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1025
Pliant Therapeutics Announces Strategic Col≠§↑laboration to Develop Novel Therapies for NAS→∞≠H and Fibrotic Diseases
Pliant Therapeutics Announce©s Strategic Collaboration to Develop Novel Thera₩↕$"pies for NASH and Fibrotic DiseasesT ≥₽HURSDAY, OCTOBER 24, 2019Pliant The∑✘§∏rapeutics, Inc., a clinical stage biopβφ&≈harmaceutical company focused>≈•≤ on discovering and developing €$novel therapies for the treatment of f™↑ibrosis, today announced it has entered in★☆βto a strategic collaboration and±"✘♥ license agreement with Novartis coveα✔ring the development and co±♣ mmercialization of Pli∞₹★ant's preclinical product candidate, PLN-147' ™4 and up to three additional int≈σ¶♣egrin targets. PLN-1474 is an internally di∏εscovered small molecule selective inhibitor of§≥∏ integrin αVβ1, currently being©γ¶ developed for the treatm∑ε ¥ent of liver fibrosis associated wit∏¥£✔h nonalcoholic steatohepatitis (NASH)."Our φ↓✘research continues to generate compellingλ€ preclinical evidence that supp £®orts the advancement≥™©♥ of PLN-1474 as a clinical candid π♠"ate and validates our approach of evaluating αVβ ♦1 integrin inhibition to treat aε₹♥dvanced liver fibrosis associated with NASπ∞π♠H," said Bernard Coulie, M.D., Ph.D., preside≤£₩©nt and chief executive office×₩r of Pliant Therapeutics. "Pairi$<αφng Pliant's leading integrin biology and dr≥>₹♦ug discovery capabilities with Novartis,γ>" a world-leader with one of the broadest pip≥¶elines investigating mono and combi±nation therapies for liver diseases iΩ≈ncluding NASH, will support our goal of developin¶®£g novel therapies for fibrotic diseaα<♥λses and potentially briπ±≤ng meaningful treatment options to patie¥↕≠nts."Pliant will initia ✘α✔lly receive $80 million from Novartis, inc ☆luding an upfront payment in co>φnnection with the collaboration agreement as •₹ well as equity investment com£δ<®mitments. The collaboration aε✘σ≤greement is for a worldwide exclusive license to ≤₽±✘PLN-1474 and up to three additionaλ♥✘λl product candidates generated under the coll£δ←αaboration. In addition,¶★€ Novartis will fund Pliant's research an♥ λ₩d development activities under the collaborati £₩₩on. Pliant will be respons₽₩↕ible for development of PLN-1474 through P∏₹✘hase 1 after which Novartis will assuγ∞₩me responsibility for ¥©≠all future development, manufacturing and co÷↕↕mmercialization. Pliant is eligib&↓±÷le to earn milestone payments, • contingent upon the achievemΩσ€ent of specified development, regulatory and com ©★"mercial milestones. The agreement also provid✘÷™es for tiered royaltiγβes payable to Pliant ranging from the mid-s&>★↔ingle digits to low double digi§±ts on product sales upon commercialization. The $ εtransaction is subject to cust≥δ≥omary closing condit£ε↑ions, including clearance under the H®•art-Scott-Rodino Antitrust Impro₩≤vements Act.NASH associated cirr±π★hosis is the fastest growing indication∞"↔ for liver transplantation in the United States.∞™ Many patients with NAS≤∞ αH develop associated liver fi ₽€brosis, which can lead to c'Ωomplications such as ππ₩ cirrhosis and ultimately liver failure. While →©♣several investigational agents taασ•rget mechanisms that ♦"impact the earlier stages of the NA÷ σ'SH continuum, Pliant is targeting αvβ1, an ₩∏integrin that activates TGF-β, a≠ putative master regulator of hepatic fγibrosis. PLN-1474 has shown signif ★×icant inhibition of fibrosi☆Ωs in live human tissue models. P©liant expects to submit an i€™nvestigational new drug (IND) app♥β←βlication to the U.S. Foo↔↓d and Drug Administration before the end of 2019."