U.S. and Can←ada
Sanofi to conduct pre∞↕cautionary voluntary recall of Z'≈antac OTC in U.S. and CanadaSATURDAY, OCTOBER ☆δ19, 2019As a precautionary measure, σδSanofi will conduct a voluntary r★ ecall of Zantac OTC (over≠$§•-the-counter) in the U.S. and Canada. This re↔>call is being taken due φ♠to possible contamination with a nitrosamine imp ↑urity called N-nitrosod¶♥imethylamine (NDMA). The company is working with≈& health authorities to dete₩Ωrmine the level and exΩλ₹tent of the recall.On September 13, 2019, the U.<♠©↑S Food and Drug Administration and Health C✔©₽βanada issued public stat∏ ✘λements alerting that λsome ranitidine medicines, inc™♠γαluding Zantac OTC, could contain NDMA at low←≠"∑ levels and asked ma αnufacturers to condu£©ct testing.Evaluatio'ns are ongoing on both drug↑•εσ substance (active ingredient) and finish¶∑ed drug product. Due to in¶✘©✘consistencies in preliminary test results of th♠↔∏e active ingredient used in the U.S. and Cana& εdian products, Sanofi has made the ♠α€βdecision to conduct the voluntary recall in ≠✘•πthe U.S. and Canada as the investigation con$₽✔tinues.Active ingredients used in Sanofi✘Ω↑'s ranitidine products outside ≥§of the U.S. and Canada are sourced from₽÷↑ different suppliers. Sanofi is committed to tran$< ×sparency and will continue♦₽ to communicate results wi®↔¥th health authorities fro↔<$★m the ongoing testing, and work with them to ∑≤πmake informed decisions based on avai£'lable data and evidence.Sanofi eσφ¥ncourages anyone using Zanta₽±c OTC to speak with their health c∑ "↔are providers or pharmΩ€±acists if they have any additional questions↔©×.information source:pharma focus ♠±☆AsiaThe original link:https:https:https://w€λ¶ww.pharmafocusasia.com/news/sanofi-to-conduc"♦∑ t-precautionary-voluntary-recall-of-¥↑£zantac-otc-in-us-and-canada2019 Asia-pacific ph♠β✘arma IP Leader Summi→♠¶t: http://en.zenseegroup.com/p/510934/&nbs↕≤≠&p;will be held in Beijing →★ on November 14-15λ>★, and will attract more thaΩ∑>n 500 industry experts fromσ ε≠ domestic and foreign pharmaceutic★★al companies, biotechnology companies, g ™overnments, associatio£≠ns, law firms, intelle&ctual property agents and other companies©₩↓✘ to attend.Official registration and consult↕λ>ation channels:Contact：AnnPhone: 021-65650305E&"×δmail：Marketing@zenseegroup.comhttp://en.zenseegro€ βup.com/p/510934 -
1018
HitGen Enters into DNA-Encoded Library Ω✔ΩεBased Drug Discovery Research ♣&Collaboration with Gal£σapagos NV
HitGen Enters into DNA-Encoded L ✘ibrary Based Drug Discov '♦ery Research Collaboration with Galapagos NVTHU®↕↕©RSDAY, OCTOBER 17, 2&™♦019HitGen Inc. today announced that it has enterεφ<↕ed into a drug discovery research collaborati&♣$₩on with Galapagos NV to ☆♣≤$identify potential small molecule leads against ±✘✔♥targets of interest to ↔¥ΩGalapagos NV. In thi™ σs collaboration, HitGen will apply its ≠₹✔technology platform, based on DNA'<-encoded library design, synthesis an♠δεd interrogation, to disc " over novel leads. Under the terms of 'λthe agreement, HitGen will receive an und&≈'isclosed upfront payment and will be eligible for•¶€ milestone payments from Gal÷§×apagos NV.“We are delighted to ent™σφer this collaboration with Galaβ☆∏βpagos NV, a leading biotechnology c'<ompany, specializing in the discovery ↕↔≈and development of small molecule '↓₩ medicines with novel mod÷$↕es of action. We believe the c∏γ± ollaboration reinforces the★↑' role of HitGen’s platform in the rapidly devel÷♦®oping field of DNA-encod↕'ed chemistry. We will work closely with Gal♠<≠apagos NV scientists to generate new small-mole ♥→™cule lead compounds for their res>•earch programs to help bring transformaσ£tive medicines to patienδ✔ts,” said Dr. Jin Li, Chairman Ω←of the Board and Chief Executive Office<≥r of HitGen.“We look forward to working wit★✔h HitGen and tap into their established DEL≤≈ technology platform ≤→to complement our internal screening an€d drug discovery technologies.” said R $☆≈omain Gosmini, Director Medicinal Chemist↓₽ry at Galapagos.infor≥↕mation source:pharma focus AsiaT↕>™he original link:https:https♠<$✔://www.pharmafocusasia.÷¥δ₽com/news/hitgen-enters-into-dna-enc€↔oded-library-based-drug-d÷$iscovery-research-collaboration-β★with-galapagos-nv2019 Asia-pacific pharma IP £≈δLeader Summit: http://en.zenseegroup.com♠← &/p/510934/ will be held in&nbσ♠×πsp;Beijing on November γ✘14-15, and will attract more than 500 industry exφ &perts from domestic and foreign βpharmaceutical companies, biotechnology c™>ompanies, governments, as≤←©εsociations, law firms, intellectσ€φual property agents €&≈and other companies to attend.Official reg♦&φ★istration and consultation channelsγ:Contact：AnnPhone: 021-65650305Email：M✔÷✔¥arketing@zenseegroup.comhttp://en.zens©♠ eegroup.com/p/510934
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