πinformation source:pharma focus AsiaThe or↔iginal link:https://www.pharmafocusasia.com/n♥<ews/pliant-therapeutics-announces-strategic-coll§♠εaboration-to-develop-nove¥<l-therapies-for-nash-and-fibrotic-≤∞δdiseases2019 Asia-pacific pharma IP Leader≠" Summit: http://en.zenseegroup.com/p/510934/&n← γπbsp;will be held in Beijing ♦₽ on Novemb<¶er 14-15, and will attract more t₩∏han 500 industry experts from domestic a♦β€→nd foreign pharmaceutical companies≥↓, biotechnology companies, governme¶£©nts, associations, law fir€₽™ms, intellectual property$☆<$ agents and other companies to attend.Officia® £l registration and consu≥"¶ltation channels:Contact：AnnPhoneγ¥↔: 021-65650305Email：Marketing@zenΩλδseegroup.comhttp://en↕'.zenseegroup.com/p/51093ε™₽4 -
1024
PDS Biotechnology Comple•εβtes Manufacturing of Clinical Batches of PDS0♠ε101
PDS Biotechnology Completes Manufactuφφring of Clinical Batches ׶≥'of PDS0101WEDNESDAY, OCTOBER ∞&✘23, 2019PDS Biotechnology Corporation, a cγ'₹≥linical-stage immuno-oncology company pioneerin• g development of multi-funct§♠∑™ional novel immunotherapies, toda≠™y announced that it has completed manufac☆∑♠±turing of clinical batches of PDS0101 wiΩΩth its partner BSP Pharmaceuticals S.p.A, a leσ' ading manufacturer of anticancer drugs.T"®he clinical batches of PDS0101 will be us♠∞γed in the Company’s ≤•×two upcoming Phase 2 studie✔•σ&s, which are expected to♣✔ start in the first quarter of 2020★₩. The trials include a combinati$✔$☆on study with Merck to evaluate PDS0101 in±& combination with KEYTRUDA® in first-line treatme♦<nt of head and neck cancer©✘↔ and a study to evaluate PDS0101 in combinat'✔↑ion with two novel clinical<∑-stage immunotherapie→÷s in advanced HPV associated cancers with §λβthe National Cancer Institute.“We are ple↕ased to have completed the manufacturing of the Ω ≥clinical batches of ☆∑PDS0101 with our partner BSP Pharmaceutical∏©λs and are honored to be colla↔←borating with two lead• ₩ers in the field of immuno-oncology±✔₽,” said Dr. Frank Bedu-Addo, CEO of PDS.α₽§ “Based on our recently announced Phase<±γ 1 clinical outcome data which demonstrated PD≠₽&S0101’s unique ability to promote the in-vivo εσαinduction of high lev®£els of HPV-specific CD8+ killer T-c™÷↕♥ells as well as the regression of pre≈✘-cancerous lesions in 60% of pa•♣§→tients, we believe th✔✔at PDS0101 could expεφ₩and the clinical efficacy of checkpoint↔>α↑ inhibitors such as KEYTRUDA>↑☆®. We are now working diligently to qγδ→ualify clinical sites for our combinat←<ion trial with KEYTRUDα↑ ↓A® in first line treatment of head and neck ¥ cancer and look forward to initiating both our '"'planned combination trials by the first quarterπ of 2020.”information&n™$bsp;source:pharma focus As≈≈iaThe original link:htt₩₽ps://www.pharmafocusasia♠ >.com/news/pds-biotechnology-completes-manufaφ"cturing-of-clinical-batches-of↔♥≠-pds01012019 Asia-pacific pharma IP Leadα£€¥er Summit: http://en.zenseegroup.com/p/404716/&∑₹₽¶nbsp;will be held in&nbs®♦p;Beijing on November 14-15, andλ≠ε will attract more than✔₩δ₽ 500 industry experts±↓ ε from domestic and f±≥<'oreign pharmaceutical companies, biotechnolo≤₹σ→gy companies, governments, associations,∞♣£γ law firms, intellectuaλβl property agents and other companieφ♥∏♠s to attend.Official registration and consulta™γ•₹tion channels:Contact：An↔×☆nPhone: 021-65650305Email：Marketin← γ"g@zenseegroup.comhttp://en.Ω✔©→zenseegroup.com/p/510934 -
1023
Moberg Pharma and DongKoo Sign Agreement for MOB-↑015 in the Republic of Korea
Moberg Pharma and Don✔&βgKoo Sign Agreement for MOB±-015 in the Republic of KoreaTUESDAY, OCTO★BER 22, 2019Moberg Pharma AB has signed a di ÷stribution agreement with DongKoo Bio & ∏ β'Pharma Co., Ltd for MOB-015 in the Republic± of Korea. Under the agrφ <eement DongKoo is granted exclusive rights♥©∏≤ to market and sell MOB-015 in theπ±®ε Republic of Korea. Moberg Pharma assumes p✔✔φπroduction and supply responsibility.DongKoo w✘™σill conduct registration activities in the ≥σ✘Republic of Korea, and will b★✘§e marketing, distributing and selling MOB-015 in™←♠€ the Republic of Korea upon completion of rπ←♦egistration."This is the fourth co€$∏mmercial agreement f§→>•or MOB-015, this time with t♥↕'he market leader in dermatology in ✘≥Korea with excellent coverage of the α ✘dermatology clinics. We£& look forward to work wit 'h DongKoo and making MOB-015 availab$✘§®le in Korea, contributing to our vi≈φ ♣sion of making MOB-015 the leading nail ₩₩ fungus treatment worldwide", say→§←₹s Anna Ljung, CEO of Mo"<berg Pharma.According to Moberg Pharma's market i™★₽≥ntelligence, the Korean market for $γtopical drugs for onychomycosis &↕amounts to $40 million (rolling 12m ending Jun☆÷₩®e 2019).information source:pharma foc®λ•↑us AsiaThe original link:https:/☆ε≤/www.pharmafocusasia.✔≈com/news/moberg-pharma" -and-dongkoo-sign-agreeme"'↔<nt-for-mob-015-in-the-republic-of-korea2019 A×β₽sia-pacific pharma IP Lea↓¶der Summit: http://en.zensee↓¥group.com/p/510934/ will be held in&n®®≥bsp;Beijing on&nλ™•bsp;November 14-15, and will attract more t✔ £han 500 industry experts from domestic a×δ€>nd foreign pharmaceutical companies, biotechnolo≈∏¥₩gy companies, governme±γnts, associations, law firms,'→ε intellectual property agents and ot↓"÷her companies to attend.Offi∞$★×cial registration and consultation channels≈ ←:Contact：AnnPhone: 021-65650305E§×λ♣mail：Marketing@zenseegroup.comhttp://en.zenseeα∞✘£group.com/p/510934 -
1022
Sanofi to conduct precau★•<®tionary voluntary recall of ↕γ♣Zantac OTC in U.S. and Cana♣$♥da
Sanofi to conduct precauti★γonary voluntary recall of Zantac OTC in U.S. an♦∏d CanadaSATURDAY, OCTOBER 19, 2019As¥☆₹∏ a precautionary measure, Sanofi™>α will conduct a voluntary rec≠§all of Zantac OTC (over-ασ↕the-counter) in the U.S. and Cana₩∑da. This recall is bei♥↓ng taken due to possi∞☆ble contamination with a nitrosamine ±☆↑impurity called N-nitrosodime≤≈thylamine (NDMA). The company÷ is working with healε∑÷th authorities to determine the le✘©vel and extent of the recall.On Septemb£×÷er 13, 2019, the U.S Fo'≈od and Drug Administration and Health Canad↕> ≤a issued public statemen$•§ts alerting that some ranitidin→e medicines, including✘≠ Zantac OTC, could contain NDMA at low levεαels and asked manufacturers to ♣&αconduct testing.Evalu ∑εations are ongoing on both drug sub£→∞>stance (active ingredient) anΩα♣d finished drug product. Due to inconsistenci↕£es in preliminary test r←€esults of the active ingredient <$used in the U.S. and Canadi ™an products, Sanofi has made the decision to λ☆conduct the voluntary recall in the U.S. anε✔βd Canada as the investigation continues.±±¶Active ingredients used in Sanofi's ranitidine ±≈products outside of the€¥ U.S. and Canada are sourced from different sup→ pliers. Sanofi is committed toβ>¥ transparency and will conti '←☆nue to communicate r÷πesults with health authorities from the✘¶✘ ongoing testing, and work <✔with them to make informed decisions based>π on available data and evidence.Sa←$nofi encourages anyone using Zantac §OTC to speak with their health care prov>↑ iders or pharmacists i'₩f they have any addi✘≤αtional questions.information ×¥;source:pharma focus Asα¶∏iaThe original link:http₹∏€s:https:https://www.pharmafocusasia.com/n÷&↔♥ews/sanofi-to-conduct-p≤↓¶λrecautionary-voluntary-recall-of-zantac-otc-in-uγ≠¶s-and-canada2019 Asia-pacifi✔✔ c pharma IP Leader Summit: http://en.zenseegrou×≈δ★p.com/p/510934/ will be held in Beij≈<δαing on ✔Ω;November 14-15, and will attract more th÷☆↕an 500 industry experts from domestic and foreigεαΩn pharmaceutical companies, biotechnolo©λ₩gy companies, governγ∑™ ments, associations, law firms, i♠↑πntellectual property agents and other c•ε↓ompanies to attend.Official "≤φregistration and consultation channels:Contact：A♣↔nnPhone: 021-65650305Email：Marketing@zenseeg δβroup.comhttp://en.zenseegroup.com/p/51Ω¥→δ0934 -
1018
HitGen Enters into DNA-Encoded Libr✔ary Based Drug Discovery Research Collaborati☆ ¥on with Galapagos NV
HitGen Enters into DNA-Encoded Library ✘•★ Based Drug Discovery Research Collabo∞↓×↕ration with Galapagos NVTHURS♠§DAY, OCTOBER 17, 2019HitGen Inc. ↕≤σtoday announced that it has entered into a $↑↑drug discovery research collaboration wi©✘αth Galapagos NV to identify potential small mo©&γ∞lecule leads against targets of interest to Gala<♠pagos NV. In this coll∞φ♣aboration, HitGen will apply its technology α™♦platform, based on DNA-encoded library design,πΩ☆£ synthesis and interrogation, to discover nove←★l leads. Under the terms of thεγπe agreement, HitGen will recei☆₩★♥ve an undisclosed upfront∏γ payment and will be eligible for milestone paym↔σ¥ents from Galapagos NV.“We are delighted t✘π •o enter this collaboration £↔with Galapagos NV, a leading biotechnolo®∑→gy company, specializing in the discovery and<→φ₽ development of small molecul&βe medicines with nov®γel modes of action. We believe t∏λ∑he collaboration reinforces the role ✔☆∏of HitGen’s platform in tφ< he rapidly developing field of DNA-enco&®¥ded chemistry. We will w"♥☆ork closely with Galapagos NV sci✘© ♣entists to generate new♣© small-molecule lead compounds for their ♥™♥research programs to help bring transformative±©∏ medicines to patients,” saiα"÷ d Dr. Jin Li, Chairman of the Board and Chief Exe☆≥cutive Officer of HitGen.“We look forward to™ε♦ working with HitGen and tap into their esta →÷blished DEL technology ☆&< platform to complement our internal screening an ♦→d drug discovery technologies.” said Romain Go•γ•smini, Director Medicδ§♥↕inal Chemistry at Galapagos.in☆★φformation source:pharma f'© ≠ocus AsiaThe original l"≠ink:https:https://www.p¶♦&harmafocusasia.com/ne★☆♠ws/hitgen-enters-intλ→×≠o-dna-encoded-library-based-drug-d∏↓&iscovery-research-colla↑₩boration-with-galapagos-₩₽ ♥nv2019 Asia-pacific pharma IP Leader Sum☆∏§mit: http://en.zenseegroup.com/p/510934/ wi±↓&ll be held in Beijing €•≠;on November 14-15, and will attract m→σ≠φore than 500 industry e♥£→xperts from domestic and foreign pharmaceutica≤≈l companies, biotechno£™Ω$logy companies, governments, associations, la≥δ¶w firms, intellectua≤l property agents and other c✔±ompanies to attend.Official registrati←¶ on and consultation channels:Contact：AnnPhone♣→ε¥: 021-65650305Email：Marketing@zenseegroup.§≈≤comhttp://en.zenseegroup.com/p/510934
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